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FDA Announces New Tool to Alert the Public of Unlawful Ingredients in Dietary Supplements

  • As our readers may remember, earlier this year the FDA announced a plan for modernizing and strengthening dietary supplement regulation and oversight. Under the plan, the FDA stated their intent to preserve consumers’ access to lawful supplements, while also upholding the Agency’s obligation to protect the public from unsafe and unlawful products. And as part of those efforts, on April 16, the FDA Deputy Commissioner for Food Policy and Response, Frank Yiannas, announced a new step to “better protect consumers from potentially unlawful dietary supplements.”  The FDA launched a tool, called the “Dietary Supplement Ingredient Advisory List” (or “the List”), to quickly alert the public when the Agency becomes aware of ingredients that appear to be unlawfully marketed in dietary supplements.

  • The List is intended as a resource for both consumers and industry, and as a means to communicate more efficiently and effectively with the public. For instance, the Deputy Commissioner acknowledged that “[a]s the dietary supplement marketplace has grown, the introduction of new ingredients often raises complex questions involving science, policy, and the law. In the time it takes the FDA to make a final determination, consumers and industry might mistakenly conclude that a lack of action by the FDA indicates that these ingredients are lawful.”

  • Ingredients will be added to the List following an initial FDA assessment indicating the ingredient may not lawfully be in dietary supplements for reasons including: (1) the ingredient appears to be excluded from use in a dietary supplement; (2) the ingredient does not appear to be a dietary ingredient and does not appear to be either an approved food additive or generally recognized as safe for use; and/or (3) the ingredient appears to be subject to the requirement for pre-market notification, but the requirement has not been satisfied. The List currently includes the following four ingredients: andarine, higenamine, hordenine, and 1,4-DMAA.

  • Notably, the inclusion of an ingredient on the List does not necessarily indicate safety concerns. Deputy Commissioner Yiannas stated the FDA will continue to communicate separately any time safety concerns about dietary ingredients or dietary supplements are identified. Additionally, the List is not exhaustive and is expected to evolve as new ingredients are identified. Thus, the FDA encourages consumer and industry feedback that may support or refute the FDA’s preliminary assessment regarding the ingredients on the List.

  • The FDA also announced the issuance of 11 warning letters “to companies whose dietary supplement products are in violation of the law.”  The FDA warned 8 companies for marketing dietary supplements containing DMHA. The products are adulterated because the FDA determined that DMHA is either a “new dietary ingredient” for which the FDA has not received the required New Dietary Ingredient notification or that it is an unsafe food additive. Additionally, the FDA warned 3 companies for marketing dietary supplements containing phenibut and stated that the products are misbranded because they label phenibut as a dietary ingredient when phenibut does not meet the statutory definition of a dietary ingredient. The companies have 15 business days from receipt of the warning letter to respond to the FDA.

© 2019 Keller and Heckman LLP

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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