SAN FRANCISCO (CBS SF) - Americans spend billions of dollars on dietary supplements that promise to treat, or stave off incurable memory destroying diseases like Azheimer's and dementia, but dozens of those products are being sold and marketed illegally, according to the U.S. Food and Drug Administration.
In an effort to crack down on this multi-billion dollar industry, the FDA sent warning letters to 17 companies whose products were "being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer's disease" last week.
In a statement, FDA Commissioner Dr. Scott Gottlieb acknowledged advances in the dietary supplement industry, but points out the proliferation of non-FDA approved "misbranded' products that tout misleading claims, are dangerous for consumers.
"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," he said.
The sellers are based as far away as Malaysia, India and Canada, but the majority are in the United States and, according to the FDA, they are illegally selling more than 58 products via websites and social media platforms which are "unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer's disease."
In one letter sent to Mill Valley-based John Gray's Mars Venus LLC, the FDA disputed specific claims in articles on the company's website. One titled "Glutathione Is The Master Antioxident" touts Gluathione as "...the secret to preventing … heart disease, dementia and necessary to treat everything from ADHD, to autism to Alzheimer's disease." One such product, Liposomal Glutathione-Super Antioxidant Brain Support' sells for over $59.99 on the website and has received 5-star ratings from 2 customers.
After the product description, MarsVenus.com adds a disclaimer that says, "the statements and products referred to throughout this site have not been evaluated by the FDA. They are not intended to diagnose, treat, cure or prevent any disease."
Still, in its warning letter, the FDA insisted such products "...are not amenable to self-diagnosis or treatment without supervision of a licensed practitioner" and "it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes."
The "products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment," said the FDA in a statement.
In another letter, this one to TEK Naturals, the FDA questioned company marketing language claiming that the product "Mind Ignite" was "clinically shown to help diseases of the brain such as Alzheimer's and even dementia."
In an email addressed to the New York Times, TEK said it was "reviewing the agency's letter and was committed to complying with legal requirements."
All of the sellers were given at least 15 days to dispute or correct the violations, or risk "legal action without further notice, including, without limitation, seizure and injunction."
READ the FDA Warning/Advisory Letters
Alzheimer's Corporation in New Mexico
Alzeimer's Organization in Florida
Dr. Fitt Intelligent Designs, LLC
Healthcare Products LLC dba The Alzheimer's Store dba MindCare store
This Wonderful Life New Age Shop, Kuala Lumpur, Malaysia
Pure Nootropics, LLC in New Mexico
TEK Naturals in South Carolina
John Gray's Mars Venus LLC in California
DK Vitamins in Florida
Peak Nootropics LLC in Texas
Gold Crown Natural Products in Florida
Earth Turns LLC in Missouri
Capris Associats Inc./BR Naturals in Canada
Nutrition Coalition in Minnesota
Sovereign Laboratories, LLC
Blue Ridge Silver
Emmbros Overseas Lifestyle PVT LTD.
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