PLT Health Solutions has put together a dossier of approved claims grounded in its own clinical trials work to back its Synapsa cognitive health ingredient. Synapsa is a patented, standardized extract of Bacopa monnieri that has been the subject of more than 30 years of clinical study. PLT’s development of the ingredient has focused on ‘peak cognitive performance,’ whereas many other products in the category focus on slowing age-related cognitive declines. The company says that in six double-blind, placebo-controlled clinical studies, healthy adults using Synapsa showed significantly improved performance in areas such as visual processing, learning rate, working memory, information retention and mental performance in cognitively demanding environments versus a placebo regimen.
Complicated regulatory environment
The making of claims for memory support was complicated in 2014 by the action the Federal Trade Commission took against DSM’s i-Health division and the memory support claims it was making for its BrainStrong Adult algal DHA product. In its agreement with FTC, DSM agreed to back away from broad-based memory claims, which the company believed were backed by the large-scale MIDAS study. The commission said in that settlement 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, areas such as episodic, sensory, working, semantic and procedural memory. Another complicating regulatory factor came last year, when FTC ordered the marketers of a purported memory support supplement to pay a $1.4 million fine for making claims on the product such as “helps users match the memory power of others 15 years younger in as little as 30 days.”
Barbara Davis, PhD, vice president of medical and scientific affairs for PLT, said the goal of the dossier was not primarily to address those concerns. Rather it was meant first and foremost to more firmly support the efficacy of the ingredient.
“This all grew out of our PLT 360 program that we’ve talked about earlier. Efficacy was one of the four pillars that we were putting together along with quality, sustainability and integrity. We chose to start with Synapsa because it has such great science behind it,” Davis told NutraIngredients-USA.
With that being said, Davis did acknowledge that making structure/function-type memory support claims has gotten trickier in recent years. Interestingly, while she and others like her in similar positions are dialed in to FTC’s sharpened focus on this area, many customers out in the marketplace are blithely unaware.
“A number of times when I’ve spoken with customers and I’ve brought up the FTC situation, they didn’t know what I was talking about,” Davis said.
Dossier links specific claims with specific studies
Davis reviewed the claims environment with the help of Risa Schulman, PhD, principal of a consultancy called TapRoot. PLT brought Schulman in to provide an independent voice in the assessment. Davis and Schulman came up with a number of claims that they believe are supported by PLT’s Synapsa science suite. The dossier is divided into claims that are for chronic or ‘acute’ use. A representative chronic (daily use) claim that is supported by four clinical studies specifically conducted using the Synapsa ingredient is: “Aids in the retention of new information.”
“We talked about all of the structure/function claims that I thought could be supported and were also of interest to our marketing group,” Davis said. She said in the memory field, such claims have to be specific, which is different from other quadrants of the structure/function universe, where the more general the claim is, the more innocuous it seems to be in the eyes of regulators.
Product development aid
Davis said the dossier is not only useful in helping customers stay on the right side of the regulatory line. Rather it can also help customers save product development time, which is part of the value-add for a branded ingredient, she said.
“It really helped with product development and figuring out what markets you want to target. I had a customer tell us that we’ve saved them six to nine months in development time,” Davis said.