GAO’s memory supplement review

‘Agencies need to do more around the most egregious memory claims’: CRN’s Mister

By Stephen Daniells contact

- Last updated on GMT

iStock/Dmitrii Kotin
iStock/Dmitrii Kotin
The majority of dietary supplements making memory claims adhere to the federal requirements but some still go too far with their claims, according to a new review from the US Government Accountability Office. 

The report, which can be viewed here​, found that about 96% of the marketing of memory supplement they identified appeared on the Internet. Of the 490 memory supplement products identified, 28 examples of advertisements linked supplement use to treatment or prevention of memory-related diseases, which is generally prohibited by federal law.

“Food and Drug Administration (FDA) officials subsequently determined that 27 of these examples appeared to violate federal requirements. Officials reported that they had issued two advisory letters to two firms and would continue monitoring all of the examples that were identified,” ​stated the report.

Steve Mister, president and CEO of the Council for Responsible Nutrition, told us that the review shows that some products out there continue to go too far with their claims.

“The review reminds us that this needs to be continued to be dealt with, and we would argue that the agencies actually need to do more around the most egregious claims,” ​said Mister. “The FDA seems to rely on warning letters, but we believe warning letters are only the first step and that FDA should do more like recalls or injunctions.”

Brain health supplements

Congressional interest in supplements positioned for memory and brain health grabbed headlines in 2015 when Sen. Claire McCaskill (D-MO), the then ranking member of the US Senate Special Committee on Aging, opened an inquiry into brain health supplements​.

The GAO undertook the review of memory supplements at the request of members of congress.

CRN’s Mister noted that another dimension to the GAO review is that the agencies need a better window in to the products making the claims, and noted that the Supplement OWL​ (Online Wellness Library), as it ramps up, will give the agencies that window. 

Oversight

brain cognitive training elderly ageing iStock.com SIphotography
Sales of dietary supplements claiming to improve memory were estimated to be $643 million in 2015, according to the GAO review. Image © iStock/SIphotography

The new report explains that oversight of dietary supplements marketed for memory falls under the Food and drug Administration’s (FDA) general authority to regulate dietary supplements and their labeling, and the Federal Trade Commission's (FTC) general authority to enforce the prohibitions against deceptive advertising.

Of the 551 enforcement actions taken by the FDA and FTC between 2006 and 2015, 19 involved memory supplements.

“The agencies coordinate enforcement actions in the same way for all dietary supplements,”​ stated the report.

Enforcement of advertising on the Internet is shared, but consumer groups were found to be unclear about the FDA’s and the FTC’s role for overseeing supplement marketing found on the Internet.

“[F]ew documents explicitly delineate their differing roles and coordination in oversight, or communicate the roles to industry and consumers,” ​stated the report. “GAO recommends that FDA and FTC provide additional guidance to consumers clarifying the agencies' differing roles in their shared oversight of memory supplement and other dietary supplement marketing on the Internet. The two agencies concurred with GAO's recommendation.”

“Streamlining government”

Commenting on the GAO review, the Natural Products Association (NPA) said it pledged to work with both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) to carry out their shared goal of protecting consumers from the illegal sale and marketing of dietary supplements. 

“We are impressed by the Trump Administration’s commitment to streamlining government by scaling back unnecessary and burdensome regulations, and we are proud to be a part of that process,”​ said Dr Dan Fabricant, NPA’s CEO and executive director. 

“The federal government, through the FTC and the FDA, has considerable resources at its disposal to stop criminals from engaging in illegal and deceptive marketing of supplement products.  We will continue to do our part and work with federal regulators to ensure that criminal attempts to market supplements illegally are met with the full force of the law.” 

Source: Memory Supplements: Clarifying FDA and FTC Roles Could Strengthen Oversight and Enhance Consumer Awareness
GAO-17-416
Publicly Released: Jun 15, 2017.

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