Regulators checking into cellulite supplement

The Associated Press

WASHINGTON -- A dietary supplement that claims to help women reduce cellulite is under scrutiny by federal regulators, who want to determine if the company can substantiate those claims.

The makers of Cellasene launched a campaign this week to dispel skepticism about the supplement by releasing studies on the product. But the Federal Trade Commission is nonetheless looking into whether the company can back up its advertising claims, according to a source familiar with the case. FTC spokeswoman Vicki Streitfeld declined to confirm whether Cellasene is under investigation. Typically, the agency doesn't publicly say whether it is investigating a company. Debbie DeSantis, vice president of Cellasene's Italian manufacturer, Medestea Internazionale, also declined to comment on whether regulators are reviewing the product. Cellasene entered the U.S. market in early March, making a big splash on the advertising pages of fashion magazines and flying off the shelves in some drug stores with its claims of reducing cellulite -- the pesky pockets of fat that cause the area around women's hips and thighs to appear dimpled. The pills, available at major drug and retail stores, cost about $40 for a two-week supply. Vitamin maker Rexall Sundown Inc., based in Boca Raton, Fla., has the U.S. distribution rights to Cellasene. On Monday, Medestea Internazionale placed a full-page ad in The New York Times directed at "the millions of women who are taking Cellasene or who are thinking about it" and who have questions about supporting research. The next day, the company released studies it said backed the assertions about the supplement's effectiveness. It claimed Italian studies, using several dozen women, demonstrated that women could reduce their hip and thigh circumference within eight weeks of treatment. Some groups who reviewed the data dismissed its findings and said the methodology was flawed. "We don't feel there is sufficient evidence to be mounting this campaign for an expensive product," said David Schardt, of the consumer advocacy Center for Science in the Public Interest. For example, a study of 25 women, with 15 taking dummy pills, was done "single-blind," meaning that those taking the measurements knew which women were using the supplement. Schardt said this could make investigators "subject to observer bias" and leave open the possibility for human error in measuring changes in circumference. Schardt also said the study didn't measure changes in visual appearance and feel of fat deposits -- what most women associate with cellulite. Another U.S. pilot study under way, which uses 10 women as subjects, will be too small to prove anything further, he said. The makers of Cellasene said they are confident enough about the research results to push ahead with a study involving 200 women at the University of Miami. DeSantis, of Medestea Internazionale, said that study also will look at other benefits accrued from using the product, such as body shaping in the ankle and arms. The company is expanding its research "not because we believe the Italian study isn't valid, but to further investigate the benefits of Cellasene," said DeSantis, who expects results by fall. By law, dietary supplements can't promise to treat or prevent disease directly. But other than that, the industry is shielded from government oversight by a 1994 act of Congress. Lawmakers said the Food and Drug Administration is supposed to intercede only if the agency proves a supplement poses an unreasonable risk or is marketed as a drug. The FTC oversees truth-in-advertising issues and has the authority to take action against companies that can't back up their claims. The agency has filed 66 cases against makers of dietary supplements in the last 15 years and in November issued guidelines on truthful advertising.

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