FDA to Tighten Oversight of Supplements

The Food and Drug Administration announced plans Monday to step up its policing of dietary supplements, which it said has mushroomed into a $40 billion industry with more than 50,000 products.

The FDA also announced a crackdown on more than a dozen supplement makers that had allegedly touted misleading claims about their products' ability to treat serious diseases including Alzheimer's and cancer.

Roughly three-quarters of American consumers regularly take dietary supplements - including four out of five older adults, Gottlieb said. FDA Commissioner Scott Gottlieb explained that the supplement market may have outpaced the agency's ability to properly regulate the volume and variety of products hitting the market, and that the agency is working toward more rapid response methods of issuing consumer warnings and halting the production and distribution of products marketed using fraudulent claims to prevent or cure conditions that can not be treated with over-the-counter supplements.

As is well known, there is no cure for Alzheimer's disease, which the FDA spelled out in its warnings Monday. "As the popularity of supplements has grown, so have the number of entities marketing potentially risky products or making unproven or misleading claims about the health benefits they may deliver", FDA Commissioner Scott Gottlieb said. The agency only has the authority to stop the sale of a supplement if it can prove the product is unsafe. The plans include communicating as soon as possible when there is a concern about a supplement and improving how the FDA evaluates the safety of such drugs.

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The FDA vowed to update its policies on dietary supplements, promising "one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years, "according to a statement by FDA commissioner Dr. Scott Gottlieb". Gottlieb said the risk posed by such illegal products has grown with the industry.

The Council for Responsible Nutrition, a trade association that represents the nutritional supplement industry, took no issue with the FDA's action. More than one unapproved pharmaceutical ingredient was found in 20% of those supplements. He said more details will be available "in the coming months". The agency said these claims can cause real harm when people forgo approved treatments that have been proven safe and effective.

The companies, which included TEK Naturals, Pure Nootropics, Gold Crown Natural Products and Sovereign Laboratories, have 15 business days to respond to the FDA's letters.

Q: What about supplements that don't make disease claims?

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