
On June 2, 2022, the U.S. Food and Drug Administration (“FDA”) announced the launch of a new “Supplement Your Knowledge” initiative, with resources targeted to consumers, educators and healthcare professionals.
The initiatives webpage includes videos, infographics, articles and a social media toolkit providing information and warnings to the targeted groups about dietary supplements.
The “Understanding Dietary Supplements” fact sheet notes the agency’s limited role in regulating supplements: “Under the Dietary Supplement Health and Education Act (DSHEA), companies are responsible for ensuring that the dietary supplements they sell are safe and properly labeled. Unlike drugs, FDA does not have the authority to approve dietary supplements or their labeling before they are sold to the public. In fact, companies can often introduce a dietary supplement to the market without notifying FDA. FDA’s role in regulating dietary supplements primarily begins after products enter the marketplace. If a product is found to be unsafe or not otherwise in compliance with the law, FDA can work with the company to bring the product into compliance or possibly remove it from the market.”
This initiative comes as some lawmakers have been pushing for increased pre-market regulation of dietary supplements. On April 26, 2022, Senators Richard Durbin and Mike Braun introduced the Dietary Supplement Listing act of 2022, which would establish a mandatory product listing rule for all dietary supplements and increase FDA’s pre-market review authority.
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Pooja S. Nair is business litigator with a proven track record of delivering creative, effective, and long-term solutions to complex legal challenges faced by middle-market companies. Known for her ability to handle high-stakes ...
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