FDA and FTC should provide better guidance to consumers on how dietary supplements marketed for memory support are regulated, says a new U.S. Government Accountability Office (GAO) report. The report stems from a request by group of U.S. lawmakers, led by Senators Claire McCaskill (D-MO) and Robert P. Casey (D-PA), for GAO to review the memory-supplements market, including how FDA and FTC regulate these products, whether such supplements violate federal laws, and how extensively they are marketed to older adults. The GAO report found that some memory supplements on the market were found to make unlawful disease claims and that many consumer groups were unclear about how memory supplements are regulated, especially when supplements are sold on the Internet.
The report, titled “Memory Supplements: Clarifying FDA and FTC Roles Could Strengthen Oversight and Enhance Consumer Awareness,” sought to review marketing claims and oversight for memory supplements available across five forms of media—including online and on television. The review was conducted over a period of two months, examining the marketing methods and claims of 490 memory supplements. GAO found that, of the 490 memory supplements identified, 34 of those supplements featured advertisements that purported to treat or prevent memory-related diseases—claims that are generally prohibited by federal law, including claims referring to “anti-Alzheimer’s herbs” or “improves cognition and behavioral symptoms in Alzheimer’s patients.”
Following those initial findings, FDA determined that 27 of those products did, in fact, appear to violate federal requirements by making disease claims.
The report found that few memory supplements specifically targeted older adults, and that only 9% of the Internet ads (138 out of 1,530 ads) that the GAO examined featured text or visuals targeting older adults. “Several of the targeted advertisements, specifically 32 of 138, also contained visuals, such as images of older adults engaging in active lifestyles or looking frustrated, older adult testimonials, or images of medical professionals,” the GAO reports. “We shared examples of advertisements we identified that contained images of medical professionals with FTC staff, to obtain their opinion on the images and whether they might be considered deceptive. FTC staff noted that a picture of a medical professional may contribute to the impression that the claimed benefits are scientifically proven. However, they explained that the FTC would not be able to determine whether the images are considered deceptive without conducting a full investigation, which includes a review of each advertisement and supporting evidence.”
Finally, the report looked at FDA and FTC enforcement actions in 2006-2015 and found that of the 551 dietary supplement actions taken by FDA during that time frame, 19 involved memory supplements. As for FTC, the GAO found that approximately 3% (2 of 78) of FTC’s dietary supplement enforcement actions during that time involved memory supplements. The report noted the agencies’ ongoing challenges in regulating not just memory supplements but dietary supplements in general. Such challenges, the GAO said, included limited information about the marketplace and a lack of finalized new dietary ingredient (NDI) draft guidance from FDA.
This new GAO report comes on the heels of Senator Claire McCaskill’s 2015 inquiry into FDA and dietary supplement retailers to review the marketing of memory supplements after McCaskill alerted FDA to a product called Brain Armor, which claimed to protect seniors against Alzheimer’s disease, dementia, stroke, and other mental health problems, and which was being sold online through Amazon.com. Brain Armor has since been removed from Amazon.com, but concerns over oversight and marketing claims for such products lingered.
As the GAO report notes, memory supplements are becoming an increasingly lucrative segment in the supplements industry. In 2015, GAO estimates, sales of memory supplements reached $643 million—almost double the sales from 2006. The report also found that 96% of this memory-supplement marketing appeared on the Internet. Given that, GAO recommended that FDA and the FTC “provide additional guidance to consumers clarifying the agencies’ differing roles in their shared oversight of memory supplement and other dietary supplements marketing on the Internet.”
In response to the report’s findings, Steve Mister, CEO, the Council for Responsible Nutrition (CRN; Washingon, DC) issued the following statement: “We appreciate the GAO report for calling attention to an issue that we are well aware of—and unwilling to tolerate—and that’s the issue of illegal products claiming to be ‘cure-all’ memory dietary supplements. We hope this serves as an important reminder that the best way to target fraudulent products is with a more educated consumer who refuses to be duped by exaggerated claims. We strongly support FDA and FTC taking aggressive enforcement against these fringe marketers, going beyond issuing advisories and taking much-needed regulatory action. We also support the need to sufficiently fund the Office of Dietary Supplement Programs at FDA as a sufficiently funded Office will have the resources to enforce against this troubling issue raised by the GAO.”
Mister also offered information geared toward heling the FDA and FTC understand the industry and promote transparency in advertising. “To further help these agencies better understand the scope of the dietary supplement marketplace, the responsible industry is doing its part to create a more complete picture, through self-regulatory initiatives such as the newly-released Supplement OWL (Online Wellness Library) and CRN’s ongoing advertising review program with the Council of Better Business Bureaus,” he said. “Finally, the industry is in alignment with FDA and FTC in making consumer safety our top priority, and we look forward to working together to protect consumers and continuing to meet their demand for safe, beneficial and quality products.”