The U.S. Food and Drug Administration has taken action against 17 companies illegally selling more than 58 products, many as dietary supplements, that claim to treat Alzheimer’s disease and other serious diseases and health conditions.
The 12 warning letters and 5 online advisory letters said the products are “unapproved new drugs and/or misbranded drugs” that have been sold in violation of the Federal Food, Drug and Cosmetic Act, as they claim to prevent, treat or cure Alzheimer’s and other diseases. The products include those sold as tablets, capsules and oils.
“These products, which are often sold on websites and social media platforms, have not been reviewed by the FDA and are not proven safe and effective to treat the diseases and health conditions they claim to treat,” the FDA said in a statement. “These products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment.”
The companies warned have been asked to respond to the FDA within days, stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, the FDA said.
The actions are part of the FDA’s efforts to address the growth of the dietary supplement industry, which has grown to a $40 billion industry, with anywhere between 50,000 and 80,000 or more products, from a $4 billion industry with 4,000 products, in the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA).
Three out of four Americans take a daily dietary supplement, including one in three children and teens and four of five older Americans.
“Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical benefit, especially when a product is marketed to treat serious and complex diseases like Alzheimer’s,” FDA Commissioner Scott Gottlieb said. “Simply put, health fraud scams prey on vulnerable populations, waste money and often delay proper medical care – and we will continue to take action to protect patients and caregivers from misleading, unproven products.”
Meanwhile, the FDA did not address CBD, or non-psychoactive cannabinoid, that some companies have claimed to have medicinal qualities, including as a treatment for Alzheimer’s. Many of the claims were made after the 2018 farm bill was signed by President Donald Trump, which legalized hemp but kept CBD illegal without FDA approval.
“We welcome the need to look ahead but FDA cannot ignore today’s challenges in the meantime: Their inaction on one of the hottest products, CBDs, is a case in point,” said the Natural Products Association in a statement.
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Here are the 17 companies that received warnings:
|Company||Products named by FDA||Warning (subject)|
|Blue Ridge Silver||BLUE RIDGE SILVER Colloidal Silver||Warning letter (new drug/labeling/misbranded)|
|Capri Associates Inc./BR Naturals||Avocado Oil, Black Seed Oil, Moringa Power, Premium Olive Oil D.O.P, Pumpkin Seed Oil, Unrefined Coconut Oil||Warning letter (new drug/labeling/misbranded)|
|DK Vitamins||Ubiquinol CoQ10, Cognispark, Vinpurazine, Melatonin Gammadyn Mn-Co, Zinc Picolinate Formula||Warning letter (new drug/labeling/misbranded)|
|Earth Turns LLC||Green Tea Extract, Cogni-Flex, GlucoFit 48mg, Fundamental D3 1000, Fundamental Omega-3||Warning letter (new drug/labeling/misbranded)|
|Emmbros Overseas Lifestyle PVT Ltd.||Morpheme Remedies Arthcare Plus, Morpheme Remedies Cinnamon, Morpheme Remedies Diabeta Plus, Daily Vital Multivitamin, Morpheme Remedies Fenugreek, Morpheme Remedies Garlic, Morpheme Remedies Guduchi, Morpheme Remedies Memocare Plus, Morpheme Remedies Mind Plus, Morpheme Remedies Mucuna Pruriens, Nourish Vitals Seed & Fruit Mix, St. Botanic Fish Oil||Warning letter (new drug/labeling/misbranded)|
|Gold Crown Natural Products||New Ultra Colostrum, Melatonin with Valerian, Anamu & Llanten, Circulation Max||Warning letter (new drug/labeling/misbranded)|
|John Gray’s Mars Venus LLC||2-AEP Membrane Complex, Ionic Silver Water, L-Glutathione, Liposomal DHA–Ultimate Omega-3 Brain Support, Liposomal Methyl B12/Folate, NAC N-Acetyl-L-Cysteine, Vectomega||Warning letter (new drug/labeling/misbranded)|
|Nutrition Coalition Inc.||Alpha-Lipoic Acid, Colostrum Alpha Whey III (Liquid), Colloidal Silver, CoQ10, Curcumin, Echinacea Root, Liva-Vite, L-Carnitine, Milk Thistle, Selenium, Ultimate Willard’s Water Lotion with Goat’s Milk, Vinpocetine, Vitamin B Complex, Vitamin C, Vitamin D3, Vitamin E, Willard’s Water||Warning letter (new drug/labeling/misbranded)|
|Peak Nootropics LLC (aka Advanced Nootripics)||Adrafinil, Aniracetam, Bacopa Monnieri, L-Dopa, L-Theanine, Noopept, Oxiracetam, Phenibut, Phenylpiracetam, Piracetam, Rhodiola Rosea, Uridine||Warning letter (new drug/labeling/misbranded)|
|Pure Nootropics LLC||Alpha GPC, Lion’s Mane, CDP Choline Capsules, Piracetam, Vitamin D3 5000 IU, Turkey Tail Mushroom Powder, Ginkgo Biloba Capsules||Warning letter (new drug/labeling/misbranded)|
|Sovereign Laboratories LLC||Colostrum-LD, Viralox, Curcumin-LD||Warning letter (new drug/labeling/misbranded)|
|TEK Naturals||BURN4Her, BurnerTEK, Mind Ignite, TEK Male, TestoTEK||Warning letter (new drug/labeling/misbranded)|
|Alzheimer’s Corp.||Memory Revitalizer, Cerebara GPC, and Life Imagined||Online advisory letter|
|Alzheimer’s Organization||Mind and Memory Support||Online advisory letter|
|Dr. Fitt Intelligent Designs LLC||BALI Greens, BALI Purples, Black Seed Oil, DHEA Capsules, Lugol’s Solution 2% Drops, Robenyzme Capsules, OMG Max Drops, New Dawn Capsules, Vitamin C with R-Lipoic Acid||Online advisory letter|
|Healthcare Products LLC (d/b/a The Alzheimer’s Store d/b/a MindCare Store)||Aromatherapy for Dementia Memory Kit Premier Edition, Aromatherapy for Dementia Memory Kit Second Edition, Bodyguard Blend Essential Oil, ClearMind Blend Essential Oil, Lavender Essential Oil, Attention Aromatherapy Patch, Calming Aromatherapy Patch, Lavender Aromatherapy Patch, Perk Up Aromatherapy Patch, Refresh Aromatherapy Patch, Rested Aromatherapy Patch, Aromatherapy Patch Sample Pack||Online advisory letter|
|This Wonderful Life New Age Shop||Dementia/Alzheimer’s (Day) Synergy Oil, Dementia/Alzheimer’s (Night) Synergy Oil, Joints/Arthritis/Rheumatism Massage Oil 50ml, Angelica Root 10% (in Coconut), Melissa 10% (in Coconut) Essential Oil 10ml, Cajeput Essential Oil, Juniperberry Essential Oil, Black Pepper Essential Oil, Nutmeg Essential Oil, Palo Santo (Ecuador) Essential Oil, Palo Santo (Peru) Essential Oil, Cinnamon Leaf Essential Oil, Vetiver Essential Oil, Yarrow Essential Oil, Sweet Thyme Essential Oil, Pine Scotch Essential Oil, Myrrh Essential Oil, May Chang Essential Oil, Manuka 10% (in Coconut) Essential Oil, Jasmine Absolute 10% (in Coconut) Essential Oil, Galbanum Essential Oil 10% (in Coconut) Essential Oil, Bergamot Essential Oil, Camphor Essential Oil||Online advisory letter|
|U.S. Food and Drug Administration|