[Federal Register Volume 66, Number 119 (Wednesday, June 20, 2001)]
[Notices]
[Pages 33092-33093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15548]


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FEDERAL TRADE COMMISSION

[File No. 002 3098]


MaxCell BioScience, Inc., et al.; 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 complaint that 
accompanies the consent agreement and terms of the consent order--
embodied in the consent agreement--that would settle these allegations.

DATES: Comments must be received on or before July 16, 2001.

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 Daynard, FTC/S-4002, 600 
Pennsylvania Ave., NW., Washington, DC 20580. (202) 326-3291.

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 FR 2.34), notice is hereby given 
that the above-captioned consent agreement containing a consent order 
to cease and desist, having been filed with an accepted 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 June 14, 2001), on the 
World Wide Web, at ``http://www.ftc.gov/os/2001/06/index.htm.'' A paper 
copy 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 to: FTC/
Office of the Secretary, Room 159, 600 Pennsylvania Ave., NW., 
Washington, DC 20580. Two paper copies of each comments 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 MaxCell 
BioScience, Inc. and Stephen Cherniske, president of the corporation 
(collectively, ``MaxCell'').
    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 about 
Longevity Signal Formula (``LSF''), a dietary supplement containing, 
among other ingredients, arginine, DHEA, and 7-Keto DHEA, and an 
Anabolic/Catabolic IndexTM (``ACI'') test, an at-home (with 
laboratory analysis) urine test that measures the ratio of 17-
ketosteroids to creatinine in one urine sample. This matter concerns 
allegedly false and unsubstantiated advertising claims made in cassette 
tapes and web sites distributed directly to consumers and through 
distributors regarding the ability of LSF to reverse the aging process 
and, consequently, to prevent, treat, or cure numerous age-related 
diseases and conditions, and the ability of the ACI test to measure a 
person's overall healthiness and youthfulness and to prove the 
effectiveness of LSF for reversing aging.
    According to the FTC complaint, MaxCell falsely claimed that the 
ACI test provides a clinical gauge of an individual's overall 
healthiness or youthfulness and demonstrates that LSF prevents or 
reverses aging. In fact, the complaint alleges that the ACI test only 
measures inactive androgen breakdown products in the urine, which 
products, in most instances, are not a significant or reliable measure 
of overall healthiness or youthfulness. The complaint further alleges 
that MaxCell falsely claimed that scientific testing demonstrates the 
ability of LSF to: Significantly reduce the risk of atherosclerosis; 
increase bone density, improve glucose tolerance, reduce body fat, 
increase muscle mass, and increase growth hormone levels in post-
menopausal women; improve liver function; and significantly increase 
life expectancy.
    In addition, the complaint challenges claims that LSF: 
Significantly reduces the risk of atherosclerosis; cures arthritis; 
lowers blood pressure; significantly lowers cholesterol levels in the 
bloodstream; strengthens bones; reduces or eliminates the need for 
corrective eyewear; promotes significant weight loss and muscle gain 
without dieting or exercise; increases glucose tolerance; increases 
Growth Hormone levels in the body, thereby causing positive clinical 
effects on health; improves liver function; prevents or reverses aging; 
and significantly increases life expectancy. The complaint alleges that 
these claims are unsubstantiated.
    Finally, the complaint charges that MaxCell, by providing 
advertisements and promotional materials to distributors for use in 
their marketing and sale of LSF and the ACI test, have provided means 
and instrumentalities to distributors of MaxCell's products in 
furtherance of the deceptive and misleading acts or practices alleged 
in the complaint.
    The proposed consent order contains provisions designed to prevent 
MaxCell and its distributors from engaging in similar acts and 
practices in the future and to redress consumer injury by requiring 
MaxCell to make a monetary payment to the Commission.
    Part I of the order bans claims that the ACI Test or any other 
substantially similar device provides a clinical gauge of an 
individual's overall healthiness or youthfulness. ``Substantially 
similar device'' is defined as any product that measures the ratio of 
17-ketosteroids to creatinine in one urine sample.

[[Page 33093]]

    Part II of the order requires that future claims that any test or 
device provides a clinical gauge of an individual's overall healthiness 
or youthfulness be true and substantiated by competent and reliable 
scientific evidence.
    Part III of the order requires competent and reliable scientific 
evidence as substantiation for future claims that LSF or any other 
food, drug, device, service, or dietary supplement provides any of the 
specific health benefits challenged above as unsubstantiated. In 
addition, Part III. L requires scientific substantiation for any future 
claim about the effect of covered products or services on any disease, 
on the structure or function of the human body, or about any other 
health benefit, or the safety, of any covered product or service.
    Part IV of the order prohibits MaxCell from providing to any person 
or entity ``means and instrumentalities'' that contain any claim about 
the effect of any product or service on any disease, or about the 
effect of any product or service on the structure or function of the 
human body, or about any other health benefit, or the safety, of any 
product or service, unless such claim is true and substantiated by 
competent and reliable scientific evidence. ``Means and 
instrumentalities'' is defined as any information, including but not 
necessarily limited to any advertising, labeling, or promotional 
materials, for use by distributors in their marketing or sale of the 
ACI test or LSF or any other product or service covered under the 
order.
    Part V of the order prohibits MaxCell from misrepresenting the 
existence, contents, validity, results, conclusions, or interpretations 
of any test, study, or research.
    Part VI of the order requires dissemination of a notice 
(``Attachment A'') about the order to MaxCell's distributors who have 
purchased the ACI Test or LSF since January 1, 2000. This notice 
indicates that MaxCell has agreed to cease making challenged 
representations, and warns distributors that they may be terminated if 
they do not conform their representations to the requirements placed on 
MaxCell.
    Part VII of the order requires dissemination of Attachment A to 
future distributors, and that MaxCell monitor their distributors, and 
terminate sales to distributors who make representations prohibited by 
the order.
    Part VIII of the order permits FDA-approved drug claims and claims 
for food or dietary supplements authorized under the Nutrition Labeling 
and Education Act of 1990.
    Part IX of the order requires that MaxCell make a payment of 
$150,000 to the Commission, which funds the FTC can forward to the U.S. 
Treasury as disgorgement or use for purposes of consumer redress.
    Parts X, XI, XII, and XIV of the order require MaxCell to keep 
copies of relevant advertisements and materials substantiating claims 
made in the advertisements, to provide copies of the order to certain 
of its personnel, to notify the Commission of changes in corporate 
structure, and to file compliance reports with the Commission. Part 
XIII requires Stephen Cherniske to notify the Commission of his 
employment status, and Part XV 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. 01-15548 Filed 6-19-01; 8:45 am]
BILLING CODE 6750-01-M