Having the right research best way to weather nootropics storm, supplier says
Nootropics, a catch-all term for any product claiming a brain health or cognition support benefit, including those that are pharmaceuticals being prescribed off label, have been in the news recently because of a warning issued by the American Medical Association about their use.
Nootropics under the spotlight
The AMA has adopted a new policy for members that discourages “the non medical use of prescription drugs for cognitive enhancement in healthy individuals.” The policy goes on to describe these products as “a variety of prescription drugs, supplements, or other substances that claim to improve cognitive functions of healthy individuals, particularly executive function, memory, learning or intelligence.”
In addition to the AMA’s action, cognitive support supplements and their ingredients have been on the radar of Missouri’s Democratic Senator Claire McCaskill. A little more than a year ago McCaskill, who is the ranking Democrat on the Senate Select Committee on Aging, sent letters to the Food and Drug Administration and to 15 major retailers of dietary supplements that specifically market products to older consumers using claims about memory support and treating Alzheimer’s disease. The retailers were asked about their policies relating to the sale and/or marketing of dietary supplements, and what they had done to prevent sales of harmful or fraudulently marketed products in their stores and on their websites and shows. The 15 retailers are Amazon, QVC, Walgreens, Home Shopping Network, Walmart, Target, CVS, Vitamin Shoppe, Safeway, eBay, Kroger, Vitamin World, GNC, Google, and Yahoo.
“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. “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.”
Focusing the research
Karen Todd, a registered dietitian who is also the director of global marketing for dietary ingredient supplier Kyowa Hakko USA, spoke with NutraIngredients-USA at this week’s Institute of Food Technologist’s trade show in Chicago. Kyowa Hakko supplies Cognizin brand citicoline, one of the better-researched cognitive support ingredients. Todd said that building a suite of scientific evidence to support proper dietary supplement-style structure function claims is what can and should set a correctly marketed dietary ingredient apart from the pack of products hovering in a gray realm between the supplement and drug worlds. Not making those distinctions clear will only add fuel to the fire that McCaskill has kindled, she said.
“That’s where we really need to distinguish ourselves. McCaskill is going after things that are making claims they definitely shouldn’t have made,” she said.
Cognizin is a mononucleotide comprised of cytosine, ribose, pyrophosphate, and choline. The empirical formula of the molecule is C14H26N4O11P2. Todd and Dr Danielle Citrolo, Pharm D, technical services manager of Kyowa Hakko USA, presented some of the research backing the ingredient at an education session at the IFT show. Among that research were mechanism of action studies showing increased energy production in brain cells and an alteration in phospholipid turnover in the cellular membranes of cranial neurons. Functional research has shown that the molecule improved attention and motor function as measured by an omission/commission error test among older women. The latest research the company has sponsored has been among adolescent males in two different studies. Those studies showed the molecule can increase focus and attention in this group as measured by a finger tap test and a Ruff 2&7 selective attention test (where the task is to cross out as many of those particular digits as possible on a paper filled with random numbers within 5 minutes.)
No magic pills
The research, taken together, backs claims along the line of supporting mental energy, focus, attention and recall, Todd said. While keeping claims in line is important, it’s also important to recognize that maintaining cognitive health as people age is a matter of supporting the whole person, including paying attention to their social setting.
“We know that it’s not just one thing, like choosing the right supplement. It’s about maintaining a positive attitude. And we know that the people who are at the highest risk of developing Alzheimer’s are those who are alone, who are inactive, so physical activity and social connection is key,” Todd said.
Dr. Danielle Citrolo, Pharm D, Kyowa Hakko USA technical services manager, echoed Todd’s warning about viewing ingredients as magic pills. It’s a point of view that has led to the current cloud that seems to hang over the category, she said.
“Nootropics may have a negative perspective from some. And not all nootropics are created equal. I think enhancing cognitive function can be healthy and safe when choosing the right products. For one, avoid stimulants. Pick products that truly have a brain health benefit proven scientifically. And finally, always look at safety, and by safe, we want it to be safe for the brain and for our entire body. The idea should be optimizing our brain health,” she said.