The US Food and Drug Administration (FDA) has issued an alert and seizes new imported dietary and sports supplements. The agency published an import alert impacting the $50 billion-a-year dietary supplement industry, news that a Washington, D.C.-based lawyer and two former regulators found encouraging.
Import Alert 54-18 relates to “detention without physical examination (DWPE) of dietary supplements and bulk dietary ingredients that are or contain new dietary ingredients” (NDIs).
Two Chinese-based firms, and an NDI known as higenamine, are identified as being subject to DWPE under the import alert.
The import alert “is not specific to a particular ingredient,” according to an email from an FDA spokesperson. “Instead, it addresses NDIs and dietary supplements containing NDIs that the FDA has determined to be adulterated under section 402(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act.”
Per the above section of the law, “a food shall be deemed to be adulterated if it is a dietary supplement or contains a dietary ingredient that is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury,” FDA explained in the import alert.
FDA confirmed higenamine has not been the subject of an NDIN. The ingredient, which is used in weight loss and sports supplements, was the subject of an article published in 2018 in the peer-reviewed medical journal Clinical Toxicology.
In the article, Dr. Pieter Cohen of Harvard Medical School and other researchers described higenamine as “a stimulant with cardiovascular properties” that the World Anti-Doping Agency (WADA) has prohibited.
According to the U.S. Anti-Doping Agency (USADA), higenamine is prohibited in and out of competition, based on its classification. It’s unclear what specific safety concerns FDA has identified related to the ingredient. Higenamine, however, is identified in an FDA “Dietary Supplement Ingredient Advisory List” of substances that do not appear to be lawful ingredients in dietary supplements.
Firms and products can be added to an import alert based on the criteria used by the FDA. Import alerts are subject to daily updates if justified by analytical or inspectional results, according to an FDA spokesperson. Running your Nutraceuticals through our product compliance database to make sure they don’t carry any illegal ingredients. HawkScanner send you automatic alerts when or if an ingredient makes it onto the unlawful ingredients list allowing you to act quickly.
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