Shot of Joy LLC

Warning LetterOpen

James B. Carty Shot of Joy LLC 1450 2nd Street, #400 Santa Monica , CA 90401 United States hello@shotofjoy.comIssued Sep 25, 2023Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations2

Issue DateSep 25, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Shot of Joy LLC
Location: James B. Carty Shot of Joy LLC 1450 2nd Street, #400 Santa Monica , CA 90401 United States hello@shotofjoy.com
FEI Number: N/A
Country: United States
Issue Date: September 25, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Shot of Joy LLC was warned for marketing unapproved new drug products, including kratom and kava shots and gummies, in violation of the Federal Food, Drug, and Cosmetic Act sections 301(d) and 505(a). The company made unsubstantiated disease claims on its website, specifically marketing kratom products for the treatment and cure of opioid addiction and withdrawal symptoms without FDA approval or evidence of safety and effectiveness. The FDA emphasized that these unapproved treatments posed a significant public health threat by potentially causing patients to forego or delay FDA-approved opioid addiction treatments during the ongoing national opioid crisis.

Shot of Joy LLC FDA Warning Letter, September 25, 2023