[Federal Register Volume 65, Number 96 (Wednesday, May 17, 2000)]
[Notices]
[Page 31322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12381]



[[Page 31322]]

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FEDERAL TRADE COMMISSION

[File No. 992 3027]


Efamol Nutraceuticals, Inc.; 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 June 12, 2000.

ADDRESSES: Comments should be directed to: FTC/Office of the Secretary, 
Room 159, 600 Pennsylvania Ave., NW, Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT: Matthew Gold or Linda Badger, Federal 
Trade Commission, Western Region, 901 Market St., Suite 570, San 
Francisco, CA 94103. (415) 356-5276 or 356-5275.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46 and Sec. 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 thirty (30) days. The following Analysis to Aid Public 
Comment describes the terms of the consent agreement, and the 
allegations in the complaint. An electronic copy of the full text of 
the consent agreement package can be obtained from the FTC Home Page 
(for May 11, 2000), on the World Wide Web, at ``http://www.ftc.gov/ftc/
formal.htm.'' A paper can be obtained from the FTC Public Reference 
Room, Room H-130, 600 Pennsylvania Avenue, NW, Washington, DC 20580, 
either in person or by calling (202) 326-3627.
    Public comment is invited. Comments should be directed: FTC/Office 
of the Secretary, Room 159, 600 Pennsylvania Ave., NW, Washington, DC 
20580. Two paper copies of each comment should be filed, and should be 
accompanied, if possible, by a 3\1/2\ inch diskette containing an 
electronic copy of the comment. 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, subject to final 
approval, an agreement containing a consent order from Efamol 
Nutraceuticals, Inc., (``Efamol''). Efamol is a marketer of dietary 
supplement products, all of which contain essential fatty acids.
    The proposed consent order has been placed on the public record for 
thirty (30) days for receipt of comments by interested persons. 
Comments received during this period will become part of the public 
record. After thirty (30) 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 misleading representations for Efalex 
and Efalex Focus, two of Efamol's dietary supplement products. The 
advertisements claimed that these products can mitigate or cure the 
effects of Attention Deficit Disorder or Attention Deficit 
Hyperactivity disorder (``ADD/ADHD'').
    The proposed complaint alleges that Efamol could not substantiate 
the following claims: (1) The Efalex and Efalex Focus can cure, 
prevent, treat or mitigate ADD/ADHD or its symptoms; and (2) that 
Efalex and Efalex Focus are effective in reducing attention and 
behavioral problems. Part I of the proposed order would address these 
misrepresentations by prohibiting Efamol from making the claims in the 
future unless it possesses and relies upon competent and reliable 
scientific evidence that substantiates the claim.
    Part II of the proposed order requires Efamol to possess competent 
and reliable scientific evidence for any claim about the health 
benefits, efficacy or safety of any food, drug or dietary supplement 
that contains essential fatty acids. Because all of Efamol's products 
contain essential fatty acids, this provision would apply to the 
company's entire current product line.
    Part III of the proposed order contains language permitting Efamol 
to make drug claims that have been approved by the FDA pursuant to 
either a new drug application or a tentative final or final standard. 
Part IV states that Efamol would be permitted to make claims that the 
FDA has approved pursuant to the Nutrition Labeling and Education Act 
of 1990.
    Parts V-VII of the proposed order contain requirements that Efamol 
keep copies of relevant advertisements and materials substantiating 
claims made in the advertisements; provide copies of the order to 
certain of its current and future personnel; and notify the Commission 
of changes in the corporate structure that might affect compliance with 
the order. Part VIII requires Efamol to file one or more reports 
detailing compliance with the order. Part IX 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.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 00-12381 Filed 5-16-00; 8:45 am]
BILLING CODE 6750-01-M