Home Supplements FDA Challenges Dietary Supplement Makers – The Wall Street Journal

FDA Challenges Dietary Supplement Makers – The Wall Street Journal

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The FDA doesn’t review supplements’ safety or effectiveness, as it does with prescription drugs and over-the-counter medicines.


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Jacquelyn Martin/Associated Press

The Food and Drug Administration said Monday that it sent letters to 17 nutritional supplement manufacturers alleging that the companies are illegally selling more than 58 products with the improper claims they can prevent, treat and cure serious diseases, including Alzheimer’s.

The agency sent 12 warning letters and five online advisory letters to the U.S. and foreign companies, which often sold their products on websites and social media platforms, according to an agency statement.

The companies have 15 business days to respond to requests to explain how the violations outlined by the FDA will be corrected, or they could be subject to further FDA enforcement.

In a separate statement Monday, FDA Commissioner Scott Gottlieb said the agency was updating its oversight of the dietary supplement industry, including adding a “rapid-response” tool to alert the public of unsafe products.

Dietary supplements are a booming industry, with some 80,000 kinds of supplements sold in 2016, according to a recent government report. Nearly $133 billion in supplements were sold in the U.S. in 2016, according to the most recent data from Zion Market Research.

Supplements, however, aren’t regulated like medicines and other products taken to improve health. The FDA doesn’t review supplements’ safety or effectiveness, as it does with prescription drugs and over-the-counter medicines. Supplement manufacturers and distributors are subsequently responsible for ensuring the safety of their products.

Write to Jared Hopkins at jared.hopkins@wsj.com

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