FDA Commissioner
Scott Gottlieb NEWS VIDEO + ARTICLE:
17 Alzheimer's supplement manufacturers received FDA warnings about 58 illegal below-standard products.
The U.S. Food and Drug Administration posted 12 warning letters and five online advisory letters issued to foreign and domestic companies that illegally sell more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions.
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. These products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment.
Video appears at end of article. Article continued below...
Protect Against Alzheimer's Scams
“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. Alzheimer’s is a challenging disease that, unfortunately, has no cure. Any products making unproven drug claims could mislead consumers to believe that such therapies exist and keep them from accessing therapies that are known to help support the symptoms of the disease, or worse as some fraudulent treatments can cause serious or even fatal injuries. 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,” said FDA Commissioner Scott Gottlieb, M.D.Unapproved or Misbranded Alzheimer's Drugs
The products cited in the warning and online advisory letters are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions, and have been sold in violation of the Federal Food, Drug, and Cosmetic Act. The products include a variety of product types, such as tablets, capsules and oils. The companies were asked to respond to the FDA within 15 days of receipt of the letters, stating how the violations outlined in the agency’s letters will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.40 Alzheimer's Warning Letters, 80 Products
As part of the FDA’s effort to protect consumers from Alzheimer’s disease health fraud, the FDA has issued more than 40 warning letters in the past to companies illegally marketing over 80 products making Alzheimer’s disease claims on websites, social media and in stores.The FDA has also taken action in recent years against companies and dietary supplements making similar claims for the treatment of serious conditions such as cancer and opioid addiction. Although these companies may have stopped selling the products or making unproven claims, numerous unsafe and unapproved products continue to be sold directly to consumers due in part to the ease with which companies can move their marketing operations to new websites.
The FDA continues to encourage consumers to remain vigilant whether online or in a store in order to avoid purchasing products that claim to prevent, treat or cure diseases without any proof they will work. Health care professionals and consumers are also advised to report adverse reactions associated with these or similar products to the agency’s MedWatch program.
Supplement Warnings and Advisories
As part of its comprehensive efforts, ... the FDA sent 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer's disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer.Products intended to treat Alzheimer's disease must gain FDA approval before they are sold in order to help ensure they are safe and effective for their intended medical use.
Dietary supplements can, when substantiated, claim a number of potential benefits to consumer health, but they cannot claim to prevent, treat or cure diseases like Alzheimer's. Such claims can harm patients by discouraging them from seeking FDA-approved medical products that have been demonstrated to be safe and effective for these medical conditions.
FDA Warning Lists & Letters
Lists & letters below video...Company Name
(Click name for
FDA Warning)Alzheimer's Disease Product Name1Image2
(Click Image
to Enlarge) Blue Ridge Silver
- Collodial Silver
BR Naturals - Avocado Oil
- Unrefined Coconut Oil
DK Vitamins - Cognispark
- Gammadyn Mn-Co
- Melatonin
- Ubiquinol CoQ10
- Vinpurazine
- Zinc Picolinate Formula
Earth Turns, LLC - Cogni-Flex
- Fundamental Omega-3
- Green Tea Extract
Gold Crown Natural Products - New Ultra Colostrum
- Melatonin with Valerian
Emmbros Overseas Lifestyle PVT LTD. - Morpheme Remedies Memocare Plus
- Morpheme Remedies Mind Plus
John Gray's Mars Venus LLC - L-Glutathione
- Liposomal DHA – Ultimate Omega-3 Brain Support
- Liposomal Methyl B12/Folate
- NAC N-Acetyl-L-Cysteine
Nutrition Coalition Inc Alpha Lipoic Acid, CoQ10, Curcumin, Liva-Vite, Milk Thistle, Selenium, Vinpocetine, Vitamin B Complex, Vitamin C, Vitamin D3, and Vitamin E 
Peak Nootropics LLC Bacopa Monnieri, L-Theanine, Noopept, Piracetam, and Uridine Pure Nootropics - Alpha GPC
- Piracetam
- Vitamin D3 5000 IU
Sovereign Laboratories, LLC Colostrum-LD® and Curcumin-LD® 
TEK Naturals - Mind Ignite
- TestoTEK
Online Advisory Letters Alzheimer's Corporation (ALZcorp)- Memory Revitalizer
- Cerebara GPC (L-Alpha glycerophosphocholine)
- Life Imagined
- DHEA Capsules
- Robenyzme Capsules
Healthcare Products, LLC d/b/a/
The Alzheimer's Store
d/b/a
MindCare Store
- Aromatherapy for Dementia Memory Kit Premier
- Aromatherapy for Dementia Memory Kit 2nd Edition
- Attention Aromatherapy Patch
- Calming Aromatherapy Patch
- Lavender Aromatherapy Patch
- Perk Up Aromatherapy Patch
- Refresh Aromatherapy Patch
- Rested Aromatherapy Patch
- Aromatherapy Patch Sample Pack
- Dementia/Alzheimer's (Day) Synergy Oil
- Dementia/Alzheimer's (Night) Synergy Oil
NOTES FROM CHART:
- The other products cited in the warning letters are not listed here.
- Product name linked to Flickr image when available.
- FDA: 12 Warning Letters
- FDA: 5 Online Advisory Letters
- FDA: U.S. Food & Drug Administration
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. - FDA 2019 Warning Letters
