FDA WARNING_LETTER - "vita heaven, llc - June 30, 2020

The FDA reviewed Hangover Heaven's website in June 2020 and found that the product "Hangover Heaven Nightlife Prep Supplement" is marketed with claims that establish it as an unapproved new drug. The website includes claims such as "Hangover Cure through Prevention," "reduce hangover symptoms," and "treatment, prevention, and cure of hangovers," which indicate the product is intended for use in the cure, mitigation, treatment, or prevention of disease, specifically alcohol intoxication.

Since the product is not generally recognized as safe and effective for these uses, it is considered a "new drug" under section 201(p) of the Act and requires prior FDA approval for interstate commerce, which it lacks, violating sections 301(d) and 505(a).

Furthermore, the product, containing N-acetyl-L-cysteine (NAC), cannot be marketed as a dietary supplement. NAC was approved as a new drug in 1963, and there is no evidence it was marketed as a dietary supplement or food prior to this approval, thus excluding it from the dietary supplement definition under section 201(ff)(3)(B)(i) of the Act.

The FDA requires prompt corrective action within fifteen working days, including written notification of steps taken to correct violations and prevent recurrence. Failure to comply may result in legal action, including seizure and injunction.