UNITED
STATES OF AMERICA
In the Matter of File No. 942-3341 AGREEMENT CONTAINING The Federal Trade Commission, having initiated an investigation of certain acts and practices of Schering-Plough Healthcare Products, Inc., a corporation, and it now appearing that Schering-Plough Healthcare Products, Inc., a corporation, hereinafter sometimes referred to as proposed respondent, is willing to enter into an agreement containing an order to cease and desist from the use of the acts and practices being investigated, IT IS HEREBY AGREED by and between Schering-Plough Healthcare Products, Inc., by its duly authorized officer, and its attorney, and counsel for the Federal Trade Commission that: 1. Proposed respondent Schering-Plough Healthcare Products, Inc. is a corporation organized, existing, and doing business under and by virtue of the laws of the State of Delaware, with its office and principal place of business located at 3030 Jackson Avenue, Memphis, Tennessee 38151. 2. Proposed respondent admits all the jurisdictional facts set forth in the draft of complaint here attached. 3. Proposed respondent waives:
4. This agreement shall not become part of the public record of the proceeding unless and until it is accepted by the Commission. If this agreement is accepted by the Commission, it, together with the draft of complaint contemplated thereby, will be placed on the public record for a period of sixty (60) days and information in respect thereto publicly released. The Commission thereafter may either withdraw its acceptance of this agreement and so notify the proposed respondent, in which event it will take such action as it may consider appropriate, or issue and serve its complaint (in such form as the circumstances may require) and decision in disposition of the proceeding. 5. This agreement is for settlement purposes only and does not constitute an admission by proposed respondent that the law has been violated as alleged in the draft of complaint here attached, or that the facts as alleged in the draft complaint, other than the jurisdictional facts, are true. 6. This agreement contemplates that, if it is accepted by the Commission, and if such acceptance is not subsequently withdrawn by the Commission pursuant to the provisions of 2.34 of the Commission's Rules, the Commission may, without further notice to proposed respondent, (1) issue its complaint corresponding in form and substance with the draft of complaint here attached and its decision containing the following order to cease and desist in disposition of the proceeding and (2) make information public in respect thereto. When so entered, the order to cease and desist shall have the same force and effect and may be altered, modified, or set aside in the same manner and within the same time provided by statute for other orders. The order shall become final upon service. Delivery by the U.S. Postal Service of the complaint and decision containing the agreed-to order to proposed respondent's address as stated in this agreement shall constitute service. Proposed respondent waives any right it may have to any other manner of service. The complaint may be used in construing the terms of the order, and no agreement, understanding, representation, or interpretation not contained in the order or in the agreement may be used to vary or contradict the terms of the order. 7. Proposed respondent has read the proposed complaint and order contemplated hereby. Proposed respondent understands that once the order has been issued, it will be required to file one or more compliance reports showing that it has fully complied with the order. Proposed respondent further understands that it may be liable for civil penalties in the amount provided by law for each violation of the order after it becomes final. ORDER For the purpose of this Order, the following definitions shall apply: A. "Sun protection product" shall mean any product intended for, or promoted as, providing users with protection against the harmful effects of sun exposure or ultraviolet radiation, including but not limited to products containing a sunscreen ingredient. B. "Children's sun protection product" shall mean any sun protection product that uses the word "babies," "children," "kids," or words of similar import in the name or promotion of the product, or that is advertised or promoted for use primarily by children under the age of twelve (12). C. "Competent and reliable scientific evidence" shall mean tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results. I. IT IS ORDERED that respondent, Schering-Plough Healthcare Products, Inc., a corporation, its successors and assigns, and its officers, agents, representatives and employees, directly or through any corporation, subsidiary, division or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of Coppertone Kids or any other children's sun protection product, in or affecting commerce, as "commerce" is defined in the Federal Trade Commission Act, do forthwith cease and desist from representing, in any manner, directly or by implication:
II. IT IS FURTHER ORDERED that respondent, Schering-Plough Healthcare Products, Inc., a corporation, its successors and assigns, and its officers, agents, representatives and employees, directly or through any corporation, subsidiary, division or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any sun protection product, in or affecting commerce, as "commerce" is defined in the Federal Trade Commission Act, do forthwith cease and desist from misrepresenting, in any manner, directly or by implication, the existence, contents, validity, results, conclusions or interpretations of any test or study. III. Nothing in this Order shall prohibit respondent from making any representation for any sun protection product that is specifically permitted in labeling for any such product under any tentative final or final standard promulgated by the Food and Drug Administration, or under any new drug application approved by the Food and Drug Administration. IV. IT IS FURTHER ORDERED that respondent shall design, produce and print a color brochure concerning the importance of sunscreen usage by children, which contains all of the following messages or themes:
Respondent shall submit a draft of the brochure, and a draft plan for its dissemination, no later than sixty (60) days after the date of service of this Order, to the Associate Director of the Commission's Division of Advertising Practices for review and approval. No later than sixty (60) days after the Associate Director's approval of the brochure and the dissemination plan, respondent shall disseminate 150,000 copies of the brochure to parents or organizations with access to parents or others who work with or care for children under the age of 12. V. IT IS FURTHER ORDERED that, for five (5) years after the last date of dissemination of any representation covered by this Order, respondent, or its successors and assigns, shall maintain and upon request make available to the Federal Trade Commission for inspection and copying:
VI. IT IS FURTHER ORDERED that the provisions of this Order shall not apply to any label or labeling printed prior to the date of service of this Order and shipped by respondents to purchasers for resale prior to one hundred (100) days after service of this Order. VII. IT IS FURTHER ORDERED that respondent, its successors and assigns, shall:
VIII. IT IS FURTHER ORDERED that respondent shall notify the Commission at least thirty (30) days prior to any proposed change in its corporate structure, such as dissolution, assignment, or sale resulting in the emergence of a successor corporation, the creation or dissolution of subsidiaries, or any other change in the corporation which may affect compliance obligations arising under this Order. IX. THIS ORDER will terminate twenty years from the date of its issuance, or twenty years from the most recent date that the United States or the Federal Trade Commission files a complaint (with or without an accompanying consent decree) in federal court alleging any violation of the Order, whichever comes later; provided, however, that the filing of such a complaint will not affect the duration of:
Provided further, that if such complaint is dismissed or a federal court rules that the respondent did not violate any provision of the Order, and the dismissal or ruling is either not appealed or upheld on appeal, then the Order will terminate according to this paragraph as though the complaint was never filed, except that the Order will not terminate between the date such complaint is filed and the later of the deadline for appealing such dismissal or ruling and the date such dismissal or ruling is upheld on appeal. X. IT IS FURTHER ORDERED that respondent shall, within sixty (60) days after service of this Order, and at such other times as the Commission may require, file with the Commission a report, in writing, setting forth in detail the manner and form in which it has complied with this Order. Signed this day of , 19 UNITED STATES OF
AMERICA In the Matter of DOCKET NO. COMPLAINT The Federal Trade Commission, having reason to believe that Schering-Plough Healthcare Products, Inc., a corporation, ("respondent"), has violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that a proceeding by it in respect thereof would be in the public interest, alleges: PARAGRAPH ONE: Respondent Schering-Plough Healthcare Products, Inc. is a Delaware corporation, with its principal office or place of business at 3030 Jackson Avenue, Memphis, Tennessee 38151. PARAGRAPH TWO: Respondent has manufactured, advertised, labeled, promoted, offered for sale, sold, and distributed over-the-counter health care products, including "Coppertone Kids" sunblock lotion, to consumers. Coppertone Kids is a "drug" within the meaning of Sections 12 and 15 of the Federal Trade Commission Act. PARAGRAPH THREE: The acts and practices of respondent alleged in this complaint have been in or affecting commerce as "commerce" is defined in Section 4 of the Federal Trade Commission Act. PARAGRAPH FOUR: Respondent has disseminated or has caused to be disseminated advertisements and promotional materials for Coppertone Kids, including but not necessarily limited to the attached Exhibits A through H. These advertisements and promotional materials contain the following statements and depictions: A. (Depiction: child performing cannonball dive off of diving board) Coppertone Kids sunblock lasts through 32 back flips, 64 cannonballs and 52 belly flops. Introducing new Coppertone Kids 6-Hour
Waterproof Sunblock. In and out of the water, all day long. Because it's the sunblock that keeps
kids As proven by kids themselves in test
after test. It goes on. And stays on. Read and follow label directions (Exhibit A)(magazine ad) B. (Depiction: child performing cannonball dive off of diving board) Coppertone KIDS sunblock lasts through 32 back flips, 64 cannonballs and 52 belly flops. Coppertone KIDS 6-Hour Waterproof
Sunblock goes on All day long. Because it's the
waterproof sunblock that It goes on and stays on. Read and follow label directions (Exhibit B)(magazine ad) C. (Sound effects: kids playing in pool)
(Exhibit C) (radio ad) D. (Sound effects: kids playing in pool; mother repeating herself) Billy, time for more sunblock. ...time for more sunblock. ...time for more sunblock... Coppertone Kids waterproof sunblock is
made to last a full 6 hours, (Exhibit D) (radio ad) E. (Depiction: Three mothers fishing at the ocean. One mother reels in her son from the water, applies sunscreen on the child, and then cuts the fishing line holding him) ...Mom's gotta keep a line on her kids... 'cause she's gotta keep re-applying that sunblock every time they come out of the water. But now there's new Coppertone Kids 6 Hour Waterproof Sunblock. (super: USE ONLY AS DIRECTED) It keeps a kid protected from the sun, and waterproof for a full six hours. So Mom puts it on...and cuts them loose... New Coppertone Kids 6 Hour Waterproof Sunblock. It goes on and stays on. (Super: It goes on. And stays on.) (Exhibit E) (tv ad) F. Coppertone Kids sunblock is uniquely formulated to provide long-lasting waterproof protection. This waterproof formula lasts for a full 6 HOURS in and out of the water, and keeps kids protected from the sun's burning UVA and UVB rays. 6-HOUR WATERPROOF - Ideal for water active kids. LONG LASTING - Kid tested to go on and stay on... (Exhibits F & G) (label and promotion sample) G. Dear Doctor: ... Coppertone, the most trusted name in
suncare, ... Coppertone KIDS Waterproof for a full 6 hours Long-lasting protection... Available in SPF 15 and 30 ... All Coppertone Children's Sunblocks are
clinically (Exhibit H) (promotional letter to doctors) PARAGRAPH FIVE: Through the use of the statements and depictions contained in the advertisements and promotional materials referred to in PARAGRAPH FOUR, including but not necessarily limited to the advertisements and promotional materials attached as Exhibits A through H, respondent has represented, directly or by implication, that a single application of Coppertone Kids provides six hours of protection from the sun for children engaged in sustained vigorous activity in and out of the water. PARAGRAPH SIX: Through the use of the statements and depictions contained in the advertisements and promotional materials referred to in PARAGRAPH FOUR, including but not necessarily limited to the advertisements and promotional materials attached as Exhibits A through H, respondent has represented, directly or by implication, that at the time it made the representation set forth in PARAGRAPH FIVE, respondent possessed and relied upon a reasonable basis that substantiated such representation. PARAGRAPH SEVEN: In truth and in fact, at the time it made the representation set forth in PARAGRAPH FIVE, respondent did not possess and rely upon a reasonable basis that substantiated such representation. Therefore, the representation set forth in PARAGRAPH SIX was, and is, false and misleading. PARAGRAPH EIGHT: Through the use of statements contained in the advertisements and promotional materials referred to in PARAGRAPH FOUR, including but not necessarily limited to the advertisements and promotional materials attached as Exhibits A,B,F, G and H, respondent has represented, directly or by implication, that it has conducted tests demonstrating that a single application of Coppertone Kids provides six hours of protection from the sun for children engaged in sustained vigorous activity in and out of the water. PARAGRAPH NINE: In truth and in fact, respondent has not conducted tests demonstrating that a single application of Coppertone Kids provides six hours of protection from the sun for children engaged in sustained vigorous activity in and out of the water. Among other reasons, none of the tests relied upon by respondent evaluated a single application of the product under the advertised conditions of use, i.e., sustained vigorous activity in and out of the water. Therefore, the representation set forth in PARAGRAPH EIGHT was, and is, false and misleading. PARAGRAPH TEN: The acts and practices of respondent as
alleged in this complaint constitute unfair or deceptive
acts or practices, and the making of false
advertisements, in or affecting commerce in violation of
Sections 5(a) and 12 of the Federal Trade Commission Act.
THEREFORE, the Federal Trade Commission this day of , 19 , has issued this complaint against respondent. By the Commission. Donald S. Clark SEAL: [Exhibits A-H attached to paper copies of complaint, but not available in electronic form.] ANALYSIS OF PROPOSED CONSENT
ORDER The Federal Trade Commission has accepted an agreement to a proposed consent order from Schering-Plough Healthcare Products, Inc. ("Schering-Plough Healthcare"). Schering-Plough Healthcare, a wholly-owned subsidiary of the Schering-Plough Corporation, is a manufacturer and distributor of health care products, including sunscreens. The proposed consent order has been placed on the public record for sixty (60) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After sixty (60) days, the Commission will again review the agreement and the comments received and will decide whether it should withdraw from the agreement or make final the agreement's proposed order. This matter involves alleged deceptive representations made in advertising for Coppertone Kids, a sunscreen product promoted for use on children. According to the FTC complaint, Schering-Plough Healthcare represented, without adequate substantiation, that a single application of Coppertone Kids provides six hours of protection from the sun, at the advertised SPF level, for children engaged in sustained vigorous activity in and out of the water. The complaint also alleges that Schering-Plough Healthcare falsely represented that it had conducted tests demonstrating that the product provides such protection. According to the complaint, among other things, the company's tests did not evaluate a single application of the product under the advertised conditions of use (sustained vigorous activity). The consent order contains provisions designed to remedy the violations charged and to prevent Schering-Plough Healthcare from engaging in similar acts and practices in the future. Part I of the proposed order prohibits Schering-Plough Healthcare from representing: (a) the length of time that Coppertone Kids or any other children's sun protection product will provide protection from the sun for persons engaged in sustained vigorous activity in and out of the water; or (b) the efficacy of any children's sun protection product in providing protection against any harmful effect of sun exposure or ultraviolet radiation, unless the company has scientific substantiation for the representation. The order defines a "children's sun protection product" as any sun protection product that uses the word "babies," "children," "kids," or other similar words in the name or promotion of the product, or that is advertised or promoted for use primarily on children under the age of twelve. Part II of the proposed order prohibits Schering-Plough Healthcare from misrepresenting the existence, contents, validity, or conclusions of any test or study concerning any sun protection product. Part III of the order allows Schering-Plough Healthcare to make any representation for a sun protection product that is specifically permitted in labeling for that product under any tentative final or final Food and Drug Administration standard or under any new drug application approved by the Food and Drug Administration. Part IV of the proposed order requires Schering-Plough Healthcare to produce and disseminate a consumer brochure addressing the importance of sunscreen usage to children and the health benefits associated with it, and promoting the proper use and application of sunscreens on children. The brochure, which is subject to FTC approval, will be disseminated by Schering-Plough Healthcare to organizations with direct access to parents or organizations with access to parents or others who work with or care for children under the age of 12. Parts V, VII, IX, and X of the proposed order require Schering-Plough Healthcare to keep copies of all materials relied upon in making any representations covered by Parts I and II of the order; to provide copies of the order to certain of the company's personnel; to notify the Commission of any change in corporate structure; and to file compliance reports with the Commission. Part VI permits respondent to use existing labeling for 100 days after the date of service of the order. Part VIII provides that the order will terminate after twenty (20) years under certain circumstances. The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms. |