NeuroHydrate LLC – FDA Warning Letter, May 18, 2021

The FDA issued a Warning Letter to NeuroHydrate following a January 2021 review of their website, neurohydrate.com, which identified the product "HM-FORMULA." The agency determined that claims made on the website establish "HM-FORMULA" as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(g)(1)(B)]. These claims, found across product descriptions, FAQs, customer reviews, and other pages, indicate the product is intended for the cure, mitigation, treatment, or prevention of disease, specifically headache and migraine prevention, and reduction of their frequency, severity, and duration. Introducing this product into interstate commerce for such uses violates the Act. Additionally, the FDA concluded that "HM-FORMULA" is not generally recognized as safe and effective for its claimed uses, classifying it as a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs require prior FDA approval before legal introduction into interstate commerce, as per sections 301(d) and 505(a) [21 U.S.C. 331(d), 355(a)]. NeuroHydrate is responsible for promptly correcting these violations and must notify the FDA in writing within 15 working days, detailing corrective actions and recurrence prevention steps. Failure to comply may result in legal actions, including seizure and injunction.