September 28, 2021

Volume XI, Number 271

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September 28, 2021

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September 27, 2021

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FDA Issues Import Alert for Higenamine Supplements

On March 12, 2021 the U.S. Food and Drug Administration (FDA) published Import Alert 54-18, which relates to the detention without physical examination (DWPE) of dietary supplements and bulk dietary ingredients that are or contain higenamine, a dietary ingredient found on FDA’s Dietary Supplement Ingredient Advisory List (“DSIA List”).  Import Alert 54-18 prohibits two Chinese companies from importing their higenamine products into the U.S., which FDA has determined to be adulterated under the Federal Food, Drug, and Cosmetic Act (“the Act”).  In Import Alert 54-18, FDA notes that there is inadequate information to “provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.”

By way of background, import alerts inform FDA’s field staff and the public that the Agency has enough evidence to allow for DWPE of products that have been determined to be in violation of the Act.  When a product and/or firm are the subject of an import alert, it will be added to the Red List found on FDA’s import alert, which identifies firms and products subject to DWPE.  To be removed from the Red List, information must be provided to the Agency to demonstrate that the firm has resolved the conditions that gave rise to the violation.

FDA has stated that it expects the Agency to use Import Alert 54-18 to identify and deny entry of non-compliant products containing higenamine.  Similar import alerts exist for supplements containing kratom and active pharmaceutical ingredients.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 77
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About this Author

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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