“There definitely are products out there with no science whatsoever to back up their claims. Or they might have science connected to one or two components of the formula, but no science connected to the formulation together,” Shea told NutraIngredients-USA.
Sen. McCaskill, D-MO, recently sent letters to FDA and to 15 major retailers as part of 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.
“People looking online for cures or treatment for Alzheimer’s Disease and dementia are at their most desperate—and it’s clear from what we’ve found that many of these products prey on that desperation,” said Sen. McCaskill in June. “Right now it’s like the wild west when it comes to the production, marketing, distribution, and sale of these products. I want to figure out why that is and what we can do to better protect America’s seniors.”
McCaskill also weighed in on the settlement of a Federal Trade Commission false advertising complaint against the marketers of a supplement called Procera AVH, which among other things was said to help users “match the memory power of others 15 years younger in as little as 30 days!”
“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.
Science to back claims
Shea said that is not the case with Perceptiv. The formula is a blend of six components - Vitamin E, folic acid, Vitamin B12, N-acetyl L-cysteine, Acetyl L-carnitine and S-adenosyl Methionine (SAMe) - that was developed and researched over a period of about 20 years through the University of Massachusetts Lowell where Shea is a the director of the Center for Cellular Neurobiology & Neurodegeneration Research. Only after the formula started to show good results was the decision taken to license it, he said.
“Some of the products out there have data via the companies’ own studies. I’m not saying they are necessarily bad studies, but there is an inherent conflict of interest. My institution funded the initial studies on the Perceptiv formulation, and subsequent studies were funded by a grant from the Alzheimer’s Association,” Shea said.
“We have done seven independent clinical studies and another is coming out in the Journal of the Alzheimer’s Association later this year,” he said.
Shea said Perceptiv’s formulation has been shown to provide antioxidant defenses to the brain, supply extra energy to brain cells and restore diminished neurotransmitter levels. Some of the company’s research has made the sort of age-comparison that the Procera AVH marketers were dinged for, except in this case, Shea said his research team actually proved it.
“We actually have data that shows you function as if your are 15 years younger. We have done mental tests where a 55-year-old performs at a speed expected of a 40-year-old. Somehow another company latched on to that,” Shea said.
“We don’t slap that up as a big advertising claim. It’s just a way to talk to consumers about the benefits of the product. As we are selling this as a dietary supplement, we are very careful what we claim. We claim to enhance mental clarity, help improve memory and help protect against the normal cognitive decline associated with aging,” he said.