FDA cracks down on dietary supplements

The U.S. Food and Drug Administration (FDA) announced Monday it would be stepping up its policing of dietary supplements.

At the same time, the agency announced it would be taking action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease, among other conditions.

The U.S. dietary supplement industry is a $40 billion industry with more than 50,000 products. In accordance with the current guidelines as stated in the Dietary Supplement Health and Education Act of 1994, dietary supplements are regulated more like food than drugs, and can make similar claims to what might be found on a box of cereal or snack bar such as “calcium builds strong bones.” However, they can’t contain drug ingredients or make claims about treating chronic diseases, such as Alzheimer’s and cancer.

Scott Gottlieb, MD, FDA commissioner, said the agency is not questioning what is currently permitted, but rather addressing criticism that it hasn’t enforced rules from prohibiting supplements from containing drugs or being marketed like them. Gottlieb says the risk posed by such illegal products has become more common in the industry.

The FDA’s dietary supplements review group has 23 employees and is planning more oversight on products that make illegal health claims. The FDA is already taking action, issuing 12 warning letters and five online advisory letters to foreign and domestic companies that are illegally selling more than 58 products, many of which are being sold as dietary supplements. Some of the products are, in fact, unapproved new drugs or misbranded drugs that claim to prevent, treat, or cure Alzheimer’s disease and a number of serious health conditions.  

“Making healthy choices about diets can have a significant and positive impact on Americans’ health,” says Gottlieb in the release. “To be able to make those choices with respect to dietary supplements, consumers need to have access to safe, well-manufactured, and appropriately labeled products. One of my top goals is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products and holding accountable those actors who are unable or unwilling to comply with the requirements of the law.”

Expert say health claims on dietary supplements may lead people to think they’re more effective than they are, but the FDA doesn’t currently review such claims before they are marketed.

Gottlieb says he sees the value in dietary supplements, both personally and as a physician. The FDA’s responsibility, he said, is making sure the products on the market are safe and effective.  

While the FDA is still figuring out exactly how it will tighten oversight, one possibility is a mandatory database for dietary supplements to improve transparency and make enforcement easier. The agency also said it’s developing a way to more quickly and consistently alert people about supplements that might have illegal ingredients.