In the settlement concerning the supplement, Procera AVH, FTC ordered the defendants to pay $1.4 million in fines over unsubstantiated memory support claims. According to the FTC’s complaint, the defendants marketed and sold Procera AVH as a “solution” to memory loss and cognitive decline, including as associated with aging. The defendants advertised the product using infomercials, direct mail flyers, newspapers, and the Internet.
In one newspaper ad for the product the headline stated: “Memory Pill Helps the Brain Like Prescription Glasses Help the Eyes … Remarkable changes observed, helps users match the memory power of others 15 years younger in as little as 30 days!”
“The defendants in this case couldn’t back up their claims that Procera AVH would reverse age-related mental decline and memory loss," said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “Be skeptical of ads promising quick and easy cures.”
Claims called 'disgusting'
But recommending that consumers be skeptical—essentially a buyer beware strategy—is not enough to satisfy Sen. McCaskill, who is the ranking Democrat on the Senate Special Committee on Aging.
“These fraudulent claims provide false hope to desperate people in order to sell them overpriced and scientifically unproven products. It’s disgusting. There’s no other word for it. We need more enforcement and harsh penalties against anyone making fraudulent and baseless claims,” McCaskill said.
“I don’t think it’s applicable to the vast majority of the industry but there is a fringe out there that displays remarkably little regard for FDA and FTC rules and regulations,” said attorney Marc Ullman, of the firm Ullman, Shapiro & Ullman.
Ullman said companies that make reasonable claims and have evidence to back up those claims have nothing to fear from regulators.
“You have to be very cautious to say that you are not offering implied remedies for dementia or Alzheimer's,” Ullman said. “One of the lessons learned here is that you have to have the level of substantiation that backs the claim.
“But if you make a claim like, we have a pill that can trigger remarkable changes that make your brain 15 years younger, you need to have that kind of substantiation,” he said.
FTC precedent
Despite McCaskill’s criticisms, FTC has set out a precedent on memory support claims. In a settlement with DSM’s iHealth division over claims relating to its BrainStrong Adult product, the agency said that there are several different types of memory, and the studies backing these sorts of claims must be designed to closely align with these different areas.
In that case, FTC 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 (which DSM used to substantiate its claim) 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.”
Inquiry ongoing
McCaskill recently opened an inquiry into brain health supplements by sending letters to the Food and Drug Administration and 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.