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These companies are illegally selling products that claim to treat Alzheimer's



The US Food and Drug Administration has taken action against 17 companies that illegally sell more than 58 products, many as dietary supplements, claiming to treat Alzheimer's disease and other serious diseases and health conditions.

The 12 warning letters and 5 Online advisory letters say 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, have not been reviewed by the FDA and have not been proven safe and effective in treating diseases and health conditions they claim to treat," the FDA said in a statement. "These products may be ineffective, insecure and may prevent a person from seeking an appropriate diagnosis and treatment."

The companies warned have been asked to respond to the FDA within days, and indicate how the violations will be corrected. Failure to correct the violations can quickly lead to legal action, the FDA says.

The actions are part of the FDA's efforts to tackle the growth of the dietary sector, which has grown into a $ 40 billion industry, anywhere between 50,000 and 80,000 or more products, from a $ 4 billion, 4,000-product industry. the 25 years since Congress passed dietary health and education law (DSHEA).

Three out of four Americans take daily supplements, including one in three children and teenagers and four in five older Americans.

"Science and evidence are the cornerstone of the FDA's review process and are critical to demonstrating medical benefit, especially when a product is marketed to treat serious and complex diseases such as Alzheimer's," FDA Commissioner Scott Gottlieb said. "Simply put, scam fraud scams prey on vulnerable populations, wasting money and often delays proper medical treatment ̵

1; and we will continue to take action to protect patients and caregivers from misleading, untested products."

Meanwhile, the FDA has not addressed the CBD, or non-psychoactive cannabinoid, that some companies have claimed to have medicinal qualities, including as treatment for Alzheimer's. Many of the claims were made after the 2018 agricultural bill was signed by President Donald Trump, who legalized hemp, but illegally held CBD without FDA approval.

Don't miss : Hemp is now legal in the US, so what does it mean for pot companies?

See also : All you need to know about CBD, non-inoxicidal cannabis elixir that is not completely legal yet.

"We are looking forward to the need to look ahead, but the FDA cannot ignore today's challenges in the meantime: Their lack of one of the hottest products, the 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 19659020] Blue Ridge Silver BLUE RIDGE SILVER Colloidal Silver Warning letter (new fabric / labeling / misbranded)
Capri Associates Inc./BR Naturals Avocado oil, Black seed oil, Moringa Power, Premium Olive oil DOP, Pumpkin Seed Oil, Unrefined Coconut Oil Warning letter (new substance / labeling / misbranded)
UK Vitamins Ubiquinol CoQ10, Cognis Park, Vinpurazine, Melatonin Gammadyn Mn-Co, Zinc Picolinate Formula
Earth Turns LLC Green Tea Extract, Cogni-Flex, GlucoFit 48mg, Fundamental D3 1000, Fundamental Omega-3 [19659019] Warning letter (new substance / labeling / misbranded) misbranded)
Emmbros Overseas Lifestyle PVT Ltd. Morpheme Remedies Arthcare Plus, Morpheme Remedies Cinnam Morpheme Remedies Diabetes Plus, Daily Vitamin 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. Botanical Fish Oil Warning Letter (New Fabric / Labeling / Misbranded)
Gold Crown Natural Products New Ultra Colostrum, Melatonin with Valerian, Anamu & Llanten, Circulation Max Warning Letter [19659026] John Gray 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 Fabric / Labeling / Misbranded)
Nutrition Coalition Inc. Alpha-Lipoic Acid, Colostrum Alpha Whey III (Liquid), Colloid Silver, CoQ10, Curcumin, Echinacea Root, Liva White e, L-carnitine, Milk Thistle, Selenium, U Lieutenant's Water Lotion with goat's milk, vinpocetine, vitamin B complex, vitamin C, vitamin D3, vitamin E, Willard's water Warning letter (new substance / labeling / misbranded)
Peak Nootropics LLC (aka Advanced Nootripics) 19659018] Adrafinil, Aniracetam, Bacopa Monnieri, L-Dopa, L-Theanin, Noopept, Oxiracetam, Fenibut, Phenylpiracetam, Piracetam, Rhodiola Rosea, Uridine Warning Letter (New fabric / labeling / misbranded)
Pure Nootropics LLC Alpha GPC, Lion's Mane, CDP Choline Capsules, Piracetam, Vitamin D3 5000 IE, Turkey Tail Mushroom Powder, Ginkgo Biloba Capsules Warning Letter (new substance / labeling / misbranded)
Sovereign Laboratories LLC Colostrum-LD, Viralox, Curcumin-LD Warning letter (new substance / labeling / misbranded)
TEK Naturals BURN4Her, BurnerTEK, Mind Ignite , TEK Male, TestoTEK tagging / misbranded)
Alzheime rs Corp. Memory Rev Italian, Cerebara GPC and Life Imagined Online Advisor Letter
Alzheimer's Organization Mind and Memory Support Online Advisor Letter
Dr. Fat Intelligent Designs LLC BALI Greens, BALI Purples, Black Seed Oil, DHEA Capsules, Lugol Solution 2% Drops, Robenyzme Capsules, OMG Max Drops, New Dawn Capsules, Vitamin C With R-Lipoic Acid Online Advisory Letter [19659023] Healthcare Products LLC (d / b / a Alzheimer's Store d / b / MindCare Store) Aromatherapy for Dementia Set Premier Edition, Dementia Memory Secondary Aromatherapy, Bodyguard Blend Essential Oil, ClearMind Blend Essential Oil, lavender essential oil, note aromatherapy patch, soothing aromatherapy patch, lavender aromatherapy patch, pearl up aromatherapy patch, update aromatherapy patch, restored aromatherapy patch, aromatherapy patch package online advisory letter
this amazing life new age shop Densia / Alzheimer (Day) Synergy Oil, Dementia / Alzheimer (Night) Synergy Oil, Joint / Arthritis / Rheumatism Massage oil 50ml, Angelica Root 10% (in coconut), Melissa 10% (in coco snow) Essential oils, essential oils, essential oils, essential oils, essential oils, essential oils, essential oils, essential oils, essential oils, essential oils, essential oils, essential oil, essential oil, essential oil, myrrh essential oil, may chang essential oil, manuka 10% (in coconut) essential oil, jasmine absolutely 10% (in coconut) essential oil, galvanic essential oil 10% oil, Bergamot Essential Oil, Camphor Essential Oil Online advisory letter
US Food and Drug Administration

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