New Analysis Unfairly Maligns and Misrepresents Brain Health Supplement Category

WASHINGTON, DC, September 23, 2020—In response to a report, “Five unapproved drugs found in cognitive enhancement supplements,” published today, September 23, in an online issue of Neurology Clinical Practice, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, issued the following statement:

Statement by Steve Mister, president & CEO, CRN:

“The results of this exercise by Dr. Cohen et al. demonstrate this unfortunate, but unsurprising truth: when researchers—or consumers—with access to an online search engine go looking for illegal products posing as brain health supplements, they are likely to find them. What’s more disturbing is the authors’ sweeping conclusions about the brain health category of dietary supplements based on a narrow selection of ten illegal products found on the internet. Fortunately for consumers, this small collection does not represent the brain health supplement category, as the products identified in the study are not legal dietary supplements, but illegal products containing unapproved drugs. Evidence indicates nutrients are essential for brain health whether achieved through diet or supplementation. Research continues to emerge demonstrating how certain dietary supplements can support brain function in combination with other factors including diet and lifestyle.

The study’s authors also wrongly claim, ‘…that consumers cannot obtain accurately labeled cognitive enhancement supplements by selecting supplements using the NIH’s or Natural Medicines’ supplement databases.’ They fail to recognize that the dietary supplement databases they examined, as well as the industry’s own voluntary registry, the Supplement OWL, must include the good, the bad, and the ugly to provide an accurate representation of all products on the market. No one questions that products that contain illegal drug ingredients are not legal dietary supplements. However, although the analysis demonstrates that illegal products can be found, especially when sought after, it does not mean consumers cannot find safe and high quality dietary supplement products in the market. Databases are not intended to be shopping tools for the public, and CRN encourages consumers to be smart supplement shoppers by educating themselves when selecting which products to use and which companies to purchase products from.

While shopping online is a viable option for purchasing safe and quality supplements, the public should be aware that many products associated with contamination problems identified by FDA are offered exclusively through unscrupulous online companies. Whether shopping online or in-store, consumers should seek products with nationally recognized brands or store brands from trusted retailers, avoid products that make drug-like claims, do their homework before starting a new supplement regimen, and always consult a doctor or healthcare practitioner for advice on using supplements effectively.

CRN does agree with the study’s conclusion that FDA must increase the effectiveness of its regulation of dietary supplements. Until FDA enforcement efforts predictably and consistently provide deterrence to drive these illegal products from the market, we should not be surprised that they exist in the corners of the internet. CRN urges FDA to take stronger enforcement action against tainted products containing illegal drug ingredients in the marketplace and CRN continues to advocate for more resources so the agency can bolster enforcement. The FDA currently lacks a system to efficiently track products that come to market, which is why we support a mandatory product listing, as it would allow FDA to determine who is using a particular ingredient, what claims are being made on the label, and whether the contact information for reporting an adverse event is properly provided. With a mandatory listing, the agency can better identify when new products are introduced and act more quickly to remove illegal products from the market.

We encourage the public to avoid taking the findings of this analysis out of context and recognize this small sample is not representative of the brain health supplement category as a whole. The mainstream dietary supplement market is made up of responsible and ethical companies that are dedicated to providing consumers with safe, quality, and beneficial products to improve their health and wellness.”


Note to Editor: The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 180+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit Follow us on Twitter @CRN_Supplements, and LinkedIn.