CHD is reporting on the FDA’s actions against a wide array of companies using unsubstantiated marketing to sell their products. As most know, the “natural” healthcare industry has been virtually unregulated, allowing almost any company to claim that they have some kind of cure or natural compound that will reverse the effects of diseases. It is gratifying to see the FDA actually continuing to crack down on these companies rather than just talk about doing something.
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Warnings issued against illegally marketing products for Alzheimer’s disease
The U.S. Food and Drug Administration (FDA) has posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling products with unsubstantiated claims that they prevent, treat or cure Alzheimer’s disease and, in some cases, other serious health problems. [FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease. FDA News Release. Feb 11, 2019] Three other warnings were send jointly by the FDA and FTC. [FTC and FDA send warning letters to companies selling dietary supplements claiming to treat Alzheimer’s disease and remediate or cure other serious illnesses such as Parkinson’s, heart disease, and cancer FTC Press Release. Feb 11, 2019] Although most of the products were marketed as dietary supplements, the disease-related claims subjected them to regulation as misbranded and/or unapproved new drugs.
Warning letters went to: Gold Crown Natural Products, Peak Nootropics LLC (aka Advanced Nootropics), DK Vitamins, Sovereign Laboratories LLC, Blue Ridge Silver, Nutrition Coalition Inc, John Gray’s Mars Venus LLC, TEK Naturals, Earth Turns LLC, Emmbros Overseas Lifestyle PVT LTD, Pure Nootropics LLC, and Capris Associates Inc. / BR Naturals.
Advisory letters went to:Alzheimer’s Corporation (ALZcorp), Alzheimer’s Organization, Dr. Fitt Intelligent Designs LLC, Healthcare Products LLC d/b/a The Alzheimer’s Store d/b/a MindCare Store, and This Wonderful Life New Age Shop.
The FDA’s total for the past five years includes more than 40 companies that promoted more that 80 products with illegal Alzheimer’s disease claims on Web sites, on social media, and in stores.