FDA WARNING_LETTER - Ebnsol, Inc - July 23, 2020

The FDA issued a Warning Letter to Mr. Radziszewski regarding the product PartyPalTM, sold on http://takepartypal.com and https://ebnsol.com/products/partypal-5-pack. The FDA reviewed these websites in June 2020.

The FDA determined that claims made on the websites establish PartyPalTM as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims include "effective hangover treatments," "hangover cure," and statements about reducing inflammation and repairing cells after drinking. The FDA clarifies that a hangover is a sign or symptom of alcohol intoxication, which meets the definition of a disease [21 CFR 101.93(g)(1)].

PartyPalTM is considered a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its claimed uses. Introducing or delivering a new drug into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [2