Jordan-Simner, Inc

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IN THE MATIER OF JORDAN-SIMNER, INC., ET AL.

CONSENT ORDER, ETC., IN REGARD TO ALLEGED VIOLATION OF SECS. 5 AND 12 OF Tile FEDERAL TRADE COMMISSION ACT Doket C-3022. Complaint; J'une 1980-Decisi, June 1980 This consent order requires, among other things, a Ft. Lauderdale, Florida manufacturer of pharmaceutical products to cease making any misrepresentations of the efficacy or novel rformance characteristics of its vaginal contracptive suppository products. The order specifically prohibits any exaggerated efficay claims for the products such as "highly" or "extremely" effective. Additionally, respondent is prohibited from making claims of efficacy without a reasonable basis consisting of a consistent boy of valid and scientific evidence. Appearances For the Commission: Susan Lernr.

or the respondents: Rayrrnd D. McMurray, Hamel, Park, McCabe & Saunders Washington, D.

COMPLAINT The F'ederal Trade Commission, having reason to believe that Jordan-Simner, Inc., a corporation, and Robert Cohen, individually and as an officer of said corporation (hereinafter "respondents ), have violated Sections 5 and 12 of the Federal Trade Commission Act, and that a proceeding in respect thereof would be in the public interest hereby issues its complaint, stating its charges as follows: PARAGRAPH 1. Respondent Jordan-Simner, Inc. is a Florida corporation with its principal place of business at 6852 N.W. I2th Ave., Ft. Lauderdale, Florida.

Respondent Robert Cohen is an officer of said corporation. He formulates, directs and controls its acts and practices, including the acts and practices hereafter set forth. His business address is the same as said corporation.

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 spermicidal contraceptive product which is inserted into the vagina prior to coitus. Body temperature or vaginal secretions dissolve the suppository and spread its sperm kiling agent through the vaginal cavity. Complaint 95 F.

(2) "Use effectiveness" 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. (3) "Commerce" means commerce as defined in the Federal Trade Commission Act, as amended.

PAR. 3. Respondents engage in the manufacturing, advertising, offering for sale and sale of pharmaceutical products, including a vaginal contraceptive suppository product named " Positive, a drug" within the meaning of Section 15 of the Federal Trade Commission Act.

PAR. 4. Respondents cause their products when sold, to be shipped and distributed from their place of business to purchasers located in various other States of the United States and the District of Columbia. Respondents maintain a substantial course of trade in all their products, including their product S'Positive, in or affecting commerce. PAR. 5. In the course and conduct of their business respondents disseminate or cause to be disseminated certain advertisements concerning S'Positive (1) by United States mails, or by varous means in or having an effect upon commerce, including but not limited to insertion in newspapers or magazines of interstate dissemination for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of S'Positive, or (2) by various means, for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of S'Positive in or having an effect upon commerce. PAR. 6. Among the advertisements and other sales promotion materials, and typical of the statements and representations made in respondents' advertisements, but not all inclusive thereof, are the advertisements identified as Attachments I and 2. PAR. 7. Through the use of such advertisements, and others not specifically set forth herein, respondents represent, directly or by implication, that:

1. S'Positive has an extremely high use effectiveness, approaching the level of oral contraceptives (hereinafter " the pil") or intrauterine devices (hereinafter "IUD"

2. S'Positivc has novel contraceptive performance characteristics. PAR. 8. In truth and in fact:

1. S'Positive s use effectiveness is approximately that of other vaginal contraceptive products. It is not considered to have a use effectiveness on the level of the pil or IUD. JORDAN-SIMNER, INC., ET AL. 873 871 Complaint 2. S'Positive does not have novel contraceptive performance characteristics except as to the characteristics associated with its method of delivery. Its sperm kiling ingredient, nonoxynol 9, has been in use for many years in various contraceptive products. Therefore, the advertisements and representations referred to in Paragraphs Six and Seven are false, deceptive or misleading. PAR. 9. Furthermore, through the use of the advertisements referred to in Paragraphs Five and Six, respondents represent, directly or by implication, that:

I. S'Positive has an extremely high use effectiveness. 2. S'Positive has novel contraceptive performance characteristics. 3. S'Positive has undergone years of successful medical or consumer testing.

PAR. IO. At the time respondents made the representations alleged in Paragraph Nine, respondents had no reasonable basis for making those representations. Therefore, the making and dissemination of such representations constitute deceptive acts or practices in or affecting commerce.

PAR. II. Furthermore, respondents market or advertise S'Positive without disclosing to the purchasing public through their advertising that:

I. For best protection against pregnancy, it is essential that one follow instructions.

2. Women for whom pregnancy presents a special health risk should make a contraceptive choice in consultation with their physician.

3. Some S'Positive users experience irritation. 4. S'Positive requires a waiting period of fifteen minutes before intercourse to ensure effectiveness.

5. S'Positive is approximately as effective as vaginal foam contraceptives in actual use.

PAR. 12. The facts described in Paragraph Eleven are material with respect to the consequences which may result from use of S' Positive as a contraceptive under such conditions as are customary or usual. Respondents' failure to disclose these material facts renders the advertisements referred to in Paragraphs Five and Six false, deceptive or misleading.

PAR. 13. Furthermore, through the use of the advertisements referred to in Paragraphs Five and Six, respondents, directly or by implication, favorably compare some characteristics of S' Positive to , ,,;, .. ,.. , ,.,,, ,,,,.,, ,,,.,,,, , ..,. .. , . ,,,,,,,,.. .. . .. .,..... .. ,.,,,.. , $ .;,,..,. . ..... .,.,.$, ,..,.,,. ,,. ...$.,..,,, ,,,,,,,,.. ...,$,,,.,,,,.. ..,..,,.,,,, , ;: ,.,:$: ,,,.,, ,_....., , ,,,, . ,,,;.. .,.; . ..,...,...,,,,, .,.,,. ...:.;, .,, ,............ ,:,..!. ,:;:. ,...... , .$ .....$,,..,... ;.,,,,,,,., ,p ,,,... ,. ,,. ,,. ... . ,,,, . ,,, ... . ,.,. , ,,,. .. ,. ,, , ... ; , 9" :r. 1)",Cl$lO l$$lO 0" 1)'" cO 't1\ ",1) ",W-'- o."ert\sell . c ,""or",,\e eo"'''''''- ,,'U ,, ,.\)e1\t "see"\1\ t\)e s"",e,,\\\ or. e'\"'", ..-0 ... ;"",' .'1 , r t\)e, C - ,\rs 0'""W'v" r '; .1""c - . . ' o' """o.!."w t"e to ,v '0 ,, . 0' $"""

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JUltUA.N-,'HIU1''I. l\" ..,'-. - n- 871 Decision and Order 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 jursidictional 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 charges 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 fied thereafter by interested persons pursuant to Section 2.34 of its Rules; now in further conformity with the procedure prescribed Section 2.34 of its Rules, the Commission hereby issues its complaint makes the following jurisdictional findings and enters the following order:

1. Respondent Jordan-Simner, Inc. is a Florida corporation with its principal place of business at 6852 N.W. 12th Ave., Fort Lauderdale Florida.

Respondent Robert Cohen is an officer of said corpration. He formulates, directs and controls its acts and practices, including the acts and practices hereafter set forth. His business address is the same as said corporation, 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 Jordan-Simner, Inc" its successors assigns, officers, agents and employees, and to respondent Robert Cohen, individually and as an officer of the corporation, whether , Decision and Order 95 F.

acting directly or through any corporation, subsidiary, division or other device. Except as otherwise provided, order provisions apply to any act taken in connection with respondents' advertising, offering for sale sale or distribution of S'Positive or any OTC (over the counter) 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" 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) " Positive" means the vaginal contraceptive suppository product marketed under the tradename S'Positive, 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, bilboard, 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; providd, however that the term advertisement does not incl ude 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 each respondent cease and desist from; A. Making in consumer (Jay) advertisements any contraceptive effectiveness claims regarding S'Positive 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 of any OTC contraceptive product.

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tive disclosure in any consumer (lay) advertisement for S'Positive in which any product or use characteristic of S'Positive is compared directly or by implication, to any product or use characteristic of oral contraceptives or intra-uterine devices:

Positive is approximately as effective as vaginal foam contraptives in actual use, but is not as effective as the pill or IUD.

O'R Positive is not as effective as the pil or IUD in actual use, but is approximately as effective as vaginal foam contraceptives.

Either above affirmative disclosure shah be made, where required in lieu of the Disclosure II.E. The disclosure shah satisfy the requirements regarding exact language, size of type and relation to the main body of the ad specified for Disclosure ILK IV.

It is further ordered That each respondent make the fonowing disclosures in any consumer (lay) TV advertisements for S' Positive: A. Follow directions exactly, including the fifteen minute waiting period. Approximately a.'i effective as contraceptives foams. The above disclosures shah be made clearly and conspicuously as video supers and in the exact language indicated above; provdhoever that if respondents have a reasonable basis, consisting of valid scientific test(s) or study(ies), respondents may modify the words 'I fifteen minutes" in Disclosure A consistent with such reasonable basis.

It is further fYrdered That respondents make the fonowing disclosure in any consumer (lay) radio advertisements for S'Positive: Positive s effectiveness is approximately equal to contraceptive foams. The above disclosure shah be made clearly and conspicuously and in the exact language indicated above.

VI.

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871 Decision and Order XII.

It is further ordered That the individual respondent named herein promptly notify the Commission of the discontinuance of his present business or employment and of his affilation with a new business or employment. In addition, for a period of five (5) years from the date of service of this order, the respondent shall promptly notify the Commission of each affiliation with a new business or employment whose activities include the sale or advertising of OTC contraceptive products or of his affiliation with a new business or employment in which his own duties and responsibilities involve the sale or advertising of OTC contraceptive products. Each such notice shall include the respondent's new business address and a statement of the nature of the business or employment in which the respondent is newly engaged, as well as a description of respondent's duties and responsibilities in connection with the business or employment. The expiration of the notice provision of this paragraph shall not affect any other obligation arising under this order.

XII.

It is further ordered That respondents 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.

Complaint 95 F.