FDA Warning Letters for Alzheimer’s Supplement Claims

On February 11, 2019, the U.S. Food & Drug Administration (“FDA”) published a warning to the public entitled “FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease” (“FDA Warning”). Found here, the FDA Warning notifies the public of recent FDA Warning Letters dietary supplement marketers for products claiming to prevent, treat, or cure Alzheimer’s disease. According to the Warning, FDA has recently issued 12 FDA warning letters and 5 online advisory letters to companies who are marketing over 58 products labeled as dietary supplements but promoted to treat Alzheimer’s disease.

Under the Federal Food, Drug and Cosmetic Act (“the Act”), products that are promoted for the prevention, treatment and/or cure of diseases are deemed drug products. 21 USC 321(g). This means that products that may otherwise be marketed as dietary supplements, including those that have “Supplement Facts” labeling and those containing only botanicals and vitamins, would be classified as drugs if they are marketed for disease treatment. Accordingly, it is important to ensure that dietary supplements are properly marketed in order to avoid classification as drug products and avoid FDA action.

When developing a product it is important to ensure that all claims made in labeling comply with federal law and regulations enforced by the FDA. If you have any questions about how you can market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com.

FDA Warning Letters