By Sy Mukherjee
February 11, 2019

Happy Monday, readers. I hope you enjoyed your weekend.

The Food and Drug Administration (FDA) is preparing to battle what has, for decades, been one of the less-regulated mass consumer industries in America: Dietary supplements.

FDA Commissioner Scott Gottlieb issued a pair of press releases on Monday that suggest an upcoming overhaul of the supplements industry, which has often gotten away with some dubious claims about what their products can and cannot do.

Case in point: Regulators sent a dozen warning letters today to companies suggesting that their dietary supplement products can help treat Alzheimer’s (these sorts of claims are also regularly made about cancers and other serious medical conditions).

“Today’s actions are part of the FDA’s larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago,” wrote Gottlieb.

The agency also provided some broader context of the unchecked growth of supplements since the initial passage of the DSHEA nearly three decades ago, noting that, “what was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000—and possibly as many as 80,000 or even more—different products available to consumers.”

So how does the FDA plan to rein in the sector? For one, through aggressive communication with the public about dietary supplements that could potentially pose a threat (such as those tainted with actual prescription drugs), as well as the creation of a modernized regulatory framework (though we have yet to see what such a framework would look like).

Read on for the day’s news.

Sy Mukherjee


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