FDA WARNING_LETTER - Peak Nootropics LLC aka Advanced Nootropics - February 11, 2019

The FDA issued a Warning Letter to Peak Nootropics LLC (aka Advanced Nootropics) on February 4, 2019, following a September 2018 review of their website, www.peaknootropics.com. The FDA determined that products sold, including Adrafinil, Aniracetam, Bacopa Monnieri, L-Dopa, L-Theanine, Noopept, Oxiracetam, Phenibut, Phenylpiracetam, Piracetam, Pramiracetam, Rhodiola Rosea, and Uridine, are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The claims on the website establish these products as drugs intended for disease treatment/prevention or to affect body structure/function. Examples of drug claims were provided for each product. Since these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" requiring prior FDA approval, which they lack, violating sections 301(d) and 505(a) of the Act.

Furthermore, products like Adrafinil, Aniracetam, Bacopa Monnieri, L-Dopa, L-Theanine, Noopept, Phenylpiracetam, Piracetam, Rhodiola Rosea, and Uridine are intended for conditions not amenable to self-diagnosis or treatment