LES Labs – FDA Warning Letter, Jul 29, 2020

The FDA issued a Warning Letter to Mr. Heathco regarding the product "DeToxx for Hangovers," sold on leslabs.com. An FDA review in June 2020 found that claims on the website, such as "DeToxx helps reduce hangover symptoms" and "Helps prevent hangover symptoms," establish the product as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) because it is intended for the cure, mitigation, treatment, or prevention of disease (alcohol intoxication).

As a drug, "DeToxx for Hangovers" is considered a "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for its stated uses. Introducing or delivering a new drug into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act.

Furthermore, the product contains N-acetyl-L-cysteine (NAC), which FDA concluded is excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) of the Act. NAC was approved as a new drug on September 14, 1963, and FDA is unaware of any evidence it was marketed as a dietary supplement or food prior to that date.

The letter requires prompt corrective action within fifteen working