FDA WARNING_LETTER - Purple Biosciences, LLC - June 30, 2020

The FDA issued a Warning Letter to Purple Tree, LLC, after reviewing their website (gotpurpletree.com) and Amazon sale page in June 2020. The FDA determined that the product "Purple Tree" is an unapproved new drug under the Federal Food, Drug, and Cosmetic Act.

The letter cites numerous claims on both the website and Amazon page that establish the product's intent for use in the "cure, mitigation, treatment, or prevention of disease," specifically hangovers, which the FDA classifies as a sign or symptom of alcohol intoxication (a disease). Examples of such claims include "hangover prevention pill," "hangover cure," and "helps to mitigate some of the hangover symptoms."

Because the product is not generally recognized as safe and effective for these uses, it is considered a "new drug" requiring prior FDA approval, which it lacks. Furthermore, the FDA concluded that "Purple Tree" cannot be marketed as a dietary supplement because it contains N-acetyl-L-cysteine (NAC). NAC was approved as a new drug in 1963, and the FDA is unaware of any evidence it was marketed as a dietary supplement or food before that date, thus excluding it from the dietary supplement definition.

Purple Tree, LLC, is required to notify the FDA in writing within fifteen working days of the specific steps taken to correct these violations and prevent recurrence. Failure to comply may result in legal action, including seizure and injunction.