The Federal Trade Commission (FTC) has charged the marketers of a dietary supplement called Coral Calcium Supreme with making false and unsubstantiated claims about the product's health benefits.
The action comes after trade association the Council for Responsible Nutrition urged the FTC and Food and Drug Administration (FDA) to take action on suppliers of coral calcium, believed by many in the industry as harming the reputation of the dietary supplement trade.
In a complaint filed in federal district court, the FTC alleges that Kevin Trudeau, Robert Barefoot, Shop America (USA) and Deonna Enterprises violated the FTC Act by claiming, falsely and without substantiation, that Coral Calcium Supreme can treat or cure cancer and other diseases, such as multiple sclerosis and heart disease.
The FTC says that these and other claims go far beyond existing scientific evidence regarding the recognized health benefits of calcium. It is seeking preliminary and permanent injunctive relief, including restitution to consumers who purchased Coral Calcium Supreme, and has asked the court for a temporary restraining order that would prohibit the defendants from making the challenged claims, and would freeze their assets.
The defendants promote the product primarily through a nationally televised 30-minute infomercial featuring Trudeau and Barefoot, and through statements made in brochures accompanying the product. The infomercial has aired on cable channels such as Women's Entertainment, Comedy Central, the Discovery Channel, and Bravo.
The FTC and the FDA recently promised to clamp down on purveyors of products with unsubstantiated health and medical claims and over the last year has shown greater action on dietary supplements making illegal claims.
Howard Beales, director of the FTC's Bureau of Consumer Protection, warned: "These cases demonstrate that the FTC will take aggressive enforcement action, particularly when, as alleged in this case, the products are marketed as cures for serious diseases like cancer and heart disease. Marketers who step over the line will find themselves between a rock and a hard place."
In a separate action, the FTC has also charged one of the defendants, Kevin Trudeau, with violating a 1998 federal district court order that prohibits him from making unsubstantiated claims about the benefits, performance, or efficacy of any products. The FTC alleges that Trudeau violated that order by making false and unsubstantiated claims about Coral Calcium Supreme, and by making unsubstantiated claims that another product, Biotape, provides significant or permanent relief from severe pain, including debilitating back pain, and pain from arthritis, sciatica, and migraines.
The FTC and the FDA are also sending strong warning letters to website operators who are marketing coral calcium products claiming that coral calcium is an effective treatment or cure for cancer and/or other diseases. The FTC refers to 'dozens of warnings' sent this week, which state it is aware of no competent and reliable scientific evidence supporting such claims and that such unsupported claims are unlawful under the FTC Act. Website operators are being instructed to remove any false or deceptive claims from their sites immediately. In a similar action, the FDA warned website operators that disease claims and unsubstantiated structure/function claims cause their products to be in violation of the Federal Food, Drug, and Cosmetic Act.
"FDA and FTC are working together to maximize our efforts to combat health fraud," said FDA Commissioner Mark B. McCellan. "We are trying to be particularly vigilant concerning fraudulent internet promotion, because this is emerging as an increasingly insidious way of trying to exploit the public."
Also today, ConsumerLab.com released its review of calcium supplements, which found that Robert Barefoot Coral Calcium contains quantities of lead above that permitted by the state of California.
Commenting on the findings, Tod Cooperman, president of ConsumerLab.com, said: "We have received many questions from consumers about coral calcium. Coral calcium is not inherently better or worse than other types of calcium. But it is sadly ironic that the most advertised brand also had the most lead."
The FTC is to challenge the claims that a daily serving of Coral Calcium Supreme provides the same amount of bioavailable calcium as two gallons of milk, and that the body absorbs significantly more of the calcium in coral calcium - up to 100 times more, and at a significantly faster rate - than the calcium contained in commonly available calcium supplements.
The Robert Barefoot product was not the only calcium supplement to contain elevated lead. Another also failed to fully break apart in disintegration testing, while a third product was found to contain only 77 per cent of its labeled amount of calcium, reported ConsumerLab.com today.
The Calcium Product Review includes results for 25 calcium supplements, including 15 reviewed and 10 others that recently passed the same evaluation through CL's Voluntary Certification Program.