FDA plans to update regulation of dietary supplements

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The use of dietary supplements has risen precipitously in the past decade, with the fastest growth in Asia Pacific, but also substantially in Europe and North America. At least three-quarters of Americans report regularly using dietary supplements, most commonly reporting taking multivitamins. That translates into an exceedingly lucrative industry, with an estimated $40bn market in the US alone.

Pointing to the dramatic market growth and widening scope of available products, Scott Gottlieb, head of the US Food and Drug Administration (FDA), in a written statement, announced a plan to modernise regulation of dietary supplements.

Notably, the last major legislation to strengthen regulatory oversight by the FDA, the Dietary Supplement Health and Education Act (DSHEA), was enacted 25 years ago. DSHEA provided a formal definition of dietary supplements and required the labelling and listing of ingredients, including the disclaimer that the FDA had not evaluated any claims about benefits of the product.

The proposed updates outlined by Gottlieb, however, indicate less of an overhaul but rather more enforcement of existing regulations. The FDA has increased the number of warnings and advisory letters issued to so-called bad actors, including manufacturers selling supplements purporting to treat or cure Alzheimer's disease, and is creating a public–private partnership called the Botanical Safety Consortium to improve safety and toxicology testing, actions that align with what Gottlieb suggests is the balance of the twin goals of the FDA: protecting the public from unsafe products and preserving consumer access.

The proliferation of supplements available to consumers highlights the crucial need to improve oversight. However, for any radical transformation of DHSEA legislation, bipartisan Congressional support would be necessary, which is unlikely because the law has long been criticised as a vehicle for manufacturers to sell products with no proven benefit and without any risk assessment. A more sceptical interpretation of the announcement is that the FDA has shifted further in its pro-industry stance, continuing to prioritise unfettered consumerism at the expense of increasing safety and accountability.

The Lancet article FDA statement

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