09 October 2020

Brain Health Supplements

Welcome back. A few years ago, I commented about the inordinate number of TV ads for prescription drugs--as if the billions of dollars (true estimate) spent marketing directly to physicians weren’t enough. It was a blog post about the safety of new prescription drugs (Drug Safety). When a new drug replaces an older drug, should you switch? The study I reviewed in the post found about a third of the drugs the Food and Drug Administration (FDA) approved from 2001 to 2010 had safety issues after coming to market.

Well, whether it’s my TV viewing choices or my imagination, there are no fewer prescription drug ads, but ads for dietary supplements, particularly those pitched to improve mental focus and memory, have increased. There are even more problems with those.

The proliferation of brain health dietary supplements (from

In short, brain health supplements offer no benefit for most people, they’re not cleared by the FDA, and unless tested, there’s no way to know precisely what’s in them.

Mental Focus and Memory
In general, scientists are skeptical about dietary supplements touted to bolster memory and cognition. While the right dose for a specific neurological condition (e.g., vitamin deficiency) or brain injury might help, there is little to no evidence that these supplements are effective at boosting memory or the ability to focus. For most people, the best approach is a healthy diet and exercise.

Claims made about memory supplements are finally coming under scrutiny by regulators. In 2017, for example, the Federal Trade Commission and New York State sued the marketers of Prevagen, for falsely claiming the product improves memory. The case was dismissed; however, the dismissal was reversed in 2019 and the case is proceeding.

The marketers of Prevagen, a popular brain health supplement, are charged with “making false and unsubstantiated claims that the product improves memory, provides cognitive benefits and is ‘clinically shown’ to work” (photo from Amazon advertisement).
FDA and Safety Issues
Although safety issues might arise after prescription drugs come to market, pharmaceuticals are subjected to rigorous clinical trials to prove they are safe and effective for their intended use before approval by the FDA.

Because there is minimal FDA regulation of supplements, they can be sold without testing for safety or efficacy. As such, there is no way to know if the supplement works or is safe, how much of the active ingredient on the label is actually in the product, or if it contains potentially harmful substances. The FDA can take action after supplements reach the market if they are mislabeled or contain unapproved drugs.

In a recent study of brain health supplements, researchers affiliated with Harvard, Mississippi and Colorado universities analyzed ten products purchased online. The product labels were advertised as having ingredients considered to be prescription drugs in countries such as Russia, China and Germany.

The researchers’ analysis detected several drugs that were not listed on the product labels and not approved for use in the U.S. Testing also found that several drugs listed on the labels were absent and that most listed drug quantities were inaccurate.

Wrap Up
Whether brain health supplements are effective or not, one would expect or hope the labels of supplements produced and purchased on site in the U.S. would be more accurate. The supplements might even be tested by a recognized third-party group, such as U.S. Pharmacopeia (USP), ConsumerLab.com, NSF International or UL.

Among sources of information, there’s a 2019 report by AARP’s Global Council on Brain Health, the University of California Berkeley Wellness Letter reviewed of the most widely used brain health supplements in 2019, and Consumer Reports keeps tabs on all manner of supplements in its magazine and website.

Thanks for stopping by. I hope it was worth your time.  

FDA and dietary supplements: www.fda.gov/food/dietary-supplements
FTC and NYS actions on dietary supplement Prevagen: www.ftc.gov/enforcement/cases-proceedings/152-3206/quincy-bioscience-holding-company
Study of unapproved drugs in brain health supplements in Neurology Clinical Practice journal: cp.neurology.org/content/early/2020/09/23/CPJ.0000000000000960
Articles on study on EurekAlert! and Consumer Reports websites:
2019 report on supplements by AARP’s Global Council on Brain Health:
Article on brain health supplements in Berkeley Wellness Letter: www.berkeleywellness.com/healthy-mind/memory/article/can-supplements-improve-memory
Articles on supplements on Consumer Reports website: www.consumerreports.org/supplements/shop-smarter-for-supplements/

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