BrainAlert, LLC – FDA Warning Letter, Jul 12, 2017

An FDA inspection of BrainAlert, LLC in Lynnwood, Washington, on June 19-20 and July 12, 2017, revealed serious violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). These violations render the BrainAlert product adulterated under 21 U.S.C. § 342(g)(1).

Additionally, FDA's review of www.brainalert.com determined that BrainAlert is an unapproved new drug and a misbranded drug due to disease treatment and prevention claims, such as "struggling with Seasonal depression? Then BrainAlert is the solution for you!" and claims about ingredients like DMAE for ADD and Gotu Kola for anxiety. The product is not generally recognized as safe and effective for these uses, making it a "new drug" under 21 U.S.C. § 321(p), requiring prior FDA approval. It is also a misbranded drug under 21 U.S.C. § 352(f)(1) for lacking adequate directions for use, as its intended uses are not amenable to self-diagnosis or treatment.

Even if not a drug, BrainAlert is an adulterated dietary supplement due to CGMP violations. The firm failed to implement production and process controls (21 CFR 111.55), lacking knowledge of their contract