Senators Launch Inquiry into Mental Health Supplements for Seniors

U.S. Senators Claire McCaskill (D-MO) and Susan M. Collins (R-ME) wrote letters to FDA and15 retailers of dietary supplements on Monday as part of an inquiry into the safeguards surrounding supplements marketed toward seniors. The letters call for more information on retailer policies regarding supplements and the steps FDA can take to address adulteration and fraudulent medical claims.

The move comes after McCaskill alerted FDA to a product called Brain Armor for sale through online retailer Amazon. The product made claims of protecting against Alzheimer’s, dementia, stroke, memory loss, and cognitive decline. Brain Armor has since been removed from Amazon.com, but McCaskill is concerned about similar products that remain available from Amazon and 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,” said McCaskill. “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.”

Letters to Retailers

The senators requested that 15 retailers provide information on their policies for the sale and marketing of dietary supplements, reporting of adverse events, receiving consumer complaints, and removal of products deemed adulterated, improperly labeled, or fraudulently marketed. The retailers that received letters were Amazon, QVC, Walgreens, Home Shopping Network, Walmart, Target, CVS, Vitamin Shoppe, Safeway, eBay, Kroger, Vitamin World, GNC, Google, and Yahoo.

“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,” said McCaskill.

One of the retailer letters can be found here.

Letter to FDA

McCaskill and Collins also wrote to Stephen Ostroff, acting commissioner of FDA, regarding their concerns about the regulatory environment for supplements marketed toward seniors. The letter inquires about the enforcement actions FDA had taken in the past against supplement manufacturers and distributors that fail to comply with FDA regulations. It also calls for a “detailed description of FDA’s process for evaluating medical and nutritional claims made by supplements already on the market,” according to a press release from McCaskill’s office.

“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 senators wrote in their letter to Ostroff.

FDA and the 15 retailers are requested to respond no later than July 13, 2015. McCaskill and Collins are the ranking member and chairman of the Special Committee on Aging, respectively.

Read more:

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NY AG Takes Dietary Supplements Fight to Congress

Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com

Photo © iStockphoto.com/DHuss