June 18, 2019

June 18, 2019

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June 17, 2019

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FDA Takes Action on Dietary Supplements Claiming to Treat Alzheimer’s Disease and Other Serious Conditions

FDA has issued warning letters and online advisories to a number of dietary supplement companies whose products claim to prevent, treat, or cure Alzheimer’s disease and other serious conditions.  The disease claims cause the supplements to be considered unapproved new drugs that violate the Federal Food, Drug, and Cosmetic Act.

The products in question include tablets, capsules, and oils containing ingredients such as avocado oil, green tea extract, omega-3 fatty acids, black cumin seed oil, and coconut oil.  In addition to making Alzheimer’s disease claims, the products also claim to treat conditions such as the flu, high blood pressure, parasites, asthma, and diabetes.

In a related press release, FDA noted that these products pose a risk to the public because they “may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment.”  Given that FDA Commissioner Scott Gottlieb has launched an initiative to improve the safety of dietary supplements, including more rapidly communicating with the public about potential safety issues, we can expect to see more of these press releases and enforcement actions in the future.

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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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