Of the Federal Trade Commission Act

Text (OCR of the scan at left; may contain errors)

PFIZER INC.

OER, OPINION, ETC., IN REGARD ‘TO THE ALLEGED VIOLATION OF SECTION 5 OF THE FEDERAL TRADE COMMISSION ACT Docket 8819. Complaint, July 6, 1970—Decision, July 11, 1972. , Order affirming the hearing examiner’s initial decision dismissing the complaint against a New York City manufacturer of a nonprescription product recom- ‘mended for use on minor burns and sunburn.” Opinion of the Commission resolves the general issue that the failure to possess a ~ “yeasonable basis for affirmative product éclaims constitutes an unfair practice in violation of the Federal Trade Commission Act. Comenatyt Pursuant: to the provisions of the Federal Trade Commission Act, and by ‘virtue of the authority vested in it by said Act, the Federal Trade Commission, having reason to believe that Pfizer Inc., a corporation, hereinafter referred to as respondent, has violated the provisions of said Act, and it appearing to the Commission that a proceeding by, it in respect. thereof would be in the. public interest, hereby issues its complaint stating its. charges in that respect as follows: Paracrary 1. Respondent Pfizer. Inc., is a ‘corporation organized, existing and. doing business under and by virtue of the laws of the State of Delaware with its principal office and place of business located 24 FEDERAL TRADE:.COMMISSION DECISIONS Complaint 81 F.T-C.

at 235 East 42nd Street, in the city-ef New York, State of New York. Par. 2. Respondent is now, and for some time. past: has-been engaged in the manufacturing, advertising, offering for sale; sale and distribution of a preparation for. sunburn: treatment: called “Un-Burn”iand other. proprietary. drugs and products to retailers for’ resale. to. the public. _ a: wy. ene Par. 3. In the | course and conduct of its business as s aforesaid, respondent now, causes, and for some time past: has caused, its:said: prod: ucts, when. sold, :to.:be shipped. from: its. plants’ and facilities to purchasers. thereof, Jocated:in various. states. other-than the state.of origination, and maintains, and at. all times mentioned herein:‘has maintained,a substantial course of trade in said products:in commerce, as “commerce” is’ defined: in the: Federal ‘Trade-Commission: Act. - _Par.:4, In the course: and: conduct ‘of its business.as aforesaid,-respondent has made‘ and. continues:to: make in: print: advertisements, including product packages and labels, and other promotional material and in television and radio broadcasts transmitted by television and radio stations located in various States of the United States and in the District of Columbia having sufficient power to carry such broadcasts across the state lines, numerous statements and representations respecting the pain relieving properties of said product when used by persons suffering from sunburn.

Typical and illustrative of said statements and representations, but not all inclusive thereof, are the following : In radio and television broadcasts:

1. New Un-Burn actually anesthetizes nerves in sensitive sunburned skin. 2. Un-Burn relieves pain fast. Actually anesthetizes nerves in sensitive sunburned skin. ;

3. Sensitive skin * * * Sunburned skin is sensitive skin. Sensitive sunburned skin needs * * * UN-BURN. New UN-BURN contains the same local anesthetic doctors often use. * * * Actually anesthetizes nerves in sensitive sunburned skin. PH tell you what I like about UN-BURN. It’s the best friend a blonde ever had! * * * I’m a blonde * * * and I know what it means to have sensitive skin. Why, I’m half afraid of moon burn! That’s why I’m mad about UN. -BURN. It stops sunburn pain in * * * less time than it takes me to slip out of my bikini. That’s. & awfully nice to know when yow’re the sensitive type. * * * On labels: “UN-BURN” comprehensive treatment for “sunburn” * * * relieves pain * * * anesthetic. * * * Par. 5. By making the above- quoted statements, and others similar thereto, but not expr ressly set forth herein, respondent represents, and has represented, directly or by implication, that each of the statements respecting the pain relieving properties of the said product has been substantiated by respondent by adequate and well-controlled scientific studies or tests prior to the making of such statements. PFIZER, INC) 0 7 * 25 23. Initial’ Decision Par. 6. In truth and in fact, the aforesaid statements respecting the said product, “Un-Burn,” have not been substantiated by. respondent by adequate and well-controlled scientific studies or tests Prior to the making of such statements.

Therefore, the representation as set forth in Parigaph Five her eof was and is false, misleading and deceptive. Par. 7. The making of any statement or representation, directly or by implication, that Un-Burn will-actually anesthetize nerves in sensitive sunburned skin, or any other statement or representation regarding the performance or effectiveness of such product, when such statement or representation is not supported by prior, fully, documented, , adequate and well-controlled scientific studies or ‘tests is in 1 itself an unfair practice. vy :

Par. 8. Respondent at all timés méritioned havin’ has been and now is in substantial competition in commerce with individuals, firms and corporations engaged in the sale and distribution of sunburn remedies of the same general kind and nature as that sold by respondent. Par. 9. The use by respondent of the aforesaid misleading and deceptive statements, representations and practices has had, and now has, the capacity and tendency to mislead members of the purchasing public into the purchase of substantial quantities of respondent’s product. As a result thereof, substantial trade has been and is being unfairly diverted to respondent from its competitors.

Par. 10. The aforesaid acts and practices of respondent, as herein alleged, were and are all to the prejudice and injury of the public and of respondent’s competitors and constituted, and now constitute, unfair methods of competition in commerce and unfair and deceptive acts and practices in commerce in violation of Section 5 of the Federal Trade Commission Act.

Mr. Edward F. Downs and Mr. Stuart Lee Friedel supporting the complaint.

Mr. Roy L. Reardon, Mr. William J. Manning, Mr. M eluyn L. Cantor, Mr. Charles E. Koob, of Simpson Thacher & Bartlett, New York, New York, and Mr. Charles F. Hagen for respondent. Initrat Decision By Water K. Bennerr, Hrarrne Examiner APRIL, 16,1971 TABLE OF CONTENTS Paga PRELIMINARY STATEMENT ~~ _ ~~ ---~- ew e+e 26 BASIS OF DECISION_..___-.___-_--_ Lee eee 29 494-841-733 26 FEDERAL TRADE::COMMISSION DECISIONS Initial Decision 81 F.T.G.

-INDEX--Continued -.) ¢,-0. fs 0. 4% : : : “ Page FINDINGS OF FACT..- a wee Tee eile » 29 | (AL Admitted = Findingss2i. 0 0lt02l 00 begins 29 B. Contested Findings teenennest Lana... 80 No Implications of Tests From Advertising seeeegcee ee (80 Development of UN-BURN, — ooiee eee 31 Tests Conducted on Un-Burn prior to’ ‘Marketing ‘' 83 Government Criticism ‘of Adequacy of: Pfizer Tests pl f 84 Summary Finding on Evidence Introduced: In ‘Complaint Counsel’s ..::! ae Case-In-Chief. ..._- ‘ a 40 _ Findings. Relating to Respondent’s Affirmative Defenses. t---n---4- . 40 . No. Reckless Disregard of Safety_ ae wel 40 . Truth of ‘Respondent’s Advertising Claims: a as — ‘Review of Medical Literature... 220222 ikl: wd Clinical Experience of Respondent’s Experts__________ 21 42 , The Post Complaint Tests and. Criticism. Thereof____.-__.__ 44. Propriety. of Reliance on. Historical Data and Clinical. Experience. . 50 Summary Finding. on Respondent’s Defenses. . : 538 ‘Summary Finding o on Complaint! Counsel’s Rebuttal_-2 2-258 REASONS FOR DECISION. . ween a 58 ‘CONCLUSIONS ~~ a ee 56 ORDER : — : : i :

PRELIMINARY STATEMENT This proceeding brought by the Federal Trade Commission by complaint filed July 15, 1970, charges respondent Pfizer Inc.,; with violation of Section 5 of the Federal Trade Commission Act. ‘The alleged factual basis for the charge is two-fold: (1) that re- ‘spondent has advertised and sold its sunburn remedy “Un-Burn” in commerce without having made adequate and well-controlled tests prior to such advertising to determine the efficacy of the product to support the claim that it anesthetizes nerves in sensitive sunburned skin and stops pain fast and (2) that it falsely implied by its advertisements that it had conducted such adequate and well-controlled tests.

On August 5, 1970, the hearing examiner scheduled a prehearing conference for August. 18, 1970, setting up the requirements that’ motions should be made returnable at such conference. Prior to answer and by motion papers filed August’ 13, 1970, respondent sought a cancellation of the prehearing, a postponement of the time to answer and a motion to dismiss and to certify to the Commission.

“Argument on the motions, initially scheduled for August 25, 197 0, was held September 21, 1970, and they were disposed of by written 115 U.S.C. 45.

Soo SO OPRIZERS ING) 001 oe tes 27 23° Initial Decision order: filed the same day’ and. not: appealed::Among-other matters, the order held that:.there was. merely:a matter of lawiinvolved, which should not be certified; and that the allegations of the-complaint were adequate to require a full-evidentiary. hearing before the mattér could be determined. «00 ey bes pe ete AN sates Cybern wy ‘Respondent's answer *filed::October:6, 1970; admitted’ that- it was incorporated and did. business as -alleged-and.had advertised the product “Un-Burn” as charged although: it ‘denied ’:that' such advertising was typical or:continuing: It denied-its advertisements made the implications :alleged:and that: it has kniewledge or information:that the claims had :not. been. substantiated ‘by :adequate and well-controlled scientific studies or tests. Respondent admitted it was in competition with others. but-denied any violation: of law or.that its:action had the effect of misleading the public.: Then; the:answer. asserted six affirmative defenses. in -effect: alleging: that: respondent had: not acted-recklessly and in disregard of: human health.and safety; nor unreasonably ; that the complaint: was defective because it-had not alleged the un= truthfulness: of! respondent’s advertisitig; that the claims were true; that the.Commission had no authority-to impose a requirement beyond the requirements.of the Comimissioner-of:the Food & Drug Administration’; and that there was no public interest in continuing the proceeding because respondent had submitted an adequate and well-controlled test demonstrating that its claims for “Un-Burn” were true. On. October 9, 1970, there was a prehearing conference primarily regarding the scheduling of proposed discovery and possible simplification of issues. The conference culminated in an order dictated on the record (Tr. 116-121) .? On November 16, 1970, respondents filed a motion under Rule 3.36 (b) for the issuance of a subpoena to the Commission. This was denied by order dated November 25, 1970. In the meantime, the parties had been attempting to define certain of the issues and by December 1, 1970, had reached an impasse on the issue of the meaning of “adequate and well controlled scientific tests.” On December 1, 1970, respondents filed a. motion to: (1) require complaint counsel to define “adequate and well controlled;” (2) secure reconsideration of the orders denying issuance of a subpoena to the Commission; (3) postpone trial. 2 The following abbreviations will sometimes be used : C. Complaint . RX Respondent's Exhibit | A. Answer ee - oS CPF Complaint Counsel’s Proposed Find- Tr. Transeript “°°. *- “ “" tings a: ;

CX Complaint Counsel’s Exhibit RPF' Respondent’s Proposed Findings (In citing proposed findings the references therein are deemed to be included) 28 FEDERAL TRADE ‘COMMISSION : DECISIONS Initial’ Decision 81 EF.T.C.

.. A second: prehearing conference was:held December 3, 1970,:to hear respondent’s motion, it having proved impossible to meet the schedule proposed following the October 9, 1970, conference. At the December 8rd conference, the meaning of adequate and well-controlled scientific tests was canvassed as well as the necessity for additional discovery. It was decided-that the formal hearings would have to be postponed and respondent was given an opportunity t to submit.a new motion for a subpoena.

On December 14, 1970, following the submission of a new motion for a subpoena to the Commission, the undersigned issued an order calling for’ limited production of Commission documents at the formal hearings. . :

“Further - motions were maide: regarding scheduling. due to the unavailability of the professional: witnesses. A hearing in Miami, Florida and a, postponement of a few days was accordingly ordered. (Orders dated January 13, 1971 and January 15, 1971.) In addition respondent made an informal suggestion concerning the order of proof, i:¢., that the issues of the implications from the advertising be first determined. This was rejected on the basis of complaint counsel’s objection. Hearings commenced January 20, 1971, in Washington, D.C. and concluded February 22, 1971. One witness was heard in Miami, Florida by consent of both parties and because of his inability to be present in Washington, D.C. There were also brief adjournments of the sort customary in judicial proceedings to meet the convenience of the expert professional witnesses taken by consent.

Counsel were most cooperative in production and authentication of documents, in the prelisting of witnesses and in the submission in advance of curricula vitae of the experts. Four expert witnesses were called by counsel supporting the complaint and over 70 exhibits were offered. Respondents called three officials and six experts and marked over 100 exhibits. Complaint counsel recalled one expert on rebuttal. After the conclusion of complaint counsel’s case-in-chief respondent moved to dismiss.* The hearing examiner then reserved decision (Tr. 809, 814-826). Respondent’s motion to dismiss at the conclusion of complaint counsel’s case is now denied because at the time of that motion all inferences favorable to complaint counsel had to be drawn and the evidence offered by respondent had to be disregarded. 3Tr. 809 For convenience of the witnesses, three of respondent’s witnesses were called prior to the argument of the motion. Their testimony accordingly is disregarded in denying the motion.

PFIZER, INC. oo, 29.

te (oC) Initial Decision BASIS OF. DECISION This decision i is based on. n the entire record, including the proposed findings and conclusions of the parties. All findings of fact not expressly, or in substance, adopted are denied as erroneous, immaterial or irrelevant. In accordance with Rule’ 3. b1(b), references are made to the specific pages of the principal supporting items of evidence in the record. The citations to the principal supporting portions of the record, however, are not intended to exclude other portions of the record, all of which have been carefully considered in light of the demeanor of the witnesses and their consistency or 5 1 4 1 9 10 1616 1147 243 64 91.736465 inconsistency5 1 4 1 9 11 1874 1144 86 32 96.821030 with4 1 4 1 10 0 634 1198 762 59 -1 5 1 4 1 10 1 634 1205 361 41 92.209038 contemporaneously5 1 4 1 10 2 1010 1198 139 59 93.820053 written5 1 4 1 10 3 1163 1202 233 33 91.520096 documents.5 1 4 1 10 4 1383 1198 17 49 61.368782 ©3 1 4 2 0 0 635 1223 1326 175 -1 4 1 4 2 1 0 674 1223 1287 89 -1 5 1 4 2 1 1 674 1256 65 34 96.311966 We5 1 4 2 1 2 757 1266 78 21 96.049713 now5 1 4 2 1 3 853 1258 52 29 96.445923 sets 1 4 2 1 4 923 1254 99 33 96.545296 forth5 1 4 2 1 5 1042 1249 63 44 96.798965 ours 1 4 2 1 6 1119 1248 168 64 60.219635 findings5 1 4 2 1 7 1293 1247 52 53 91.123764 of5 1 4 2 1 8 1351 1223 110 78 94.719292 facts,5 1 4 2 1 9 1464 1245 224 38 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8 1592 2178 106 32 97.009407 resales 1 7 2 6 9 1719 2181 35 28 96.227318 to5 1 7 2 6 10 1773 2177 60 32 96.227318 thes 1 7 2 6 11 1853 2175 117 43 96.978256 publica 1 7 2 7 0 649 2233 403 45 -1 5 1 7 2 7 1 649 2235 78 43 92.226814 (C2,5 1 7 2 7 2 740 2235 71 40 91.737617 A2;5 1 7 2 7 3 826 2246 54 20 96.316704 sees 1 7 2 7 4 895 2234 90 33 95.679123 CPF5 1 7 2 7 5 1000 2233 52 42 95.114418 2).3 1 7 3 0 0 643 2259 1330 372 -1 4 1 7 3 1 0 685 2259 1285 61 -1 5 1 7 3 1 1 685 2288 28 30 95.301987 3.5 1 7 3 1 2 738 2286 44 31 96.290321 In5 1 7 3 1 3 794 2259 59 58 96.976532 thes 1 7 3 1 4 865 2295 118 22 96.782249 courses 1 7 3 1 5 997 2284 67 32 96.118767 ands 1 7 3 1 6 1078 2283 146 33 96.105843 conducts 1 7 3 1 7 1237 2283 38 31 96.105843 of5 1 7 3 1 8 1289 2283 45 31 96.796989 its5 1 7 3 1 9 1346 2282 154 32 96.977707 business5 1 7 3 1 10 1513 2292 37 21 96.543953 as5 1 7 3 1 11 1563 2280 185 40 96.498795 aforesaid,5 1 7 3 1 12 1763 2277 207 43 96.390953 respondent4 1 7 3 2 0 643 2328 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2387 36 28 96.372261 to5 1 7 3 3 11 1618 2382 203 42 96.819771 purchasers5 1 7 3 3 12 1834 2379 137 33 94.968414 thereof4 1 7 3 4 0 644 2431 1326 45 -1 5 1 7 3 4 1 644 2439 132 32 96.588821 located5 1 7 3 4 2 790 2438 37 32 96.625252 in5 1 7 3 4 3 842 2437 138 33 96.965752 various5 1 7 3 4 4 992 2440 105 30 96.934601 states5 1 7 3 4 5 1111 2436 97 32 96.429222 others 1 7 3 4 6 1219 2436 87 32 96.429222 than5 1 7 3 4 7 1319 2436 57 31 96.916389 thes 1 7 3 4 8 1390 2438 88 30 96.936981 states 1 7 3 4 9 1490 2435 39 32 96.955254 of5 1 7 3 4 10 1543 2433 223 43 96.655571 origination,5 1 7 3 4 11 1779 2431 70 33 93.283188 ands 1 7 3 4 12 1862 2431 108 32 90.877457 main-4 1 7 3 5 0 644 2482 1328 49 -1 5 1 7 3 5 1 644 2491 102 40 96.866768 tains,5 1 7 3 5 2 760 2489 70 32 96.866768 ands 1 7 3 5 3 845 2492 36 29 96.627190 at5 1 7 3 5 4 896 2489 48 32 95.789680 all5 1 7 3 5 5 959 2488 100 33 96.882919 times5 1 7 3 5 6 1073 2488 197 32 96.666519 mentioned5 1 7 3 5 7 1282 2487 118 32 96.192436 herein5 1 7 3 5 8 1414 2487 64 31 96.750656 has5 1 7 3 5 9 1492 2485 223 39 96.601967 maintained,5 1 7 3 5 10 1731 2495 21 21 96.409607 a5 1 7 3 5 11 1764 2482 208 42 96.550095 substantial4 1 7 3 6 0 645 2533 1328 47 -1 5 1 7 3 6 1 645 2552 116 22 96.383636 courses 1 7 3 6 2 775 2540 38 33 96.912315 of5 1 7 3 6 3 825 2540 100 32 97.004532 trades 1 7 3 6 4 937 2539 37 33 96.257622 in5 1 7 3 6 5 987 2539 76 33 96.257622 said5 1 7 3 6 6 1075 2539 164 41 95.924500 products5 1 7 3 6 7 1250 2539 38 31 96.312531 in5 1 7 3 6 8 1299 2548 194 30 96.723511 commerce,5 1 7 3 6 9 1506 2547 38 22 96.662682 as5 1 7 3 6 10 1555 2535 226 33 94.616188 “commerce”5 1 7 3 6 11 1795 2534 30 32 96.028496 is5 1 7 3 6 12 1837 2533 136 32 93.183235 defined4 1 7 3 7 0 646 2584 1324 47 -1 5 1 7 3 7 1 646 2593 37 31 96.798981 in5 1 7 3 7 2 696 2593 58 31 96.787392 thes 1 7 3 7 3 766 2591 147 33 96.709793 Federal5 1 7 3 7 4 925 2590 116 32 96.667122 Trades 1 7 3 7 5 1054 2590 227 33 96.267715 Commissions 1 7 3 7 6 1293 2590 68 31 96.756592 Acts 1 7 3 7 7 1381 2588 78 43 89.842461 (C3,5 1 7 3 7 8 1471 2589 71 40 61.858200 A3;5 1 7 3 7 9 1558 2587 91 34 95.861656 CPF5 1 7 3 7 10 1663 2589 37 38 93.214310 8;5 1 7 3 7 11 1714 2597 53 21 93.185448 sees 1 7 3 7 12 1778 2585 95 33 92.607635 RPF5 1 7 3 7 13 1888 2584 82 42 95.826027 1.3).3 1 7 4 0 0 644 2635 1330 150 -1 4 1 7 4 1 0 687 2635 1286 43 -1 5 1 7 4 1 1 687 2646 29 29 75.516243 4.5 1 7 4 1 2 740 2644 44 31 96.436005 In5 1 7 4 1 3 797 2643 58 31 96.436005 thes 1 7 4 1 4 869 2652 117 22 96.736702 courses 1 7 4 1 5 1000 2641 68 33 96.482712 ands 1 7 4 1 6 1081 2641 146 32 95.930328 conducts 1 7 4 1 7 1241 2639 39 33 96.400383 of5 1 7 4 1 8 1292 2640 45 32 96.996536 its5 1 7 4 1 9 1351 2639 152 32 96.419373 business5 1 7 4 1 10 1516 2650 37 21 96.504791 as5 1 7 4 1 11 1567 2637 184 41 96.966202 aforesaid,5 1 7 4 1 12 1765 2635 208 42 96.466766 respondent4 1 7 4 2 0 644 2686 1330 50 -1 5 1 7 4 2 1 644 2695 63 31 96.751251 has5 1 7 4 2 2 728 2694 99 32 95.875557 made5 1 7 4 2 3 850 2692 38 33 96.046211 in5 1 7 4 2 4 910 2693 97 41 95.747612 prints 1 7 4 2 5 1029 2692 291 44 96.845627 advertisements,5 1 7 4 2 6 1342 2689 180 42 96.266533 including5 1 7 4 2 7 1544 2687 148 44 93.375298 products 1 7 4 2 8 1713 2688 169 42 96.648308 packages5 1 7 4 2 9 1904 2686 70 32 96.707100 anda 1 7 4 3 0 644 2737 1330 48 -1 5 1 7 4 3 1 644 2745 117 40 96.333519 labels,5 1 7 4 3 2 784 2744 70 32 96.427864 ands 1 7 4 3 3 876 2743 99 32 96.592361 others 1 7 4 3 4 997 2743 230 42 96.158058 promotional5 1 7 4 3 5 1250 2741 158 32 96.062683 materials 1 7 4 3 6 1431 2741 70 32 96.200523 ands 1 7 4 3 7 1523 2741 38 31 95.910873 in5 1 7 4 3 8 1582 2739 179 33 96.776367 televisions 1 7 4 3 9 1783 2738 71 32 96.620216 ands 1 7 4 3 10 1876 2737 98 32 95.190094 radio 30 FEDERAL TRADE:;COMMISSION DECISIONS Initial: Decision 81 F.T.C.

broadcasts transmitted by television and radio stations located in various States of the United States and in the District of Columbia having sufficient power to carry such broadcasts across the state lines, numerous statements: and representations respecting the pain relieving properties of said product’ when used by persons suffering from sunburn. . Some of said’ statements and: representations, but not all inclusive thereof, are the following: .

, “In radio and television broadcasts: ;

a. New Un-Burn actually anesthetizes nerves in . sensitive sunburned skin. oD. Un-Burn relieves’ pain’ fast. Actually anesthetizes nerves in sensitive sunburned skin. . :

c. Sensitive skin * * * * Sunburned. skin is sensitive. skin. Sensitive sunburned skin needs * .*.*. UN-BURN.,New UN-BURN:contains.the same. local. anesthetic doctors often’ use. * # & “Actually anesthetizes nerves in. sensitive sunburned skin. Pu ‘tell you ‘what I like about’ UN-BURN. It’s the’ best friend a blonde ever had! * * * I'm a blonde * * * ‘and Pknow what it means to have sensitive skin. Why, I’m half afraid of moon burn! That’s why I’m mad about UN-BURN. It stops sunburn pain in * * * léss time than it takes me to slip out of my bikini. That’s awfully nice to know when you're the sensitive type * * * On labels: [“ON-BURN”. comprehensive treatinent for ]* “sunburn” * # * relieves pain * * * anesthetic.* * * (C4, A4; see CPF 4). . 5. Respondent at all times mentioned herein has been and now is in substantial competition in commerce with individuals, firms and corporations engaged in the sale and distribution of sunburn remedies of the same general kind and nature as that sold by respondent (C8, A8; CPF 10).

B. Contested Findings The following findings are based on the hearing examiner’s evaluation of the evidence:

No Implication of Tests from Advertising 6. On the basis of all of the evidence offered with respect to the advertising of the product Un-Burn and having carefully observed the pictures and sound reproduced from T.V. advertising (CX 1-13) it has not been established to the satisfaction of the hearing examiner that respondent has represented directly or by implication, that each of the statements respecting the pain relieving properties of the said product had been substantiated by respondent by adequate and well-controlled scientific studies or tests prior to the making of such statements. While 4 After the conclusion of their case counsel supporting the complaint conceded that the words in brackets should be out of the case (Tr. 811). It should be noted that both records and T.V. sound tape are available in evidence and it is respectfully suggested to any reviewing authority that the actual tape projection rather ‘than ‘the foregoing quotations be observed in order that proper inferences may be drawn (see Tr. 211-212).

| COPRTZER GINGS oo DA eS at 23 pon Initial Decision:

the hearing examiner does not consider himself bound in any way by’ the expert testimony of Dr. Joseph G. Smith, a psychologist called by respondent, Dr. Smith’s analysis (see Tr. 752 et seg.) was both lucid and convincing on the issue of the lack of implication from the advertising matter. that “adequate and. well-controlled scientific tests” had been conducted prior to issuance of the advertising material (Tr. 729- 798, particularly 752-762, 795-796, 797-798). Moreover, quite apart from Dr. Smith’s testimony, the hearing examiner perceived no such representations or implications from the advertising materials: either viewed one by one or considered as a whole. In addition Mr. Ross the’ (CX 1-13) president of the Leeming Division of Pfizer said he had reviewed. consumer reaction and there was noné td’ ‘that’ effect (Tr. 615-617; see RPF TIT). The most the advertising implied was s that the product ‘could work as represented.

Development, of Un- Burn 7. As described by Henry L. Ross, Jr., president of the Leeming Division of Pfizer, the concept of the product Un-Burn was first presented to Pfizer by an advertising agency in the form of a package . with a design and the name “Un-Burn” (Tr. 597). Thereafter, a decision was made to develop a product in the sunburn remedy field that would use the name and design suggested (Tr. 598). The company took a careful look at the products on the market in that category and particularly the product Solarcaine (Tr. 599). The company decided to go ahead because a profitable product seemed feasible and it would fulfill a need for a product to be sold principally during the summer which was a slack season for Pfizer (Tr. 599). Mr. Ross approved the use of the topical anesthetics benzocaine and menthol after receiving assurances from the medical people that the advertising claims could be supported by these two active ingredients at the level selected to put into the product (which was patterned closely after Solarcaine the market leader (Tr. 600) ), and that all available literature had been thoroughly reviewed and favorable conclusions had been reached on their efficacy as a topical anesthetic (Tr. 600-601). 8. The parties have stipulated that if appropriate named individuals were called from named competing companies they would testify that the following products containing benzocaine had been on the market, since the date set opposite the name and that the product was recommended for the treatment also set opposite the name. Initial Decision 81 F.T.C.

; Dateon ie Ss Ss Name. ‘ . market = - oe Recommended for Burtone_____.- eile - 1955 ~~ ~-' Minor burns-and sunburn. : Bo, Solareaine_____.-- 2222-22222 Leek 1949 . .. Sunburn, other minor burns and other ailments. Derma Medicone O -~ ' 1948 Not stated. -- Burn-A-Lay-_..- ~ ... 1935. -. Burn treatment. Lon Morusan -1946° * + Temporary reliefof discomfort due to minor burns. Americaine__ 1948 -. Relief of sunburn, other-burns, cuts and scratches. (Stipulation 2/0/71; Tr. 1186-1138; RPF 2.8.) 9. James. W.. Jenkins, vice president in charge of the research and development sections of Pfizer-Leeming/Pacquin Divisions, (Tr. 647) testified concerning the formulation of the product Un-Burn by his division and the extent of research and testing done (Tr. 644-727). One of the first: things done was to make a drugstore survey of the products already on the market (Tr,.648). These included: Dermoplast, Surfacaine, Pontocaine, Mediquik, Bactine, Lanacane, Campho Phenique, Johnson and Johnson First Aid Spray, Johnson and Johnson First Aid Cream, Safeguard, Solarcaine Spray, Solarcaine Lotion, Unguentine. Spray, Unguentine Ointment and Nupercainal (Tr. 649; RPF 2.9). He found that benzocaine and menthol were prominently used in these products and that the marketing people regarded Solarcaine as the market leader (Tr. 649). Initially Pfizer had contemplated producing a “cosmetically elegant” product to compete with Johnson’s First Aid Cream and Noxzema. This contained benzol alcohol and menthol as active ingredients for the anesthetic effect (Tr. 650). A cream using these ingredients was developed in the spring of 1966 and tested in a very small test on the beach that summer (Tr. 651). In the fall of 1966, however, the marketing group determined that an aerosol caine product should be produced with benzocaine and menthol as the active ingredients (Tr. 651). These active ingredients were later incorporated in the cream and in a lotion so that by the time in the summer of 1969 that the product was distributed nationally, benzocaine and menthol were the active ingredients in all Un-Burn products (Tr. 653). Benzocaine was selected because of the drugstore survey and because of a literature search that “told us that it was an effective and safe and esthetic ingredient to be used in this type of product.” Further it was discussed with Dr. Carlozzi of the Pfizer medical staff (Tr. 652). Menthol, also used, was chosen because it was reported in medical literature as a local anesthetic and antipruritic (a product to. stop itching (Tr. 652) ).

PFIZER, INC. : 33 23 Initial Decision Tests Conducted on. Un-Burn Prior to Marketing 10. Marketing tests to determine acceptability by consumers were made in 1967, in the fall of 1968, and in the winter of 1968-69 in Florida (Tr. 653-654). In addition under Dr. Jenkins’ supervision considerable safety testing was done on animals, a prophetic patch test was done on humans and there was testing with human serum. of the antiseptic qualities of the product. A test was also conducted by injecting guinea-pigs to determine whether any ingrédient of the Un- Burn base interfered with the anesthetic action of the benzocaine (Tr. 655; CX 16-67.) Tests were conducted on the formulations leading up to the final product as well as on the final. formulation. (Tr. 656). Those on the final formulation included: a report on tests by an independent laboratory as to the anti-bacterial effectiveness of the lotion, aerosol and cream with human serum (Tr. 651-659; CX.48, 51, 61) ; two reports of guinea pig wheal tests on the aerosol and lotion (Tr. 657; CX 40, 50); three skin irritation tests on rabbits for the lotion, aerosol and cream (CX 52, 53, 67; Tr. 662-663) ; Draize Eye irritation tests conducted on rabbits with the aerosol (CX 54), the lotion (OX 55) and the cream (CX 66; Tr. 657) ; and prophetic patch tests on 100 human subjects to determine whether the ingredients were capable of producing primary irritation or sensitivity of the skin (CX 56; Tr. 657, 666-667). After describing the tests Dr. Jenkins (Tr. 659-667) testified that in his opinion they were adequate and wellcontrolled scientific tests demonstrating that there was no safety hazard in the use of the product and that it would support the claim of antibacterial activity (Tr. 668; RPF 4.8). With respect to the efficacy of the ingredients benzocaine and menthol, Dr. Jenkins said he caused a survey to be made of the Pfizer library on references to benzocaine and menthol, that he reviewed the literature surveyed, discussed the matter with the medical director of Pfizer, and reached the conclusion that the tests made and historical information reviewed establish the safety and efficacy of the product (Tr. 672-673). Dr. Michael Carlozzi, the medical director of Pfizer, corroborated Dr. Jenkins and expressed the opinion that the literature reviewed and the clinical experience of the medical profession justified Pfizer’s reliance upon such sources for the efficacy of benzocaine and menthol rather than conducting unnecessary efficacy tests (Tr. 1097-1099, 1125-1126). He also pointed out that as part of the guidelines for panels on drug efficacy (RX 110; Tr. 1106-1108) the experience and informed judgment of the members of the panel were part of the criteria to be considered (Tr. 1108-1109, 1119-1129).

34 FEDERAL TRADE~COMMISSION DECISIONS Initial Decision: 81 F.T.C.

Government Criticism of Adequacy of Pfizer Tests ‘11. Counsel supporting the complaint as part of their case offered all of the tests performed by Pfizer (CX 16-69) and also the advertising and labeling used (CX.1-16). Then they attacked the adequacy of the testing for efficacy by calling their 4 expert witnesses. _ 12. The first Commission witness, Dr. Harry M. Robinson, Jr. (Tr. 223-285) is a practicing physician 3 in Baltimore and.a professor. of dermatology with thirty years experience in the field.® He is also an expert: in testing drugs.and evaluating tests (Tr. 225, 238). He had not however done specialized research in. the -field: of topical anesthetics-or sunburn (Tr. 230) and had done no adequate and wellcontrolled scientific studies on benzocaine or menthol or any other sunburn preparation (Tr. 236).

13. Over objection by counsel for respondent Dr. Robinson testified that he had examined the tests done by Pfizer (CX 16 thru 68) and that in his opinion. the tests conducted were not adequate to prove that: Un-Burn anesthetizes nerves in sensitive sunburned skin; relieves sunburn fast; ‘stops sunburn pain; is a comprehensive treatment for sunburn; is an anesthetic when used on sunburned. skin; is so effective in relieving, sunburn pain that persons with sensitive skin such as a fair-skinned blonde girl need not fear or worry about being exposed to the sun (Tr. 240-241).

14. Dr. Robinson was then asked (Tr. 241-270) concerning each of the tests (CX 16-68) made by respondent (despite the objection that some were on-earlier formulations (Tr: 242-245) ). As to each, he responded that they were not adequate to establish that Un-Burn anesthetized nerves in sensitive suburned skin but (except for the consumer research study (CX 68)) were all safety tests. The consumer research study. was not adequate because it was not controlled (Tr. 269-270). As clarified on cross examination the tests were of five types: skin irritation, eye irritation, antibacterial, prophetic patch and guinea pig wheal tests (Tr. 271). They were largely safety tests to determine whether the product to be marketed is safe (Tr. 273) and the testing done was sound (Tr. 273) and adequate for the purpose of showing that there was no hypersensitivity produced in humans, and no eye irritation or skin irritation in animals (Tr. 271-278). One type of test to determine. anesthesia in animals was inadequate because not topically applied but injected (Tr. 250, 255, 259, 265-266). Another type of test having to do with consumer reaction (Tr. 269) Dr. Robinson dismissed as inadequate because pain is subjective and mere yes and no answer was insufficient to determine the anesthetic quality of > His curriculum vitae was received as Exhibit 70 (Tr. 223). PFIZER, ING. 6 35 23 : Initial Decision anything. (Tr. 269-270). He suggested a polygraph test might be required (‘Tr. 270) but on eross examination he stated he: had never seen 4 polygraph used on tests regarding sunburn (Tr. 279). He also indicated.that a single blind study was worthless (‘Tr. 280). - 15. On: the basis of Dr. Robinson’s testimony and before the next witness took the stand, the parties stipulated (Tr. 288) that the witness’s testimony would be that the tests described in the following ex~hibits were not designed to prove that Un-Burn anesthetizes nerves or relieves the pain of sunburn (CX 16-23, 25-38, 41-49, 51-56, 59-69, all numbers being inclusive) and that accordingly these exhibits did not establish those facts.° Identical stipulations were made as to the other two. witnesses called by counsel supporting the complaint (Tr: 318, 501).

16. The second Commission witness, Dr. Ji ohn Adriani, (Tr. 289- 313) is a specialist in surgery, anesthesiology, and pharmacology. He is chief of the anesthesia services of Charity Hospital in New Orleans, Louisiana, and is also professor*in both Tulane University. School of Medicine and Louisiana State School of Medicine (Tr. 290-291). He was for four years Chairman of the Advisory Committee of the United States Food and Drug Administration on Anesthetics and Respiratory Drugs (Tr. 292) and was also a member of the Committee of the Secretary of the United States Department of Health, Education and Welfare on the Evaluation of the Task Force Report on Prescription Drugs (Tr. 292-293). He does laboratory testing in the pharmacology department laboratory at Louisiana State University and performs clinical pharmacology testing at Charity Hospital (Tr. 291). He acts as consultant to the Food and Drug Administration’s Bureau of Medicine. And, he has done extensive editing and publication of medical journal articles and texts (Tr. 294). Dr. Adriani has been testing drugs including local anesthetics for some 35 years (Tr. 296). 17. Dr. Adriani said he was familiar with the ingredients in Un-Burn and that he had tested products which had some or all-of such ingredients (Tr. 295-298). He said animal tests would have to be fol-: lowed by tests on humans because animal studies in relief of sunburn were not adequate (Tr. 298). He stated he had examined Commission Exhibits 24, 39, 40, 50, 57 and 58 (Tr. 300, 301). He was shown the T.V. program CX 4 (Tr. 303-304) via projector equipped with sound and 6 At. Tr. 288 line 18, the numbers CX 25-38 are omitted but they were inserted the following day by stipulation (Tr. 318).

7By direction and inthe interests of expedition the transcript of January 26, 1971, starts with p. 500 rather than 375 because the last page number was not available to the reporter at Miami.

8 His complete curriculum vitae is marked CX 71. 36 FEDERAL TRADE ‘COMMISSION DECISIONS Initial Decision 81 F.T.C.

testified that the testing “positively” did not support the claims in the advertising (Tr. 308) because the product. was sprayed on the subject in the movie and injected in the tests (Tr. 308) and that the injection has no “correlation at all” with the topical (sprayed.on) application (Tr. 310). He then testified as to each test that it-did not substantiate the claims (Tr. 311-312). Moreover, none was reasonably designed to prove and did not prove that Un-Burn when used topically will anesthetize nerves in sunburned skin or relieve sunburn pain (Tr. 312). There was no cross examination (Tr. 318).- 18. The Commission’s third witness was Dr. William Thomas Beaver (Tr. 318-373). Dr. Beaver.is‘a Clinical Pharmacologist, and as such specializes in the effects of drugs in living systems (Tr. 319). He is also a Doctor of Medicine and is Associate Professor in Georgetown University where he teaches-medical students and staff and does research. His major area of interest is pain relieving drugs and the design of experiments demonstrating the efficacy of drugs in man (Tr. 320). From 1963 to 1967 he was a research associate at Sloan-Kettering Institute for Cancer Research and was almost exclusively involved in doing drug studies in analgesics. Hé was also a member of the National Academy of Science, National Research Council panel on relief of pain, drug efficacy study (Tr. 320) which was one of those engaged in the review of drugs for efficacy under the auspices of the Food and Drug Administration (Tr. 8320-323). He acts also as consultant to the Food and Drug Administration (Tr. 324) and has had experience in designing and reviewing protocols for tests (Tr. 325). 19. Dr. Beaver after reading the T.V. storyboard (CX 11) was asked concerning the tests described in CX 25, 39, 40, 50, 57, and 58. Before testifying on these he was subjected to an extensive voir dire examination attempting to determine just what standards he used in evaluating the tests i.¢., those of the F_D.A. or those of the dictionary definition of adequate and well-controlled (Tr. 328-341). He was guided according to his testimony by general principles accepted by the community of clinical pharmacologists that at the moment coincided with the F.D.A. principles (Tr. 330). Dr. Beaver then testified that the tests did not substantiate the claims in the advertising because: (1) the study was on animals and could not be extrapolated with any degree of confidence to human beings; (2) the study deals with interdermal injection and could have a totally different result from topical application; (3) he could not be sure of the identity of the material tested with Un-Burn (Tr. 348-345). He then described what in his opinion would be an adequate test (Tr. 351-356). This included : 9 Dr. Beaver’s curriculum vitae is Exhibit 72 (Tr. 320). PFIZER, INC. re 37 23 ‘fnitial Decision (1) use of human subjects; (2) production of the sunburned condition; (3) comparison with a placebo of ‘essentially. the same formulation without the anesthetic, applied at random ;‘(4) development of a standard for the amount of sunburn; (5) use of double blind approach so that neither the subject or the tester could identify which was.the active product and which the placebo; (6) reading on the pain on stimulation or at. rest over a time period; (7) adequate number of subjects; (8) calculation to determine that differences in recorded scores was not due to chance (Tr. 351-356)..A’ motion was made to strike this testimony because it was based on the FDA standard. This was denied on the basis of.a voir dire examination (Tr. 356-367). On cross examination Dr. Beaver testified that on panels of National Academy of Sciences and the National Research Council, some panels accepted the informed judgment of the panel members:asto the effectiveness of drugs (Tr. 372). On the panel on which he served, the panel members insisted upon studies although in some: cases they assumed the adequacy of the test reported when the decumentation was not entirely clear (Tr. 869-371). .A motion to.strike Dr: Beaver’s testimony was denied because in the hearing examiner’s opinion Dr. Beaver’s description of the tests'required came within the dictionary definition of adequate and weil-controlled (Tr. 374). 20. Dr. Harvey Blank was the final expert called by the Commissicn. He is a Doctor of Medicine and specializes in dermatology (Tr. 502-592). He is a professor and chairman of the department of dermatology of the University of Miami School of Medicine (Tr. 502).2° Previously he had been associate medical director of Squibb Institute of Medical Research and it was his duty to help in the development of products, to set up and evaluate tests, and to advise Squibb Pharmaceutical Company (Tr. 503-504). He is experienced in testing drugs and evaluating tests and has tested preparations recommended for sunburn pain (Tr. 505). He was chairman of the panel of the drug efficacy study of the National Research Council for the Food and Drug Administration to evaluate drugs for use on the skin (Tr. 506). He described preliminarily the types of tests, agreed that testing on human beings was necessary because of the difference between animal skin and human skin and indicated that in skin preparations for the relief of itching, for example, many ingredients had a soothing effect and care must be taken to determine whether the active or anesthetic ingredients do more than the product without the active ingredients (Tr. 509, 510).

21, Dr. Blank then compared the claims made by the TV commercial His curriculum vitae is marked Exhibit 73 (Tr. 503). Initial Decision 81 ETC.

(CX 10) with the tests described in Commission Exhibiti24. After an extensive voir dire examination (Tr. 511-522). ‘in:-which Dr. Blank indicated he utilized the FDA: standard plus some other considerations ‘in making his evaluation, he testified that the test described in CX 24 _ did-not substantiate the TV claims because of the following principal reasons: first; the product: was-injected arid: not administered topically ‘and second, you cannot transfer studies on a guinea pig to man without confirmation. He-also said: the same objections applied to the tests described in CX 24; 39, 40,'50, 57, and 58 (Tr. 522-523). With regard to the reason why’ there is a difference between. injection and: topical ‘application Dr. Blank explained that the skin was a barrier that most agents do not penetrate in.any substantial amount. and: therefore.in testing drugs to be applied to the skin you have to know whether the product will go through the skin (Tr. 524-526). ae 22. On-cross examination Dr. Blank. refused to state whether. the panel he chaired had exercised:the right to rely.on the experience of the panel:members in ‘approving drugs for efficacy because the panel report had not been released (Tr. 530). The hearing examiner upheld this refusal (Tr.537, 548). The doctor said that in ‘preliminary discussions the panel chairmen were informed they had that right to utilize previous experience rather than insisting upon adequate and well-controlled scientific tests (Tr. 585). There was also an attempt to have the report of the panel produced. The hearing examiner ruled that this must be done by motion for a subpoena to the Department of Health, Education and Welfare (Tr. 555). It was then brought out that the witness had refused to talk with counsel for respondent because he was given very short notice at an inconvenient time (Tr. 558). His folder of papers to which he referred during his direct testimony was examined by the hearing examiner-and ordered produced (with the exception of one document which dealt with another company and with enzymes (Tr. 559-562) ). After examining the file respondent offered a report submitted in April 1959 under the witness’ administrative supervision (Tr. 563). This is marked RX 99A-K and is an unpublished report to Plough Inc., regarding the product Solarcaine with correspondence relating thereto. The University of Miami was paid a fee for the study (Tr. 568). The documents were received in evidence (Tr. 570). It was established that in 1959, Dr. Blank approved a letter and report attesting to the efficacy of Solarcaine, a Benzocaine product (RX 99F). (It will be:recalled that Solarcaine was one of the products Un-Burn was developed to compete with and to emulate (Tr. 599) ). os ees. 8 OPRIZBRS ING. OS 39 23, initial Decision ' 93.-On redirect examination ‘Dr. ‘Blank indicated: that he thought the results which had been obtainéd were ‘from ‘the us¢: ofan’ occlusive patch (Tr. 575) placed over the lotion becanise' éf lack ‘of-action without it (Tr. 578).

24. On recross, although Dr. Blank reiterated that a patch had té be used to get the anesthesia (Tr. 576), lie said he did not tell Plough Inc., that they were going to have to tell people to use patches on top of the lotion when. they used: it (Tr.:576):-and. he admitted: that’-he had written Plough that their. product “had:a distinct pain relief, cooling and soothing properties whick relieved the discomfort:of minor sunburn and other minor burns and such localized-sensations as itching, tingling, and soon? :(Tr. 577:)° He‘dlso-admitted ‘there was nothing in his letter which told Plough the product had: tobe applied with the:.aid. of a patch (Tr. 577-578) -and further admitted that: the test he used (RX 99 A-E) was not adequate:by present standards (Tr. 579). He testified, however, that the test-had:no relevance to Un- Burn (Tr. 580). He'then testified that he and his associates:had tested Un-Burn spray and cream in the past four or five months: but: that he -had not published the result of the test-or reduced it to writing in‘any form (Tr: 580). With regard to the Plough ‘product’ (Solarcaine) he found “down [sic] at that time” that the product “containing benzocaine was effective on normal skin and produced an effect in fifteen minutes” and advised Plough “that the products worked” knowing that: Plough- was: going. to séll the product to the: public (Tr. 581-582). On further redirect examination, Dr. Blank said that he and his associates had tested Un-Burn by techniques now used for anesthesia of the skin, ¢.e., instead ‘of pricking the skin with a needle which allowed the lotion to penetrate the skin barrier they were now using a hot beam of ‘light to determine whether or not anesthesia is produced (Tr. 583). On tests he conducted on Un-Burn he testified “that even after one hour of application it was impossible to detect. any. anesthesia with Un-Burn” (Tr: 585). On recross, Dr. Blank admitted that he had known he was to testify (Tr. 585) and had told counsel supporting the complaint about the tests which had been conducted on associates (Tr. 586-587). He further admitted that the test was preliminary and that.he.did not.consider it to be an adequate and well-controlled. scientific study. and test: of.the efficacy of Un-Burn (Tr. 588)..The. test was.-made.. only’ on - three .-people repeated many times but “we got no effect so we. didn’t go on”: (Tr. 589). The. three subjects performed the test on themselves (Tr. 590) and there was no written protocol or written result (Tr. 591).-Dr. Blank did not tell Plough Inc., at-any time that he had modified his Initial Decision 81 F.T.C.

conclusions expressed in the report sent to it (Tr. 592). -Although invited to make a further statement the witness indicated that he did not feel it necessary to doso (Tr. 592).

Summary Finding on Evidence Introduced in Complaint Counsel’s Case-i -in-Chief 25. At the conclusion of complaint ‘counsel’s. case-in-chief it had been established that respondent Pfizer Inc., had advertised, on TV and in other media with interstate coverage, that Un-Burn anesthetizes nerves insensitive sunburned skin and relieves: pain fast. It was also established prima: facie from the testimony of the experts called that the tests conducted by Pfizer prior to marketing were not adequate to determine the efficacy of the product on-human beings but merely determined its safety and its efficacy as an antibacterial agent. There was inconclusive evidence concerning the efficacy of the product apart from the adequacy of. the tests.. And, evidence that on undamaged: skin a topical anesthetic would not ‘penetrate to the nerve endings.

It: was conceded that:the product was sold i in ‘interstate commerce and that it was in competition with other products produced by others.

Findings Relating to Respondent’s Affirmative Defenses We shall now consider the facts relating to respondent’s six affirmative defenses under the following three headings: Vo Recklessness or Disregard of Safety; Truth of Respondent's Advertising Claims ; Propriety of Reliance on Historical and Clinical Hwperience. No Recklessness or Disregard of Safety 26. As heretofore described in Finding number 10 hereof, respondent made elaborate test on both animals and humans at all stages of the development of the product to insure that it was safe to use and would not cause undue irritation or sensitivity. Complaint counsel’s first expert witness, Dr. Harry M. Robinson, Jr., made this very clear after his detailed analysis of the tests that were conducted by Pfizer Inc. (Tr. 241-278). So, there is really no contest in that regard. Respondent’s officials in charge of development also testified that Pfizer had conducted tests to insure the safety of the product and described them in detail (Tr. 668). There was no proof offered that cast any doubt on the safety of the product in normal usage.

PFIZER, INC.. - 41 2 Initial Decision Truth of Respondent’s Advertising Claims 27. Respondent bases its claim that its product Un-Burn. anesthetizes nerves and stops pain fast on three types of proof: first, its review of the medical and pharmaceutical literature concerning the active ingredients benezocaine and menthol; second, the clinical experience of its experts and their knowledge of ‘the history of the acceptability of these drugs as topical anesthetics; and, third, a test conducted after the commencement of this “proceeding, We deal with each of ‘these separately under ensuing subheadings. Review of the Medical Literature..- 28. Henry L. Ross, Jr., the president of Leeming Division of Pfizer, who was director of marketing at the time of the development of Un-Burn (Tr. 597) testified that he was assured by Pfizer’s medical people that the claims it planned to use could. be supported by the two active ingredients at the level selected to be put into Un- Burn, which was patterned closely to Solarcaine, and he was further assured that all available literature or information on the two active ingredients had been thoroughly reviewed and favorable conclusions reached as to the efficacy of the ingredients as topical anes. thetics (Tr. 600-601; see also 605). He reiterated this position on cross examination and added that they had found products which had made these same claims with the same active ingredients for many, many years (Tr. 618-620). He specifically claimed that as to active ingredients, Un-Burn was the same as Solarcaine, the leader in the field (Tr. 620). He also took the position that in the case of these well known ingredients a review of the literature was equivalent to testing and that if he put out a product containing ingredients listed in the literature it works (Tr. 629-630). 29. James W. Jenkins, a doctor of philosophy in chemistry, who was vice president of Research and Development of Pfizer’s Leeming/Pacquin Divisions (Tr. 647) and responsible for quality control and testing, corroborated Mr. Ross (Tr. 652) and said he had discussed the problem with Dr. Carlozzi of the medical staff and that. the literature search “told us it was an effective and safe and esthetic ingredient” (Tr. 652). Dr. Jenkins ordered a survey at the library at the Parsippany laboratory to be made, got a list of references and reviewed them himself adding an additional reference (Tr. 670). The references pertaining to benzocaine and menthol included: Grollman, Pharmacology and Therapeutics;

The Merck Index;

Goodman and Gillman;

494-841—73—_4 42 FEDERAL TRADE: COMMISSION DECISIONS Initial ‘Decision 81 FTG.

Remington’s Practiée of Pharmacy $° WS journal of Pharmacology. . and, Experimental ‘Therapy, Harry; Greenberg & Lester “Handbook of Cosmetic Materials” ; Journal of American Pharmaceutical Associates—an article; - Abbott Laboratories—Technical Bulletin on. Benzocaine; ; - The Dispensatory of the United States of America.‘ (Tr. 67 1). “As a result of the safety and other tests, his review of the literature and his discussions with Dr. Carlozzi, the medical director of Pfizer, Dr. Jenkins gave his opinion that the testing done was sufficient to establish the safety and efficacy of Un:Burn. (Tr. 672-673). .. On cross examination, Dr. Jenkins testified that the literature examined had no test data just simple statemerits (Tr. 7 05) and admitted that he was a specialist j in neither dermatology ¢ or anesthesiology ( Tr. part, that no. clinical studies had been made of the. relative suitability of many of ‘the established’ jocal | anesthetics ‘for use on ‘burns (Er. 4 13) but it did.not change his opinion about Un- Burn. (Tr. 714). _80. Dr. Michael Carlozzi, the medical director of Pfizer’ (Tr. 1090- 1134), a graduate of Long Island College of Medicine, obtained exper ience as a. medical officer duri ing World War TI and has had exten- Sive experience in the medical departments of several pharmaceutical companies (Tr. 1091).*! He testified that he had advised Pfizer that Un-Burn would be effective in alleviating sunburn pain, based on the facts: that they were incorporating bénzocaine and menthol agents which had been available for decades and had been in widespread use as topical anesthetic agents; that they were accepted as ‘such by standard textbooks and by the clinical experience of the medical profession (Tr. 1097). The fact that other such products were on the market also had an influence in his decision (Tr. 1097, see also Tr. 1098). He consulted Dr. George Clinton Andrews’ work on dermatology (RX 87) and several other standard textbooks (Tr. 1128). . 31. Dr. William Beaver who was called by complaint counsel on rebuttal attested to the fact that the National Formulary and the U.S. Pharmacopoeia, United States Dispensatory, Goodman and Gillman, and Merck Index were standard reference works used, by doctors and pharmacists (Tr. 1274-1279). .

Clinical Experience of Respondent’s Experts — - 32. Dr. Norman Orentreich who conducted a post-complaint test on Un-Burn and whose qualifications are later described, testified with re- 1 His curriculum vitae is RX 106 (Tr. 1091). PFIZER; INC: ae 43 - 23 . Initial Decision ‘gard to his use of benzocaine in his personal practice (Tr. 848) and by -other dermatologists (Tr. 847). He said that it had-been in-use asa -local topical anesthetic since at least the turn of the century (Tr. 848) ‘and that it was his opinion that it works by interfering with the con- -ducting of impulses along the nerves or anesthetizes them.({Tr. 848). -He said that the opinion that benzocaine was an effective topical an- ‘esthetic. was taught in medical school-as early as 1948 (Tr. 850). He ‘gave similar testimony regarding menthol. (Tr. 853-854) .. 33. Dr. Norman Kanoff (Tr. 1037-1087), whose qualifications are also later described, testified that he used benzocaine in his practice and ‘it was recognized as a topical local anesthetic by him and by other doctors for at: least 50 years (Tr. 1043-1044). He explained: what sunburn was (Tr. 1040) and its effect on the permeability of theskin (Tr. 1040- £1043) and expressed the opinion that benzocaine acted on the nerve -endings themselves to interfere with the conduct of nerve impulses and -anesthetized them (Tr. 1043) and he would recommend it to relieve *skin pain (Tr. 1044). He said he was also familiar with: menthol and ‘that it was recognized as-an antipruritic and mild: anesthetic and -used by: him and by: other’ doctors. (Tr. 1044).: He. admitted. on-cross ,examination that. some accepted drugs had later been proved ineffectual (Tr. 1065). He also admitted: he could not be certain his patients did what he recommended (Tr. 1060-1061) and that mild sunburn was self-limiting and would get better if not treated at all (Tr. 1082). 34. Dr. Robert A. Berger (Tr. 1142-1171), a specialist in dermatol- -ogy; has been in practice since 1959. He is assistant professor at Mount Sinai Hospital and was formerly associated with teaching at University Hospital of New York and Bellevue Hospital (Tr. 1144). [fe sees some 12,000 patients in private practice and another 3,000 in the hospitals (Tr. 1145). He described what: sunburn is and. stated his opinion that sunburned skin was damaged skin (Tr. 1146). He also _ said that the pain of sunburn was irritation of nerves and nerve endings in the upper layers of skin (Tr. 1147). He described benzocaine as a topical anesthetic agent used in creams, sprays and ointments and recognized as such in his speciality (Tr. 1147). It has been in use for over 50 years (Tr. 1198). He also described menthol as an antipruritic agent and also to a degree an anesthetic agent: (Tr. 1148). Both benzocaine and menthol-are used by doctors (Tr. 1148-1149). Dr. Berger has used benzocaine and menthol in his practice and often advised patients by telephone on first aid for sunburn to use an over-the-counter product with benzocaine (Tr. 1150). He said it was his opinion that it penetrated the skin (Tr. 1151). On cross examination Dr, Berger 2 His curriculum vitae is Exhibit 107 (‘Tr. 1143). : 44 FEDERAL TRADE. COMMISSION DECISIONS Initial Decision 81 F.T.C.

said he had not conducted blood tests to determine whether menthol or benzocaine penetrated the skin and were present in the blood stream (Tr..1156). Dr. Berger also admitted he did not know that patients followed his advice but thought it was reasonable to assume they did (Tr. 1158, 1159, see also 1169-1171) ..He agreed that there were drugs which had been used and gained acceptance which were later found to be ineffective (Tr. 1164). On redirect examination he reiterated that in his opinion there was adequate medical support for Pfizer’s claims regarding Un-Burn in May.1969 (Tr. 1168-1169). 35. Dr. James W. Burks (Tr. 1174-1202) , a practicing dermatologist and clinical professor of dermatology at Tulane University Medical School,® testified that he saw 80-100 patients with sunburn in his office each year but that most:of his sunburn practice was over the telephone (Tr. 1177, 1179). In his practice asa whole he sees some 20,000 patients.a year (Tr..1179). He said sunburned skin was damaged skin that was no longer intact and that this was caused by chemical damage to the small cells of the skin (Tr. 1177-1178). Dr. Burks said benzocaine had been used by doctors since the 1800’s and was:one of the first anesthetics used by dermatologists and it is used today for the treatment of topical skin problems particularly those that itch (¢.¢., a form of nerve irritation) (Tr. 1180). He prescribes benzocaine both for those who call at his office and those who call on the phone, particularly the latter because they can get one of the caines, Solarcaine, or Un-Burn without a prescription at 2:00 a.m. (Tr. 1181). Dr. Burks also gave a similar opinion concerning menthol and its uses as a mild anesthetic and antipruritic agent (Tr. 1181). It is also used by doctors and by Dr. Burks for relief of itching, burning, stinging or discomfort of the skin because of its cooling or anesthetic effect (Tr. 1182). In the armed forces during the doctor’s experience in New Guinea in World War II, benzocaine lotion was one of the two topical remedies that the army supplied. It was of great service (Tr. 1183).

The Post-Complaint Tests and Criticism Thereof 36. Dr. James W. Jenkins, vice president of Pfizer’s Leeming/Pacquin Division, identified a test (RX 84) which was run by Dr. Orentreich in October and November 1970 (some three months after issuance of the complaint) (Tr. 674), based on a test plan or a protocol in the preparation of which he had collaborated with Dr. Orentreich (Tr. 674). Dr. Jenkins testified that in his opinion the study was both adequate and well-controlled and explained his reasons (Tr. 676). The 3 His curriculum vitae is Wxhibit 104 (Tr. 1176). PFIZER, INC.: : 45 23 Initial Decision product to be tested and the placebo were coded. Dr. Jenkins retained the code until after the study was completed, then caused it to be/handwritten on the first page of the report (Tr. 677). The placebo was the same as the active product with the benzocaine and the menthol removed (Tr. 679). Dr. Jenkins calculated the results arithmetically and determined that taking all subjects in each-case the active ingredient was more effective than the placebo (Tr. 680). In the case of particular individuals tested on the aerosol : 17 found the active more effective | 1 found no difference 1 favored the ‘placebo over the active e (Tr 680). In the case of the lotion :

19 found the active more effective 2 favored the placebo over the active (Tr. 680). Dr. Jenkins also calculated the results by test intervals and reached’ a comparable conclusion (Tr. 681). He summarized the results by saying that “Un-Burn aerosol and. Un-Burn lotion proved to be effective in relief of pain from sunburn” (Tr. 682). In his cross examination, he indicated he was relying on Dr. Orentreich’s experience in testing (Tr. 716) and he could not supply detailed information concerning ‘the number of subjects or just how the tests were conducted (Tr. 716-718). 37. Dr. Norman Orentreich who was responsible for the post-complaint study on Un-Burn testified with respect to it (Tr 855 e¢ seq.). Dr. Orentreich is an associate professor of Clinical Dermatology in New York University College of Medicine.‘* He has been active in medical societies and has written numerous articles. He is director of the Orentreich Medical Group consisting of four qualified dermatologists. It handles some 40,000 patients a year of which he sees some 20,000. He described in technical terms what sunburn was and how it damaged the skin (Tr. 838-843). He also indicated that it diminished the barrier function of the skin (Tr. 848-847) so that it became more permeable. He stated that in his opinion benzocaine was capable of penetrating the skin and anesthetized the nerves (Tr. 848). He also stated that menthol was a standard topical antipruritic agent and had a coolant as well as a direct anesthetic action (Tr. 853). Testifying with regard to the test identified by Dr. Jenkins, Dr. Orentreich said it had been conducted under his supervision with coded products so neither he nor any of his staff knew which were active products and which placebo (Tr. 856). The 22 subjects selected were from within the doctor’s medical group with a broad spectrum of caucasian skin types who were able to discriminate and be objective 4 His curriculum vitae is in evidence RX 105 (Tr. 833-834). 46 FEDERAL TRADE: COMMISSION DECISIONS Initial Decision 81 E.T.C.

about their subjective responses (Tr. 856-858). .A tested and specially designed lamp was used to closely resemble sunlight and inflict-a-small area of sunburn at.a.constant distance. Subjects were. each given. the same 2-minute exposure (which had been predetermined: to cause a substantial first degree sunburn on all types) on five different approximately 1 x 1:inch square areas on their backs, sufficiently separated so there was no leakage of.effect from one site to another (Tr. 858-861). Four of the sunburned areas each got an application from one-of thé four coded products. The fifth area was left as a control (Tr. 862). Then each area was stroked from the unburned skin over the burned area and the reaction. was compared with the control. There was also random cross checking. The control area was rated 4 and the response from the other areas 4 if no change. The response from treated area was rated 3 if there was mild discomfort; 2 if moderate diminution of: discomfort ;-1 if marked diminution of discomfort; and 0 if there was no discomfort at all (Tr. 863). This testing was done a sufficient number:of times, trying to fool the individual, to get reproducible dat: The ‘data was tabulated and submitted in the report. (Tr. 863). After the code was broken Dr. Orentreich said the conclusion he reached was that the active: ingredients were more effective than the placebo. This verified what he already knew, that the product would be effective for sunburn discomfort (Tr. 864). In the doctor’s opinion the test was:an adequate and well-controlled scientific test which substantiates the claim that Un-Burn actually anesthetizes nerves in sensitive sunburned skin (Tr. 864-865).

37a. On cross examination of Dr. Orentreich it was brought out that he knew that there was a question about the advertising claim for Un-Burn and that he was to design a. test to determine whether the product would stop pain and anesthetize nerves (Tr. 874). He indicated that Mr. Edwards of his organization probably submitted an outline of the technique of testing (Tr. 875) ; but, that he himself was involved in setting up the procedure (Tr. 876). The number of subjects was determined by Pfizer’s willingness to pay (Tr. 876-879). and Dr. Orentreich assumed that was on the basis of the statistical evaluation by Pfizer (Tr. 877) because there were three series of tests (Tr. 877). Dr. Orentreich said he thought there were 15 different subjects and that some had participated in more than one series of tests (Tr. 878). He averred that neither the subjects or the testers whom he identified knew which was the placebo and which the active product though of course they knew which was aerosol and which lotion (Tr. 882). The actual tests were conducted by two nurses under. Mr. Edwards supervision and the results were recorded by Miss Con- “ PRIZBR;INC.. © 0. 47 QB i Initial Decision nor (Tr. 882-883). Dr: Orentreich maintained general supervision (Tr. 883). The subjects were all female; two-thirds were nurses, others ~ were laboratory technicians or medical secretaries; and they received extra compensation for their participation (Tr. 886). Their age range was 21-40: (Tr. 887) and about 24 were fair and light skinned, 14 on. the dark side (‘Fr..887). He also described the details of how, exposure was made, how far apart the areas of exposure. were, how the lamp was constructed and operated and how it had been pretested (Tr. 888- 890). He described the pain produced by the lamp. and the reasons for testing after a'16-lour period (Tr: 890-894). He expressly stated that the burn caused was above-minimum and a discomforting advanced first-degree ‘burn just short of blister formation (Tr. 895-896). He éxplained how the products were applied or randomized (Tr. 896) and that a mask was used to-insure that the areosol spray was localized. The lotion was applied in a constant fashion. (Tr. 897). He did not think the menthol and its removal caused. the: placebo: to.smell differ-. ently from the active product (Tr. 898). He testified that he was satisfied that the subjects had no preconceived notions of which product was applied'to each site (Tr. 899). He indicated that the tests were. made within a 16-18 hour range after the injury was inflicted and justified that time period and interval (Tr. 900-1002). % Dr. Orentreich also. described in detail how the subjects were stroked with an orange stick to cause pain and how the subjects responded and were cross checked by additional strokings (Tr. 1003-1007). He said there was no measuring instrument on the stroking and no study of each of the subject’s tolerance to pain but that in-his opinion the technique used. was sufficiently standard to create meaningful data (Tr. 1008). The cross examination then drew attention to a number of responses by subjects where the response was slight or was the opposite of-the study'as a whole (Tr. 1009-1016). The doctor explained that there was an effect from the aerosol spray but that it was a fleeting effect so that an active ingredient was necessary (Tr. 1017). He said no blood samples were taken to determine whether the benzocaine was in the blood stream (Tr. 1017). He explained however, that he was of the opinion that the test established that Un-Burn anesthetized nerve ends (Tr. 1019) and gave a technical explanation of why this was so (Tr. 1020-1021). He further explained that while benzocaine did not penetrate the-skin rapidly placing it on the surface has a prolonged reservoir effect (Tr. 1022). He said that the percentage of benzocaine was 14 percent in the lotion and almost 1 percent in the spray but that 4 In the transcript the number 900-1000 was used on one page presumably for the convenience of the typists.

Initial Decision 81 F.T.C.

when the spray equilibrated with the skin surface there was a concentration of about 12 percent and 3 percent in the lotion (Tr. 1022). Dr. Orentreich explained that the placebos gave some relief becausé they prevented exposure to the air or had a cooling effect; but, that the study showed the active ingredients had an additional positive effect (Tr. 1024). Dr. Orentreich said he had not written an article because the test had just been done and was not done for that purpose (Tr. 1025— 1026). He said he might sit down with a statistician and see if the latter thought it was statistically adequate. He did not, however, do the test for that purpose and was told it was statistically significant (Tr. 1026).

38. On redirect examination, Dr. - Orentreich testified that no.one knew of the identity of any of the coded products (Tr. 1027—1028);. that the tests for a subjective response were recognized tests (Tr. 1028) that the placebo effect here was due in part to the properties of the base as well as to the psychological effect (Tr. 1029-1030); and, that the cost of a visit to a dermatologist to get.a prescription drug was sufficiently high so that most persons with sunburn used an overthe-counter preparation (Tr. 1031-1032). Mr. Cantor, of counsel for respondent, during the re-cross examination stated that he had written the code equivalents on the face of RX 84 on December 17, 1970, and that was the first time the code was broken (Tr. 1033). The witness testified that he had not gone over the details of the test with Pfizer but that during his conference with Dr. Jenkins there were discussions on how one could design a test that would show that the active agent worked (Tr. 1034). On questions by the examiner, the witness stated that there was a single application of the medication and testing for responses after certain periods of time (Tr. 1035). 39. Dr. Norman Kanoff testified that he thought Dr. Orentreich’s test established that Un-Burn relieved sunburn pain (Tr. 1055, 1084). He said, however, that he could not ascertain certain factors from the report itself (Tr. 1066-1069) but placed reliance on the test because Dr. Orentreich, who had been his colleague at New York University for 15 years, had done the testing (Tr. 1086). 40. Dr. Robert A. Berger testified that Dr. Orentreich’s study indicated that benzocaine penetrated sunburned skin while in his opinion it would not penetrate normal skin (Tr. 1151). 41. Dr. James W. Burks testified that he thought the testing done by Dr. Orentreich (Exhibit 84) was adequate to substantiate that benzocaine will penetrate sunburned skin and anesthetize nerves (Tr. 1188).

PFIZER, INC. |. 49 23. Initial Decision .. 42. Dr. David Salsburg, a Doctor. of Philosophy from the University of Connecticut ** and :an. expert statistician employed by Pfizer Pharmaceuticals, téstified regarding: the statistical significance of Dr. Orentreich’s tests. (RX. 84). Using an arbitrary determination of the onset of activity (‘Tr. 1210) and the Paired T test, he determined that there was considerably Jess than a five percent chance that the results found by the study were-due to chance (Tr. 1214). From his caleulations he reached the conclusion “in lay language—that the Orentreich study provides statistically significant evidence that the Un-Burn formulation will do better than its carrier alone, in both lotion and aerosol, in terms of speed of action, of anesthetizing effect, and duration of activity.” (Tr.1215).

43. On cross examination, Dr. Salsburg testified that he was a probabilist in that he did not: believe that anything proved anything but that the study “provided strong evidence that the Un-Burn formulation does work.” (Tr. 1216). He said his arbitrary selection of a point for the onset of activity was done in accordance with standard statistical procedure (Tr. 1223-1224). He also testified regarding the results shown on particular subjects. On redirect examination, Dr. Salsburg indicated that in his opinion there was a statistical probability that the observations were done in a truly random fashion (Tr. 1227). On re-cross, Dr. Salsburg stated that according to his calculations there was only a 14 percent chance that his conclusion was in error (Tr. 1229) and that in all probability another experienced statistician would have chosen the same figure for the onset of activity (Tr. 1230). On examination by the undersigned, Dr. Salsburg said he could not tell whether or not the subjects were an adequate sample of the entire population (Tr. 1231) but that question was seldom asked in clinical research (Tr. 1232). He said he could tell that there were a sufficient number of subjects because there were significant results (Tr. 1232). He also said that the chances of getting a result of 16 subjects finding a preference for Un-Burn by pure chance was 0.2 percent (Tr. 1234).

44, Dr. William Beaver was recalled by counsel supporting the complaint on rebuttal (Tr. 1242-1313). He testified he had formed an opinion concerning the adequacy of Dr. Orentreich’s test (RX 84; Tr. 1243). On voir dire examination, it was made clear that his opinion was based on the test paper alone as he had neither read nor heard about Dr. Orentreich’s testimony concerning the study (Tr. 1243- 1244), It was his opinion that he could not tell whether the study was adequate to demonstrate whether the inclusion of benzocaine in the 16 His curriculum vitae is Exhibit 108 (Tr. 1204-1205). 50 FEDERAL TRADE“.COMMISSION DECISIONS Initial. Decision 81 F.T.C;

formulation enhanced the efficacy ‘of the product: because the descrip- ‘tion of the-methods used was not ‘adequate (Tr. 1246): The’ specific criticisms’ and answers which ‘would’ have been ‘found: if Dr.. Oren: treich’s and’ others’ testimony had. béen considered were:. : - 1. There ‘was no description of the exact ‘nature-of the wslacabo and the. active product.so that’ hé could :be -assuréd: that: the study “was double-blind (Tr. 1247). Dr. Orentreich testified that: the > Btudy was double- blind-and‘Dr. Jenkins concerning’ thie‘ placebo). ° 2 2. The exact nature-of the coding of ‘the medications 4 is not! shoiwh: Were the same containers used over and over or ‘did each individual have his own set’ (Tr. 1248). (Dr. Orentreich made it:clear'that neither: . subject nor testers knew what was placebo and -what active and i in any event: Dr. Beaver didnot regard this defest-as fatal (‘Tr. 1248). . 8. The nature of the test preparation. ‘It -is ‘not clear whether: it produced.a condition comparable to naturally occurring sunburn (Tr. 1949). (Dr. Orentreich testified:that they had pretested the lamp and that the burn given was just under 2nd: degree). -4.: How :were the test: squares. laid out: (Tr 249). (Dn Oreitreich testified in detail concerning this).

5. How were the test medications: assipniéd to various areas.: Were they truly on random fashion (Tr. 1249). (Dr. Orentreich testified as to this and Dr. Salsburg testified that the results indicated statistically that the application was made in a random fashion). 6.. How were the test areas compared against the control area and what were the criteria for response (Tr. 1250). (Dr. Orentreich testified with respect to this at some length).

7. There was no statistical analysis (Tr. 1251). (Both Dr. Salsburg and Dr. Jenkins testified with respect to the statistical results). 8. There was no description of how the measured effect was elicited (Tr. 1251). (Dr. Orentreich covered this thoroughly on both direct and cross examination).

45. In light of the fact that the criticisms made of Dr. Orentreich’s study were all covered by the latter’s testimony or other testimony introduced in the case, Dr. Beaver’s testimony based solely on the test paper itself simply did not rebut the other testimony concerning the adequacy of the test. Accordingly, Dr. Orentreich’s test must be regarded as adequate to establish that Un- Burn anesthetizes: nerves in sunburned skin and relieves sunburn pain. © Propriety of Reliance on Historical Data and Clinical Experience 46, In regard to the drug efficacy studies conducted for the Food and Drug Administration, expert witnesses for both counsel support- “PFIZER, INC; 51 230 02~C~S Initial Decision ing the coniplaint and counsel for respondent were in agreement that the judgment of the physicians on the panel could be ‘considered i in evaluating the efficacy: of drugs (Dr.' Carlozzi—Tr.: 1101-1108; RX 110; Dr. Blank—Tr. 582-534; Dr. Beaver—Tr. 371-372, Tr. 1981). Oat, Dr. Norman Orentreich; who had conducted the post- complaint test (CX 84), expressed ‘the opinion that it'was ‘reasonable for Pfizer to make the claim that Un-Burn anesthetizes nerves in sensitive sunburned skin on the basis of thé safety and othér tests it had conducted and on the state of medical learning as-of May 1969 (Tr. 866). Among the reasons given were that “benzocaine has for seventy yéars, at least, been considered an effective topical anesthetic. I think that for a time students were taught it was the only effective topical anesthetic” (Tr. 867). He then analyzed the tésting done and stated “you had every reason to believe that it was reasonable that you had a safe and effective preparation” (Tr. 867-868).

48. Dr. Norman Kanoff; who had conducted the ‘prophetic patch test (CX 56; Tr. 1045) which is one of the safety tests relied on by respondent, is a specialist in dermatology, a graduate of Georgetown School of Medicine and an associate professor of dermatology at New York University *7 and director of Dermatology in New York Polyclinic Hospital (Tr. 1037-1039). He stated that the test he conducted was adequate and well-controlled and described how it was conducted (Tr. 1045) and that the other tests conducted (CX 40, 48, 50, 51, 52, 53, 54, 55, 56, 65, 66 and 67) were adequate for the purpose for which they were conducted (Tr. 1045) and that based on the tests and the state of medical learning in May 1969, it was reasonable for Pfizer Inc., to make the claims it did in its advertising (Tr. 1047-1049). One of the reasons was there was “generally accepted medical knowledge concerning the active ingredients” (Tr. 1049). He also testified that the clinical experience of practitioners is the ultimate test (Tr. 1049). 49. After reviewing the tests made by Pfizer, Dr. Robert A. Berger expressed the opinion that it was not necessary to run efficacy tests to make the claims made by Pfizer because the tests made showed safety, lack of irritation and sensitivity to allergic reaction and because the active ingredients have been in existence for many years, are present in many competitive formulations, and there is reference to them in the literature and much clinical experience as to their efficacy (Tr. 1153). He said that clinical experience in his opinion was what counted because the goal is to achieve a clinical result (Tr. 1154). 50. Dr. James W. Burks testified that the tests made by the Pfizer Company were adequate for the purpose for which they were con- 7 His curriculum vitae was received as RX 108 (Tr. 1037). Initial Decision 81 F.T.C.

ducted. (Tr. 1182) and that in his opinion based on a review of the tests and the state of medical learning in May. of 1969 it was reasonable for Pfizer to claim that Un-Burn would anesthetize: nerves in sensitive sunburned skin (Tr. 1183-1184). He said that he thought the tests were enough, if not more than enough, to establish the safety and lack of complications (Tr. 1084). He said he believed that clinical experience was the final test of the value of a drug and that investigative findings were purely supportive (Tr. 1185.). He said in the case. of these topical anesthetics. the doctors and the patients know they work (Tr. 1185). | :

On cross examination Dr. Burks. said. he based his opinion on the state of medical learning on.the first training he had and on the books he had studied. Benzocaine was listed as one of.the most useful anesthetics of the skin (Tr. 1190).. He also reiterated that if a drug was used for 50.to 70 or 100 years and was not found to be dangerous but highly effective it would make it unnecessary to do any investigative work (Tr. 1198). He also.acknowledged the placebé effect (Tr. 1194) and said it-gave relief i in “direct proportion to the enthusiasm of the one that gives it” (Tr. 1194). If you believe in the product you are prescribing it rubs off on the patient. (Tr. 1195). While acknowledging he could not control the patient he assumes that when he tells a patient at 2:00 a.m. to get a certain preparation that indicates the patient gets it, puts it on and if he doesn’t call back the doctor assumes the product worked (Tr. 1197). He also distinguished between the topical anesthetic benzocaine which was useful to ease reliably mild discomfort in sunburn and an anesthetic to prevent any feeling in an operation (Tr. 1199). With regard to the concentration, 1 or 2 percent is effective to permit the patient to get enough dulling effect to be able to sleep (Tr. 1200-1201).

51. Dr. William Beaver was recalled by counsel supporting the complaint on rebuttal and was asked concerning the efficacy of clinical experience. He testified that clinical experience alone in his opinion was not medically acceptable evidence of a drug’s ability to stop sunburn pain unless the medication dramatically, immediately and invariably stopped the pain (Tr. 1258). Having previously testified that he could not tell from reading the responses whether they were dramatic enough or not he was not permitted to testify whether or not the responses were sufficiently dramatic in the case of Un-Burn (Tr. 1264-1266).

PFIZER, INC. ~ 53 23 Initial Decision Summary Finding on Respondent's Defenses So 52. At the conclusion of respondent’s case it was established that: a, There was no implication from the advertising that adequate and well-controlled tests had been made. | b. Sunburned skin is not undamaged skin and has greater permeability than undamaged skin.

c. Recognized medical literature and the medical practice of dermatologists for between 50 and 70 years regarded the active.ingredients in Un-Burn as efficacious for the relief of sunburn pain. d. It was reasonable for respondent to rely on such clinical experience and medical literature for the efficacy of. Un-Burn without making adequate and well-controlled scientific tests to determine its efficacy, since there had. been adequate and well-controlled. scientific tests to determine its safety.

e. Following the issuance of the complaint, respondent catised a test to be made by Dr. Orentreich’s organization that conforms to the requirements for adequate and well-controlled testing. This test showed that it was much more probable than not that Un-Burn. was: more effective than its base materials in relieving sunburn pain. Summary Finding on Complaint Counsel’s Rebuttal . The testimony offered on rebuttal was inadequate to counter they proof offered by respondent.

REASONS FOR DECISION As pointed out in the order declining to dismiss the complaint or to certify the question to the Federal Trade Commission,"* it is very clear that the Commission not only possesses the authority to determine what facts constitute an unfair trade pactice but that it is its duty to maintain a vigilant watch over commerce to prevent new types of corrosive practices that impede fair competition. Accordingly, nothing in this decision denigrates the Commission’s power to declare that it is an unfair trade practice for a pharmaceutical company to advertise that its product has a particular effect unless the company has made certain by a reasonable * investigation made prior to the issuance of the advertising that such an effect can reasonably be expected to be produced.

Unlike the usual case of false advertising, there is no charge here that the claims made in the advertising are not wholly accurate. The 18 Order dated September 21, 1970. See particularly p. 3 citing FTC v. Brown Shoe Company, 384 U.S. 316, 821 (1966) and FTC v. Tewaco, 393 U.S. 223, 225 (1968). 19 See order of September 21, 1970, p. 2, 3 and the cases there cited. 54 FEDERAL TRADE, COMMISSION DECISIONS Initial. Decision 81 F.T.C.

charge is: (1) that the advertisement implies that adequate and wellcontrolled scientific tests were made prior to the advertising and (2) that: it is an unfair practice to advertise the product without having made adequate.and: well-controlled scientific tests as to its efficacy. Having viewed the T.V. presentation with a projector and listened to the simultaneous sound. recording device several times, as well as having studied the texts in evidence, the hearing examiner failed to observe anything that would: reasonably ®° imply that prior adequate and. well-controlled ‘scientific tests were conducted to determine the effectiveness of the product: Un-Burn:as charged in the complaint. Dr. Smith, the.expert called by the respondent, reinforced the hearing examiner’s.judgment by a careful and logical analysis. There was no rebuttal evidence:offered. We now consider the ‘second charge that it is an unfair practice to advertise a product like Un- Burn unless prior to the advertising, adequate and well-controlled scientific tests were conducted: to determine the products affieacy to anesthetize nerves and stop sunburn pain. :

In the opinion of the. undersigned, the practice ‘in this instance should: not: beheld to be-an unfair practice because thé active ingredients of Un-Burn, benzocaine and menthol, have for a great many years been recognized as effective topical local anesthetics in medical and pharmaceutical literature and have been in continuous use by doctors specializing in dermatology for the topical relief of sunburn pain for many years. There was no reckless disregard of the safety of the users, because carefully controlled tests were made first on animals and then on humans to determine that the product was safe, non-irritating and non-sensitizing. It was also established by an animal test that the base into which the active ingredients were compounded did not inhibit the anesthetic effect of the active ingredients. Clearly, no prior adequate and well-controlled scientific test was made on: human beings to-determine whether the product was efficacious in human beings. Thus, the ‘allegations of the complaint in this regard were established. And, if it were not for the fact that for between 50 and 70 years the medical profession and particularly those doctors who specialized in dermatology had been successfully using the active ingredients i in Un-Burn, benzoéaine and menthol, to relieve sunburn*pain, clearly an order should properly be issued because to advertise: an untried remedy without adequate testing would: be as the Commission charged an unfair trade practice. However, to take the position that a particular type of test must be made, wholly disregards the value of the clinical experience of a 2 The implication clearly must be within the bounds of reason,, FTO v. Colgate- Palmolive Co., et al., 380 U.S. 874: (1965). 23°) ~C- Initial Decision number of experts in the dermatology field. of medicine such as those called by: respondent.. Moreover, such a position would appear to repudiate clinical experience entirely.. and: to insist that- laboratory testing be substituted in all instances where advertising is involved. This would submerge the art ‘of medicine in a sea of laboratory tests. There was no dispute that the ingredients were used by doctors for the purpose claimed. Accordingly, | it does not seem reasonable to suppose that the Federal Trade ‘Commission would, deliberately take a position disregarding clinical experience particularly: since that .position would be contrary to the. position taken by the Food and Drug Administration in the adequacy testing ‘of drugs’ (See RX 110). It would seem, therefore, that the Federal Trade Commission under its announced policies would defer. to the agency that is specifically charged by, Congress’ with, determining the adequacy. and. safety of drug products." We assume that knowledge of the clinical tise of the product by. dermatologists was not brought to the attention of the Commission, at the time of the issuance of this complaint. Of the’ utmost significance is the fact also that the evidence. introduced demonstrated that the product i is in all probability quite effective to relieve, sunburn pain. So, it would be an exercise in futility to prevent claims being made without proof when now such proof has been made.

Only one doctor called by counsel supporting the complaint claimed that on test (which was concededly preliminary), he found Un-Burn ineffective. The same doctor some years before (using a method of testing which he now criticizes) had told one of respondent’s principal competitors in this field that its product Solarcaine was effective. He has not withdrawn such advice. Respondent’s product was designed to emulate Solarcaine and used much the same ingredients. After the complaint was issued by the Commission, moreover, respondent caused a test to be conducted that in the opinion of the undersigned was adequate to establish that the product was probably effective to relieve sunburn pain by anesthetizing nerves. The only criticism of the test completely disregarded the testimony given by the doctor who had conducted the test and by the statistician who attested to its statistical validity. The criticism was founded solely on the text of the unpublished report. oo -On the basis of the evidence as a whole, therefore, particularly the evidence of clinical. use which presumably was not before ‘the Com- 21Tt will be recalled that in the matter of National Association. of Women’s and. Chil- “dren’s Apparel Salesmen, Docket 8691 (76 B.T.C. 1082], the Commission ‘deferred to the decision of NLRB under'similar conditions. . . 56 FEDERAL TRADE..COMMISSION DECISIONS Initial Decision 81 FTC.

mission when it: issued the complaint, and on-the basis of the postcomplaint testing we are of the opinion that the public interest would not be served: by the. entry of a cease and desist order j in this case. CON’ CLUSIONS 1. The Commission has jurisdiction over the ‘pei'son of respondent and over the subject matter of this pr oceeding. . 2. The. evidence failed to establish that the advertising reasonably implied that adequate. and. well-controlled. scientific tests had been. made prior to the issuance of the advertising. . The evidence failed to establish that the product was 5 not effective to Trodues relief from sunburn. -pain.

4, While the evidence established that no adequate and well- -controlled scientific tests were conducted to determine. the efficacy of the product prior to the issuance of the advertising, the medical literature and well-recognized clinical experience demonstrated that the ingredients in the product had been considered efficacious by specialists in the field of dermatology for between 50 and 70 years and it was reasonable for the respondent in those special circumstances to make claims based on such historical and clinical proof and to test only for safety. The safety tests were adequate and well-controlled. 5. It would thus in the opinion of the hearing examiner not be in the public interest under the peculiar facts established in this proceeding, particularly those developed after the complaint was filed, to issue a cease and desist order.

6. The following order should be issued.

ORDER It is ordered, That the complaint herein be and the same is hereby dismissed.

OPINION OF THE ComMMISSION By Kimxrarricx, Commissioner :

I THE PROCEEDINGS On July 15, 1970, the Federal Trade Commission issued its complaint alleging that Pfizer, Inc., had violated Section 5 of the Federal Trade Commission Act. Respondent Pfizer contested the allegations of this complaint and the matter was assigned to a hearing examiner for a hearing. The hearing examiner decided that the Commission’s staff counsel had failed to establish that an order to cease and desist ' PFIZER, INC...) 57.

23. Qpinion should issue. Counsel supporting. the complaint have appealed the examiner’s decision to the Commission. Upon consideration of the record of the proceedings before the hearing examiner, the examiner’s initial decision, and the briefs and arguments of the patties, the Commission has decided that the decision of the hearing examiner should be affirmed.

1 THE COMPLAINT — The Commission’s staff counsel, who have the burden of proving the allegations of the complaint, challenge certain advertising by Pfizer for the product “UN-BURN,” a nonprescription product recommended. for use on minor burns and sunburn. The complaint cited the following radio and television. advertising for Un-Burn as typical . and representative: fe ogo New Un-Burn actually: anesthetizes nerves: in senatitve sunburned skin. Un-Burn relieves pain fast. Actually anesthetizes nerves in sensitive .sun-: burned skin. : :

Sensitive skin * * * Sunburned skin is sensitive skin * ** Sensitive sunburned skin needs * * * UN-BURN. New UN-BURN contains’ the ‘same local anesthetic doctors often use'* * * Actually anesthetizes nerves in sensitive sunburned skin. I'll tell you what I like about UN-BURN. It’s the best ‘friend: a! blonde ever had! * * * I’m a blonde * * *-and I know what it means to ‘have sensitive skin. Why I’m half afraid of moon burn! That’s why I'm mad about UN-BURN. It stops sunburn pain in * * * less time than it takes me to slip out of my bikini. That’s awfully nice to know when you’re the sensitive type * *.*? | The complaint alleges that the foregoing advertising claims were not substantiated by Pfizer by “adequate and well-controlled scientific studies or tests prior to the making of such statements.” Based on these facts, complaint counsel set forth charges alleging two separate and distinct violations of Section 5 of the Federal Trade Commission Act—first, a charge of unlawful deception, and second, a charge of unlawful unfairness. The deception charge alleged that Pfizer’s advertising constituted a deceptive practice in representing to consumers that “each of the statements respecting the pain-relieving properties of the said product has been substantiated by respondent by adequate and well-controlled scientific studies or tests prior to the making of such statements.” The unfairness charge rests upon the proposition that it is an wnfaér practice to make advertising claims of this nature lacking adequate and well-controlled studies or tests." 1As recommended by. the hearing - examiner in his initial decision, during the-oral argument before it the Commission observed the TV commercials being challenged, and ‘listened to the radio tapes. (See I.D., pp. 6-7 [p. 30 herein]. CX 4, 5, 6, 7.) These advertisements for Un-Burn contain two primary representations: (1): Un-Burn will actually anesthetize nerves in sunburned skin; (2) Un-Burn will stop sunburn pain fast. 494-841-—73 5"

58: FEDERAL TRADE “COMMISSION DECISIONS Opinion’ 81 FTC.

Ta, DECEPTION”

Section. 5 of the, Federal. Trade Commission Act: provides that decep>, tive acts or practices in-commerce-are unlawful. In‘Section 5. advertis-; ing cases, the requisite “acts or practices”. have usually taken one of three forms: (1) advertising containing direct representations; (2): advertising containing representations which reasonably may be said to be implied by the advertising, or (3) advertising which fails to disclose material facts. The Commission may utilize:its. accumulated “expertise” in analyzing the facts of each case to determine what: direct: and’ ‘implied representations. are’ contained in: advertising.” Its expértise is also: utilized’ in evaluating what facts‘are material to consummers, and theréby to determine the situations in which material’ facts have not been disclosed. A sufficient showing of deception is made: if there;exists a. “capacity:to deceive.?” In evaluating the capacity. of an advertisement: to:deceive, the net impression of the’ advertisement, evaluated from the perspective | of the audience to whom the advertising is directed, i is controlling. | It is: against the foregoing regulatory framework that the deception. charge j in this case must be viewed. “While there were many direct’ representations contained i in the Un- Burn advertising, they are not being challenged. Thus, unlike most deceptive advertisting cases, the truth or falsity, or deceptiveness, of advertising claims such as “New Un-Burn,” or “actually anesthetizes nerves,” or “relieves pain fast” is not an issue in this proceeding. The complaint does charge, however, that respondent’s advertising, both directly and by implication, represented that each of the statements respecting the pain-relieving properties of Un-Burn has been substantiated by respondent by adequate and well-controlled scientific studies or tests prior to the making of such statements. Complaint counsel have not undertaken to prove explicit deception, but rather are relying solely upon the Commission’s expertise to find that the implied representation is reasonably contained in the advertising, and that it has the capacity to deceive consumers.* Complaint 2 FTC v. Colgate-Palmolive Co., 380.U.S: 874 (1965).° 8 See Gellhorn, Proof of Consumer Deception Before ‘the Federal Trade Commission, 17 Kansas L. Rev. 559 (1969). :

*(O.A. Tr. p. 4). Complaint counsel frame their argument in the following terms : “(I]t is obvious that (1) because respondent's advertising clearly represented that Un- Burn is a drug that will stop sunburn pain fast (Tr. 779), (2) because the public believes that an advertiser cannot make false claims about -his: product (Tr. ‘774, 776, 778), (8) because the public expects a product to work (Tr. 778, 779), and. (4) because the public expects a manufacturer to have evidence that:his product will work as claimed (Tr. 778, 779;.780, 781), respondent did“in fact represent in its.advertising that each of. the statements respecting the: pain relieving properties claimed for Un-Burn had been substantiated: by respondent with adequate and reliable evidence and that this evidence was obtained prior to the making of such statements.” (Complaint counsel’s appeal brief, pp,,5 & 6.) 2 Opinion’ .

counsel argue that Un-Burti’s‘ advertising’ implied that—each statement, in advertising—respecting pain-relieving .properties—has been substantiated—by respondent—by adequ ate—and ‘well-controlled— scientific tests—or' studies—conducted prior to he making. of such statements: Thus, we are urged, for >, tc o make th following distinctions: (1) between‘ ‘pa, ° of product eflency, sont ty $I F have been “by” someone else (competitors, doctors, Soman, re dependent laboratories, ete.) ; (3) between a very precise ‘type of sub: stantiation (“adequate and well-controlled scientific studies or tests”), and other possible standards of substantiation (¢.9., adequate'substan- 4 1 6 1 5 0 631 1260 1349 63 -1 5 1 6 1 5 1 631 1270 136 47 96.991753 tiation,5 1 6 1 5 2 781 1265 103 44 96.644356 usual5 1 6 1 5 3 892 1269 81 52 94.689110 ands 1 6 1 5 4 981 1264 204 58 81.840141 customary.5 1 6 1 5 5 1181 1261 113 62 60.691578 ‘steps,5 1 6 1 5 6 1309 1265 202 38 69.849487 reasonable5 1 6 1 5 7 1522 1266 103 45 85.763390 basis,5 1 6 1 5 8 1640 1262 162 58 94.596603 reliable,5 1 6 1 5 9 1807 1260 155 51 71.512238 compre-5 1 6 1 5 10 1975 1260 5 17 17.528572 *4 1 6 1 6 0 630 1297 1350 76 -1 5 1 6 1 6 1 630 1297 164 76 17.731491 hensive,5 1 6 1 6 2 805 1328 62 28 92.261307 etc.)5 1 6 1 6 3 900 1349 14 23 84.439568 5,5 1 6 1 6 4 942 1314 53 52 96.888168 (4)5 1 6 1 6 5 1026 1317 160 56 71.199303 between5 1 6 1 6 6 1189 1313 211 59 62.158379 “Scientific,5 1 6 1 6 7 1413 1320 131 44 97.004242 studies5 1 6 1 6 8 1570 1331 38 21 96.911186 or5 1 6 1 6 9 1633 1317 105 35 95.939949 tests”5 1 6 1 6 10 1755 1313 80 48 96.682838 ands 1 6 1 6 11 1858 1308 92 56 96.596001 others 1 6 1 6 12 1966 1310 14 53 94.734993 |4 1 6 1 7 0 628 1353 1352 83 -1 5 1 6 1 7 1 628 1367 131 69 94.920479 possible5 1 6 1 7 2 785 1386 18 33 66.167801 |5 1 6 1 7 3 795 1373 102 49 70.310516 bases5 1 6 1 7 4 909 1369 67 56 95.581657 for5 1 6 1 7 5 987 1367 139 57 2.231178 substan5 1 6 1 7 6 1169 1365 112 60 76.955872 ation,5 1 6 1 7 7 1285 1373 84 45 96.287209 such5 1 6 1 7 8 1386 1368 39 50 96.287209 as5 1 6 1 7 9 1444 1357 147 61 94.168991 medical5 1 6 1 7 10 1610 1353 195 64 96.240303 literature,5 1 6 1 7 11 1821 1360 159 42 52.276058 clinical’4 1 6 1 8 0 629 1407 1351 83 -1 5 1 6 1 8 1 629 1426 207 41 96.711769 experience,5 1 6 1 8 2 840 1421 188 37 0.000000 consumers 1 6 1 8 3 1038 1409 216 62 85.889046 experience;5 1 6 1 8 4 1257 1407 95 49 59.766106 ‘and:5 1 6 1 8 5 1357 1413 65 52 96.763893 (5)5 1 6 1 8 6 1429 1418 152 37 96.956940 between5 1 6 1 8 7 1586 1419 155 45 67.100098 “prior”5 1 6 1 8 8 1745 1419 133 71 96.095398 testing5 1 6 1 8 9 1887 1419 70 66 96.915039 anda 1 6 1 9 0 628 1475 908 42 -1 5 1 6 1 9 1 628 1488 19 21 96.538658 a5 1 6 1 9 2 657 1476 199 33 94.009026 reasonable5 1 6 1 9 3 863 1476 93 33 96.775658 basis5 1 6 1 9 4 967 1476 58 33 96.862320 for5 1 6 1 9 5 1033 1476 121 50 96.388084 belief,5 1 6 1 9 6 1159 1480 40 28 96.943130 or5 1 6 1 9 7 1205 1475 208 48 96.106667 subsequent5 1 6 1 9 8 1421 1477 115 29 40.248444 tests.3 1 6 2 0 0 631 1494 1352 585 -1 4 1 6 2 1 0 676 1494 1287 88 -1 5 1 6 2 1 1 676 1527 208 55 60.837471 Complaints 1 6 2 1 2 891 1517 148 57 68.771210 counsel’5 1 6 2 1 3 1040 1521 114 57 83.960869 argué5 1 6 2 1 4 1162 1521 86 46 40.016541 that:5 1 6 2 1 5 1248 1522 252 55 9.740662 -respondent’s5 1 6 2 1 6 1506 1518 221 59 95.462334 advertising5 1 6 2 1 7 1741 1494 222 74 89.059151 represented4 1 6 2 2 0 632 1569 1347 51 -1 5 1 6 2 2 1 632 1571 54 40 91.932076 to5 1 6 2 2 2 693 1578 208 35 63.656631 consumers5 1 6 2 2 3 910 1572 94 48 17.078011 that’5 1 6 2 2 4 1012 1572 182 49 50.921967 Un-Burn’5 1 6 2 2 5 1210 1574 40 43 23.494865 is’5 1 6 2 2 6 1264 1587 21 31 23.494865 a5 1 6 2 2 7 1300 1569 105 51 96.659660 drugs 1 6 2 2 8 1423 1569 118 49 94.905342 which5 1 6 2 2 9 1555 1569 159 53 83.705101 actually5 1 6 2 2 10 1737 1569 242 50 39.477482 anesthetizes5 1 6 2 2 11 1969 1565 12 61 0.000000 _4 1 6 2 3 0 632 1612 1337 59 -1 5 1 6 2 3 1 632 1626 119 36 96.766685 nerves5 1 6 2 3 2 769 1629 39 33 96.738297 in5 1 6 2 3 3 825 1623 163 47 96.527779 sensitive5 1 6 2 3 4 1000 1614 211 54 80.986633 sunburned,5 1 6 2 3 5 1220 1612 90 59 96.996712 skin,5 1 6 2 3 6 1327 1626 71 41 96.306908 ands 1 6 2 3 7 1416 1615 115 44 96.832520 which5 1 6 2 3 8 1548 1625 73 33 96.636703 will5 1 6 2 3 9 1639 1617 151 49 73.580673 provide.5 1 6 2 3 10 1800 1621 74 38 89.303818 fast5 1 6 2 3 11 1891 1623 78 40 82.207100 anda 1 6 2 4 0 631 1673 1330 47 -1 5 1 6 2 4 1 631 1680 88 32 96.999184 totals 1 6 2 4 2 738 1679 101 33 95.349930 relief5 1 6 2 4 3 858 1679 40 33 95.349930 of5 1 6 2 4 4 916 1680 156 32 96.787186 sunburn5 1 6 2 4 5 1090 1678 93 42 96.537300 pain.5 1 6 2 4 6 1204 1668 200 51 96.643547 Complaints 1 6 2 4 7 1422 1664 137 46 96.775230 counsels 1 6 2 4 8 1577 1675 66 33 96.850853 cites 1 6 2 4 9 1660 1675 60 32 96.746437 thes 1 6 2 4 10 1737 1674 126 42 93.281509 phrases 1 6 2 4 11 1880 1673 81 32 93.100830 “an-4 1 6 2 5 0 632 1725 1329 45 -1 5 1 6 2 5 1 632 1730 179 34 93.241272 esthetizes5 1 6 2 5 2 832 1741 120 22 96.446625 nerves5 1 6 2 5 3 974 1730 93 32 96.430031 fast”5 1 6 2 5 4 1090 1729 70 33 96.788025 ands 1 6 2 5 5 1180 1728 73 33 77.484970 thes 1 6 2 5 6 1261 1727 214 43 61.394138 advertising5 1 6 2 5 7 1497 1727 191 33 96.776741 references5 1 6 2 5 8 1709 1729 36 29 96.916725 to5 1 6 2 5 9 1766 1725 135 33 96.549408 doctors5 1 6 2 5 10 1924 1734 37 22 96.566368 as4 1 6 2 6 0 634 1775 1328 53 -1 5 1 6 2 6 1 634 1782 197 46 96.905853 statements5 1 6 2 6 2 846 1780 114 34 97.009872 which5 1 6 2 6 3 975 1790 194 23 96.974579 consumers5 1 6 2 6 4 1183 1779 73 33 96.620247 will5 1 6 2 6 5 1272 1778 164 34 96.864799 associates 1 6 2 6 6 1450 1778 87 32 96.555656 with5 1 6 2 6 7 1551 1776 165 34 96.263916 scientific5 1 6 2 6 8 1730 1776 105 42 96.696877 proofs 1 6 2 6 9 1849 1775 40 43 96.945930 of5 1 6 2 6 10 1900 1775 62 32 94.743614 thea 1 6 2 7 0 634 1826 1326 48 -1 5 1 6 2 7 1 634 1830 174 44 91.812988 product’s5 1 6 2 7 2 824 1828 135 46 96.176895 efficacy5 1 6 2 7 3 977 1831 70 33 96.314186 ands 1 6 2 7 4 1064 1842 38 22 95.825851 as5 1 6 2 7 5 1119 1829 173 44 96.533356 implying5 1 6 2 7 6 1308 1829 145 33 96.257561 medical5 1 6 2 7 7 1472 1827 231 43 96.123695 approbation5 1 6 2 7 8 1720 1826 40 33 93.253799 of5 1 6 2 7 9 1775 1827 185 41 90.656250 Un-Burn.4 1 6 2 8 0 634 1876 1329 48 -1 5 1 6 2 8 1 634 1884 44 31 96.719948 In5 1 6 2 8 2 699 1893 169 31 96.135063 response,5 1 6 2 8 3 888 1878 209 45 96.867233 respondents 1 6 2 8 4 1116 1892 123 31 96.387840 argues5 1 6 2 8 5 1258 1881 79 32 96.131149 that5 1 6 2 8 6 1355 1881 60 31 96.878204 thes 1 6 2 8 7 1435 1881 87 31 96.966339 totals 1 6 2 8 8 1543 1879 128 42 96.394958 settings 1 6 2 8 9 1690 1878 40 33 96.455147 of5 1 6 2 8 10 1747 1878 61 32 96.967575 thes 1 6 2 8 11 1828 1878 55 40 96.878387 ad,5 1 6 2 8 12 1900 1876 63 40 88.773949 thea 1 6 2 9 0 634 1928 1328 47 -1 5 1 6 2 9 1 634 1934 169 33 96.748512 frivolous5 1 6 2 9 2 818 1937 123 29 96.612923 nature5 1 6 2 9 3 955 1933 42 33 96.651794 of5 1 6 2 9 4 1012 1933 60 33 96.651794 thes 1 6 2 9 5 1086 1929 171 46 96.896622 dialogue,5 1 6 2 9 6 1271 1932 60 32 96.533730 thes 1 6 2 9 7 1345 1942 61 22 96.774712 uses 1 6 2 9 8 1420 1931 40 32 96.773537 of5 1 6 2 9 9 1474 1943 22 21 93.243195 a5 1 6 2 9 10 1509 1929 156 34 92.196877 bikinied5 1 6 2 9 11 1679 1929 123 40 96.601074 model,5 1 6 2 9 12 1819 1928 68 33 96.237434 ands 1 6 2 9 13 1902 1928 60 32 96.941597 thea 1 6 2 10 0 634 1977 1327 51 -1 5 1 6 2 10 1 634 1996 124 32 96.213257 general5 1 6 2 10 2 794 1984 107 33 96.454803 “aura5 1 6 2 10 3 922 1984 40 33 96.703392 of5 1 6 2 10 4 985 1984 168 33 96.782478 sexiness”5 1 6 2 10 5 1176 1986 145 40 96.849022 prevents 1 6 2 10 6 1341 1977 60 38 96.959000 thes 1 6 2 10 7 1423 1982 54 41 96.682404 ad,5 1 6 2 10 8 1498 1981 105 33 96.509209 taken5 1 6 2 10 9 1625 1991 38 23 96.829613 as5 1 6 2 10 10 1684 1991 21 22 96.891159 a5 1 6 2 10 11 1726 1979 120 41 96.978584 whole,5 1 6 2 10 12 1868 1978 93 33 96.411438 from4 1 6 2 11 0 634 2031 1173 48 -1 5 1 6 2 11 1 634 2036 171 43 96.248627 carrying5 1 6 2 11 2 811 2036 59 32 96.722328 thes 1 6 2 11 3 884 2034 165 34 96.993507 scientific5 1 6 2 11 4 1063 2037 178 31 96.509834 overtones5 1 6 2 11 5 1254 2034 131 43 96.461411 argued5 1 6 2 11 6 1399 2033 46 43 96.619461 by5 1 6 2 11 7 1459 2031 189 43 96.618668 complaints 1 6 2 11 8 1662 2031 145 33 96.435165 counsel.3 1 6 3 0 0 634 2080 1351 609 -1 4 1 6 3 1 0 678 2080 1284 48 -1 5 1 6 3 1 1 678 2086 199 42 82.571159 Complaints 1 6 3 1 2 891 2086 164 43 92.976837 counsel’s5 1 6 3 1 3 1069 2085 96 34 96.999603 sixth5 1 6 3 1 4 1179 2085 171 43 96.474533 proposed5 1 6 3 1 5 1363 2084 137 43 96.490746 findings 1 6 3 1 6 1513 2082 41 34 96.482269 of5 1 6 3 1 7 1568 2082 75 34 96.565063 facts 1 6 3 1 8 1656 2082 115 33 96.565063 would5 1 6 3 1 9 1784 2081 85 33 96.559097 holds 1 6 3 1 10 1883 2080 79 33 96.534088 that4 1 6 3 2 0 634 2131 1326 62 -1 5 1 6 3 2 1 634 2138 207 42 90.461418 respondents 1 6 3 2 2 861 2127 218 52 90.461418 represented5 1 6 3 2 3 1098 2136 56 57 96.313377 by5 1 6 3 2 4 1162 2135 218 43 96.433014 implications 1 6 3 2 5 1397 2135 79 32 96.433014 that5 1 6 3 2 6 1494 2135 60 32 96.929237 thes 1 6 3 2 7 1573 2126 199 41 96.758247 statements5 1 6 3 2 8 1789 2132 80 33 93.186882 that5 1 6 3 2 9 1886 2131 74 35 92.647476 Un-4 1 6 3 3 0 635 2181 1349 45 -1 5 1 6 3 3 1 635 2190 99 32 93.057327 Burns 1 6 3 3 2 756 2188 224 33 92.720276 anesthetizes5 1 6 3 3 3 1003 2198 121 23 96.557182 nerves5 1 6 3 3 4 1146 2187 38 32 96.640152 in5 1 6 3 3 5 1206 2185 161 35 96.540993 sensitive5 1 6 3 3 6 1390 2185 78 33 96.999413 skins 1 6 3 3 7 1490 2179 71 39 96.736885 ands 1 6 3 3 8 1584 2188 95 38 96.761909 stops5 1 6 3 3 9 1702 2175 155 42 96.263718 sunburn5 1 6 3 3 10 1874 2181 89 44 66.612167 pain.5 1 6 3 3 11 1981 2203 3 7 66.612167 .4 1 6 3 4 0 634 2234 1328 46 -1 5 1 6 3 4 1 634 2241 73 33 94.580719 fast5 1 6 3 4 2 727 2240 89 32 96.046745 have5 1 6 3 4 3 835 2239 85 33 96.046745 been5 1 6 3 4 4 940 2237 253 35 96.070992 substantiated5 1 6 3 4 5 1213 2238 45 42 96.745712 by5 1 6 3 4 6 1279 2236 208 43 95.971405 respondents 1 6 3 4 7 1507 2237 46 41 96.391533 by5 1 6 3 4 8 1574 2235 187 43 96.611389 “adequate5 1 6 3 4 9 1780 2234 182 34 96.501251 evidence”4 1 6 3 5 0 635 2284 1327 49 -1 5 1 6 3 5 1 635 2290 98 43 97.001945 prior5 1 6 3 5 2 748 2293 37 30 96.952171 to5 1 6 3 5 3 800 2291 61 32 95.999527 thes 1 6 3 5 4 877 2289 145 44 96.517784 making5 1 6 3 5 5 1037 2289 41 33 96.705772 of5 1 6 3 5 6 1094 2289 84 49 96.776077 such5 1 6 3 5 7 1194 2292 208 29 96.758232 statements.5 1 6 3 5 8 1421 2287 203 45 93.253265 Complaints 1 6 3 5 9 1639 2286 166 33 88.969246 counsel’s5 1 6 3 5 10 1819 2284 143 34 96.966301 seventh4 1 6 3 6 0 634 2335 1351 49 -1 5 1 6 3 6 1 634 2341 171 43 96.593910 proposed5 1 6 3 6 2 821 2340 137 44 96.593910 findings 1 6 3 6 3 974 2341 40 33 97.013885 of5 1 6 3 6 4 1031 2340 84 41 96.987061 fact,5 1 6 3 6 5 1132 2336 45 38 96.874741 on5 1 6 3 6 6 1192 2340 60 33 96.947212 thes 1 6 3 6 7 1268 2340 99 32 96.376671 others 1 6 3 6 8 1382 2339 106 41 96.916992 hand,5 1 6 3 6 9 1504 2349 82 32 96.441742 goes5 1 6 3 6 10 1597 2328 152 43 96.714470 further.5 1 6 3 6 11 1767 2336 62 33 96.578827 It5 1 6 3 6 12 1819 2346 32 23 96.917549 is5 1 6 3 6 13 1866 2335 96 33 31.346725 there4 1 6 3 7 0 635 2364 1327 72 -1 5 1 6 3 7 1 635 2393 129 43 96.615814 argued5 1 6 3 7 2 786 2393 87 32 73.129135 that5 1 6 3 7 3 889 2392 45 43 84.590202 by5 1 6 3 7 4 956 2391 239 43 96.288231 representing5 1 6 3 7 5 1215 2391 81 32 94.849594 that5 1 6 3 7 6 1315 2391 84 42 94.849594 they5 1 6 3 7 7 1420 2364 71 59 96.956093 had5 1 6 3 7 8 1514 2389 199 42 96.069038 “adequate5 1 6 3 7 9 1723 2387 180 44 96.018967 evidence”5 1 6 3 7 10 1920 2390 42 29 96.729744 to4 1 6 3 8 0 635 2438 1333 47 -1 5 1 6 3 8 1 635 2443 227 40 96.490486 substantiate.5 1 6 3 8 2 884 2443 91 33 85.887093 theirs 1 6 3 8 3 998 2442 228 43 85.887093 advertising5 1 6 3 8 4 1234 2442 130 41 96.594391 claims,5 1 6 3 8 5 1387 2441 208 41 96.221283 respondents 1 6 3 8 6 1616 2439 141 43 96.761429 thereby5 1 6 3 8 7 1780 2438 188 42 92.575912 impliedly4 1 6 3 9 0 636 2485 1327 53 -1 5 1 6 3 9 1 636 2495 237 47 96.956268 represented5 1 6 3 9 2 865 2494 78 42 96.720070 that5 1 6 3 9 3 956 2494 82 43 96.720070 they5 1 6 3 9 4 1052 2494 174 43 96.776535 possessed5 1 6 3 9 5 1240 2493 165 49 96.776535 adequate5 1 6 3 9 6 1419 2493 68 40 96.766800 ands 1 6 3 9 7 1501 2490 283 34 94.907097 well-controlled5 1 6 3 9 8 1794 2485 169 51 91.891174 scientific4 1 6 3 10 0 635 2540 1343 40 -1 5 1 6 3 10 1 635 2546 130 34 96.789139 studies5 1 6 3 10 2 789 2557 40 21 96.925537 or5 1 6 3 10 3 851 2549 85 29 96.968094 tests5 1 6 3 10 4 961 2545 115 33 96.407372 which5 1 6 3 10 5 1099 2539 252 38 96.565811 substantiated5 1 6 3 10 6 1367 2539 92 44 96.565811 such5 1 6 3 10 7 1482 2542 128 33 96.097923 claims.5 1 6 3 10 8 1634 2542 78 33 95.426613 Thes 1 6 3 10 9 1735 2534 243 48 87.070961 Commissions 1 6 3 10 10 1965 2530 15 58 63.697144 .4 1 6 3 11 0 635 2590 1328 75 -1 5 1 6 3 11 1 635 2599 81 32 96.154022 does5 1 6 3 11 2 735 2601 59 28 95.709152 not5 1 6 3 11 3 814 2597 129 32 95.709152 believes 1 6 3 11 4 961 2596 79 33 95.910011 that5 1 6 3 11 5 1058 2596 83 32 95.910011 such5 1 6 3 11 6 1158 2599 47 29 96.022133 an5 1 6 3 11 7 1217 2590 152 75 88.723373 implied5 1 6 3 11 8 1388 2590 284 61 79.487206 representations 1 6 3 11 9 1678 2603 66 22 96.374069 cans 1 6 3 11 10 1759 2591 204 59 96.742958 reasonably4 1 6 3 12 0 635 2645 725 44 -1 5 1 6 3 12 1 635 2650 40 32 96.967392 be5 1 6 3 12 2 689 2648 130 33 96.161476 found5 1 6 3 12 3 811 2659 35 21 93.212044 in5 1 6 3 12 4 859 2647 235 42 91.881851 respondent’s5 1 6 3 12 5 1107 2645 253 44 91.913681 advertising..5 1 6 3 12 6 1350 2641 15 55 90.078705 .2 1 7 0 0 0 1106 1372 74 38 -1 3 1 7 1 0 0 1106 1372 74 38 -1 4 1 7 1 1 0 1106 1372 74 38 -1 5 1 7 1 1 1 1106 1372 74 38 95.000000 60° FEDERAL TRADE. COMMISSION DECISIONS Opinion 81 F.T.C,.

We UNFATRNESE, :

The Commission's jurisdiction to proseri e “unfair”. commercial practices ‘has been utilized. ‘frequently as an. ‘independent basis for Commission action.® Most often the. term is ‘coupled, perhaps i in an effort to add direction and’ content, ‘either to the decéptive or to the © restrictive aspects of the practice - in “question. The Commission, of course, has been delegated the j power by Congréss to give definition and content to the term “unfair practices.”? The 1938 Wheeler-Léa, Amendment. made it clear that this jurisdiction extends to’ the protection of consumers; . Lo feng dine be * *.* this. amendment makes. the consumer, _ who may. be injured by an 1 unfair trade, practice,, of. equal concern, before the law, with the merchant or manufacturer ‘injured by the unfair ‘methods of a “dishonest competitor.® The Commission’s responsibilities with regard to unfair trade prac. tices were. analyzed i in its 1969 All State I ndustries opinion: ® [T]he responsibility of the Commission in: this réspéct is a dynamic, one: it-is charged not only with preventing, well-understood, clearly. defined, . unlawful conduct but, with utilizing its broad powers of. investigation and its ‘accumulated ; knowledge and experience in the field of trade’ ‘regulation to investigate, identify, and define those practices which should be forbidden as unfair because contrary to’ the public policy declared in the Act. The Commission, in short, is expected to proceed not only against practices forbidden by statute or.common law, but also against practices not previously considered unlawful, and thus to create a new body of law—a law of unfair trade practices adapted to the diverse and changing needs of a complex and evolving competitive system. . The recent S & H case sets forth a succinct confirmation of the Commission’s jurisdiction over unfair practices : [T]he Federal Trade Commission does not arrogate excessive power to itself if, in measuring a practice against the elusive, but congressionally: mandated standard of fairness, it, like a court of equity, considers public values beyond simply those enshrined in the letter or encompassed in the spirit. of the antitrust laws. ® « ® Cf, All-State Industries, et al., Docket No. 8738: (April 1, 1969), 423 F.2d 423 (1970), cert. denied, 400 U.S. 828 (1970) ; FTO v. R. F. Keppel & Bros., Inc., 291 U.S. 804 (1934) ; Wolf v. FTO, 185 F.2d 564 (7th Cir. (1943) ) 3 First Buckingham Oommunity, Inc., Docket 8750 (May 20, 1968) [73 F.T.C. 938]; Ohemway Oorporation, Docket C-1945 (June 14, 1971) [78 F.T.C. 1250].

© See, e.9., Topper Corporation, et al., Docket C-2073 (November 1, 1971) {79 WTC. 681].

7 FTO vy, Sperry & Hutchinson, Dockets 8671 (June 1968), ‘rev'd, 432 F.2d 146 (5th. cir. 1970), rev’d, 405 U.S. 288 (March 1, 1973). ‘+ ELR. Rep. No. 163, 75th Cong. 1st Session, p. 3 (1937). © Slip opinion at p. 11.

10 Federal Trade Commission v. Sperry ¢ Hutchinson Co., supra. 2300. Opinion Tn footnoting this statement; the’ court said: The ‘Commission has described the factors it considers i in determining ‘whether “a “practice which is neither in violation of the antitrust laws nor deceptive is is nonetheless unfair: ie , €1) whether: the practices, ‘without, necessarily, having peen previously. considered unlawful, offends. public policy. as: it: has, been established. .by statutes, the common ‘law, or otherwise—whether, in other words, it ig (within. ‘at least the penumbra of some common law, statutory, or other established concept of unfairness; * (2) “whether: it is immoral, “unethical, oppressive or unscrupulous, : 8), whether it causes: substantial injury: to consumers (or competitors: or other ‘Health Hazards of t Smoking]. ” 295 1 5 1 1 8 1212 1155 80 60 69.390968 Fed,5 1 5 1 1 9 1294 1155 57 66 72.371986 ‘Re,5 1 5 1 1 10 1386 1143 81 72 61.941017 8824,5 1 5 1 1 11 1480 1156 72 62 60.594757 83565 1 5 1 1 12 1569 1144 119 74 67.809402 (1964).4 1 5 1 2 0 1335 1181 38 40 -1 5 1 5 1 2 1 1335 1181 38 44 69.262192 Be2 1 6 0 0 0 630 1207 1343 1186 -1 3 1 6 1 0 0 630 1207 1343 371 -1 4 1 6 1 1 0 649 1207 1324 71 -1 5 1 6 1 1 1 649 1271 3 2 0.000000 »5 1 6 1 1 2 688 1230 59 33 95.992546 An5 1 6 1 1 3 758 1213 204 50 93.163673 unfairness5 1 6 1 1 4 977 1216 151 61 96.870789 analysis5 1 6 1 1 5 1144 1207 85 58 83.765862 will,5 1 6 1 1 6 1232 1210 84 53 96.969810 takes 1 6 1 1 7 1327 1227 76 51 96.460800 into5 1 6 1 1 8 1417 1214 145 60 88.248764 accounts 1 6 1 1 9 1574 1225 108 50 96.939400 many5 1 6 1 1 10 1686 1209 111 61 75.606453 basics 1 6 1 1 11 1797 1230 176 45 95.579857 economic4 1 6 1 2 0 647 1280 1323 46 -1 5 1 6 1 2 1 647 1280 92 37 96.065979 facts5 1 6 1 2 2 750 1281 73 33 29.956818 and.5 1 6 1 2 3 831 1281 288 42 29.956818 considerations,5 1 6 1 2 4 1123 1282 69 32 96.210564 ands 1 6 1 2 5 1203 1273 75 41 96.572197 will5 1 6 1 2 6 1288 1282 132 44 95.663673 permits 1 6 1 2 7 1425 1293 20 21 95.663673 a5 1 6 1 2 8 1455 1273 109 44 96.806549 broad5 1 6 1 2 9 1576 1282 117 35 96.388649 focus5 1 6 1 2 10 1677 1269 20 59 94.123177 i5 1 6 1 2 11 1684 1292 41 34 86.900146 in-5 1 6 1 2 12 1729 1273 70 44 92.280235 thes 1 6 1 2 13 1800 1281 170 42 91.923523 examina-4 1 6 1 3 0 645 1323 1326 54 -1 5 1 6 1 3 1 645 1331 76 37 96.975777 tions 1 6 1 3 2 736 1332 40 43 96.975777 of5 1 6 1 3 3 789 1332 198 44 96.622490 marketing5 1 6 1 3 4 1001 1326 176 50 93.222000 practices.5 1 6 1 3 5 1192 1332 234 39 92.756981 Unfairness5 1 6 1 3 6 1416 1343 33 33 96.589737 is5 1 6 1 3 7 1456 1333 215 44 96.367233 potentially5 1 6 1 3 8 1681 1344 19 27 96.604309 a5 1 6 1 3 9 1715 1323 161 53 96.755112 dynamics 1 6 1 3 10 1891 1343 80 34 90.594505 ana-4 1 6 1 4 0 646 1368 1326 63 -1 5 1 6 1 4 1 646 1368 121 62 96.467171 lytical5 1 6 1 4 2 784 1383 71 43 86.147293 tools 1 6 1 4 3 874 1383 141 44 86.147293 capable5 1 6 1 4 4 1026 1383 59 42 90.877151 of5 1 6 1 4 5 1089 1395 20 21 72.954292 a5 1 6 1 4 6 1126 1383 226 45 95.998535 progressive,5 1 6 1 4 7 1369 1370 163 61 94.369453 evolving5 1 6 1 4 8 1547 1374 212 54 96.320953 applications 1 6 1 4 9 1775 1383 120 43 0.000000 which.5 1 6 1 4 10 1906 1394 66 22 0.000000 can4 1 6 1 5 0 641 1418 1328 78 -1 5 1 6 1 5 1 641 1431 97 45 96.285080 keeps 1 6 1 5 2 741 1443 83 33 96.211655 pace5 1 6 1 5 3 835 1423 85 42 96.936409 with5 1 6 1 5 4 932 1444 23 33 81.251434 a5 1 6 1 5 5 960 1418 144 64 96.959267 rapidly5 1 6 1 5 6 1112 1421 177 61 96.422829 changing5 1 6 1 5 7 1297 1430 186 66 31.736031 economy.”5 1 6 1 5 8 1472 1437 27 17 52.914078 115 1 6 1 5 9 1508 1434 100 39 29.693275 'Thus5 1 6 1 5 10 1615 1445 38 22 96.654205 as5 1 6 1 5 11 1663 1445 193 34 96.714066 consumers5 1 6 1 5 12 1864 1423 105 55 92.808456 prod-4 1 6 1 6 0 630 1469 1339 64 -1 5 1 6 1 6 1 630 1485 89 42 9.867767 ,ucts5 1 6 1 6 2 736 1484 70 42 96.235283 ands 1 6 1 6 3 822 1469 197 64 96.854019 marketing5 1 6 1 6 4 1032 1484 170 45 96.332199 practices5 1 6 1 6 5 1217 1485 158 43 97.012383 changes 1 6 1 6 6 1365 1497 38 21 96.990509 in5 1 6 1 6 7 1418 1479 154 50 96.611824 number,5 1 6 1 6 8 1588 1477 224 51 96.408836 complexity,5 1 6 1 6 9 1823 1485 146 43 96.674171 variety,4 1 6 1 7 0 645 1536 1307 42 -1 5 1 6 1 7 1 645 1536 71 50 86.134827 ands 1 6 1 7 2 727 1536 169 40 86.134827 function,5 1 6 1 7 3 907 1536 185 42 96.850830 standards5 1 6 1 7 4 1100 1536 42 43 96.925308 of5 1 6 1 7 5 1153 1536 148 43 96.389954 fairness5 1 6 1 7 6 1312 1540 42 29 85.931168 to5 1 6 1 7 7 1358 1536 61 43 85.931168 thes 1 6 1 7 8 1426 1547 178 32 93.230286 consumers 1 6 1 7 9 1606 1536 169 42 88.874756 may.also5 1 6 1 7 10 1784 1536 143 42 93.176544 change.5 1 6 1 7 11 1949 1562 3 3 65.580841 .3 1 6 2 0 0 637 1577 1333 816 -1 4 1 6 2 1 0 655 1577 1315 54 -1 5 1 6 2 1 1 655 1610 13 16 46.566925 .5 1 6 2 1 2 682 1576 280 52 13.308258 Generally,5 1 6 2 1 3 906 1572 60 60 96.339638 thes 1 6 2 1 4 985 1577 199 53 78.630898 individual.5 1 6 2 1 5 1203 1598 178 33 96.299469 consumers 1 6 2 1 6 1396 1587 41 33 94.187592 ‘is.5 1 6 2 1 7 1456 1591 36 29 86.122009 at.5 1 6 2 1 8 1513 1598 22 21 86.122009 a5 1 6 2 1 9 1557 1587 142 32 94.038673 distinct5 1 6 2 1 10 1720 1586 250 42 94.038673 disadvantage4 1 6 2 2 0 641 1632 1326 47 -1 5 1 6 2 2 1 641 1637 184 40 96.544907 compared5 1 6 2 2 2 841 1640 37 28 96.544907 to5 1 6 2 2 3 892 1638 64 31 57.074722 the.5 1 6 2 2 4 967 1637 169 41 57.074722 producers 1 6 2 2 5 1153 1649 39 21 96.914543 or5 1 6 2 2 6 1207 1632 207 38 96.390862 distributors 1 6 2 2 7 1429 1640 43 31 96.650635 of5 1 6 2 2 8 1480 1638 110 41 96.835434 goods5 1 6 2 2 9 1605 1638 37 31 96.999916 in5 1 6 2 2 10 1657 1637 164 42 93.276573 reaching5 1 6 2 2 11 1831 1637 136 32 92.321754 conclu-4 1 6 2 3 0 642 1686 1328 44 -1 5 1 6 2 3 1 642 1686 92 33 96.405754 sions5 1 6 2 3 2 747 1687 207 42 96.221596 concerning5 1 6 2 3 3 965 1688 60 32 96.752190 thes 1 6 2 3 4 1036 1688 190 42 96.501663 reliability5 1 6 2 3 5 1238 1689 41 31 96.541054 of5 1 6 2 3 6 1290 1689 147 41 95.954521 products 1 6 2 3 7 1449 1689 126 32 95.954521 claims.5 1 6 2 3 8 1589 1689 95 41 96.584084 Very5 1 6 2 3 9 1696 1689 97 31 95.916962 often5 1 6 2 3 10 1804 1689 59 31 96.398430 thes 1 6 2 3 11 1875 1687 95 42 96.879501 price4 1 6 2 4 0 641 1737 1328 45 -1 5 1 6 2 4 1 641 1737 40 32 96.952034 of5 1 6 2 4 2 696 1748 20 21 95.492813 a5 1 6 2 4 3 731 1749 177 21 96.823753 consumers 1 6 2 4 4 922 1739 148 41 96.733566 products 1 6 2 4 5 1083 1739 29 32 97.006630 is5 1 6 2 4 6 1126 1740 201 42 96.385384 sufficiently5 1 6 2 4 7 1341 1740 67 32 96.663620 lows 1 6 2 4 8 1420 1740 79 32 96.828545 that5 1 6 2 4 9 1511 1740 60 32 97.014610 thes 1 6 2 4 10 1585 1743 71 29 96.070152 costs 1 6 2 4 11 1668 1743 38 28 96.889069 to5 1 6 2 4 12 1717 1739 60 32 96.929245 thes 1 6 2 4 13 1790 1749 179 22 96.838066 consumer4 1 6 2 5 0 640 1788 1327 44 -1 5 1 6 2 5 1 640 1788 41 32 96.802216 of5 1 6 2 5 2 694 1788 183 42 96.514404 obtaining5 1 6 2 5 3 892 1789 155 32 96.620651 relevant5 1 6 2 5 4 1062 1791 147 41 96.511414 products 1 6 2 5 5 1224 1790 228 33 96.621605 information5 1 6 2 5 6 1467 1791 139 42 96.661163 exceeds5 1 6 2 5 7 1618 1791 61 31 96.667328 thes 1 6 2 5 8 1692 1789 140 33 93.299576 benefits5 1 6 2 5 9 1847 1789 120 32 90.676331 result-4 1 6 2 6 0 640 1839 1327 43 -1 5 1 6 2 6 1 640 1839 62 42 96.415024 ings 1 6 2 6 2 721 1839 94 33 96.352310 from5 1 6 2 6 3 832 1839 60 33 96.720757 thes 1 6 2 6 4 910 1840 175 32 95.449745 increased5 1 6 2 6 5 1103 1840 218 33 95.449745 satisfaction5 1 6 2 6 6 1339 1841 162 32 96.855896 achieved5 1 6 2 6 7 1517 1842 152 40 96.650558 thereby.5 1 6 2 6 8 1689 1842 43 31 96.173035 In5 1 6 2 6 9 1749 1840 100 32 96.868080 others 1 6 2 6 10 1865 1850 102 29 96.335403 cases,4 1 6 2 7 0 638 1890 1330 44 -1 5 1 6 2 7 1 638 1890 68 32 80.038841 thes 1 6 2 7 2 723 1881 209 52 92.417091 complexity5 1 6 2 7 3 958 1891 40 32 96.237221 of5 1 6 2 7 4 1022 1902 21 21 96.909210 a5 1 6 2 7 5 1067 1902 178 21 96.895088 consumers 1 6 2 7 6 1270 1892 157 42 96.479454 product,5 1 6 2 7 7 1452 1893 68 31 96.685173 ands 1 6 2 7 8 1545 1891 220 42 96.167778 accordingly5 1 6 2 7 9 1788 1891 60 32 96.889458 thes 1 6 2 7 10 1870 1891 98 41 96.894447 large4 1 6 2 8 0 640 1941 1326 43 -1 5 1 6 2 8 1 640 1945 141 28 95.661682 amounts 1 6 2 8 2 797 1941 39 33 96.699486 of5 1 6 2 8 3 851 1942 150 33 96.017433 detailed5 1 6 2 8 4 1016 1943 147 41 96.422134 products 1 6 2 8 5 1177 1943 230 32 96.101891 information5 1 6 2 8 6 1420 1954 177 30 96.324646 necessary5 1 6 2 8 7 1611 1947 36 28 96.338501 to5 1 6 2 8 8 1663 1954 43 21 96.747887 an5 1 6 2 8 9 1720 1942 174 33 92.933037 informed5 1 6 2 8 10 1909 1942 57 33 91.527634 de-4 1 6 2 9 0 639 1968 1326 69 -1 5 1 6 2 9 1 639 1992 118 41 96.599472 cision,5 1 6 2 9 2 774 1992 116 32 96.770607 makes5 1 6 2 9 3 907 1992 59 33 96.701859 thes 1 6 2 9 4 982 1997 88 29 96.729782 costs5 1 6 2 9 5 1087 1995 40 31 96.660217 of5 1 6 2 9 6 1143 1993 181 43 96.660217 obtaining5 1 6 2 9 7 1340 1995 147 42 96.576599 products 1 6 2 9 8 1502 1968 227 58 96.825020 information5 1 6 2 9 9 1745 1992 220 43 96.324501 prohibitive.4 1 6 2 10 0 640 2043 1327 44 -1 5 1 6 2 10 1 640 2043 85 32 95.929947 This5 1 6 2 10 2 742 2043 155 42 95.929947 problems 1 6 2 10 3 913 2043 30 33 96.975418 is5 1 6 2 10 4 959 2044 138 33 96.727806 furthers 1 6 2 10 5 1112 2045 187 41 95.554192 magnified5 1 6 2 10 6 1313 2045 46 42 96.636398 by5 1 6 2 10 7 1375 2045 59 32 96.979317 thes 1 6 2 10 8 1448 2046 96 41 96.717377 large5 1 6 2 10 9 1559 2045 143 32 96.085838 numbers 1 6 2 10 10 1716 2044 39 33 95.380142 of5 1 6 2 10 11 1769 2043 198 42 96.815598 competing4 1 6 2 11 0 640 2094 1324 44 -1 5 1 6 2 11 1 640 2094 163 42 96.202400 products5 1 6 2 11 2 820 2105 45 21 95.622726 on5 1 6 2 11 3 880 2095 61 32 93.298538 thes 1 6 2 11 4 956 2096 172 32 48.800171 market.’?5 1 6 2 11 5 1145 2096 107 41 96.379913 Thus,5 1 6 2 11 6 1268 2096 85 32 96.566574 with5 1 6 2 11 7 1369 2096 59 32 96.864548 thes 1 6 2 11 8 1444 2096 238 42 96.037346 developments 1 6 2 11 9 1696 2096 69 32 90.591476 ands 1 6 2 11 10 1780 2094 184 43 90.591476 prolifera-4 1 6 2 12 0 638 2144 1332 44 -1 5 1 6 2 12 1 638 2144 75 32 96.019516 tions 1 6 2 12 2 728 2145 40 32 95.480942 of5 1 6 2 12 3 781 2145 126 43 96.100105 highly5 1 6 2 12 4 921 2146 155 42 96.632584 complex5 1 6 2 12 5 1091 2147 69 32 96.791061 ands 1 6 2 12 6 1173 2147 170 32 90.974709 technical5 1 6 2 12 7 1358 2148 173 40 96.905014 products,5 1 6 2 12 8 1545 2147 95 32 96.478981 there5 1 6 2 12 9 1655 2147 30 32 96.712257 is5 1 6 2 12 10 1699 2146 97 33 96.677536 often5 1 6 2 12 11 1809 2157 44 22 93.283478 no5 1 6 2 12 12 1867 2154 103 33 39.301567 prac-4 1 6 2 13 0 637 2196 1329 42 -1 5 1 6 2 13 1 637 2196 83 32 96.097610 tical5 1 6 2 13 2 740 2207 78 31 96.950981 ways 1 6 2 13 3 840 2196 58 32 96.667114 for5 1 6 2 13 4 918 2207 194 23 95.652229 consumers5 1 6 2 13 5 1131 2200 38 30 95.652229 to5 1 6 2 13 6 1188 2198 170 36 96.624298 ascertain5 1 6 2 13 7 1377 2199 59 31 96.125366 thes 1 6 2 13 8 1456 2198 232 32 96.533371 truthfulness5 1 6 2 13 9 1706 2198 39 32 96.081230 of5 1 6 2 13 10 1765 2196 201 33 96.298462 affirmative4 1 6 2 14 0 637 2247 1330 44 -1 5 1 6 2 14 1 637 2247 148 42 96.328964 products 1 6 2 14 2 805 2247 119 33 96.315773 claims5 1 6 2 14 3 944 2247 98 43 96.808556 prior5 1 6 2 14 4 1060 2251 37 30 96.725479 to5 1 6 2 14 5 1116 2248 133 42 96.537224 buying5 1 6 2 14 6 1270 2250 68 31 96.521248 ands 1 6 2 14 7 1358 2249 102 42 95.721924 using5 1 6 2 14 8 1479 2249 59 32 96.489021 thes 1 6 2 14 9 1558 2249 154 41 96.489021 product.5 1 6 2 14 10 1731 2248 114 34 96.441261 When5 1 6 2 14 11 1864 2247 103 33 81.554222 faced4 1 6 2 15 0 637 2298 1329 43 -1 5 1 6 2 15 1 637 2298 87 31 96.852211 with5 1 6 2 15 2 743 2309 20 21 95.367874 a5 1 6 2 15 3 783 2301 77 29 95.367874 vast5 1 6 2 15 4 879 2298 161 33 95.880554 selections 1 6 2 15 5 1059 2299 40 33 96.443970 of5 1 6 2 15 6 1117 2300 164 41 96.310585 products5 1 6 2 15 7 1299 2304 35 28 96.310585 to5 1 6 2 15 8 1354 2301 119 31 96.602829 chooses 1 6 2 15 9 1494 2300 101 37 93.762009 from,5 1 6 2 15 10 1612 2300 61 32 96.739807 thes 1 6 2 15 11 1690 2298 130 43 96.440346 typical5 1 6 2 15 12 1839 2298 127 42 95.428955 family4 1 6 2 16 0 638 2349 1328 44 -1 5 1 6 2 16 1 638 2349 78 32 96.687531 units 1 6 2 16 2 740 2349 30 32 96.334831 is5 1 6 2 16 3 794 2352 62 30 96.531265 not5 1 6 2 16 4 879 2349 202 43 95.984756 sufficiently5 1 6 2 16 5 1105 2351 97 41 96.449547 large5 1 6 2 16 6 1225 2352 146 41 96.248268 enough,5 1 6 2 16 7 1396 2351 70 32 95.589340 ands 1 6 2 16 8 1489 2351 46 32 95.589340 its5 1 6 2 16 9 1558 2351 244 41 96.043884 requirements5 1 6 2 16 10 1826 2361 57 22 96.763908 ares 1 6 2 16 11 1906 2353 60 29 96.885025 too2 1 7 0 0 0 1715 1189 43 22 -1 3 1 7 1 0 0 1715 1189 43 22 -1 4 1 7 1 1 0 1715 1189 43 22 -1 5 1 7 1 1 1 1715 1189 43 22 95.000000 2 1 8 0 0 0 635 2433 1329 367 -1 3 1 8 1 0 0 635 2433 1328 64 -1 4 1 8 1 1 0 671 2433 1292 29 -1 5 1 8 1 1 1 671 2433 76 22 71.794647 “Sees 1 8 1 1 2 763 2434 64 21 92.786148 FTO5 1 8 1 1 3 844 2439 23 17 92.609985 v.5 1 8 1 1 4 884 2434 132 23 96.171288 Standards 1 8 1 1 5 1031 2434 147 23 86.848228 Education5 1 8 1 1 6 1193 2434 112 28 96.248840 Society,5 1 8 1 1 7 1321 2436 33 22 90.954895 865 1 8 1 1 8 1369 2436 28 21 78.776688 F.5 1 8 1 1 9 1415 2436 32 22 88.441284 2d5 1 8 1 1 10 1464 2436 56 26 96.556404 692,5 1 8 1 1 11 1538 2436 48 22 96.450172 6965 1 8 1 1 12 1608 2436 44 25 95.586929 (2d5 1 8 1 1 13 1670 2435 48 22 92.109955 Cir.5 1 8 1 1 14 1736 2436 90 25 88.066574 1936),5 1 8 1 1 15 1843 2435 71 22 90.424950 rev’d5 1 8 1 1 16 1930 2440 33 17 96.588478 on4 1 8 1 2 0 635 2469 684 28 -1 5 1 8 1 2 1 635 2469 75 21 96.707054 others 1 8 1 2 2 720 2470 120 25 95.905525 grounds,5 1 8 1 2 3 852 2470 48 21 95.905525 3025 1 8 1 2 4 911 2470 57 21 95.759407 U.S.5 1 8 1 2 5 981 2470 47 21 96.465996 1125 1 8 1 2 6 1044 2470 90 26 95.945015 (1937)5 1 8 1 2 7 1153 2471 97 26 91.376221 (Hand,5 1 8 1 2 8 1262 2471 57 25 85.287018 J.):3 1 8 2 0 0 637 2503 1327 129 -1 4 1 8 2 1 0 670 2503 1294 27 -1 5 1 8 2 1 1 670 2503 85 25 60.997051 “[Thes 1 8 2 1 2 773 2503 204 26 91.809128 Commission’s]5 1 8 2 1 3 999 2509 99 20 96.578918 powers5 1 8 2 1 4 1115 2509 45 17 96.484772 ares 1 8 2 1 5 1177 2506 48 20 96.855324 not5 1 8 2 1 6 1242 2505 116 21 96.635918 confined5 1 8 2 1 7 1375 2505 28 22 96.661552 to5 1 8 2 1 8 1420 2505 63 21 96.897446 such5 1 8 2 1 9 1500 2506 125 24 95.491562 practices5 1 8 2 1 10 1644 2509 29 16 96.898773 as5 1 8 2 1 11 1689 2504 83 21 96.429398 would5 1 8 2 1 12 1790 2504 30 20 96.790131 be5 1 8 2 1 13 1837 2503 127 22 95.457535 unlawful4 1 8 2 2 0 637 2536 1323 28 -1 5 1 8 2 2 1 637 2536 88 22 96.415276 before5 1 8 2 2 2 739 2537 22 21 95.871300 it5 1 8 2 2 3 775 2539 93 23 96.647675 acted;5 1 8 2 2 4 884 2539 62 24 96.033791 they5 1 8 2 2 5 963 2544 44 16 96.737228 ares 1 8 2 2 6 1022 2544 69 16 96.609306 more5 1 8 2 2 7 1107 2539 65 21 96.422203 than5 1 8 2 2 8 1189 2539 167 25 96.055504 procedural;5 1 8 2 2 9 1375 2539 35 21 95.807182 its5 1 8 2 2 10 1427 2539 63 25 95.807182 duty5 1 8 2 2 11 1508 2539 26 21 95.668823 in5 1 8 2 2 12 1552 2541 58 23 96.415611 parts 1 8 2 2 13 1629 2539 28 20 95.265472 at5 1 8 2 2 14 1675 2543 49 20 96.427780 any5 1 8 2 2 15 1741 2539 65 24 96.635780 rate,5 1 8 2 2 16 1825 2538 22 21 95.862488 is5 1 8 2 2 17 1864 2539 28 20 93.278008 to5 1 8 2 2 18 1909 2537 51 22 92.530510 dis-4 1 8 2 3 0 637 2569 1326 27 -1 5 1 8 2 3 1 637 2573 76 17 96.167313 covers 1 8 2 3 2 727 2569 52 21 96.383675 ands 1 8 2 3 3 794 2571 74 21 96.765495 makes 1 8 2 3 4 882 2570 107 24 96.765495 explicit5 1 8 2 3 5 1003 2571 75 22 96.066986 those5 1 8 2 3 6 1091 2572 173 24 96.542854 unexpressed5 1 8 2 3 7 1279 2572 139 22 96.077301 standards5 1 8 2 3 8 1434 2572 27 22 96.796585 of5 1 8 2 3 9 1473 2572 55 21 96.233696 fair5 1 8 2 3 10 1542 2572 103 24 95.923874 dealings 1 8 2 3 11 1659 2572 82 21 96.469025 which5 1 8 2 3 12 1756 2572 45 21 96.469025 thes 1 8 2 3 13 1816 2573 147 20 89.020721 conscience4 1 8 2 4 0 637 2604 655 28 -1 5 1 8 2 4 1 637 2604 29 22 96.011490 of5 1 8 2 4 2 674 2605 45 20 95.774452 thes 1 8 2 4 3 729 2605 157 25 95.774452 community5 1 8 2 4 4 896 2611 59 19 96.841118 may5 1 8 2 4 5 966 2606 185 25 95.603737 progressively5 1 8 2 4 6 1162 2606 130 26 96.535912 develop.”3 1 8 3 0 0 635 2638 1326 162 -1 4 1 8 3 1 0 670 2638 1290 28 -1 5 1 8 3 1 1 670 2638 61 21 62.872051 In5 1 8 3 1 2 746 2638 45 21 96.566124 thes 1 8 3 1 3 806 2639 233 22 96.424843 over-the-counters 1 8 3 1 4 1055 2641 66 24 95.584946 drugs 1 8 3 1 5 1135 2640 67 25 96.704605 field,5 1 8 3 1 6 1219 2641 42 21 96.804077 for5 1 8 3 1 7 1277 2641 123 25 96.725357 example,5 1 8 3 1 8 1417 2641 22 21 95.724777 it5 1 8 3 1 9 1454 2641 47 21 96.748894 has5 1 8 3 1 10 1517 2641 61 21 96.813766 been5 1 8 3 1 11 1597 2640 134 21 96.522171 estimated5 1 8 3 1 12 1747 2639 63 22 96.263519 that5 1 8 3 1 13 1825 2639 73 22 96.218834 there5 1 8 3 1 14 1914 2644 46 16 96.186218 area 1 8 3 2 0 637 2672 1321 28 -1 5 1 8 3 2 1 637 2672 114 22 95.974808 between5 1 8 3 2 2 767 2672 107 26 95.447067 100,0005 1 8 3 2 3 890 2674 51 21 95.447067 ands 1 8 3 2 4 958 2672 107 26 96.578918 200,0005 1 8 3 2 5 1081 2674 122 25 96.498116 products5 1 8 3 2 6 1220 2674 135 22 96.250343 available.5 1 8 3 2 7 1376 2674 159 26 95.981522 (Statements 1 8 3 2 8 1552 2674 28 21 96.594902 of5 1 8 3 2 9 1594 2674 45 21 96.653015 Dr.5 1 8 3 2 10 1657 2673 106 22 93.293022 Charles5 1 8 3 2 11 1780 2673 28 22 89.552048 C.5 1 8 3 2 12 1825 2674 133 24 52.828842 Edwards,4 1 8 3 3 0 637 2704 1324 30 -1 5 1 8 3 3 1 637 2704 204 27 95.859932 Commissioner,5 1 8 3 3 2 859 2705 72 22 96.398827 Foods 1 8 3 3 3 947 2707 52 20 96.654297 ands 1 8 3 3 4 1017 2706 73 26 96.654297 Drugs 1 8 3 3 5 1105 2707 228 27 96.383743 Administration,5 1 8 3 3 6 1349 2707 29 21 96.074852 in5 1 8 3 3 7 1395 2707 128 27 96.595161 Hearings5 1 8 3 3 8 1540 2708 94 20 96.947739 Before5 1 8 3 3 9 1651 2707 44 21 96.945847 thes 1 8 3 3 10 1714 2707 197 22 95.526031 Subcommittee5 1 8 3 3 11 1928 2712 33 17 96.067650 on4 1 8 3 4 0 637 2739 1321 28 -1 5 1 8 3 4 1 637 2739 138 25 96.616890 Monopoly5 1 8 3 4 2 800 2740 29 21 96.776100 of5 1 8 3 4 3 853 2740 54 21 95.456818 the.5 1 8 3 4 4 925 2740 83 22 95.456818 Selects 1 8 3 4 5 1034 2740 153 23 96.086624 Committees 1 8 3 4 6 1212 2747 34 16 96.086624 on5 1 8 3 4 7 1273 2742 80 21 95.467384 Small5 1 8 3 4 8 1379 2742 131 25 96.199593 Business,5 1 8 3 4 9 1537 2742 51 21 88.927208 92d5 1 8 3 4 10 1615 2741 131 25 96.603722 Congress,5 1 8 3 4 11 1773 2741 46 22 89.963104 ists 1 8 3 4 12 1846 2740 112 27 96.480347 Session,4 1 8 3 5 0 635 2773 317 27 -1 5 1 8 3 5 1 635 2773 60 26 96.596519 May5 1 8 3 5 2 706 2773 40 26 96.669449 25,5 1 8 3 5 3 757 2773 73 27 94.832184 1971,5 1 8 3 5 4 841 2774 66 22 95.263260 Parts 1 8 3 5 5 916 2774 36 25 95.263260 1.) Opinion 81 FEC.

varied, to allow detailed investigation of the goods to. be purchased. The consumer, simply cannot make the hecessary. tests or investigations.to. determine whether the. direct, and, affirmative. claims. made for a product are true.

Given: the imbalance of ite hate and resources between a, busi snes te gon each his afm consumer: ‘to: test, investigate, or experi- ‘ment for himself. ‘The ‘manufacturer ‘has' the ability, the knowhow, “thé equipmenit, the tite and’ ‘the resources to ertake’s such infor ma tion by testing or otherwise—the consumer usually does not. Turning to that: part of the complaint’ which challenges respondent’s marketing” practices as ‘tinfair, the’ Commission i is of the view. ‘that it is an unfair practice in violation: of the Federal Trade: Com- ‘mission Act to’ ‘make’ an affirmative product ‘claim without a reasonfairness to competitors; ‘dictates thi¥ conic able. basis ‘for waking that claim.’ Fairn consumer, as well'as sion. Absent‘ a reasonable basis" for a vendor’ 's affirmative product claiths‘a a consumer’s ability ability to conlipete on the basis of price,’ quality, service or convenience, are materially impaired and impeded. The balance of this opinion will concern itself with an analysis of the reasonable basis standard i in relation to the record before us.

The consumer is entitled, as a matter of marketplace fairness, to rely upon the manufacturer to have a “reasonable basis” for making performance claims. A consumer should not be compelled to enter into an economic gamble to determine whether a product will or will not perform as represented. The economic gamble involved in a consumer’s reliance upon affirmative product claims is created by the vendors’ activities, and cannot be easily avoided by consumers. Taking a different and analytical perspective and weighing the minimal cost and burden on vendors by requiring that there be a reasonable basis for affirmative product claims, against economic losses to consumers which can fairly be ascribed to advertising claims lacking such reasonable basis (losses which are, in a practical sense, unavoidable for the consumer), it is likewise clear that economic fairness requires that this obligation be imposed on vendors."* The record reflects the fact that 13 Compare Fletcher, Fuirness and Utility in Tort Theory, 85 Harv. L. Rev. 537, 542 (1972).

“Reasonableness 1s determined by a straightforward balancing of costs and benefits. {@ the risk yields a net social utility (benefit), the victim is not entitled to recover from the risk-creator; if the risk yields a net social disutility (cost), the victim is entitled the ‘cost: to:a consumer of -4.visit,to,a.dermatologist to. obtain-a prescription drug is sufficiently high that most: persons .with ‘sunburn utilize an over-the-counter commercial. preparation: (‘I'r. 1031-1082); Thus, the consumer is to a. great degree dependent on the; mancfacturer for information concerning products of this type. ... .. In addition,.fairness.to competitors requires that, the vendor have.a reasonable basis:for his. affirmative . product ‘claims. A: sale made-as. a result of. an. unsupported. advertising claim deprives competitors. of the opportunity to have made that sale forthemselves. ..-.. >. . This. view. finds direct. support. in the recent. decision. in. Leon, A. Tasho f v. F.7.0.4 There, the Commission found that:a retailer. falsely advertised that. his products were available at‘ discount: prices. ‘The Commission in effect. ordered the: respondent’ to stop advertising, that he.sold any product: at a discount. price unless he had a reasonable basis for such a,claim. In. view of this retailer’s past history, the Com; mission prescribed. a specific type of “reasonable basis”—the Commission ordered that, the respondent; before.advertising: that: he. sells. at discount prices, «.must - take - a. statistically significant, survey ...to demonstrate: that prevailing ‘market -prices are -substantially.. above respondent’s prices. In. affirming the Commission’s decision, the. Court expressly noted that this order subjected the respondent-to civil penalties if the respondent advertises discount prices without having taken the survey, even if the advertisement is true. The unfairness analysis in the Commission’s All-State Industries“ case is also directly on point.

When a seller knows, but the buyer does not know, that the debt contracted by the buyer in making a credit purchase will be assigned to a third party, the buyer may be entering into a transaction quite different in its characteristics from the one the buyer imagines he is entering. * * * In this circumstance, we find it palpably unfair for a seller who routinely assigns instruments of indebtedness executed by his purchasers to third parties to fail to disclose to his pur- ‘chasers that such transfer is contemplated and may result in a substantial alteration of the buyer’s rights and liabilities. (Emphasis added.) to recover. The premises of this paradigm are that reasonableness provides a test of activities that ought to be encouraged and that tort judgments are an appropriate medium for encouraging them.”

This balance admittedly gives more consideration to the producers’ interests than does the test suggested by Adam Smith: “[TJhe interest of the producer ought to be attended to only so far as it may be necessary for promoting that of the consumer.” Smith, An Inquiry Into The Nature and Causes of the Wealth of Nations, 625 (Modern Library Edition, 1937). :

4 437 F.2d 707 (D. C. Cir. 1970).

% All-State Industries, Docket No. 8738 (slip opinion, pp. 13-14), aff'd, 423 F.2d 423 (1970), cert. denied, 400 U.S. 828 (1970).

64 FEDERAL TRADE" ‘COMMISSION DECISIONS Opinion 81 LTC.

‘In summary, the Commission’ concludes ‘thatthe making of an affirmative product:claim in advertising ** is unfair to consumers unless there ‘isa reasonable basis for making that claim: :' ae ’ This’ standard, it should be noted, focuses in large-part on the adequacy of the underlying evidence, and is not solely a “reasonable man”. ‘test. It thus‘rounds out the Kirchner case, which suggested that an advertiser “* * *. should have ‘in his possession such ‘information as would satisfy a reasonable and prudent businessman, acting in good faith, that such representation was true.” This test evaluates both the reasonableness of an advertiser’s actions and the adequacy of the evidence upon which such actions were based: Be The question of what constitutes a ‘reasonable basis is essentially a factual issue which: will be affected by the interplay of overlapping considerations such as (1) the type and specificity of the claim made CDs safety, efficacy, dietary, health, medical; (2) the type of product—e.g., food, drug, potentially hazardous consumer product, other consumer product; (3) the possible consequences of ‘a false claim— ég., personal injury, property daniage; (4) the degree of reliance by consumers on the claims; (5) the’type, and aécessibility, of evidence adequate to form a ‘peasonable basis for making‘ the particular claims. More specifically, there may be some types of claims for some types of products for which the only reasonable basis, in fairness and in the expectations of consumers, would be a valid scientific or medical basis. The precise formulation of the “reasonable basis” standard, however, is an issue to be determined at this time on a case-by-case basis. This standard is determined by the circumstances at the time the claim was made, and further depends on both those facts known to the advertiser, and those which a reasonable prudent advertiser should have discovered. Such facts should be possessed before the claim is made. In like manner, the criteria listed above will serve as a touchstone for evaluating those instances in which the Commission is unlikely to proceed against advertisers for failure to have support for an advertisement. In the past, the Commission has recognized that there is a category of advertising themes, in the nature of puffing or other hyperbole, which do not amount to the type of affirmative product claims for which either the Commission or the consumer would expect documentation. In Kirchner," we held that advertising an inflatable swimming aid as “invisible” is harmless hyperbole. * 16This standard pertains only to advertising representations, and does not deal with the question of whether the mere fact of marketing a product implies or requires that certain standards of safety and health must be met. Cf. Chemway Corporation, Docket C-1945 (June 14, 1971) [78 E.T.C. 1250); H. W. Kirchner, 63 F.T.C. 1282 (1963). 1763 F.T.C, at 1290, . PFIZER, INC. . | 65 23 . Opinion True, as has been reiterated many times, the Commission’s responsibility is to prevent deception of the gullible and credulous, as well as the cautious and knowledgable (see e.g., Charles of the Ritz Dist. Corp. v. F.T.C., 143 F.2a° 676 (2d Cir. 1944) ). This principle loses its validity,’ however, if. it is applied uncritically or pushed to an absurd extreme in respect: of every conceivable misconception, however outlandish, to which his representations might be subject among the foolish or feebleminded. Some people, because of ignorance or incomprehension, may be misled. by even a scrupulously honest claim. Perhaps a few misguided souls believe, for example, that all “Danish pastry” is made in Denmark. Is it, therefore, an actionable deception to advertise “Danish pastry” when it is made in this country? Of course not. A representation. does hot become “false and deceptive” merely because it will be unreasonably misunderstood by an insignificant and unrepresentative segment of the class of persons to whom the representation is addressed. If, however, advertising is aimed at a specially susceptible group of people (e.. g., children), its truthfulness must be measured i by the impact it will make on them, not other to whom it is primarily directed.: ‘In this case, complaint counsel is aparently challenging the reasonableness of the basis for two specific affirmative product claims made for Un-Burn: (1) Un-Burn actually anesthetizes nerves in sunburned skin,1* and (2) Un-Burn stops pain fast.”

The Standard of Reasonableness ~ Complaint counsel’s unfairness charge basically urges that the only reasonabie basis for performance or effectiveness representations for a drug or medical product would be fully documented, adequate and well-controlled scientific studies or tests. Complaint counsel deny that a reasonable basis could be found in the medical literature, clinical experience, or general medical knowledge. Respondent, on the other hand, argues that it possessed a reasonable basis to support its affirmative product claims, and therefore did not need to take the additional step of obtaining controlled scientific tests. Respondent rested its defense on the proposition that the complaint set forth too narrow a view of the type of support required to make affirmative product claims, and contended that there was in fact a reasonable basis for making the questioned claims for Un-Burn.

On. appeal, complaint counsel argue that courts have held that the only form of evidence which is adequate and reliable to sustain claims for a drug such as Un-Burn is adequate and well-controlled studies or tests. In support of this proposition, complaint counsel cite cases which hold, based upon a reading of statutory language and the pertinent legislative history, that the Food and Drug Administration validly issued administrative regulations establishing criteria for adequate +8 Complaint, Paragraph 4.

19 CX 4~—7 ; Complaint, Paragraph 4.

66 FEDERAL TRADE “COMMISSION DECISIONS Opinion 81 BTC:

is for determining drug ‘effi- Hi discla: ationship, between FDA tandards,.of drug: efficacy: and, the definition. of. “adequate and wellcontrolled:-scientific studies: or:tests”.-as:set: forth in their-complaint; however. complaint: counsel ‘cannot now: attempt td’ rely,-directly ot indirect Lys _ those" FDA “standards, ‘Complaint ‘counsel have rested WO! equate and. well-controlled: “scientific. studies 0 or - tests” —it 3 is, accordingly, 0 on this. ‘basis, that..the Commission: must: evalnate: their argument and! the: record evidence: PRGA es Lee OD ny : Adequate and ‘Well: Controlled. Seientife Studies. or Tests Bek Or Complaint counsel argue that the: only reasonable basis for making efficacy and. performance. claims for a drug such, as Un-Burn would:be adequate and. well- controlled scientific studies or tests conducted prior to the: marketing of the. product. ‘Thus, a,-primary | issue. at. trial. was the existence or non-existence of such studies or tests. It is clear that Pfizer’s safety testing was not designed to, and did not in fact, support. the affirmative efficacy representations made for the product (I.D. » Pp. 9-10 [p. 33. herein]). Respondent’s pre-marketing tests consisting of injections of benzocaine could not indicate the probable anesthetic effect of a topical application of this substance (Tr. 259, 308, 344, 522). The tests for the product’s antiseptic effects do not lend any support to the anesthetic effects claimed (Tr. 288, 311). Nor were the tests on guinea pigs sufficient to substantiate the efficacy of the product on human beings (Tr. 726). The hearing examiner found, and the record amply supports his determination, that Pfizer did not conduct adequate and well-controlled scientific studies or tests prior to marketing Un-Burn to substantiate the efficacy claims for Un-Burn (I.D., pp. 17, 35 [pp. 40, 54 herein])...

More generally, the record i in this matter is clear that for a test, standing alone, to provide a reasonable basis for an affirmative product claim, the test should be an adequate and well-controlled scientific test (I.D., pp. 10-17 [pp. 83-40 herein]; Tr. 330-331, 351-356). Such a test should be conducted on human beings, not on animals (Tr. 298, 343, 351, 509, 522). A pre-existing test protocol is usually essential to an adequate. test (Tr. 296, 345, 1065). The record also indicated the strong desirability of double-blind scientific tests (Tr. 280, 37 0). ”» PMA y; Richardson (D. Del. 1970). Upjohn Oo. v. Finch, 422 F.2d 944 (6th Cir. 1970). “This precludes consideration, in connection with this particular case, of the FDA’s activities in defining the scientific content of “adequate and well-controlled clinical investigations.” See HX-1; 35 Fed. Reg. 8073 (February 17, 1970), “85 Fed. Reg.. 7250 (May 8, 1970).

SSTOYIONG AOPRIZERAINGsi 8 fo (oo cgerece 67 28-112 38 Opinion.

» Some:'time»after the: >presetit proceeding was: instituted, ‘respondent did: undertaké’to conduct’ ah - adequate and ‘well-dotitrolled® ‘test: of Un-Burn’s efficacy (Tr. 676). This was the test conducted” by’ Dr! Orentreich: (Tr. 6475 ILD: 30 '[p: 51 hérein]).’ While there: was soine argument as:to: wliethér this. test actually met the ‘standards: of an adequate ‘and:well-controlled scientific. test (O.As: 14+15)??' it' Seems clear that? it: was: designed ' tobe: such (Tr. 674-676; 864-865)! The Orentreich test’ stands 'in:marked ‘comparison’ to. the tests:undettaken by respondents prior to marketing;‘and graphically dénionstrates the insufficiency of such premarketing tests to support the efficacy claims made for the product” res 716; '863, 1116, 1188, 1215, 1226). Even assuming that the Orentreich test did establish that Un-Burn actually anesthetizes nerves,” the, fact, that ‘this test was not conducted prior to making the affirmative product . claims for Un-Burn pr ludes it, from, being considered. as a defense to. the. ‘violation charged in this. complaint.. In. order. to. have had a reasonable basis, the ‘tests must have been conducted. prior 0, and .c ually. relied upon. in, connection with,, the marketing. of the product, i in question. Nor, doeg the fact. that. the, product subsequently performed as advertised indicate that: there is a lack of public interest, in. the tmatter.*4 The fundamental, unfairness results from i imposing on the consumer the unavoidable economic risk that the product may not perform as advertised; that is, at the time of sale, neither the consumer nor the vendor have a reasonable basis fer belief in the affirmative product claims.

It is thus clear that the tests conducted by Pfizer did not provide a reasonable basis for the making of these performance claims. The tests were not adequate and well-controlled scientific tests conducted prior to the making of the efficacy representations. {(T]o take the position that. a particular type of test must be made, wholly disregards the value of the clinical experience of a. number of experts in the dermatology field of medicine such. as those called by respondent. Moreover, The nature and intricacy of the debate on the adequacy Of this test leads to the view that the Commission’s role should simply be one of attempting to determine the existence and general quality of the tests and a threshold determination as to the reasonabic ness of reliance thereon, rather than an attempt to conclusively determine the adequacy of the tests.

3 One definite obstacle to such a finding is the fact that this test undertook to compere the effectiveness of Un-Burn with the noneffectiveness of.a placebo, rather’ than.to. compare Un-Burn’s effectiveness with the level of effectiveness claimed by Pfizer’s advertising (See, Tr. 680-682, 1215).

24 Compare FTC v. Colgate- Palmolive Co., 380 U.S. 374, 888 (1965). A false represeniation violates Section 5 even if the misstatement in no way affects the qualities of the product. The concern is “with methods designed to get a- consumer to purchase a product, not with whether the product, when purchased, will perform up to expectations.” In short, the focus is upon the method of marketing... See also, Philip Morris, Inc., Docket 8828 (March 12, 1971) (marketing practices which allegedly constitute safety hazards sre challenged as allegedly unfair) ; FTO v. Algoma Lumber Oo., 291 U.S. 67 (1934). 68 FEDERAL TRADE: “COMMISSION DECISIONS Opinion 81 FTC;

such: a”position would appear to repudiate ¢linicat experience entirely .and. to insist that. laboratory testing be substituted in, all, instances ;where advertising is involved.” . . ers i Asa question of fact, based on ‘the evidence i in n this record, the Commission finds that complaint counsel have. failed to demonstrate that the only reasonable basis for these affirmative product claims would-be adequate and well-controlled scientific studies or tests. It is accordingly necessary. to.consider, as.a matter of fact, the other bases put forth: by respondent i in. support of their “reasonable basis” defense, - Composition of Competing: Products ny.

As one of the factors in the argument that there existed a reasonable basis for the product claims in question, respondent alleges that’ it surveyed competing products on the market to determine (1) the ingredients in such products, and (2) the advertising claims which were being made for such products. Respondent apparently reasons that since the ingredients in Un-Burn are substantially identical to those competing ‘products,”* it is permissible to make the same advertising claims as are made for such competing products—or at least those which have not been challenged as false by a government agency (Tr. 1116, 1180, 1162). The restatement of this argument is sufficient to refute it. The Commission clearly can give no weight to this type of argument in evaluating whether there was a reasonable basis for respondent’s claims.

‘The fact that apparently there did exist a valid efficacy test for a competing product of similar composition which was known to and verified by respondent, however, might have provided a reasonable basis for similar efficacy claims for Un-Burn (CX 99; Tr. 562-573; O.A. 24).?" The evidence with regard to this particular test, however, falls substantially short of constituting an adequate test for the particular anesthetic claims made for Un-Burn. Nor is there sufficient evidence that Pfizer knew of, and relied upon, this test in marketing Un-Burn.

Medical Literature Respondent urges that its search of the medical literature contained in Pfizer’s library, prior to marketing Un-Burn, provided a reasonable basis for the Un-Burn efficacy representations. While complaint coun- 2 1.D., p. 85 [67 herein].

* This argument is weakened by the fact that apparently no scientific analysis was made to determine whether the competing products had the same formula as Un-Burn (Tr. 703). *7 Such claims, of course, cannot imply that respondent’s product is unique or different from the competing product in question.

. PFIZER, INC. :).- rere 69 23 2 Opinion sel: do not meet this:argument directly, their argument that the only reasonable basis would be ‘scientific studies or tests encompasses this point. In oral argument, however, ‘complaint counsel did concede that medical literature containing reports on adequate, and well-controlled tests might be sufficient.

The record evidence is sufficient. to demonstrate to the Commission that medical literature might, in some instances, be sufficient. basis for making: affirmative product elaims, (Tr. 671, 104, 718, 1054, 1108, 1118, » Closely allied with medical: literature asa reasonable besis, would be the general state of medical kriowledge‘at the time the claims were made, regardless of how that knowledge is ascertained (Tr. 1049, 1097, 1134; ID. 20-23 [pp. 42-45 herein], 30-32 [pp. 51-52, herein) Thus, the examiner found that: , .

Recognized medical literature - ‘and the ‘medical practice of dermatologists for between. 50 and 70 years regarded: the active ingredients in Un-Burn as efficacious for the relief:of sunburn pain...(1.D. 32 [53 herein].) : Persuasive in this regard is the fact that the NAS-NRC panels utilized by the Food and Drug: Administration were permitted to recognize as probative reports on studies contained in the medical and scientific literature (RX 110, p. 5; HX 1; Tr. 369, 371, 535). The guidelines for these NAS-NRC panels * set. forth the following basis for judgments as to drug efficacy :

The judgments of the Panels will be based on the following criteria: (1) factual information that is freely available in the scientific literature, (2) factual information that is available from the FDA, from the manufacturer or other sources, or (3) on the experience and informed judgment of the members of the Panels. (See also, Tr. 535.) These guidelines later discuss one instance where scientific literature alone could provide the basis for a judgment as to effectiveness: It is anticipated that substantial evidence for the effectiveness of many of the drugs assigned to a Panel will be found to be well-documented in the scientific literature familiar to the members of the Panel. In these cases, the Panel may be prepared to make its recommendations and to support them by citations from the scientific literature alone. © In a later section, the guidelines disouss other types of evidence of effectiveness:

Tx. Some Special: Considerations:

In the deliberations: of: the Panels, issues will almost certainly arise as to considerations, other than factual evidence, that should’ be weighed in arriving 28 Guidelines for the Drug Efficacy Study of the National Academy of Sciences-National Research Council, August 1966 (RX 110; 1.D., p. 30 [pp. 50-51 herein] ). 70 FEDERAL TRADE“COMMISSION DECISIONS at ‘fudgtietits| buiceftectiveness.” rhe’ significance of: many: Lf these! factors: will * rbieré yal: Tikely; be. cases: in: “which a Panel! is in! ‘doubt! as’ ‘to the’ suffidieney of evidence of effectiveness of a drug that has gained repute among practicing physicians ofthat, has been. in-wide. te these erin of years. It. will -be.quite in The informed judgment and experience of ‘the members of the Paneis in valid ‘evidence contributory::to:the final decision: on-'thée-efficacy ofa drug forthe indications presented. In justifying’ its. decision, however; thé Panel is expected to delineate the exterit ! to:which- itis’ Supported: ‘by ithe substantive evidence available for its review:

. Complaint: counsel’s, purden i in, this. proceeding: i is. that of. demon: strating ‘that respondent’s actions‘in: reliance-upon thé medical literature did: not provide: a reasoiable ‘basis for the affirmative product claims. Complaint counsel for example, could have offered evidence or argument that: (1) respondent’s ‘search.of the medical literature was.of such a limited scope that it was unreasonable, or (2) the conclusions drawn by respondent from the medical literature actually reviewed were unreasonable, or (3) the “testimonial” quality of the medical literature was not sufficient basis for the product claims.?°.Complaint counsel’s insistence that the medical literature specifically report on actual tests fails to address itself to, or satisfy, their burden in this regard.?° Complaint counsel’s primary evidence on this point was the rebuttal testimony of Dr. Beaver, who basically showed a possible conflict in the medical literature. This does not. satisfy. the burden of proot resting on complaint ¢ counsel on. this i issue. u bad Complaint counsel's argument was s misdirected to some » degree, to. any ‘medical iiterature which a witness may have reviewed (Tr, 1312; CCRB 2; Compare TD., p. 19 (pp. 41-42 herein]).

* Thus, we do not reach several significant issues pertinent to this point, ¢.g., did the medical literature deal with the Un-Burn ingredients in the same combination and amounts as they appear in the final formulation of Un-Burn (0.A., 4,.16) ; is chemical equivalence sufficiently indicative of therapeutical equivalence (Tr. 1081, 1116, 1117, 0.A. 12); are ‘authors’ opinions: and. conclusions -sufficient, or must the actual underlying tests be described ;..or .whether the medical Hterature will ever be. capable of supporting product ‘claims which relate to a condition which varies so widely among the © People it affects as does sunburn, ao . ae i on .

Respondent's final’ 4 dargtiient is that the éliniéal experience of the medical profession in itself provides'a reasonable basis for making efficacy claims for Un-Burn. Again, in view of complaint counsel’s primary focus on the necessity for scientific ‘tests, the Commission i is not ina position to definitely evaluate whether clinical experience as to benzocaine and nienthol would ‘provide'a reasonable’ basis for assum= ing its efficacy. It was clear from the evidence of record, however, the “clinical experience” covers: a: wide range ‘of ‘eireumatances: and mist be carefully analyzed’ and evaluated, including’ consideration’ of the type of ailment being treated. Accordingly, the reasonableness of clinical experience must be. evaluated | as.a ‘factual: issue. in.each | (Tr. 1083, 1097, 1108, 1122, 1185, 1253, 1258, 1263, 1300). In: ‘this: regard, the relevant. inquiry is into.a. respondent's knowledge of, and re- ‘Jiance upon, clinical experience prior to, making the. product: claims j in question. Thus, Pfizer’s witness. as to clinical experience -who,, were contacted, by. Pfizer. only. in preparation, for trial, are irreleva: issue (See I.D., pp. 20-23 [pp. 49-44. herein]). : Respondent's Efforts to Provide A Reasonable’ Basis for Affin m0 Pfizer’s director of Marketing testified. that he took three measures to satisfy himself as to the efficacy of the product Un-Burn. First, he received “complete assurance” from Pfizer’s medical people:that ‘the claims he planned to use for Un-Burn could be supported by the two active ingredients ‘in the quantities in which they. were:to be used in the product. He was assurred that the way a topical anesthetic works is to anesthetize nerves and thereby stop pain (Tr. 605).:He was also assured by the “medical people” that the product was patterned very closely after the market leader, Solarcaine. Secondly, he was assured that all available literature or information on these two active ingredients had: been thoroughly reviewed and favorable conclusions derived from this review as to the efficacy of the ingredients as topical anesthetics. Finally, he personally reviewed all competitive advertising to satisfy himself that Pfizer-would not be-claiming. anything more than other products: with the same active ingredients, The director of marketing testified that Pfizer did not conduct tests on humains to determine whether the efficacy claims could. be supported, but. consciously “accepted another method of satisfying” themselves by going-over-the history of the ingredients. No specific tests were conducted on human beings to prove that Un-Burn anesthetizes.nerve ends (L. D., pp-10, 19 [pp. 33, 41 herein] ; Tr. 623-624).

Opinion 81 FTC.

The Pfizer medical official responsible for testing all new Pfizer Products, testified that two efficacy tests were run on Un-Burn: . 1, Testing with regard to the antibacterial properties of the prod ~ uct, and - 2. The guinea pig wheal tests.

These latter tests involved the injection of Un-Burn into guinea pigs. His conclusions as to the results of Pfizer! s testing on Un-Burn were as follows: 2 , ; ;

{The products: passed the safety: and efficacy: tests. The tests demonstrated that there were no safety hazards pertaining to the products, and that the antibacterial activity. of the product: would support the antiseptic claim, and finally, the guinea wheal test demonstrated ‘to us that the active ingredient, one of the active ingredients, benzocaine, was not inactivated by anything in the formulations. ‘Ab result of the safety and other tests, his review of the literature, and his discussions with Dr:' Carlozzi, the medical director of Pfizer, Dr. Jenkins gave his opinion that the testing done was sufficient to sstablish the safety and efficacy of Un- Burn (Z. D. -» p. 20 [p. 42 herein]; Tr. 672-673). * Inasmuch as complaint counsel’s argument -did not go directly to the reasonableness of these actions, we lack a sufficient basis for a finding in this regard. In future cases, we would be interested in both the qualifications of the medical and scientific advisors, and some showing that their judgments were rendered on an informed and unbiased basis. Also properly considered here would be the issue of whether reliance upon medical literature and clinical evidence as to the separate ingredients in Un-Burn is appropriate, or whether additional consideration must be given to (1) the combination of ingredients as they appear in the final product, and (2) the various conditions of use to which the product can reasonably be expected to be subjected, including variations as to skin types and degrees of sunburn. The Commission is not, moreover, convinced of the reasonableness of respondent’s attempts to rely upon clinical experience as to the efficacy of benzocaine and menthol in general, to support the specific degree of efficacy (“anesthetizes” nerves, “stops” sunburn) claimed for Un-Burn.* Evidently respondent made no written report setting forth the actions which-were taken to support the existence of a reasonable basis for its advertising claims. Such a report, if made in good faith prior to #1 The Orentreich test evaluated the efficacy of Un-Burn only in comparison to a placebo— it did not attempt to determine whether nerves were “actually anesthetized” or sunburn pain had in fact “stopped.”” (CCRB 3-4.) ° PFIZER, INC. ©. > : 73 23 Opinion .

marketing, if reasonable in scope and approach,*? and if reasonably clear as to the evidentiary basis for the specific claims in question (be they scientific tests, specified medical references, or specific clinical evidence), would certainly have, in itself, gone a considerable distance in demonstrating the existence of a reasonable basis for their affirmative product claims.

oo ne V REMAINING: ISSUES Respondent raises a number of collateral arguments which should be noted. First, respondent argues that “fairness” § is an unconstitutionally vague standard upon which to base a Commission order. Second, a holding based on fairness would violate the First Amendment to the Constitution. Third, the Food, Drug, and Cosmetic Act implicitly limits the Commission’s Section 5 5 jurisdiction in certain circumstances. Fourth, the “focusing of Congressional attention” on this proceeding was inconsistent with the Fifth Amendment. The Commis- ‘sion finds none of these arguments persuasive. VI CONCLUSION Having reviewed the record, initial decision, briefs and argument i in this proceeding, the Commission has determined that the hearing examiner’s dismissal of the complaint should be affirmed. The divergent approaches of complaint counsel and counsel for respondent, both to the appropriate legal standard and to the facts of this case, resulted in the issue simply not being satisfactorily joined. While the Commission finds that respondent failed in its attempt to demonstrate affirmatively the existence of a reasonable basis for its Un-Burn advertising, the evidence is not sufficient to prove that respondent in fact lacked a reasonable basis for its advertising claims. The record evidence is simply inconclusive with regard to the adequacy of the medical literature and clinical experience relied upon by respondent, and with regard to the reasonableness of such reliance. ° While this failure of proof might be cured by a remand, the Commission does not believe further proceedings are warranted in the public interest. The reformulation of the legal standard from “adequate and well-controlled scientific studies or tests” to “reasonable basis” might warrant an extensive trial de novo, and the advertising in question has already long been discontinued. The significance of this particular case lies, therefore, not so much in the entry of a cease and desist order against this individual respondent, but in the resolution of the general issue of whether the failure to possess a reasonable basis The issue of whether an advertisement has appropriately formulated the standard of what constitutes a “reasonable basis” remains a separate question of fact. See discus sion at pp. 16-17 [pp. 66-67 herein], supra. 494-841-——-73——-6 74 FEDERAL TRADE’ COMMISSION DECISIONS Final Order 81 E.TC.

‘for affirmative product:claims constitutes an:uhfair practice in -viola- ‘tion of the ;Federal:Drade Commission: Act.;As to that i issue,’ the fore- ‘going opinion expresses.the views of the Commission. In-'view'of these circumstances, the Commission has determined to:affirm:-the order and ‘initial: decision of the hearing: examiner except:to the extent inconsistent with this opinion. sin eed Commissioner MacIntyre-coneurs‘as:to the result reached by the - majority. - ‘Commissioner Jo ones concurs in the statement of Taw applic this case as laid out in the opinion, but in light’ of the opinion record in this matter, dissents to the disposition f the case, since it deprives respondent. ofa an. opportunity. to seek. a court, review of the issues involved.

| Favat Orne - This matter having } besn: heard by. the Comission upon + thé appeal of counsel supporting the ‘complaint: ‘from’ the hbaritigexaminer’s initial decision, and upon briefs and oral argument in support thereof and in opposition thereto, and the Commission, for the reasons stated in the accompanying opinion, having-denied the appeal: at It is ordered, That:the order of the hearing examiner + be affirmed and that, except to the extent inconsistent with the accompanying opinion, the examiner’s initial decision he, and it: hereby i is, adopted as the decision of the Commission.

It is further ordered, That the complaint be, and it hereby is, dismissed.

Commissioner MacIntyre « concurs as to the result reached by the majority. Commissioner Jones concurs in the statement of law applicable to this case as laid out in the opinion, but in light of the opinion and the record in this matter, dissents to the disposition of the case since it deprives respondent of an opportunity to seek a court review of the issues 8 involved.