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Spotlight on Cellasene, the
cellulite pill
Rexall, a unit of Dutch nutritionals giant Royal Numico,
wants to have its reputation upheld as the Mercedes-Benz of
dietary supplements. The FTC, which is seeking millions in
customer refunds, is drowning in its fight against a
gullywasher of unregulated dietary supplements and could
use a big victory.
``The FTC goes after the big cases -- and this is one that the
FTC couldn't ignore,'' said David Schardt, an associate
nutritionist with the Center for Science in the Public Interest
in Washington, D.C.
Rexall's Anti-Cellulite Drug Study Fails
Dr. Brian Berman, head of clinical studies at the University of Miami, said
he has halted testing of Cellasene, a drug that Boca Raton-based Rexall
Sundown (Nasdaq: RXSD) announced as the world's first antidote to cellulite.
Berman said the 240 women in the study were required to show up six
times for the clinical testing but most did not. Sales last year were
expected to exceed $300 million but hit only $54 million after negative press.
Sales are expected to be $20 million this year.
Boca Woman Sues Rexall over Cellasene
Dorothy Greenfield of Boca Raton filed suit against Rexall Sundown in Palm
Beach County Circuit Court late Thursday, claiming the company deceived
consumers by misrepresenting Cellasene's ability to reduce cellulite.
Greenfield is seeking class-action status in the case. Meanwhile, the U.S.
Federal Trade Commission said Thursday it will seek full refunds for
women in the United States who purchased Cellasene to remove cellulite.
It is estimated that this action could cost the company at least $75 million.
Late Wednesday, the FTC filed suit against Cellasene distributor Rexall,
accusing it of making false claims on the product's efficacy. Rexall, now a
subsidiary of Royal Numico N.V. of the Netherlands, denies the FTC's
allegations and vowed Thursday to defend the truthfulness of its claims for
Cellasene, an herbal dietary supplement.
The FTC suit, filed in U.S. District Court for the Southern District of
Florida, seeks an injunction to halt the advertising claims and asks the
court to order refunds to consumers. The case has been assigned to U.S.
District Judge Wilkie Ferguson in Fort Lauderdale. The FTC plans to
interview and possibly depose Dr. Brian Berman, a dermatologist at the
University of Miami, whose recent clinic trial on Cellasene produced no
results because the patients did not comply with the study guidelines.
The defense is expected to call Debbie DeSantis, a registered pharmacist
and the company's senior vice president for product development. She is
the daughter of Rexall Sundown founder Carl DeSantis.
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