Dietary supplements have been in the news frequently this year, as much for their lack of oversight as for their lack of efficacy. The FDA’s authority to regulate dietary supplements is currently quite limited.
One newer supplement niche area – “nootropics” – the so-called “brain boosters” and “cognitive-, intelligence-, and memory enhancers” is on its way to becoming a booming business. But media coverage directed at these products has been limited and mostly sympathetic. There’s been little to no real scrutiny of their safety. It appears nootropics have sailed along under the radar, quite unencumbered by reports of harms or regulations, and there’s little reason to expect that will change anytime soon.
Nootropics got a big boost just the other day when investor Andreessen Horowitz announced plans to invest $2 million in a nootropics start-up called Nootrobox. According to the New York Times, “The start-up’s founders say they are part of the ‘biohacking’ movement, which treats the human body as software that can be improved through constant tweaking.” Andreessen told the NYT he wanted to be part of that close community.
According to conventional wisdom, nootropics were made popular on Internet forums by chemistry students looking for DIY (do-it-yourself) brain boosters. Indeed, nootropics are promoted heavily to students and young professionals, and judging from the ads and websites – overwhelmingly to young males.
Like the “nutraceuticals” in Megan Thielking’s excellent, in-depth piece for STAT (“Celebrity selfies, lax regulations drive booming supplement industry”), nootropics require no clinical trials, no proof of safety or effectiveness, no FDA approval and no prescription from the doctor. A broad regulation directed at supplement makers is that they can’t claim to cure or treat a disease. If companies take care not to run afoul of marketing regulations, they can sell their products online and on store shelves.
But unlike nutraceuticals, which rely heavily on celebrity endorsements to generate sales, nootropics’ marketing is aimed at students and young professionals wanting to excel, be competitive, win. A video on Nootrobox.com shows a young, bearded male tarrying alone in front of a computer in an office late at night with a voice-over talking about the subject’s drive to succeed (see screenshot at right).
The compounds frequently marketed by nootropics sellers include caffeine and L-theanine, an amino acid found in green tea, and more complex substances like aniracetam, piracetam, pramiracetam, and adrafinil, billed as a cousin to the alertness drug, modafinil. Sometimes they’re sold already “stacked” together as a brain enhancing cocktail in capsule form, but just as often they’re sold in bulk and customers must measure out small amounts and make their own capsules. For example, the product description on Powder City’s website says Noopept, sold for improved memory and concentration, requires a scale to accurately measure out “10 mg = one rounded red micro scoop.”
Both the FDA and the Federal Trade Commission (FTC) have ordered supplement makers off the market if they receive enough reports of harms or if labels contain unproven claims. But the deluge of nootropics, nutracueticals and related supplements reaching consumers makes it extremely likely a harmful substance could escape notice for years.
The NIH announced in September 2015 a $35 million program for grantees to examine the health claims of nutraceuticals. It will be worth following to see whether these brain enhancers – the newer kids on the block – are included in these scientific inquiries.
Until then, there are few cautions other than the anecdotal kinds directed at people willing to take their chances on unregulated brain enhancers. One wonders how many doing their research will consider the “Hazards” section on the Reddit nootropics forum for beginners:
“Our bodies are complex and unique, as such you can’t predict with certainty that you won’t have an adverse reaction to any particular compound. Many new and exotic compounds are not known to be safe or well-tolerated, their use confers unknown but significant risk.
Uncertainties increase when stacking multiple compounds. Each stack confers a certain level of risk. While the risk associated with an average stack may not be great, the risk associated with the practice of regularly making yourself a guinea pig for new stacks could very well be great.”
Kathlyn Stone is an associate editor for HealthNewsReview.org. She contributes regularly to the blog.