Vitamin maker Rexall Sundown is to pay up to $12 million to resolve Federal Trade Commission charges regarding its marketing of the dietary supplement 'Cellasene', a purported treatment for cellulite.
The settlement must first be approved by the federal district court in Miami, along with related settlements in pending lawsuits against Rexall in California and Florida. If approved, the FTC and class action settlements together will provide up to $12 million in redress for consumers throughout the United States who purchased Cellasene.
The final order would also ban Rexall from making any unsubstantiated cellulite reduction or elimination claim for Cellasene.
"Hundreds of thousands of consumers were misled by the claims for this product," said Howard Beales, director of the FTC's Bureau of Consumer Protection. "This case should alert advertisers to the fact that their chances of getting away with making unsubstantiated claims are slim to none."
Florida-based Rexall is a subsidiary of Dutch company Royal Numico. It makes a variety of nutritional supplements and consumer health products and first introduced the Cellasene product in 1999, amid a major public relations campaign.
Advertising involved a 'video news release' that described the Cellasene clinical studies as 'impressive', according to the FTC. The company also advertised Cellasene in major newspapers including The Washington Post and USA Today, in magazines, the Internet, and on television and radio. Sales of Cellasene exceeded $40 million in the United States. The eight-week Cellasene regimen cost consumers almost $200.
The FTC first sued Rexall in the US District Court for the Southern District of Florida in July 2000, alleging that the company violated the FTC Act by making unsubstantiated claims about the ability of Cellasene to eliminate or substantially reduce cellulite and false claims that it had clinical evidence establishing Cellasene's efficacy. In its promotional materials, Rexall had stated that 'clinically researched' Cellasene was 'The One That Works', and that, 'Unlike massages and creams, Cellasene works from within, nutritionally, to help eliminate cellulite at its source'.
The FTC has in the past months cracked down on several supplement firms making false claims, and is urging the industry to stop misleading weight-loss claims. At the end of last year the FDA said it was to renew its focus on consumer protection and this week proposed draft GMPs for the manufacturing of dietary supplements.