FTC Takes Action Against Rexall's Cellasene; Seeks Refunds

BOCA RATON, Fla.--On July 20, the Federal Trade Commission (FTC) filed a lawsuit against Rexall Sundown Inc. for its Cellasene product, an herbal dietary supplement purported to eliminate cellulite. According to the FTC, Rexall's marketing of Cellasene as a product that is clinically proven to eliminate cellulite is false and unsubstantiated and misleading to consumers.

FTC reported that Rexall had no clinical evidence to support claims that Cellasene "fights cellulite from the inside," but the company had a different opinion.

"The Commission's action completely ignores the sound scientific research into the effectiveness of Cellasene," said Debbie DeSantis, senior vice president of product development at Rexall and daughter of Rexall Sundown founder, Carl DeSantis. "Cellasene was designed and formulated by one of the world's leading herbal/pharmaceutical extract companies with foremost expertise in cellulite research." According to Rexall, the product was studied in two clinical studies in Italy and was the subject of more research in France. The company cited the product's safety and efficacy record in Europe, where it has been on the market for six years. FTC has been asking Rexall to document Cellasene's effectiveness since its 1999 introduction to the American market. According to DeSantis, Rexall has "tried on numerous occasions" to give FTC the documentation, but FTC has "shown no interest in allowing any scientific dialogue among government and industry experts."

"We are fully prepared to present our scientific substantiation in court and welcome the opportunity to finally be able to examine the FTC's witnesses and objections," said DeSantis.

FTC charges that Cellasene, which contains ginkgo biloba, grapeseed extract, bladderwrack and sweet clover as well as iodine, borage seed oil and fish oil, is making false claims in its advertising. The company claimed the product increases the body's metabolic rate and improves circulation, thereby reducing fluids and trapped fat. FTC is seeking to interview Dr. Brian Berman, a dermatologist at the University of Miami who conducted a clincial trial on Cellasene in which no results were produced because participants did not comply with study guidelines. FTC is looking into getting a sworn testimony from Dr. Berman, if necessary.

The product is advertised in major news outlets, including The New York Times and other newspapers as well as on television and radio. An eight-week regimen, consisting of three Cellasene geltabs per day, costs $180 to $240; sales totaled $54 million in 1999. FTC is seeking full refunds for women in the United States who bought the product--the amount could reach $75 million. If the FTC wins the suit and refunds are awarded, FTC is expected to accept affidavits from women who did not keep the packages or proof of purchase.

Rexall is a wholly-owned subsidiary of the Dutch company, Royal Numico, N.V., which also owns brands such as Met-Rx, GNC and Enrich. For more information, visit www.ftc.gov, www.rexallsundown.com or www.numico.com.