The settlement ends iHealth’s use of what FTC called “unsubstantiated memory improvement and prevention of cognitive decline claims for the DHA-containing supplement Brainstrong Adult.” According to iHealth, the product was marketed as "clinically shown to improve memory" as well as "help[ing] protect against normal cognitive decline as we age.”
Large study used to back claims
DSM is a multinational corporation with a long history of backing its ingredients with science and for adding well-researched products to its portfolio via acquisition. Therefore, it’s unlikely to conclude that the FTC action was similar in kind to decrees involving companies making outright disease or one-size-fits-all type of claims. Rather, i-Health’s interaction with FTC revolved around what conclusions can be drawn from the study that i-Health was using to back up its claim, and in an unusual twist, the FTC commissioners themselves were not unanimous in their opinion, with three voting in favor, one concurring (meaning agreement with the conclusion but not necessarily all of the reasoning) and one dissenting.
According to a statement from iHealth, the company said, “These claims were based on the Memory Improvement with Docosahexaenoic Acid Study, or MIDAS, which was a randomized, double-blind, placebo-controlled, parallel, multi-center, six-month, peer-reviewed, journal-published study of 485 subjects. i-Health believes that MIDAS provided statistically significant results demonstrating the benefits of DHA in maintaining and improving brain health in older adults and was not deceptive in its advertising of the BrainStrong Adult product.”
FTC: Claims went beyond study
FTC disagreed, basing that decision on the idea that memory has a number of different aspects, not all of which were covered in the MIDAS study. 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.”
Wright went on to say that in his opinion the design of the study did not support a more narrow claim of episodic memory improvement either. That measurement was broken down into tasks involving visuospatial memory, visual pattern recognition memory, and visual-verbal memory and Wright said the results of these tests, taken together, did not make a case for improvement with supplementation.
Match claims to study
But this judgement obviously rests on a fine line of how the claims matched what the study said. It’s a reminder to make sure that the science substantiation foundation supports every aspect of the claims building, said Marc Ullman, an attorney with the firm Ullman, Shapiro & Ullman who counts many supplement and food companies among his clients.
“The standard is reasonable basis. The respondents here did rely on a large published study. The commissioners obviously felt the study had weaknesses, but the did recognize that the company had relied on a study and I think that’s why this was an administrative case with no consumer redress, no financial penalties, and the primary remedy is fencing in,” Ullman told NutraIngredients-USA.
“I would caution my clients against making any sort of broad-based memory claim. Maybe if the claim had been ‘Clinically proven to improve memory in older adults with mild memory loss’ (the study group in the MIDAS trial) there would have been no case. It’s a reminder to make sure your claims match the study precisely,” he said.
The ruling will set a precedent for future claims on memory support, according to a statement from GOED, the Global Organization for EPA and DHA Omega-3s. “It appears that the bar for competent and reliable scientific evidence on memory claims would require clinical evidence substantiating a benefit in all accepted memory domains,” the statement said.
i-Health: Moving forward
I-Health, for its part, is ready to put the matter behind it. The consent decree is the culmination of a two-year interaction between FTC and the company.
"Due to the FTC Consent Agreement not imposing any monetary penalties, nor requiring i-Health to significantly modify their record keeping and preservation requirements, as well as requiring a substantiation threshold that i-Health is comfortable with, we saw no need to further pursue this matter and are pleased that the Consent Agreement resolves the FTC's investigation,” said Wes Parris, CEO and president of i-Health.