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Lunada Biomedical, Inc. and its three principals have settled
Federal Trade Commission charges that they deceptively marketed Amberen, a
dietary supplement, to women over 40 who are perimenopausal or menopausal,
making a range of unsupported claims about its ability to help users lose
weight and belly fat, and relieve menopause-related symptoms such as hot
flashes and night sweats.
The proposed
stipulated order bars the defendants from making unsubstantiated
efficacy or health benefit claims for any dietary supplement, food, or drug,
as well as other illegal conduct related to consumer satisfaction claims,
“risk free trial” offers and consumer endorsements.
“The Lunada defendants made strong claims about the
effectiveness of their supplement without the scientific evidence to back them
up,” said Jessica Rich, Director of the FTC’s Bureau of Consumer
Protection. “The relief provided by this court order is intended to prevent
the defendants from making unsupported health benefit claims in the
future.”
The FTC filed its original
complaint in May 2015 and an amended
complaint in December 2015. The amended complaint alleges that the
defendants made unsubstantiated claims that their dietary supplement,
Amberen, causes substantial and sustained weight loss, loss of belly fat,
and an increase in metabolism in women over 40 who are perimenopausal or
menopausal, and false claims that Amberen is clinically proven to cause
substantial and sustained weight loss in those women.
The Commission also alleged that the defendants made unsubstantiated
claims that Amberen alleviates nearly every common symptom of menopause,
including hot flashes, night sweats, sleep problems, fatigue, and
irritability, and false claims that the product is clinically proven to
provide these benefits.
The amended complaint further alleges that the defendants
failed to disclose their relationship with certain consumer endorsers and
falsely claimed consumer satisfaction and success rates of nearly 93
percent and that consumers could try Amberen “risk-free” for 30 days.
The proposed order settling the FTC’s charges prohibits the
defendants from:
1) claiming that any dietary supplement, food, or drug
causes weight loss, sustained weight loss, or loss of belly fat; boosts
metabolism; relieves hot flashes, night sweats, and other specific symptoms
of menopause; or cures, mitigates, or treats any disease, unless they have
human clinical testing that meets certain requirements and is sufficient to
substantiate that the claims are true,
2) making any misleading or
unsubstantiated claim about the health benefits or efficacy of any dietary
supplement, food, or drug;
3) misrepresenting the results of any test of
the product;
4) misrepresenting any material fact about the product or any
material terms and conditions of any offer for it; and
5) failing to
disclose any material connections (such as financial relationships) they
have with endorsers. They also are subject to a $40 million judgment, all
but $250,000 of which will be suspended based on their inability to pay.
The Commission vote authorizing the staff to file the proposed
stipulated final judgment and order was 3-0. The proposed order will be
filed in the U.S. District Court for the Central District of California
against defendants Lunada Biomedical, Inc.; and Donna Kasseinova, Roman
Trunin, and Emil Arutyunov (a/k/a Emil Chiaberi), individually and as
officers of Lunada.
NOTE: Stipulated final orders have the force of
law when approved and signed by the District Court judge.
The FTC is a member of the National Prevention Council, which
provides coordination and leadership at the federal level regarding
prevention, wellness, and health promotion practices. This case advances
the National Prevention Council’s goal of increasing the number of
Americans who are healthy at every stage of life. These cases are part of
the FTC’s ongoing effects to protect consumers from misleading health
advertising.
The Federal Trade Commission works to promote competition, and
protect
and educate consumers. You can learn more
about consumer topics and file a consumer
complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC
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Contact Information
MEDIA CONTACT:
Mitchell J. Katz
Office of Public Affairs
202-326-2161
STAFF CONTACT:
Michael J. Davis
Bureau of Consumer
Protection
202-326-2458
Shira D. Modell
Bureau of Consumer
Protection
202-326-3116
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