[Federal Register Volume 62, Number 149 (Monday, August 4, 1997)]
[Notices]
[Pages 41965-41966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20450]


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FEDERAL TRADE COMMISSION

[File No. 962-3210]


Global World Media Corporation; Sean Shayan; Analysis to Aid 
Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed Consent Agreement.

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SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair or deceptive acts or 
practices or unfair methods of competition. The attached Analysis to 
Aid Public Comment describes both the allegations in the draft 
complaint that accompanies the consent agreement and the terms of the 
consent order--embodied in the consent agreement--that would settle 
these allegations.

DATES: Comments must be received on or before October 3, 1997.

ADDRESSES: Comments should be directed to: FTC/Office of the Secretary, 
Room 159, 6th St. and Pa. Ave., N.W., Washington, D.C. 20580.

FOR FURTHER INFORMATION CONTACT:

Joel Winston, Federal Trade Commission, S-4002, 6th St. and Pa. Ave., 
N.W., Washington, D.C. 20580. (202) 326-3153.
Michelle Rusk, Federal Trade Commission, S-466, 6th St. and Pa. Ave., 
N.W., Washington, D.C. 20580. (202) 326-3148.
Nancy Warder, Federal Trade Commission, S-4002, 6th St. and Pa. Ave., 
N.W., Washington, D.C. 20580. (202) 326-3048.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46, and Section 2.34 of 
the Commission's Rules of Practice (16 CFR 2.34), notice is hereby 
given that the above-captioned consent agreement containing a consent 
order to cease and desist, having been filed with and accepted, subject 
to final approval, by the Commission, has been placed on the public 
record for a period of sixty (60) days. The following Analysis to Aid 
Public Comment describes the terms of the consent agreement, and the 
allegations in the accompanying complaint. An electronic copy of the 
full text of the consent agreement package can be obtained from the 
Commission Actions section of the FTC Home Page (for July 29, 1997), on 
the World Wide Web, at 
``http:www.ftc.govosactionshtm.'
' A paper copy can be obtained from the FTC Public Reference Room, Room 
H-130, Sixth Street and Pennsylvania Avenue, N.W., Washington, D.C. 
20580, either in person or by calling (202) 326-3627. Public comment is 
invited. Such comments or views will be considered by the Commission 
and will be available for inspection and copying at its principal 
office in accordance with Section 4.9(b)(6)(ii) of the Commission's 
Rules of Practice (16 CFR 4.9(b)(6)(ii)).

Analysis of Proposed Consent Order To Aid Public Comment

    The Federal Trade Commission has accepted an agreement to a 
proposed consent order from Global World Media Corporation (``GWMC''), 
the marketer of Herbal Ecstacy or Ecstacy (``Ecstacy''), and its owner, 
Sean Shayan [hereinafter sometimes referred to as respondents].
    The proposed consent order has been placed on the public record for 
sixty (60) days for reception of public 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.
    The Commission's complaint in this matter concerns safety claims 
respondents made in advertising for Ecstacy, a dietary supplement that 
respondents promoted as a natural ``high'' and expressly likened to the 
illegal street drug MDMA. More specifically, the complaint alleges that 
respondents represented that Ecstacy, when taken in the recommended 
doses or other reasonably foreseeable amounts, is absolutely safe and 
has no side effects. The complaint explains that Ecstacy contains a 
botanical source of ephedrine alkaloids, which can have dangerous 
effects on the nervous system and heart. Thus, according to the 
complaint, the claim that Ecstacy is safe and side effect free is both 
false and unsubstantiated.
    In addition, the complaint charges that respondents represented in 
their advertising for Ecstacy, including in ads that ran on cable 
programming stations with substantial youth audiences, such as 
Nickelodeon and MTV, that Ecstacy is a safe alternative to illegal 
drugs to produce euphoric, psychotropic (mind-altering), or sexual 
enhancement effects, but failed to disclose the health and safety risks 
of using the product. According to the complaint the undisclosed facts 
would be material to consumers and, therefore, respondents' omission of 
the facts about the health and safety risks of Ecstacy in their 
advertising is alleged to be a deceptive practice.
    Finally, the complaint challenges an endorsement of Ecstacy's 
safety and lack of side effects contained in respondents' advertising 
and attributed to a Dr. Steven Jonson of Tel Aviv, Israel. According to 
the complaint, the endorsement is false because Dr. Jonson is a 
fictitious person.
    The proposed consent order contains provisions designed to remedy 
the violations charged and to prevent respondents from engaging in 
similar acts and practices in the future.
    Part I of the order prohibits (1) claims that Ecstacy or any other 
food, drug, or dietary supplement is safe or will cause no side 
effects; or (2) any other safety or

[[Page 41966]]

side effects claims, unless the claim is true and substantiated by 
scientific evidence.
    Part II prohibits respondents from making any representation for 
any food, drug, or dietary supplement that contains ephedrine alkaloids 
that consumers can appropriately take such product in an amount that 
exceeds the level established by any regulation of the Food and Drug 
Administration (``FDA'') for ephedrine alkaloids or any other 
ingredient in the product.
    Part III requires the following clear and prominent disclosure in 
all future advertising and labeling of, and all consumer communications 
concerning, any ephedrine-alkaloid-containing product sold by 
respondents:

    Warning: This product contains ephedrine which can have dangerous 
effects on the central nervous system and heart and could result in 
serious injury. Risk of injury increases with dose.

Under Part III, if the product is subject to an FDA rule or regulation 
that requires a labeling warning, that warning is required in labeling 
in lieu of the warning set forth above.
    Part IV prohibits respondents from assisting others, including by 
selling product to them, when respondents have reason to believe that 
they are deceptively promoting respondents' ephedrine-containing 
products.
    Part V prohibits misrepresentations about endorsements and 
testimonials.
    Part VI prohibits respondents from directing to individuals under 
the age of twenty-one advertising and promotional activities for 
Ecstasy or any other ephedrine product marketed as an alternative to an 
illegal drug or for its euphoric, psychotropic, or sexual effects. Part 
VI includes examples of prohibited activity, including advertisements 
and promotions to audiences half or more under twenty-one.
    Part VII requires the respondents to conduct and submit annual 
analyses of the levels of ephedrine alkaloids in any ephedrine-
containing product that they sell for the next five (5) years.
    Part VIII provides that nothing in the order permits the 
respondents to market any product (1) in a state where its sale has 
been banned; (2) in a manner that is inconsistent with state 
restrictions on its sale; or (3) in a way that is inconsistent with any 
applicable FDA rule or regulation.
    Parts IX and X provide safe harbors for claims approved pursuant to 
FDA's regulation of the labeling for drugs and foods, respectively.
    Part XI requires respondents to send a letter (Attachment A to the 
order) to anyone who provides the public with information about any of 
respondents' ephedrine-containing products. The letter advises the 
recipient that the disclosure required by Part III of the order must be 
made in all communications with consumers concerning any of 
respondents' ephedrine-containing products and that the only 
permissible statement about the dose of any such product is the 
information on the label. Part XII sets forth the record keeping and 
surveillance requirements with respect to Part XI.
    Part XIII requires respondents to send a letter (Attachment B to 
the order) to distributors and resellers, including any person who 
purchases more than 100 units of any of respondents' ephedrine-
containing products in any there (3) month period. The letter describes 
the Commission's action in this case and advises recipients to 
discontinue use of any promotional materials that do not comply with 
the order. Part XIV set forth the record keeping and surveillance 
requirements with respect to Part XIII.
    The remaining parts of the order contain standard provisions 
pertaining to record keeping, compliance, sunsetting of the order, and 
similar matters.
    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.
Donald S. Clark,
Secretary.
[FR Doc. 97-20450 Filed 8-1-97; 8:45 am]
BILLING CODE 6750-01-M