Benton & Bowles, Inc

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IN THE MATTER OF BENTON & BOWLES, INC.

CONSENT ORDER , ETC. , IN REGARD TO ALLEGED VIOLATION OF SECTIONS 5 AND 12 OF THE FEDERAL TRADE COMMISSION ACT Dockel C-3055. Complaint, March 4. 1981-Decision, March 4. 1.981 This consent order requires, among other things, a New York City advertising agency to cease, in connection with the advertising and sale of Encare or any similar over-the-counter vaginal contraceptive suppository product, misrepresenting or failing to substantiate claims relating to the product's effectiveness, safety and performance characteristics. The firm is further prohibited from disseminating advertisements using performance or quality heightening modifiers such as "highly, " or "extremely," in conjunction with words like effective" or "reliable. " Additionally, the order requircs the company to disclose in print, radio and TV consumer advertising, certain facts material to contraceptive suppository use; and to maintain business records for a period of three years.

Appearances For the Commission: Shirley F Sarna and Paula K. Stein. For the respondent: Stuart L. Friedel, Davis Gilbert New York City.

COMPLAINT The Federal Trade Commission, having reason to believe that Benton & Bowles, Inc., a corporation (hereinafter "respondent"), has violated Sections 5 and 12 of the Federal Trade Commission Act, and that a proceedi:1g in respect thereof would be in the public interest hereby issues its complaint, stating its charges as follows: PARAGRAPH 1. Benton & Bowles, Inc. is a New York corporation with its principal place of business at 909 Third Ave., New York New York.

Allegations stated in the present tense include the past tense. PAR. 2. For purposes of this complaint the following definitions shall apply:

(1) A vaginal contraceptive suppository is a spermicida) contraceptive product which is inserted into the vagina prior to coitus. Body temperature or vaginal secretions dissolve the suppository and spread its sperm killing agent through the vaginal cavity. (2) "Use effectiveness means that level of effectiveness which is obtained when the contraceptive method is used by large numbers of J68 FEDERAL TRADE COMMISSION DECISIONS Complaint 97 F.

subjects not all of whom follow the instructions accurately or use the contraceptive method each time they have sexual relations. (3) Commerce means commerce as defined in the Federal Trade Commission Act, as amended.

PAR. 3. Respondent Benton & Bowles, Inc. is an advertising agency for Morton-Norwich Products, Inc. and Eaton-Merz Laboratories Inc. In such capacity respondent Benton & Bowles, Inc. has prepared and placed advertising for publication and has caused the dissemination of advertising, including the advertising referred to herein, to promote the sale of a vaginal contraceptive suppository product named "Encare" or "Encare Oval" (hereinafter "Encare ) a "drug within the meaning of Section 15 of the Federal Trade Commission Act.

PAR. 4. In the course and conduct of its business respondent has disseminated or caused the dissemination of certain advertising concerning Encare (1) Y U niterl Statlcd mail, or by variuus means in or having an effect upon commerce, including but not limited to insertion in newspapers 01 magazines of interstate dissemination and radio broadcasts of interstate transmission for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of Encare; or (2) by various means, for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of Encare in or having an effect upon commerce. PAR. 5. Respondent has disseminated or caused the dissemination of the advertisement identified as Attachment 1 which is incorporated by reference herein.

PAR. 6. Through the use of this advertisement, respondent represents, directly or by implication, that: 1. Encare has an extremely high use effectiveness, approaching the level of oral contraceptives (hereinafter "the pill") or intrauterine devices (hereinafter "IUD"

2. Encarc has novel contraceptive performance characteristics. PAR. 7. In truth and in fact:

1. Encarc s use effectiveness is approximately that of other vaginal contraceptive products. It is not considered tc? have a use effectiveness on the level ofthe pill or IUD. 2. Encare does not have novel contraceptive performance characteristics except as to the characteristics associated with its method of delivery. Its sperm killing ingredient, nonoxynol 9, has been in use for many years in various contraceptive products. :\., U-'L' "-V"'-'-''-, U'V.

167 Complaint Therefore, the advertising and representations referred to in Paragraphs Five and Six are false, deceptive or misleading. - PAR. 8. At the time respondent made the representations alleged in Paragraph Six, respondent had no reasonable basis for making those representations. Therefore, the making and dissemination of such representations constitute deceptive or unfair acts or practices in or affecting commerce.

PAR. 9. Through dissemination of the advertisement. identified as Attachment 1, respondent advertises Encare without disclosing to the purchasing public through the advertising that: 1. Women for whom pregnancy presents a special health risk should make a contraceptive choice in consultation with their physician.

2. Some Encare users experience irritation in using the product. 3. Encare requires a waiting period of ten minutes before intercourse.

PAR. 10. Furthermore, respondent advertises Encare without disclosing to the purchasing public through the advertising that: Encare is approximately as effective as vaginal foam contraceptives in actual use. PAR. 11. The facts described in Paragraphs Nine and Ten are material with respect to the consequences which may result from use of Encare as a contraceptive under such conditions as are customary or usual. Respondent's failure to disclose these material facts renders the advertising referred to in Paragraphs Four and Five false, deceptive or misleading.

PAR. 12. Furthermore, through the use of the advertising referred to in Paragraphs Four and Five, respondent, directly or by implication favorably compares some characteristics of Encare to the pill or the IUD and represents in the same advertising that Encare has an extremely high use effectiveness. Favorable comparison of Encare to certain characteristics of the pill or IUD has the tendency and capacity to lead members of the public into the erroneous and mistaken belief that Encare s use effectiveness is equal to that of the pill or IUD. Respondent fails to disclose the material fact that Encare has a use effectiveness below that of the pill or IUD and approximately the same as other vaginal foam contraceptive products.

PAR. 13. The fact described in Paragraph Twelve is material in light of the comparative representations made in respondent' advertising. Respondent's failure to disclose this material fact in advertising containing such comparative representations renders ;,!i1 O- K2- 170 FEDERAL TRADF; COMMISSION DECISIONS Complaint 97 FTC.

the advertising referred to in Paragraphs Four and Five false misleading or unfair.

PAR. 14. In the course and conduct of its business, and at all times mentioned herein, respondent is in substantial competition in or affecting commerce with corporations, firms and individuals engaged in the sale of services of the same general kind and nature as are sold by respondent.

PARA. 15. The US8 by respondent of the aforesaid false, misleading, deceptive or unfair statements, representations, acts or practices and the dissemination of the aforesaid false advertising has the capacity and tendency to mislead members of the public into the erroneous and mistaken belief that said statements and representations are true and into the purchase of substantial quantities of respondent' products or services by reason of said erroneous and mistaken belief. PAR. 16. The aforesaid acts and practices of respondent as herein alleged, including the dissemination of false advertising, are all to the prejudice and injury of the public and of respondent's competitors and constitute unfair methods of competition or unfair or deceptive acts or practices in or affecting commerce in violation of Sections 5 and 12 of the Federal Trade Commission Act. The acts and practices of respondent, as herein alleged, are continuing and will continue in the absence of the relief herein requested. Commissioner Pitofsky did not participate. y, , ,,, ::_ j :: : . ;; ). , ;: . . .. _.. BENTON & BOWLES. INC 171 JG7 Complaint L8ir&l. 1join:I ' '0 ,'IR"

,..ot.. ':1j. , ,0\-:- lQh lll i -- At la5!, Encue:' ;i1t,.rward. E..ch :rn i"'ert contain. an found 10 b" h,ghly eii"Cli,, (amp..(1. no b'38er !h.Jn your act r:"em...",red..mol.nrOllhecll;"if", c;.o, Ene Jr pro, en jp rm;c'c . nonO'Yrlol9 Simply sale '\ 'd'; b om,ng 11'" cally mr, ! I..I dbaulcon!ldC,-pr"e And .r you your g' n"(Oro ,.r ll b" re "L.ro- you ..boric En(J'e hdv IQd 'C' Ihm EnCJre eJnnot rjr.. VerySimplyeifective.irnply. Encar", "orh;: nel.tral- hear Fre,.!ro."Thormc"..I\.deeiiecl' KJ'I! - 1\ .. a,J. II' ""'lnput.l prl" flp. il,ng Iperm, When L.led prur:e,l body the way the pill or ILO mr l;on. A"d'lmjgh(weilbethe Encare melt and g'Call\' elre",e Cl"S. Wh;ch medn . ,OU Sire;1I" ' (J" ;:;-, f";I tm",lhodOlb'rlh(onlrO!y(Jlj spreading!hrou'$h- - worriedabo..trho,e wdl e(u Sig1pl:r' S:T1pl You \",,I\" ""en En(aa' " .rl1 the lip oiyouri,ng r Th..'e\no, vmeJ,ur. ;;i;;;; ins. no lu ::n. or\. And no cnn(JI('L.n\- no i-pl' m""jY pJ'Jp ,"".","":ao....n',,' e'nJI'd locle..nup !pe,m,c1oe'"JS E"CJre - r .. - ""O'-' Birth controi simplified.

172 FEDERAL TRADF: COMMISSION DECISIONS Decision and Order 97 FTC. DECISION AND ORDER The Federal Trade Commission having initiated an investigation of certain acts and practices named in the caption hereof, and the respondents having been furnished thereafter with a copy of a draft of complaint which the New York Regional Office proposed to present to the Commission for its consideration and which, if issued by the Commission, would charge respondents with violation of the Federal Trade Commission Act; and The respondents, their attorneys, and counsel for the Commission having thereafter executed an agreement containing a consent order, and admission by the respondents of all the jurisdictional facts set forth in the aforesaid draft of complaint, a statement that the signing of said agreement is for settlement purposes only and does not constitute an admission by respondents that the law has been violated as alleged in such complaint, and waivers and other provisions as required by the Commission s Rules; and The Commission having thereafter considered the matter and having determined that it had reason to believe that the respondents have violated the said Act, and that complaint should issue stating its charge in that respect, and having thereupon accepted the executed consent agreement and placed such agreement on the public record for a period of sixty (60) days, and having duly considered the comments filed thereafter by interested persons pursuant to Section 2.34 of its Rules, now in further conformity with the procedure prescribed in Section 2.34 of its Rules, the Commission hereby issues its complaint, makes the following jurisdictional findings and enters the following order:

1. Respondent Benton & Bowles, Inc. is a New York corporation with its principal place of business at 909 Third Ave., New York New York.

2. The Federal Trade Commission has jurisdiction of the subject matter of this proceeding and of the respondents, and the proceeding is in the public interest.

ORDER This Order applies to respondent Benton & Bowles, Inc. its successors, assigns, officers, agents and employees, whether acting directly or through any corporation, subsidiary, division or other device; provided however, that this Order shall not apply to ethical (professional) advertising prepared or disseminated by Medicus Communications, Inc. for any OTC (over-the-counter) contraceptive product other than Encare or any other vaginal contraceptive , LH-".L'.L'-.L' .. 1JV"1J.L H''-.

167 Decision and Order suppository product. Except as otherwise provided, Order provisions apply to any act taken in connection with respondent's adverti"ing, offering for sale, sale or distribution of Encare or any OTC contraceptive product in or affecting commerce within the United States, including the Commonwealth of Puerto Rico and any territory or possession of the United States. The reasonable basis standards used in this Order are not intended to set a standard for drug products other than OTC contraceptives. For purposes of this Order, the following definitions shall apply: 1) Use effectiveness or effectiveness in actual use means that level of effectiveness which is obtained when the contraceptive method is used by large numbers of subjects not all of whom follow the instructions accurately or use the contraceptive method each time they have sexual relations.

2) Encare means the vaginal contraceptive suppository product marketed under the tradename Encare or Encare Oval, or any vaginal contraceptive suppository product of substantially the same chemical formulation.

3) "Advertisement" means any written, verbal or audiovisual statement, illustration, depiction or presentation, which is designed to effect the sale of any OTC contraceptive product, or to create interest in the purchasing of such products (except a package or package insert) whether same appears in a brochure, newspaper magazine, leaflet, circular, mailer, book insert, catalog, billboard, public transit card, point-of-sale display, film strip, video presentation, or in a radio or television broadcast or in any other media, regardless of whether such statement, ilustration, depiction or presentation is characterized as promotional, educational or informative; provided, however that the term advertisement does not include material which solely refers to the product without making any claims for the product.

4) Product or use characteristic includes but is not limited to efficacy, safety or convenience.

It is ordered, That respondent cease and desist from: A. Making in consumer (Jay) advertisements any contraceptive effectiveness claims regarding Encare which use the words " effective" or "reliable" in conjunction with any performance or quality heightening modifiers such as "highly extremely" and the like. B. Misrepresenting, directly or by implication, the effectiveness , Decision and Order 97 F.T.C. of any OTC contraceptive product; unless respondent neither knew nor should have known that the representation was false, deceptive or misleading.

C. Representing, directly or by implication, that Encare has novel contraceptive performance characteristics except as to the characteristics associated with its method of delivery. D. Making any representation, directly or by implication, concerning the effectiveness of any OTC contraceptive product unless respondent has a reasonable basis for such representatioh consisting of a consistent body of valid and reliable scientific evidence; provided, however that respondent may represent that Encare is effective or reliable or make other effectiveness claims as permitted by this Order (for example Encare provides reliable protection against pregnancy It is ordered That respondent make the following affirmative disclosures in any consumer (lay) print advertisement for Encare: A. For best protection against pregnancy, it is essential to follow package instructions.

B. If your doctor has told you that you should not become pregnant, you should ask your doctor which contraceptive method including Encare, is best for you.

C. Some Encare users experience irritation in using the product. D. It is essential that you insert Encare at least ten minutes before intercourse.

E. Encare is approximately as effective as vaginal foam contraceptives in actual use.

The above affrmative disclosures shall be made clearly and conspicuously. Disclosures C, D and E shall be made in the exact language indicated above; provided, however, that if respondent has a reasonable basis, consisting of valid scientific test(s) or study(ies), respondent may modify the words "ten minutes" in Disclosure D consistent with such reasonable basis. Disclosures D and E shall be made in type at least as large as the type face of the major portion of the text of the advertising copy. Disclosures D and E shall be separate and distinguishable from the main body of the advertisement for the period from the date of signing of this Order to February 19, 1982.

RENTON & nOWLES, ING 175 167 Decision and Order It is further ordered, That respondent make the following affirmative disclosure in any consumer (lay) print advertisement for Encare in which any product or use characteristic of Encare is compared directly or by implication, to any product or use characteristic of oral contraceptives (hereinafter "the pill") or intrauterine devices (hereinafter "IUD"

Encare is approximately as effective as vaginal foam contraceptives in au-ual use, but is not as effective as the pijJ or IUD.

Enc8rc is not as effective as the pill or IUD in actual use, but is approximately as effective as vaginal foam contraceptives. Either above affirmative disclosure shall be made, where required in lieu of Disclosure 1LE above. The disclosure shall satisfy the requirements regarding exact language, size of type and relation to the main body of the advertisement specified for Disclosure H. It is further ordered, That respondent make the following disclosures in any consumer (lay) TV advertisements for Encare: A. Follow directions exactly, including the ten minute waiting period.

B. Encare is approximately as effective as vaginal foam contraceptives in actual use.

The above disclosures shall be made clearly and conspicuously as video supers and in the exact language indicated above; provided, however, that if respondent has a reasonable basis, consisting of valid scientific test(s) or study(ies), respondent may modify the words "ten minutes" in Disclosure IV.A consistent with such reasonable basis. It is further ordered, That respondent make the following disclosure in any consumer (lay) radio advertisements for Encare: Encare is approximately as effective as vaginal foam contraceptives in actual use. The above disclosure shall be made clearly and conspicuously and in the exact language indicated above.

Decision and Order 97 F.TC. It is further ordered, That respondent shall make the following disclosures in ethical (professional) advertisements for Encare. A. Irritation accompanies use of the product in some instances. B. Encare must be inserted according to product instructions and at least ten minutes before intercourse.

C. Encare is approximately as effective as vaginal foam contraceptives in actual use, but is not as effective as the pil or IUD. Encare is not as effective as the pill or IUD in actual use, but is approximately as effective as vaginal foam contraceptives. Affirmative Disclosures A and B shall be made in language the same as or substantially similar to the language set forth above; provided, however that if respondent has a reasonable basis consisting of valid scientific test(s) or study(ies), respondent may modify the words "ten minutes" in Disclosure B consistent with such reasonable basis. Disclosure C shall be made in the exact language indicated above, in typeface at least as large as the typeface of the major portion ofthe text of the advertising copy. VII It is further ordered, That respondent cease and desist from: A. Disseminating or causing the dissemination of any advertisement, by means of the United States mail or by any means in or affecting commerce within the United States, including the Commonwealth of Puerto Rico and any territory or possession of the United States, which contains any of the representations prohibited in Paragraph LA-C of this Order or, with respect to Encare, fails to include any of the disclosures required by this Order. B. Disseminating, or causing to be disseminated, by any means for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase of Encare or any OTC contraceptive product in or affecting commerce within the United States, including the Commonwealth of Puerto Rico and any territory or possession of the United States, any advertisement which contains any of the representations prohibited in Paragraph LA-C of this Order or, with respect to Encare, fails to include any of the disclosures required by this Order.

J67 Decision and Order VII It is further ordered, That resp6ndent tnai'htain complete business records relative to the manner and form of its compliance with this Order. Such records shall include, but not be limited to, copies of and dissemination schedules for all advertisements; and documents which substantiate or contradict any claim made in advertising, promoting or selling the products. Such records shall be retained for at least three (3) years beyond thc last dissemination of any relevant advertisement. Upon thirty (30) days notice respondent shall make any and all such records available to Commission staff for inspecti or photocopying.

It is further ordered, That respondent forthwith deliver a copy of this Ordcr to each operating division and to all employees or agents now or hereafter engaged in the sale or offering for sale of Encare or in any aspect of the preparation, creation or placing of advertising for Encare on behalf of respondent. A statement acknowledging receipt of this Order shall bc obtained in each case. It is further ordered, That respondent notify the Commission at least thirty (30) days prior to any proposed change in corporate respondent in which the respondent is not a surviving entity, such as dissolution, assignment or sale resulting in the emergence of any successor corporation or corporations, or any other change in said corporation which may affect compliance obligations arising out of this Order.

It is further ordered, That respondent shall, within sixty (60) days after service upon it of this Order, file with the Commission a report setting forth in detail the manner and form in which it has complied with this Order.

Commissioner Pitofsky did not participate. 178 FEDERAL TRADE COMMISSJON DECISIONS Complaint 97 F.T.C.