Remember to back up memory claims with precise substantiation, expert says

17-Aug-2015 - Last updated on 24-Aug-2015 at 23:09 GMT

Image: © iStockPhoto / stocksnapper

Losing one’s memory continues to be one of consumers’ number one health concerns. While that represents a healthy market opportunity, companies seeking to address that concern with a dietary supplement need to be very careful about what they say about their products to avoid stepping over FTC boundaries or inflaming the ire of legislators, a claims expert asserts.

Memory claims have stepped to the forefront with recent comments and actions by Sen. Claire McCaskill. In June, Sen. McCaskill, D-MO, sent letters to 15 major retailers after launching an inquiry into 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.

The retailers have been asked about their policies relating to the sale and/or marketing of 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. The 15 retailers are Amazon, QVC, Walgreens, Home Shopping Network, Walmart, Target, CVS, Vitamin Shoppe, Safeway, eBay, Kroger, Vitamin World, GNC, Google, and Yahoo.

“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 Sen. McCaskill. “Right now it’s like the wild west when it comes to the production, marketing, distribution, and sale of these products.”

FTC actions

The Federal Trade Commission has been active, too; last year it came to an agreement with DSM on claims it had been making on its iHealth algal DHA product. DSM believed it had research backing for a broad-based memory support claim. In an unusual split decision (most FTC rulings are unanimous) FTC disagreed with that conclusion. Commissioner Joshua Wright issued a statement saying, “There are several types of human memory, including episodic, sensory, working, semantic, and procedural. Although the MIDAS study included one test of working memory, which found no benefit from supplementation, the study’s focus was episodic memory. Therefore, to the extent that consumers took away an understanding that BrainStrong Adult would improve general memory, rather than a single dimension of human memory, that claim was unsubstantiated.”

Do’s and don’ts

Attorney Ivan Wasserman, managing partner of the Washington DC office for Manatt, Phelps & Phillips, said even with the apparent lack of unanimity on the subject, no one should assume that FTC has changed its view of the subject.

Cognitive health under the spotlight

Experts from Abbott Nutrition, GOED, Nordic Naturals, The University of Toronto, McMaster University, and NutraIngredients-USA will discuss a range of cognitive health topics during NutraIngredients-USA’s Cognitive Health Online Summit.

“I don’t think we’ve seen any evidence that the FTC has changed its position. I do think memory is a complex physiological system. There are many different components and different tests are designed to evaluate different aspects of memory,” Wasserman told NutraIngredients-USA.

“We have recently seen that Sen. McCaskill has targeted memory claims. With the aging population and the seeming increase in the number of Alzheimer’s cases or at least the awareness of the devastating effects of Alzheimer’s we can expect that the close scrutiny of memory claims will continue,” he said.

The settlement in the DSM case was an administrative action only with no financial penalties, in an apparent recognition that the company had in fact done its research. MIDAS, which stands for Memory Improvement with Docosahexaenoic Acid Study, was a six-month, randomized, double-blind, placebo-controlled study of 485 subjects that was published in a peer-reviewed journal. FTC was disagreeing about what the study precisely showed. In a more recent action, FTC levied a $1.4 million fine against the marketers of a supplement called Procera AVH, which the agency claimed was being touted without substantiation as a “solution” for memory loss.

Wasserman said the take away from all this is not a new story. Make sure you do your homework, and that you filled in the correct pages in your workbook. It’s a huge potential market, and despite Sen. McCaskill’s concern, its open to companies that do things the right way.

“FDA has specifically allowed claims dealing with age related memory loss. I don’t see the memory category dying. I would never caution a marketer against trying to make the claim. Marketers just have to make sure they have the right kind of substantiation. It all relates to substantiation, and that’s not unique to the memory category,” Wasserman said.