Hydroxycut Gets Cut by the FDA

Unless you have lived in a cave for the last several years you have seen or read the ads for Hydroxycut. Shapely women and men showing off their weight loss and new bodies from the positive effects of the diet supplement, which listed appetite control, weight loss, and improved energy among its positive effects.

On May 1st, the Food and Drug Administration warned consumers to stop using the popular line of weight loss products. The agency had reported receiving 23 reports of adverse health effects in Hydroxycut users, including one death and one person who required a liver transplant. Other problems reported included heart problems and a type of muscle damage that could lead to kidney failure.

The Hydroxycut products, widely sold at national chain stores including GNC and the Vitamin Shoppe, are used by dieters and body builders. The maker Iovate Health Sciences of Oakville, Ontario reported selling more than 9 million units of the brand in 2008 according to the FDA.

Vitamin Shoppe and GNC reported they were removing Hydroxycut products from their web sites and stores. A GNC spokeswoman said, “As soon as we become aware of potential problems with any products, we take immediate action, as we have done in this situation.” Both companies stopped selling StarCaps, another well-known weight loss brand several months ago because it contained a powerful prescription diuretic.

The recall is one in a series of incidents that raise the question of whether the FDA has proper authority to regulate the dietary supplement industry to provide consumer protection. The problem is the difference between drugs, by definition products that prevent or cure disease, and dietary supplements, which cannot claim to treat specific symptoms or diseases.

Drug manufacturers are required to provide safety and effectiveness data before they can sell the products, while dietary supplements do not need FDA approval for sale. It is supposed that the manufacturers of dietary supplements are insuring safety and effectiveness of their products. The Food and Drug Administration can act on dietary supplements only when a harmful or adulterated product is already on sale.

The dietary supplement industry believes that current regulations are adequate to protect consumers because manufacturers conduct their own safety tests. John Hathcock, vice president of scientific and international affairs at the Council for Responsible Nutrition, a trade group, said “Nobody goes to market without testing.” He said that neither drug makers nor supplement manufacturers can ensure total product safety once an item has moved from the lab into mass circulation.

Dr. Linda Katz, interim chief medical officer of the FDA Center for Food Safety and Applied Nutrition said Friday, that part of the problem is that the agency is looking at consumer safety from a post-marketing position; tracking an isolated adverse incident is hard to do.

A new law requiring manufacturers to notify the FDA of any reports of serious health problems helped officials identify a pattern linked to Hydroxycut users, and the agency cited reports in medical journals of diagnoses of serious liver disease in six people who had taken the supplement. The Hydroxycut formula has changed over time and the product contains blends of proprietary ingredients. The agency has not yet determined which of the ingredients might constitute a hazard.

Iovate Health Sciences said that the number of adverse events reported by the FDA in the advisory is small relative to the millions of people who have used Hydroxycut products over the past seven years. The company’s web site said that they were recalling the products out of “an abundance of caution” and that their assessment of the potential risk differs from that expressed by the FDA.

Ano Lobb, a public health researcher who has studied Hydroxycut and other dietary supplements for Consumer Reports, said the problem may be an ingredient called hydroxycitric acid. Derived from a tropical fruit, it has been linked in one medical journal to liver problems. Lobb said that it is likely that other supplements containing the same ingredient remain on the market. “You really have to be careful about dietary supplements, especially weight-loss pills,” said Lobb, “People belief that the FDA has verified that these products are at least safe and effective, and that’s really not the case. When you see fantastic claims – that’s generally what they are.”

The Council for Responsible Nutrition, a trade association representing the dietary supplement industry, said that both the FDA and Iovate “took appropriate action today.” Steve Miller, the council’s president and CEO said that the group commended the FDA for warning consumers, of possible safety problems associated with the products and encouraged that Iovate Health Services recalled the products from the market until the determination of the cause of the adverse affects can be made.