Published on July 21st, 20150
Oversight of Dubious Brain Supplement Products Under Scrutiny
But how brain products with particularly questionable claims are being monitored and why they are being sold by major stores and websites is the subject of an inquiry by members of the U.S. Senate’s Special Committee on Aging, who sent letters to the FDA and more than a dozen major retailers including Amazon, Target and Google.
Aging Committee Chairwoman Susan Collins, a Republican from Maine, and ranking member Claire McCaskill, a Democrat from Missouri, expressed concern in a recent letter to the FDA that the agency “lacks a systemic approach to preventing adulterated, mislabeled and fraudulent products from entering the market” and is not effectively using its authority to require manufacturers to register supplements containing new dietary ingredients.
The FDA does not have authority to approve supplements before they reach the market, as it does with pharmaceutical drugs. But dietary supplement makers are prohibited from making claims that their products can cure or treat diseases and must have substantiation to back up any general well-being or structure/function claims. They must also have substantiation that the product ingredients are safe. While the FDA’s oversight of supplements is limited, the agency can remove adulterated products or send a warning to companies making drug treatment claims. But the agency’s actions regarding supplements have been called into question in recent months by critics who say key leaders at the agency, including the head of the agency’s dietary supplement division, face conflicts of interest because they previously worked in the supplement industry.
Preying on desperate seniors
The Senators called into question a specific supplement sold on Amazon’s site that claimed it protected against Alzheimer’s, dementia and stroke. McCaskill said the supplement, Brain Armor was pulled from the site only after she alerted the FDA. But she said similar supplement products making deceptive claims that are aimed at seniors are still widely available both online and in retail stores.
“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,” she said.
Earlier this month, the manufactures of a memory pill claiming it is clinically proven to help reverse memory loss and support cognitive function settled allegations of deceptive advertising brought by California law enforcement officials and the FTC, which has publicly signaled that it is intensifying scrutiny of brain product claims. The product, Procera AVH, claimed consumers could regain the memory and brain power they had 15 years ago by using it.
What has the FDA been doing?
In their inquiry, the senators requested a plethora of information from the FDA including:
- All actions taken in the past five years against dietary supplement makers.
- A description of the FDA’s policies and procedures used to ensure that companies are reporting new dietary ingredients and any penalties imposed on companies for not complying.
- All serious adverse event reports relating to dietary supplements and efforts to make the reports transparent.
- The role of contractors and third-party testing labs play in the agency’s inspection of dietary supplements.
- A description of the FDA’s process for evaluating and ensuring the validity of a supplement’s health claims.
- A list of dietary supplement manufacturers currently registered with the FDA.
The FDA would only comment that it has received the letter and “will respond directly to the Senators.” TINA.org has submitted a Freedom of Information request seeking copies of all information the FDA is providing to the committee in response to the letter.
Responsibility of retailers
There is no shortage of brain supplements on the market in the U.S. A search on Amazon.com returned more than 20 pages of products claiming a range of cognitive support, from helping to improve memory and brain efficiency to helping brains continue to fire on all cylinders.
Along with Brain Armor, McCaskill’s staff found others making illegal treatment claims, including Memo Plus Gold, which promises to ease forms of dementia and Alzheimer’s.
In a letter to Amazon CEO Jeffrey Bezos, McCaskill said:
While I appreciate Amazon’s efforts to work with the FDA to remove from the site (Brain Armor) that made claims about prevention or treatment of a disease — a practices that is prohibited by law — I am concerned about how the product came to be sold on Amazon in the first place, and about how other products that make similarly fraudulent or otherwise invalid claims might still be offered on the site.
Contending that search engines and company websites play a pivotal role in determining what supplements are “used and trusted” McCaskill asked Amazon, as well as other retailers and search engine sites — including Google, Yahoo,, CVS, Target and GNC — to provide their policies and practices relating to the marketing and safety of dietary supplements they sell, relationships they have with supplement providers and mechanisms the sites have in place to receive complaints from consumers about the products.
Amazon did not respond to TINA.org’s request for comment nor did the National Retail Federation.
Drew Pusateri, communications director for the aging committee, said it is awaiting a formal response from the FDA and has already met with several retailers. McCaskill had given the retailers and the FDA a July 13 deadline to provide the information requested.
Pusateri said the committee has found dozens of examples of brain products with questionable claims.
“We need to make sure agencies are exercising their oversight authority to the best of their ability and also, correspondingly, get a handle on what kinds of policies and processes retailers have in place on what’s getting on their shelves,” he said.
Find more on TINA.org’s coverage of brain supplements here.