FDA WARNING_LETTER - Shot of Joy LLC - September 25, 2023

The FDA issued a Warning Letter to Shot of Joy on September 25, 2023, after reviewing their website, shotofjoy.com, in September 2023. The FDA determined that Shot of Joy is marketing and selling various Shot of Joy brand kratom and kava products, including "Classic – Kratom & Kava Shot," "Relax – Kratom & Kava Shot," "Focus – Kratom Shot," "Kava Only Shot," "Kratom Gummies," and "Classic Kratom & Kava Gummies," as unapproved new drugs.

These products are considered drugs under section 201(g)(1) of the FD&C Act because they are intended to diagnose, cure, mitigate, treat, or prevent disease, and/or affect the body's structure or function. Examples of drug claims on their website include marketing kratom for anxiety, depression, opioid addiction, withdrawal symptoms, and PTSD. Kava products are marketed for alleviating ADHD symptoms, depression, cardiovascular health, neuroprotection, and antidepressant effects.

The FDA states these products are not generally recognized as safe and effective (GRASE) for their intended uses, making them "new drugs" under section 201(p) of the FD&C Act. Introducing or delivering these products into interstate commerce without FDA approval violates sections 301(d) and 505(a) of the FD&C Act. The