What happened
Original notice title
BrainAlert, LLC 12/14/17
From the archived source record
The inspection revealed serious violations of the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your BrainAlert product to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that it has been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Based on our review, we have concluded that your BrainAlert product is an unapproved new drug and misbranded drug and that, even if it were not a drug, it would be a misbranded dietary supplement, as explained further below. Unapproved New Drugs/Misbranded Drugs FDA reviewed your website www.brainalert.com in August 2017 and again in December 2017 and determined that you take orders there for your product BrainAlert. The following are examples of citations as listed on your website used to market BrainAlert for disease treatment and prevention and are thus evidence of your product’s intended use as a drug: “Schonheit K, Gille L, Nohl H, Institute of Pharmacology and Toxicology, Veterinary University of Vienna, Austria. Huperzine A, a potential therapeutic agent for dementia, reduces neuronal cell death caused by glutamate. Psychopharmacol Bull 1982;18:7-18.” “Yun TK, Choi SY. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, BrainAlert fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- f7df0b8dd392
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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