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Rick Collins and Jay Manfre Address Category of Nootropics in NutraIngredients-USA Article

Nootropics, often referred to as “smart drugs,” is a hot topic in the dietary supplement industry – with this category of ingredients sometimes considered to be in a gray area between drugs and dietary ingredients. With nootropics continuing to be a complex area of the law, NutraIngredients-USA — the online news service focusing on US dietary supplements, health and nutrition – has published an article addressing how some questionable ingredients are now “finding a home” in the nootropics category … and what supplement manufacturers need to know about nootropics and current dietary supplement law.

The article, “Some Shady Ingredients Find Home in Nootropics Category,” appears in today’s special edition found on NutraIngredients-USA.com – and features both Rick Collins and Jay Manfre addressing not only this important subject in general, but providing legal insight into a specific case study of an ingredient that is known to be popular among nootropic enthusiasts: piracetam (which is part of the bigger category of ingredients known as racetams.) Noting that this particular ingredient not only was not recognized by the FDA as a dietary ingredient but also received a warning letter in 2010 – yet supplement-like products with the ingredient are available on “some lower profile web portals” – Rick Collins offers insight into how, and why, this may be occurring noting, in part, that “FDA has limited resources and tends to focus its enforcement on ingredients that receive a lot of media attention (Kratom, CBD) or result in alleged consumer injury or death (DMAA, Ephedra). The lack of enforcement from FDA against companies that are marketing and selling these ingredients is likely because FDA is currently focusing on other ingredients.”

Also quoted in the article, CGMB associate Jay Manfre states that whatever enforcement there has been in the area of nootropics generally has focused on claims rather than the regulatory status of the ingredient, noting “When other nootropic products have been targeted, it was mostly for their claims: and further stressing that “… even if a dietary supplement contains only legal ingredients, the marketing and claims made about a product can cause it to be considered a misbranded drug by the FDA.”

To read the article and see both Rick and Jay’s full quotes on this important and growing issue in dietary supplement law, click here. In addition, if you have any questions about nootropics and the law, or would like to speak with Rick or Jay regarding current regulations in the dietary supplement industry and how to ensure regulatory compliance in this complex area, call us at 516-294-0300 or email us at info@supplementcounsel.com