McCaskill Opens Inquiry into ‘Brain Armor’ and Other Dietary Supplements Targeting Seniors

Senator seeks information from FDA, 15 major retailers on products marketed to those suffering from Alzheimer’s, dementia, memory loss

WASHINGTON – U.S. Senator Claire McCaskill, the top-ranking Democrat on the Senate Special Committee on Aging, today began an examination of products, regulations, and retailers in the dietary supplement industry that specifically market to seniors using claims about improving memory and treating dementia and Alzheimer’s disease. One of the supplements, sold by retailer Amazon, was recently pulled from the online retailer’s website after McCaskill alerted the Food and Drug Administration to claims it made about ‘protecting against Alzheimer’s, Dementia, (and) Stroke…’. While that product is no longer sold on Amazon.com, similar products remain on Amazon’s website and the websites of several other national retailers.

“People looking online for cures or treatment for Alzheimer’s Disease and dementia are at their most desperate—and it’s clear from what we’ve found that many of these products prey on that desperation,” McCaskill said. “Right now it’s like the wild west when it comes to the production, marketing, distribution, and sale of these products. I want to figure out why that is and what we can do to better protect America’s seniors.”

McCaskill has sent a letter to the Food and Drug Administration (FDA) asking about its obligation to prevent fraud and review new supplement ingredients. The letter also asks what enforcement actions FDA has taken against dietary supplement manufacturers and distributors that fail to comply with FDA regulations and for a detailed description of FDA’s process for evaluating medical and nutritional claims made by supplements already on the market.

“While we understand that the FDA undertakes periodic reviews and targeted investigations of dietary supplements currently on the market, concerns have been raised that the FDA’s current regulatory authorities lack a systemic approach to preventing adulterated, mislabeled, and fraudulent products from entering the market,” the letter to FDA Commissioner Stephen Ostroff reads.  

McCaskill also sent letters to 15 retailers inquiring about their review policies for dietary supplements and what they had done to prevent sales of harmful or fraudulently marketed products in their stores and on their websites and shows. McCaskill sent inquiries to the retailers Amazon, QVC, Walgreens, Home Shopping Network, Walmart, Target, CVS, Vitamin Shoppe, Safeway, eBay, Kroger, Vitamin World, GNC, Google, and Yahoo—asking each about their policies relating to the sale and/or marketing of dietary supplements.

In the letter to Amazon, McCaskill specifically referenced the Brain Armor product recently removed from the Amazon website, writing “While I appreciate Amazon’s efforts to work with the FDA to remove from the site this dietary supplement that made claims about prevision or treatment of a disease – a practice prohibited by law – I am concerned about how the product came to be sold…”

“Customers, myself included, respect these businesses enough to shop at them, and it’s important that these companies respect their customers in turn by doing what they can to not sell products that are unsafe or misleading.”   

These letters follow briefings that the FDA and Federal Trade Commission had provided to McCaskill’s staff concerning their respective roles in ensuring consumer safety within the dietary supplement industry.

As past Chairman of the Senate’s Consumer Protection Subcommittee, McCaskill held a hearing examining misleading and false claims made by makers of weight-loss products.

A copy of McCaskill’s letter to the FDA is available online HERE. Letters to retailers are available HERE. An image of the Brain Armor product previouslybeing sold on the Amazon website if available HERE.    

Visit mccaskill.senate.gov/consumers to learn more about McCaskill’s fight to strengthen protections for American consumers.

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