FDA WARNING_LETTER - Happy Hour Vitamins - July 29, 2020

On July 23, 2020, the FDA issued a Warning Letter to Happy Hour Vitamins (H2V) after reviewing their website and Amazon sale page in June 2020. The FDA determined that H2V's product, Happy Hour Vitamins, is an unapproved new drug under the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because it is marketed with claims for the cure, mitigation, treatment, or prevention of disease, specifically hangovers, which the FDA defines as a sign or symptom of alcohol intoxication (a disease).

Examples of violative claims include "Multivitamin Specially Formulated to Help with Hangovers," "KILL YOUR HANGOVER BEFORE IT EVEN STARTS," and "These are the hangover cure pills you are looking for!" The letter also cited personal testimonials on the website and similar claims on the Amazon sale page.

Furthermore, the FDA stated that even without therapeutic claims, Happy Hour Vitamins could not be marketed as a dietary supplement because it contains N-acetyl-L-cysteine (NAC). NAC was approved as a new drug on September 14, 1963, and the FDA is unaware of any evidence it was marketed as a dietary supplement or food prior to that date, thus excluding it from the dietary supplement definition under section 201(ff)(3)(