American Home Products Corporation D/B/A Whitehall Laboratories

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I" THE J\1ATTE OF A::IERICAN HOlIE PRODUCTS CORPORATIO D/B/A WHITEHALL LABORATORIES ORDER, OPINION , ETO. IN REGARD TO THE ALLEGED VIOLATION OF THE FEDERAL TRADE coj\unSSION ACT Docket 84', 8. Complaint, Apr. 1962--Dectsion, Sept. , 1968 Order requiring ew York City distributors of a liquid anesthetic designated Omgro " to cease representing falsely through advertising in newspalJel'S and magazines, and especially by television broadcasts, that their said preparation ,vould instantly relieve and would cure ingrown toenails and the pain and infection therefrom; and to cease using t11e word ';Outgro " without a conspicuous accOilpan ying statement that the proc111et would not affect the growth or position of the toenail.

CO:\IPLAIKT Pmsuant 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 American 1-10me Products Corporation, doing business under the trade name \Vhite. hall Laboratories, hereinafter referred to as respondent, has violated the provisions of said Act, and it appeared to the Commission that a proceeding by it in respect thereof would be in the public interest 7S0-01S-- : .

934 FEDERAL TRADE COM:\IISSIO:N DECISIO Complaint 63 F.

hereby issues its complaint stating its charges in that respect as follows:

PARAGRAPH 1. Respondent American Home Products Corporation is a corporation organized, existing and doing business under and by virtue of the laws of the State of Delaware, with its principal offce and place of business located at 685 Third A venue in the city of New York, State of New York.

PAR. 2. Respondent is now, and for some time last past has been engaged in the sale and distribution of a preparation which comes within the classification of drugs as the term "drug" is defined in the Federal Trade Commission Act.

The desigTIation used by respondent for said preparation, the formula thereof and directions for use are as follows: Designation: Outgro Fonnllla; ctive Ingrec1ients: 21.0 glu.ins of Chlorobutnnol (:1 chlol'of'llff (le)' j"l1tive) to endl ft. OZ,) Tannic ). ric1 , and Isopropanol (anhYllL'ous) 81. 22%. J)jn,actions: Outgro is a local anesthetic. Apply :3several (hops in crevice where nab is gTo\Ying into flesh. 'York On1-I;1'(1 well 1111de1' the nails. I et dry t1101'- 0\1g111:;. Don t 1'Ilb off! Apply a few drops seycrnl times a day, Do not apply if toe is infected, but see your physician at' foot specialist. Diabetics should not use OUt2TO. Do not use near fire or tiawe. Keep all medication ont of the reflch of children PAR. 3. Respondent causes the said preparation, when sold, to be transported from its place of business in the State of New York to purchasers thereof located in various other States of the United States and in the District of Columbia. Respondent maintains, and at an times mentioned herein has maintained, a course of trade in said preparation in commerce as "commerce" is defined in the Federal Trade Commission Act. The volume of business in such commerce has been and is substantial.

PAR. 4. In the course and conduct of its said business, respondent has disseminated, and caused the dissemination of, certain advertisements concerning the said preparation by the United States mails and by various Ineans in comnlerce, as "commerce" is defined in the Federal Trade Commission Act, including, but not limited to, advertisements inserted in ne\vspapers, magazines, and other advertising media, and by means of television broadcasts over networks t.ransmitted by stations located in various States of the United States and by means of other television continuities broadcast by statjons having suffcient power to carry such broadcasts across state lines, for tile purpose of inducing, and which were likely to induce, directly or indirectly, the purchase of said preparation; and has djsseminated and caused the dissemination of, advertisements concerning said preparation by various mea, , including but not limited to the afore- .

WHITEHALL LABORATORIES 935 ll33 Complaint said media, for the purpose of inducing and which were likely to induce, directly or indirectly, the purchase of said preparation in commerce, as "commerce" is defined in the Federal TradeCommissian Act.

PAR. 5. Among and typical, but not all inclusive, of the statements and representations contained in said advertisements dissemjnated as hereinabove set forth are the following:

FIDEO AUDIO CU: OF TOES OF FOOT. REVEAL ANKCR: (ECHO) SWOLLEN AREA OF BIG TOENAIL Ingrown toenail (ECHO OUT)AXD PAlX Llj\ ES. TITLE ABOVE: IKGROWN TOENAIL. brings (A reproduction is attached hereto marked Exhibit A" and made a part hereof) CO);TINUE PAljX LINES. pain and COXTINUE PAIN LIKES. danger of infection. FLIP TO TOES , REVEALING NOR- (ECHO) Outgro (ECHO OUT) brings oIAL BIG TOE. TITLE ABOVE: relief and protection! OC'l' GRO.

ClJT TO iCV OP AN:\TCR. BEHL\T Don t suffer pain or risk infection DESK. unnecessarily. A,,XCR. HOLDS BOTTLE OF OUT- Get Outgro for ingrown toenail. GRO. BOTTLE ZOOMS UP. LOSE ANNCR.

CUT TO CU OF TOES. PAIN LIKES With the Outgro way, a few drops FRO:\I BIG TOE. REVEAI. APPLI.

CATOR DROPS.

(A reproduction is attached here-to marked Exhibit "B" and made a part hereof) PAIN FLASHES DISAPPEAR TITLE: RELIEVES PAD! IN- relieves pain instantly, STAKTLY.

(A reproduction is attached hereto marked Exhibit "0" and made a part hereof) TITLE POPS OFF, POP O L'TITLE:

Guards AGAINST Infection. guards against infection oIOYE IN O !DCU mG TOENAIL (A reproduction is attached hereto marked Exhibit "D" and made a part hereof) .Pictorial Exhibits A, B, C, D, E, F, and G are omitted in printing. ? , .. Complaint 63 F.

VIDEO AUDIO LOSE TITI.E AS SIZED toughens skin uuderneath so nail can XAIL GROWS IN. be cut NAIL IS !.;R lal, ADD TITLE to restore normal foot comfort! ABOVE: "NOIDIAL FOOT e0;1- FORT.

(A reproduction is attached hereto marked Exhibit "E" and made a part hereof) CL'T TO SPLIT SCREEN TITLE So don t sulIer pain and danger'" T G R 0 LEFT. " ,"Y N TOENAIL" ABOVE BIG TOE. TITLE RIGHT:

OUTGRO" ABOVE XORMAL BIG TOE.

(A reproduction is attached hereto ilarked Exhibit "If" and made a part hereof) X" OUT SeREEN LEFT. of ingro,vn toenail. Use Outgro! (A reproduction is attached hereto marked Exhibit 0" aJJd made a pl1rt hereof) FLIP TO Eei: OF OI:TGRO BOTTl" Outgro! For immediate relief and AXD PACKAGE. protection: PAR. o. Through the use of said advertisements, a.nd others similar thereto not specifically set out. herein, respondent has represented, and is no," representing, directly and by implication: 1. That Outgro relieves pain of ingrown toenails instantly. 2. That Outgro relieves infection from ingrown toenails. 3. That Outgro offers immediate relief from ingrown toenails. 4. That Outgro wil cure ingrown toenails. PAR. 7. The said advertisements were and are misleading in material respects and constituted, and now constitute false advertisements" as that term is defined in the Federal Trade Commission Act. The use of Outgro according to directions wil have no significant effect upon pain or infection nor wil it cure or offer relief from ingrown toenails.

PAR. 8. Respondents' use of the trade name " Outgro" is false and misleading in material respects in that it represents directly and by implication that the product wil cure ingrown toenails. In truth and in fact "Out.gro" win not cure ingrown toenails. PAR. 9. The dissemination by tl,e respondent of the false advertisements, as aforesaid, const-tuted, and now constitutes, unfair and WHITEHALL LABORATORIES 937 833 Initial De-ision deceptive acts and practices, in commerce, within the intent and meaning of the Federal Trade Commission Act. M,.. F,.edenck J. McManus and M,.. Oha,.les J. Oonnolly supporting the complaint.

Oa,.etta and Oounihan Washington, D. , by ilh. Albe,.t A. Oa,.. ,.etta for respondent.

IXITIL DECISION BY ANDREW C. GOODHOPE I-I: ARING EXAl\IIN"ER DECE3-fiber 28 1962 The Federal Trade Commission issued its complaint against the respondent on April 16, 1962. The complaint charged respondent with false and deceptive advertising as to therapeutic merits of a drug product sold under the trade name "Outgro . The complaint also charged that the trade name "Outgro" itself was deceptive. This proceeding is before the hearing examiner for final consideration upon the complaint, answer, testimony and other evidence, and proposed findings of fact and conclusions fied by counsel for respondent and by counsel supporting the complaint. Consideration has been given to the proposed findings or fact and conclusions submitted by both parties, and all proposed fil1dings of fact and conclusions not hereinafter specifically found or concluded are rejected and the hearing examiner, havjng considered the entire record herein makes the fonowing findings of fact, conclusions drawn therefrom and issues the following order:

FINDINGS OF FACT 1. Respondent American Home products Corporation l' is a corporation organized, existing and doing business under and by virtue or the laws of the State of Delaware, with its principal offce and place of business located at 685 Third Avenne in the city of New York State of K ew York.

2. Respondent is now and for some time in the past has been engaged in the sale and distribution of a product designated as Outgro . The trade name "Outgro" is owned by the respondent and is registered with the U.S. Patent Offce. 3. The active ingredients of the product "Outgro " are Chlorobutanol, Tannic Acid, Isopropyl Alcohol and Ethyl Cellulose? 1 The respondent was described in the complaint as "A.american Home Products Corporat:on dlbla Whitehall Laboratories, The Dame was shortened, as appears herein, by order of the examiner with the agreement of counsel for both sides. 2 The complete formulation of the Ingredients appears on Commission Exhibit 5 A. Initial Decision 63 F.

4. Respondent manufactureB its product "Outgro" in Elkhart Indiana, and shipments thereof are made therefrom to various other States of the United States and to the District of Columbia. Respondent maintains a course of trade in its product "Outgro commerce, as "commerce" is defined in the Federal Trade Commission Act.

5. The product "Outgro" is a "drug" within the definition of the term "drug" contained in the Federal Trade Commission Act. 6. The respondent has caused advertisements of its product "Outglo " to be disseminated in commerce by various means, including advertisements in newspapers and magazines, but principally by means of television hroadcasts on networks transmitting such broadcasts across state lines. The purpose of such advertisements was to induce the purchase in commerce of respondent' s product "Olltgro by the public.

7. The theme of respondent's advertising under consideration in this proceeding was that the product "Outgro" was an effective remedy for the condition generally known as ingrown toenai1. The advertisements made claims that the product when applied '" directed 3 was effective in relieving the pain and guarding against the infection of ingrown toenails. In addition, respondent's ads claim that "Outgro" offers immediate relief from, and will in effect cure, ingrown toenails.

8. An ingrown toenail is a condition resulting when the cornel' of the nail gro,,'s into the soft tissue at the outer end of the toe. usually involves the great toe, but others may be involved. Another cause may be an excess of soft t.issue at the outer end of the toe lapping over the nail.' The cause of this condition is usually improper trimming of the nail or improperly fitting shoes. As the nail presses into the soft tissue, it causes pressure on the tissue and may even penetrate the skin covering.

The usual symptoms of ingrown toenails are pain, infiamation and swelling. If the skin is penetrated and bacteria are present, there is danger or infection. In the examiner s opinion, howe\ , it is imma- The directions for the appEcation of "Outgro" ftre as follows: Directions: Outgro is a local anesthetic. Apply several drops in crevice where nail is growing into flesh. Work Outgro well under t!1p. nails. Let dry thoroughly. Don t rub of!! Apply a few drops senral times a dny. Do not apply if toe is infected. but see your physician or foot specialist. Dil1betics should not me Ontgro. Do not use near fire or fln1l"

Keep all medication out of the reach of children. 4 An ingrown toenail is defined in the American IlltJstrated Medical DIctionary by Dorlnnd a overlapping of the nail by the fiesh. " and the word "fiesh" Is defined as "the .!It, muscular tissue of the animal body. Consequently, the technical definition 0:1 ingrown toenail is "overlapping of the nan by the soft, muscular tissue ()f the animal body. WHITEHALL LABORATORIES 939 B33 Initial Decision terial whether or not there has been an actual penetration of the skin by the nail with the resultant danger of infection before the condition becomes an ingrown toenail. The respondent:s advertising makes no such distinction, and an examination of the advertising establishes that the claims involved herein are made for the prodnet. regardless of whether a penetration of the skin has occurred. 9. Examples of the respondent' s advertising in recent years include the following:

Nov. 11, 1956-lifay, 1958 Jww 1961-P'" e8ent Is an ingrown nail hurting ou? Nmy get immediate relief with OUTGH-G. t a few drops of Ot7l'GRO brings blessed relief from the tormentlng pain of ingro\Yll nail! OL'TCHO toughens the skin unclerneath the nail, allo\vs the nail to be Cll and thus pre\ents further pain and discomfort. So to get immediate relief from the tormenting pain of ingrown nail, to protect against dangerous infection '" '" * get OUTGHO today! :!' ow at all drug counters! May 1958-May, 1961 Ingrown toenail brings pain and danger of infection. OU1'GHO brings rpJief and protection! Don t suffer' pain 01' risk infection unneccssarily. Get 0TJ1"- GRO fol' ingrown toenail. 'With the OUTGRO way, Ii few drops relic\'cs pain instantl;r, guards against infection, toughens skin underneath so nail can be cnt to restore normal foot comfort So don t suffer pain and dangcl' of ingro'YlJ toenail. 1;8e OU' GRO For irnilClliflte relief and protection! Naroh 1961--July, 1961 Ingrown toenail b1'inns pain and rlflngcr of infection. With O"CTGRO just tlll' drops bring relief ald protection! ),TOW watch how OUT'GRO relie\'es pain instantly, guards against infection. Used as directed OUTGllO toughens skin undcl'eath so nail C3IJ be cut to restore normal foot comfort. Don t suffer the pain and danger of ingrown toenail. ,With OUTGRO just three drops brings relief and protection. Get: OUTGHO Each of the three statements set. forth above constitute the audio portion of a television 8.c1vcrtiscment which is spoken in eonjunction with a series of slides or frames which are broadcast and appear visually on the television screen. The audio portion set forth above should be heard in connect.ion with the visual portion of the ads to ascertain their fun import. The film strips containing both the audio and the video portions of the. ads arc in the record. 10. The first charge of dcceptive advertising is that respondent ra.lsely claims that its proc1uet "Outgro': will relieve the pa.in of ingrown toenail instantly. It is found that the clear import of the 940 FEDERAL TRADE CO nIISSION DECISIONS 63 F. Initial Dccision respondent' s advertising is that the application of the product "Outgro" to the affected area wjJ immediately relieve the pain caused by an ingrown toenail. The product "Outgro" contains a small amount of Chlorobutanol, which is a topical anesthetic. The credible testimony in the record is that the use of the small amount of Chlorobutanol present in "Outgro" will have no appreciable effect npo!! the pain of ingrown toenail and that, if it has any, it is very slight and of short duration. The examiner finds that respondent:s adver tising claims that the use of "Outgro" wjJ relieve the pain of ingrown toenail instantly are false.

J 1. The second charge is that respondent falsely claims that "Outgro" relieves infection from ingrown toenail. Respondent urges that its advertising is only to the affect that "Outgro" wjJ "guard against" infection resulting from ingrown toenail. If the skin is not broken as a result of the, ingrown toenail, there will generally be no infection present to guard against. If the skin is broken the use of respondent's product which contains a small amount of Iso propyl Alcohol wjJ have no effective antiseptic results. Respondent' claim that the tannic acid forms a "coating over the affected areas which will prevent any infection from entering is without foundation. Tannic acid has no antiseptic effect and, in fact, the coating over the affect.ed area may result in infectious matter being contained rather than permitted to exude naturally. The examiner finds that respondent' s claims that "Outgro" will guard against or relieve the infection from ingrown toenails are false. 12. The third charge is that respondent falsely claims that the product "Outgro" offers immediate relief from ingrown toenail. The credible evidence in the record is that the product "Outgro" does not provide any immediate or any other relief from ingrown toenail. The examiner finds that respondent' s claims in this regard are false. 13. The fourth charge in the complaint is that respondent falsely claims that "Outgro " will "cnren ingrown toe,nails. Counsel for respondent has conceded that the product "Outgro" will not "cure ingrown toenails, and urges that the respondent has never so advertised. Respondent's advert.ising docs not nse the "\orel "cure" anywhere in their text. The examiner has vie"\ed the television tapes used by respondent in advertising "Outgro:: and the clear import of the respondent's Rch'ertising is that the use of the, product "Ontgro will effect an almost immediate cure of ingre\yn toenai1. This is based principally upon the comparison in such television commercials of a swollen and infected ingrown toe with a perfectly normal toe which the advertising claims will re,salt from the use of WHITEHALL LABORATORIES 941 933 Initial Decision Outgro . The examiner finds that respondent's claims that "Outgro" will cure ingrown toenails, and that such claims are false. 15. The examiner accepts as credible the t.testimony of the experts in this field who testified on behalf of counsel in support of the complaint. Their qualifications as experts in t.their fields and in the subject matter herein involved are unquestioned. Their testimony, based upon their training, clinical experience and knowledge of the ingredients of the product "Outgro" and the directions for its use, is that the use of "Outgro " will have no significant effect on pain or infec tien, not will it cure or offer relief for ingrown toenails. In fact some testified t.hat its use may well have aggravated the condition in at least some insiances which they had observed in their practjces. The testimony of respondent' s experts as to the effectiveness of the respondent' s product "Outgro:' is rejected. The two principal expert witnesses called by the respondent identified and testified about a clinical study which they had conducted on behalf of the respondent. This clinical study made by Drs. Grinnell and Brodey was received in evidence. Commission counsel requested that the names of the subjects of their study be given him for the purpose 01 interviewing them. This was ordered by the examiner. Counsel for respondent insisted that rat.her than permit the subjects to be interviewed by Commission counsel that respondent's counsel ,vauld bring them all from New York to "Tashington to he interviewed on the record before the examiner. Commission counsel refused this offer. Theree'Yaftr, interviews wit.h certahl of the subjects were conducted in N York City. At the request 01 respondent's counsel, he was present together with a reporter who transcribed the interviews ycrba.tim. Of the 44 patients involved in the study, Commission counsel intcrviewed 11. Permission to interview the remainder was refused by Dr. Grinnell since t.he questions being asked by counsel in support of the complaint might endanger his practice. Counsel for respondent would not permit my witness CGrinnellJ to be endangered in his profession by questions asked hy Counsel in support 01 the complaint. Whereupon, the examiner st.truck the studies from the record and all 01 the testimony of Drs. Grinnell and Brodey in regard thereto. In view of the refusal by Dr. Grjnnel1 and counsel for respondent to have more than a few of the subjects of the study intervie,yed by Commission cOllnseJ and having observed the demeanor of Dr. Grinnell and Dr. Brodey on the witness stand, the examiner is of the opinion that no crcdence can be given either their clinical study or testimony.

16. The last charge is that "respondent' s nse of the trade name OUTGRO is false and misleading in material respects in that it Initial Decision 63 F.

represents directly and by implication that the product wi1 cure ingrown toenails." Counsel for respondent has conceded that "Outgro" will not cure ingrown toenails. In support of this charge counsel in support of the complaint requested the examiner to take offcial notice that the respondent's use of the trade name ' Out.gro represent.s directly and by implication that the product wi1 cause ingrown toenails to grow out again, thereby curing the ingrown toenail." This request was denied by the examiner. The word "outgrow" from which respondent has ohviously dropped the " " to obtain its trade name, is defined in l'Vebster s New International Dictionary as: "1. To surpass in growing. 2. To grow out of or away from." It is t.therefore quite clear that the secondary meaning of "outgrow" is directly applicable to and descriptive of a method of treatment of ingrown toenails; namely, to get the nail to grow out of or away from the flesh against which it has grown. The testimony of the experts in the record is that an ingrown toenail can only be effectively treated and cured by surgery to remove the causative factor. This involves the removal of the offending portion of the najJ including a portion of the matrix cells at the base of the nail. These matrix ceJJs create the growth of the na.il and it is therefore necessary to remove R portion of rhe mntrix to prevent the nail from again growing in such a fashion that it. becomes ingrown again. If the ingrowing nail is treated at an early stage, it can be packed so that the nail may grow up over the tissue thus preventing the nail from becoming ingrown. The record establishes that the product "Outgro" has no effect upon either the matrix cells of the nail or in the way that the nail grows. The product docs not cause the nail "to grow out of or away from " the skin or tissue of the toe. The examiner is convinced that mftn:v members or the public purchasing respondent's products have and will purchase "Outgrow" with the mistaken belief arising from its trade name that it win somehow aH'ect the growth of the nail and eliminate the symptoms or the ing-ro',n nail. The use of the. trade lJame "Outgro" advertised as it is as a preparation for use on ingrown toenails clearly has the rapflcit.y to mislead members of the public, nncl tJlC examiner feels that the public int.erest requires an order prohihiting its u e on re.sponc1enfs foot Cflre product. COXCLUSIO"!T The dissemination by tl1c respondent of the advertising found above to be false and tlle use by respondent of the trade name "Olltgro" in connection with its foot preparation constituted and now WHITEHALL LABORATORIES 943 933 Opinion consHtutes unfair and deceptive acts and practices, in commerce within the intent and meaning of the Federal Trade Commission Act.

ORDER TO CEASE AND DESIST It i8 ordered That respondent American Home Products Corporation, a corporation, and its offcers, representatives, agents and employees, directly or through any corporate or ot11cr device, in connection with the offering for sale, sitle or distribution of its foot preparation sold under the trade name "Outgro, or of any other product of substantially similar composition, do forthwith cease and desist from:

1. Disseminating 01' causing to be disseminated any advertisement by United States mails or by any means in commerce, as commerce" is defined in the Federal Trade Commission Act which:

(a) Represents, directly or hy implicittion, that such product relieves the pain of ingrown toenails. (b) Repre.sents, directly or by implication, that such product relieves or guards against infection from ingrown toenails.

(c) Represents, directly or by implication, that such product cnres or offers relief from ingrown toenails. (d) Contains the word "Olltgro" or any other brand name that represents, directly or by implication, that the product win cure ingrown toenails.

2. Disseminating or causing to be disseminated any advertisement by any means for tlle purpose or inducing or which is likely to induce, directly or indirectly. the purchase in commerce, as " commerce" is defined in the Federal Trade Commission Act, of said medicinal preparation. which advertisement contains any of the representations prohibited in Paragraph 1, above.

OPINION OF THE CO BIISSIOX SEPTMBER 27 : 1963 B:r ELMAX. Oomml-ssio11er:

The comphint in this matter charges respondent with disseminating advertisements misleading in material respects and hence constituting false advertisements within the meaning of Section 12 of the Federal Trade Commission Act, in connection with it medicinal preparation (a "drug" within the meaning of Section 15(c) of the Act) which respondent manufactures ancl sens, under the regis- 944 FEDERAL TRADE COMMISSION DECISIOXS Opinion 63 F. tered trade name "Outgro, for the treatment of ingrown toenails. An ingrown toenail results when the corner of the nail, commonly the nail of the big toe, grows into the soft tissue of the outer end of the toe. In pressing into the tissue, the nail may penetrate the skin covering. The usual symptoms of an ingrown toenail fite pain, in- flammation and swelling; if the skin is penetrated and bacteria are present, there is danger of infectjon. There are two recognized effective remedies for an ingrown toenai1. The less drastic il volves lifting up the corner of the nail over the soft flesh, usually by means of a wad of cotton, to permit the nail to grow out over the flesh. If the nail is too far ingrown for this remedy to be effective, thensurgery-which inyolY8S cutting away the ent.ire nail in the affected area, including the matrix (the skin immediately underneath the nail)-may be required.

Outgro" is a local anesthetic in liquid form. Cone-edeellY1 it c not cure an ingrown toenail or an infection resulting therefrom. Indeed, if "Outgro" is used when infection has already set in the tannic acid in the product lnay "seal" the infection in the toe, retarding treatment and possibly causing the infection to spl'E't1d. Respondent does contend, hmvever, that "Outgro" affords at lea partial or temporary relief from the pain and discomfort resulting from ingrown toenalJ and, by toughening the soft flesh in the surrounding area, acts to some degree as a prophylactic aga,inst new infec60n resulting from ingrown toenail, and also facilitates the cutting of the nail should surgery prove necessary. Although the hearing examiner concluded that HOntgro " is .jthout any therapeutic value, we find, on the basis of all the evidence, including a clinical study prepared by respondent which the examiner improperly excluded from evidence but which the Commission has fully considered on this appeal ' that complaint counsel has not sustained the burden aT proving that. "Olltgro " does not have t1w limited properties argued for it by respondent. In its advertising, ho\")ever, respondent has made 110re sweeping claims for its product-claims which cannot be substant1nted and are, in consequence unlawTn1. The record in this cam contains "Tbe basis of the c:examiner s rnllng c:Scludlng the study in que",tlon (RX 9-11) was respond(!Dt' R refusal to nbide b ' an order of the examiner which gave complaint counsel permission to interview informally" everyone of the 44 patients who had participated in the study. Respondent. however, objected Dot to conventional cross.examlnation jn respect of the study, but only -1(1 complilint c011nsel's interviewing the patients oll/side of the examiner s presence. Inured, re j)ondent freeJ ,. provided complaint counsel with the !lames and nddresses of each of the 44 patients find with aU other Information, notes and records which might ban been helpful in impeaching the study on cross-examination. Since com. plaint counsel thus had ample opportunity for adequate cross-examination, tile study should bail' been received In evidence, and we hale considered it as part of the record upon which our findings are basea.

, ; WHITEHALL LABORATORIES 945 G33 Opion many instances of excessive advertising claims. For example, in one television commercial for "Outgro" (eX 6a-6b) the viewer is shown first a toe with ingrown toenail, the corner of the nail bnried under the soft flesh; then "Outgro" being applied to it; and immediately thereafter, the nail growing over the flesh to form a perfectly normal toenail. 'While this metamorphosis is occurring before the viewer s eyes, the announcer is remarking that ' Outgro toughens skin underneath o na.il can be cut to restore normal foot comfort". Even on the dubious assnmption that the viewer would understand the reference to cutting to denote Sllgery by a doctor and not mere trimming of the nail by the user of "Outgro" himself with scissors or nail clipper, the qualifying words are believed by the visual presentation, in which the ingrown nail, unaided by surgery or any other treatment besides "Outgro, is shown growing back to normal. J\foreover, other statemcnts accompanying the visual presentation are misleading because they omit essential qualifications: Outgro brings relief and protection! Don t suffer pain or risk infection unnecessarily. Get Outgro for ingrown toenail" So don suffer pain and danger of ingrown toenail. Use Outgro!" The clear implication of the advertisement as a whole is that the use of "Outgro, without more, will restore an ingrown toenail to normal. No reference is made to surgery, packing of the na.i, or other treatment that is ordinarily necessary. The average viewer of such an advertisement would probably believe that "Outgro " is a completely effective home remedy for ingrown toenail; he is not told, and would not be likely to understand, that "Olltgro" is merely a local anesthetic and cn,nnot give more than temporary, symptomatic relief, with some prophylaxis against infection. In the case of a medicinal preparation having limited properties such as "Outgro, the law requires in appropriate eases that the limitations also be clearly disclosed where the claim is made that the product has such properties. This duty not to mislead the public is not satisfied merely by refraining from making claims which in themselves are false. Section 15 (a) (1) of the Federal Trade Commission Act expressly provides that, i11 determining \'!whether an advertisement for a food, drug, device or cosmetic is misleading find hence false. "there sllal1 be taken into account (among other things) not only re presentations made or suggested * ' * but also tile extent to which tile a,c1vertisement fails to reveal fnets m:1terial in the ligllt of such representations * * * To a person seeking to be rid of an ingrown toemril: it is certainlv material that "Outgro " does not cure the condition 01' infecdoes not effect n complete and permanent tions" resulting therefrom 946 FEDERAL TRADE COMMISSIOK DECISIOKS Opinion 63 F.

cessation of pain and discomfort, and should not be used if infection has already set in. These limitations, which are the corollaries of the claims that i: Outgro " relieves pain and "protects" or "guards against" infection, must be clearly expressed, for without them the unqualified chims become deceptive half-truths. Such express disclaimers are a.l the more necessary if the misconceptions created by respondents affrmative misrepresentations of the properties of Outgro" are to be dispelled. Of. Waltham Preoision Instrument 00. C. Docket 6914 (decided October 16, 1962), 61 F. C. 1027 1048 , 1049.

The examiner found the trade name "Outgro" false and misleading pe1' 86 and ordered respondent to cease using it in its Rehertising. ,Ve agree that the lUlme is likely to deceive the prospective purchaser, who may be led by it to believe that the product wil cause an ingrown toenail to grow out or away from the flesh against fl.which it is pressing. However, while the fact that "Outgro" is registered trademark is not controlling in this proceecling Chcu1es of the Ritz Dist. OOTP, v. FTO 143 F. 2c1 676 (2c1 Cir. 1944), an order prol1ibiting altogether the use. of a valuable trade name-here one that has been used by respondent lor more than thirty yearsis a drastic measure which TIe prerer not to invoke if a less severe remedy i readily available that will adequately protect the public interest. See FTO v. Royal iJIilli!i1g 00. 288 U.S. 212. In the pre3ent circumstances, it will suffce to require 8.n appropriate flffrmatin' disclrimer in conjunction ,,'ith the use or the name "Outgro ' ill adve.rtising. There are, to be sure cases in which the addition of an affirmative disclaimer to a misleading trade name would only conruse the consumer-and in such cases, excision or the name may , BakeJ's FTanchise Ccrp.be the only practical remedy. See C. Docket 7472 (decided July 19, 1961), 59 F. C. 70 77. We are sa.tisfiec1 however, that in the instant case an order requiring respondent to clisclosB, clearly and conspicuously, in immediate conjunction with the name "Outgro, that the product does not in any "fly affect nail grmyth, shape or position, 1,yill not confuse the consumer and "ill fully obviate any danger or consumer deception caused by the trade name.

Except as set forth in this opinion. the findings of fact and conclusions of law contained in t.he initial decision n.re adopted by the Commission. ",Vo have revised somewl1at the terms and provisions desist. \s has been stated many times.of the order to cease and the purpose of an order of the Commission is to tUide and instruct a view' to prevention of future vio-in ihe. requirements of )a" with lations, not to punish. This purpose is best ruInned here, "e think WHITEHALL LABORATORIES 947 933 Final Order by an order which distinguishes between what is permitted and what is forbidden to respondent in clear and precise terms. The order in this case does not prevent or inhibit respondent from making truthful claims on behalf of "Outgro; it requires only that those claims be expressed in such terms, and with such qualifications where necessarYj that prospective purchasers will not be misled. FINAL ORDER SEPTE1IBER 27 , 1963 This matter has been heard hy the Commission on respondent' appeal from the initial decision of the hearing examiner. The Commission has rendered its decision, granting the appeal in part but denying it in an other respects. The Commission has determined for the reasons stated in the accompanying opinion, that the order to cease and desist contained in the initial decision should be modified and, as modified, issued as the Commission s final orc1el' Therefore It is ordej. That respondent, American Home Products Corporation, a corporation, and its offcers, agents, representatives and employees, doing husine.ss under' any name or through any corporate or other de'dce, in connection with the sale, offering for sale or distribution of the product that respondent manufactures and sells under the name of "Ontgro, or any other product of substantially similar composition and intenoed use, do forthwith cease and desist from disseminating or causing to be disseminated (1) by United States mails, or in commerce by any me,ans for the purpose of inducing, or which is likely to induce, directly or indirectly, the purc11false of said proc1ucl (2) by any means, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase in commerce of said product any advertisement which:

(A) states or implies, whether by words or pictures or a combination thereof, that said product can or will: (1) cure, or provide an effective remedy for, the condition known as ingrown toenail;

(2) relieve pain or discomfort resulting from said condition, unless respondent clearly and conspicuously states, in immediate conjunction with any such representation, tllflt such relief is partial.l and temporary only and is not complete or permanent;

948 FEDERAL TRADE COM IISSION DECISIONS Complaint 63 11 (3) relieve, improve or cure infection caused by or accompanying said condition; or (4) protect, prevent or guard against such infection, un less respondent clearly and conspicuously states, in immediate conjunction with any such representation, that said product is preventive only and cannot relieve, improve 01' cure an already existing infection, and should not be used if infection lws already set in; or (B) contains the word "Outgro" or any similar-sounding or similar-appearing word suggestive of growth, unless respondent clearly and conspicuously states, in immediate conjunction with any such word, that said product does not affect in any way the growth, shape or position of the toenail. It dered. That respondent shall file with the Com- furthe mission, within sixty (60) days after service of the order herein upon it, a report in writing setting forth in detail the manner and form of respondent's complia.nce with the order.