Special edition: Cognitive Health

Strict adherence to science backing only way to avoid memory claim pitfalls, experts say

By Hank Schultz

- Last updated on GMT

Related tags Memory Ftc

Strict adherence to science backing only way to avoid memory claim pitfalls, experts say
Helping consumers maintain healthy memory function is one of the peaks many dietary supplement formulators seek to climb.  And it is one of the most likely targets for regulatory enforcement action, too.

The pull of memory claims is undeniable. As long ago as 2008 a survey showed that worries about developing dementia​ have topped cancer as the No. 1 health fear of aging consumers in the industrialized West.  Recently, a 17-member panel assembled by the National Academies of Sciences concluded that three common lifestyle strategies for slowing the onset of dementia—controlling blood pressure, engaging in ‘brain training’ and getting adequate physical activity—had only thin research backing​. Two categories of drugs—cholinesterase inhibitors and mentamine—have been approved to treat mild to moderate Alzheimer’s, but neither category is a sure-fire bet, and effects are modest at best. According to the Mayo Clinic: Alzheimer's drugs don't work for everyone, and they can't cure the disease or stop its progression. Over time, their effects wear off.

In that context, it’s no wonder that consumers would grasp at any product that might claim to help in this regard.  And, as far as critics of the industry such as Sen. Claire McCaskill, D-OR are concerned, it creates a situation in which bad actors can swoop in and prey upon the vulnerable.

Experts contacted by NutraIngredients-USA agreed that the field of memory claims is fraught with potential pitfalls. But a case history of regulatory action, spurred in part by prodding from lawmakers such as Sen. McCaskill, provide some guideposts to avoid those traps.

It remans an area maybe even more so than weight loss at this point where companies need to be cautious,​said Marc Ullman, an attorney at counsel with the law firm Rivkin Radler.

DSM case lays out road map

A seminal case in the development of regulatory thought on memory claims was the Federal Trade Commission vs DSM action​.  FTC had taken DSM to task over claims made by its i-Health division on it BrainStrong Adult DHA product.

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 i-Health, 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 studys 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.

Quincy Bioscience case adds another signpost

But this judgement obviously rested on a fine line of how the claims matched what the study said.  Another guidepost in this process will likely arise from the recent case in which FTC cooperated with New York Attorney General Eric Schneiderman charged Quincy Bioscience for making false and unsubstantiated claims on its product Prevagen​, which is based on a protein first isolated from jellyfish. Quincy Bioscience has run extensive national advertising campaigns for its Prevagen product, including TV spots on national broadcast and cable networks such as CNN, Fox News, and NBC. The ads feature charts depicting rapid and dramatic improvement in memory for users of the product.  FTC and the NYAG alleged that those claims went far beyond what could be supported by the research conducted on apoaequorin, the jellyfish protein.

The marketers of Prevagen preyed on the fears of older consumers experiencing age-related memory loss,​said Jessica Rich, director of the FTC’s Bureau of Consumer Protection.But one critical thing these marketers forgot is that their claims need to be backed up by real scientific evidence.

 The action is ongoing, and Quincy Bioscience did not respond to a request for comment for this report.  But at the time of the filing of the action in January, the company said: The sole dispute rests on the interpretation and analysis of the data, with the regulators attempting to hold the company to a standard that is unreasonable, scientifically debatable, and legally invalid. Their experts simply disagree with ours over how to interpret the study results.

Matching claims to studies

The cases provide a strong reminder to companies to precisely match claims to the underlying study results, legal experts said.

With respect to cognitive function, I would say it is very difficult to measure change,​ said Jason Sapsin, an attorney in the firm Faegre Baker Daniells.Its not like bone health where that measurement, relatively speaking, is straightforward.

Then you add in the fact that you really cant use subjects who are truly impaired because it wouldnt be ethical treat people suffering from a disease with a dietary supplement. So most of the time you are looking at people who are not truly affected with dementia. Having said that I would advise a client not to abandon a memory-claim product, but to make sure claims are strictly limited to those areas that are clearly supported by existing studies.  Its always tempting to infer from existing data ​(whether in the public domain or the company’s own research) to say that if the product can do this, it should also be able to do that. You want to limit inferences,​ Sapsin said.

Attorney Justin Prochnow, a shareholder in the firm Greenberg Traurig, concurred with Sapsin take on the support of claims.  And he added that memory claims are becoming a hot topic among state attorneys general.

I was at a conference in New York City recently and was on a panel with Karl Racine, the Attorney General for the District of Columbia  He said state AG offices are really looking at claims on these kinds of products for possible enforcement actions.  So I think we will see more of this from state AGs.

You really had better have your ducks in a row with science that backs the claims. You cant, for instance, just rely on a general study that might back ​Ginkgo biloba for memory. Youd need a study that backs the same amount of ginkgo that you have in your product for a specific aspect of memory,​ Prochnow said.






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1 comment

food or medicine?

Posted by Doni,

Near the end, this article implies that disease is never treatable with a dietary supplement. Given that some diseases have been found to be due to nutritonal deficiencies and that there are lots of interactions between nutritional states and disease states, I believe this attitude is wrong and interferes with the pursuit of health.

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