Be Smart: Brain-health supplement claims Dos and Don’ts

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With the population graying-one in every five U.S. residents will be of retirement age by 2030, per the U.S. Census Bureau’s 2017 National Population Projections-it’s no surprise that cognitive-support supplements’ prospects are rising.

Indeed, a 2019 report¹ from Grand View Research foresees a global market for brain-health supplements worth $10.7 billion by 2025-suggesting that many of those future retirees are taking precautions in advance of their big 2030 ageing-up.

But the report also notes that brain-health market drivers extend beyond obvious antiaging concerns to include depression, anxiety, and sleep recovery, among other cognitive issues-which proves that the brain-health category holds promise for more than just the elderly.

But brain-health brands best be careful about which promises they make. Just ask Quincy Bioscience (Madison, WI), which found itself staring down a lawsuit from the Federal Trade Commission (FTC) and New York attorney general accusing it of deceptively claiming that its Prevagen supplement improves memory on the basis of a single study that the plaintiffs said failed to show any statistically significant improvement over placebo.

As the case makes its way through the courts, it should give marketers pause for thought. For while the smart money’s still on brain-health supplements, their potential won’t pan out if brands don’t wise up on what to say, and not to say, when educating consumers about them.

Brain Boom

The Council for Responsible Nutrition’s (CRN; Washington, DC) latest Consumer Survey on Dietary Supplements shows “very steady” support for brain-health formulations, notes Andrea Wong, PhD, the organization’s senior vice president of scientific and regulatory affairs.

From 2015 to 2019, the percentage of supplement users citing brain health as a reason for supplementing stayed roughly static, fluctuating from 15% at the outset to 14% last year. “And while there doesn’t appear to be significant growth in use,” Wong notes, “this is a growing interest area for our members and for companies overall in the dietary supplement space.”

Wong adds that the CRN survey found use of brain-health supplements holding steady across all demographics, as well, and Daniel Fabricant, PhD, CEO and president, Natural Products Association (NPA; Washington, DC), thinks he knows why.

He credits the category’s big-tent appeal. “Are we talking about memory?” he asks. “About focus? Brain health is a different concern for everybody.”

Yes, an aging population’s desire to stay sharp fuels the category. “But the other side of brain health is where you find nootropics and products for gamers who go on gaming binges at their consoles for eight hours straight and need focus,” he adds. When has a heart-health supplement ever enjoyed such broad cachet?

Food for Thought

Regardless of the audience, interest in brain-health formulations is justified. As Wong points out, “Long-term cognitive health is influenced by a combination of diet, lifestyle, genetics, and the environment.” So it’s no surprise that her organization “recognizes considerable evidence showing that proper nutrition through balanced diets or supplements is essential to support brain function.”

Of course, more research is always welcome to “further inform our understanding of nutrition’s role in the prevention of cognitive decline,” Wong goes on. But emerging science continues to demonstrate connections between omega-3 fatty acids, amino acids, probiotics, caffeine, and phospholipids-among other supplemental ingredients-and improved brain function, she says.

Fabricant’s background is in botanical ingredients, he says, and “one thing you learn with botanicals is the importance of group 2 metals”-alkali earth metals like zinc and magnesium. “They’re involved in everything that happens neurologically,” he notes.

“Then you’ve got the whole area of the gut-brain axis,” he continues. “That’s the big story now. Everyone’s looking into how probiotics seem to have an effect on neurological performance.”

Blow to the Head

So the enthusiasm is understandable: There’s much to learn, and much good that might come from it. But that’s where some in industry may have gone too far, Fabricant says.

“You’re often dealing with an older population that doesn’t want its memory to slip,” he says, “but doesn’t necessarily want to go to the doctor about it, either. So they’re looking for a different approach to self-care. And the FTC has long since been smart about that, and it’s focusing as a priority on the claims that some supplement companies are making.”

Wong agrees. “The Federal Trade Commission has been paying close attention to brain-health claims in recent years, so marketers should ensure-as is their responsibility with all claims-that their product claims are supported by sound evidence,” she says.

Consider FTC’s recent action against NeuroPlus’s allegedly deceptive claims that its products could protect the brain against Alzheimer’s disease and dementia, reverse memory loss, and improve memory and cognitive performance, she suggests.

Or the commission’s more recent targeting of Geniux products for their promise to improve short- and long-term memory, increase focus by as much as 300%, increase concentration, prevent memory loss, boost brain power by as much as 89.2%, effectively double IQ, and improve users’ information-processing speed. Ads apparently billed the company’s “Smart Pill” a “Viagra for the brain” capable of producing “extreme IQ effects,” Wong notes, and also allegedly falsely claimed that the products had been tested in more than 2,000 clinical trials.

Fabricant was actually at FDA during what he calls “blitzes” of combined FDA and FTC effort to uncover bad industry actors. “And knowing that both FDA and FTC are out there and interested should give anyone a moment of pause,” he says.

Getting It Right

Bob Durkin, of counsel, Arnall Golden Gregory LLP (Mount Airy, MD), and former deputy director of the office of dietary supplement programs at FDA, is familiar with these blitzes, himself, and understands their merit.

“While there are definitely dietary ingredients and supplements that help with cognition,” he allows, “the problem for legitimate players is that they wind up in an environment where the bad players control the message. Even when they put their claims in the right perspective, good players can get drowned out, and it’s really hard to stay afloat in that sea.”

But smart brands can rise above the tide, especially if they follow the right advice.

“Companies should be particularly careful when marketing toward vulnerable populations, like children and the elderly,” Wong suggests.

Indeed, none other than FTC’s Bureau of Consumer Protection director, Andrew Smith, says, “With an aging population, it’s more important than ever that advertisers have solid evidence to back up their claims about memory and cognitive-health benefits.”

But careful consideration of populations should begin before claims are even drafted and inform study design itself. Fabricant warns against conducting brain-health supplement research in diseased subjects, “where you’re no longer dealing with normal aging,” he says. “That goes outside the bounds of what supplements are supposed to do and will attract unwanted attention.”

And when it’s time to draft evidence-based claims, “Focus groups are important, too,” he says. “What do these claims mean to people? That’s another piece that’s going to be critical.”

In all likelihood, most supplement brands serving the brain-health category are already operating by these guidelines. As Wong says, “While some products fall prey to illegal activity, it’s important to remember that these products do not represent the mainstream dietary supplement market, and they should not malign the entire category. Any product claiming to cure, mitigate, treat, or prevent a disease-like Alzheimer’s or dementia-is an illegal product that consumers should avoid.” And brands should avoid marketing them that way.

References:

1. Grand View Research. “Brain Health Supplements Market Size Worth $10.7 Billion by 2025.” Published May 2019.