FDA WARNING_LETTER - Pure Nootropics, LLC - February 11, 2019

The FDA issued a Warning Letter to Pure Nootropics, LLC, on February 5, 2019, following a review of their website, www.purenootropics.net, in October 2018. The FDA determined that products sold, including Alpha GPC, Lion’s Mane, CDP Choline Capsules, Piracetam, Vitamin D3 5000 IU, Turkey Tail Mushroom Powder, and Ginkgo Biloba Capsules, are unapproved new drugs and misbranded drugs.

The claims on the website establish these products are intended for disease cure, mitigation, treatment, or prevention, thus classifying them as drugs under section 201(g)(1)(B) of the Act. Since they are not generally recognized as safe and effective for these uses, they are "new drugs" under section 201(p) and require prior FDA approval, which they lack, violating sections 301(d) and 505(a).

Furthermore, products like Alpha GPC, Lion’s Mane, CDP Choline Capsules, Piracetam, Vitamin D3 5000 IU, and Ginkgo Biloba Capsules are intended for conditions requiring professional supervision, making it impossible to provide adequate directions for layperson use. This renders them misbranded under section 502(f)(1) and their introduction into interstate commerce a violation of section 301(a).