“In the cognitive health space it is probable there is as much ignorance of the line drawing that FDA proffers as adherence to it,” Stuart Pape, a partner in the firm Squire Patton Boggs told NutraIngredients-USA. Pape is head of the firm’s FDA practice.
Authorities: Evidence lacking for most ingredients
Dietary supplement ingredients have been promoted for benefits in a wide arena of cognitive conditions: mood disorders, ADHD, Asperger’s syndrome or autism, and the biggie, Alzheimer’s. Proponents say evidence for efficacy continues to pile up for some ingredients such as omega-3 fatty acids, acetyl-l carnitine, ginkgo, phosphatidylserine and others, while many ingredients struggle to clear the bar of statistical significance in studies. According to the National Center for Complementary and Alternative Medicine, there is currently insufficient evidence to recommend B vitamins, omega-3 fatty, ginkgo and other supplement ingredients for use in connection with Alzheimer's, even though smaller scale studies have been promising in some circumstances. "There is no strong evidence that any complementary health approach or diet can prevent cognitive impairment," the Center said. But that doesn’t stop the claims parade, Pape said.
“If I did a search on supplements and Alzeheimer's or supplements and autism, I would get a whole bunch of hits where marketers are comfortably over the line that FDA would draw,” Pape said.
Claims are claims
There is more at stake in the cognitive health realm than with almost any other health indication. ADHD, autism and mood disorders can have profound effects on children’s development and on the prospects for adults to lead well adjusted and successful lives. And with Alzheimer's, the destruction of memory and personality is tantamount to the very loss of one’s self. It’s a more acute situation than if a person suffers occasional gas and bloating or if their night vision isn’t what it used to be, for example.
But even with the profound nature of the conditions that fall under the cognitive health umbrella, the issue with making claims in this arena is no different than it is with other health indications, Pape said.
“You can make a structure function claim but you can’t make a disease claim. If I have good evidence that my supplement helps to lower serum cholesterol, for example, I can’t say that but what I can say is it helps to maintain healthy cholesterol levels,” Pape said.
“Then there is the issue of substantiation. This is one of the most common things that we see, that the claims are excessive and the substantiation dossier doesn’t take up two sides of a piece of paper,” he said.
“I don’t know if this has been an area of special concern for FDA, but there has been some FTC enforcement on this,” said Justin Prochnow, an attorney in the firm Greenberg Traurig.
“In the FDA’s rule on structure function claims it says specifically you can talk about natural states of the body, and you can talk about conditions associated with those natural states. It mentions aging and pregnancy as two of these natural states, and you could talk about mild memory problems associated with aging,” he said.
An FTC ruling in early June helps set some boundaries of what can be legally claimed in the marketing of a memory support product. The agency came to an agreement with iHealth, the consumer products division of ingredient supplier DSM over memory support claims the company was making for its algal DHA ingredient.
The settlement ended 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.”
DSM based its claim on a large-scale study, but FTC disagreed with the company in whether the study’s results backed the specific claim. In a statement, iHealth 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 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.”
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.
Prochnow said an important thing to keep in mind when fashioning claims is that FTC looks at it from a consumer’s point of view. You might say one thing in your marketing, but are you also implying something else? Or could your customers make that leap in their own minds?
“If for example you market a product as being good for depression, and you don’t specify mild or situational depression, the FTC might take the position that you are also be responsible for somebody believing it would be good for manic depression,” Prochnow said.
Even with the new clarification from FTC in the iHealth case, the market still has something of the Wild West about it, Pape said. Without stricter and more timely enforcement, responsible companies are put at a disadvantage.
“Over time the marketplace has become so chaotic it has become difficult if not impossible to separate the legitimate companies from the illegitimate, the made-up claims from those that are scientifically supported,” he said.
“The barriers to entry in this industry are relatively low and there are folks who go way over the line (on claims) and get in trouble and do get their profits confiscated. But for every one of those there are probably 10 or 100 who don’t. There is huge consumer demand for many of these products because people would love to have an affordable alternative to treat their autistic son or a parent with Alzheimer's.
“It’s an inefficient market in that abiding by the rules can cause you to be less successful,” Pape said.