The recall of Hydroxycut, which as pointed out above is one of the best-known weight-loss brands, is the latest in a series of incidents that raise the question of whether the FDA has adequate authority to regulate the dietary supplement industry and provide consumer protection. At issue is the difference in the way the agency oversees drugs — defined as products that prevent or cure disease — and dietary supplements, which can offer general health benefits but cannot claim to treat specific diseases or symptoms. Unlike drugs – whose manufacturers must provide safety and effectiveness data before receiving federal approval to sell the products – dietary supplements don’t need FDA approval to go on sale. That means only the manufacturers of dietary supplements are themselves responsible for ensuring and documenting the safety and efficacy claims of their products. That’s not good for obvious reasons.
According to the law governing dietary supplements, the FDA is empowered to act only in cases when it identifies a harmful or adulterated product that is already on sale. Dr. Linda Katz, interim chief medical officer of the agency’s Center for Food Safety and Applied Nutrition, told the Times:
Part of the problem as you know is that FDA looks at dietary supplements from a postmarket perspective, so that an isolated incident is often difficult to follow.
The agency has been on a campaign to identify and warn consumers about tainted weight-loss pills that illegally contain prescription drug ingredients. Since December, the FDA has issued a list of 70 brands that contained hidden and potential hazardous drugs including an antiseizure medication.
Source: New York Times
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.