FDA WARNING_LETTER - Relax Relief Rejuvenate Trading, LLC dba RRR Trading or EDP Kratom - July 15, 2025

The FDA issued a warning letter on June 25, 2025, to Messrs. Robinson and Patel concerning their product, EDP 7OH Mitragyna Speciosa Extract 50 mg shot. The inspection revealed that the product contains 7-hydroxymitragynine (7-OH), which is classified as a "new dietary ingredient" under the Federal Food, Drug, and Cosmetic Act. The FDA has not evaluated 7-OH for safe use and has received adverse event reports linked to products containing this ingredient, which reportedly has opioid-like effects.

The product is considered adulterated under section 402(f)(1)(B) of the Act because there is insufficient information to ensure that 7-OH does not pose a significant risk of illness or injury. Consequently, the introduction of these adulterated dietary supplements into interstate commerce violates section 301(a) of the Act.

The FDA requires the company to address these violations by investigating their causes and implementing measures to prevent recurrence. The company must respond in writing within 15 working days, detailing corrective actions and providing supporting documentation. Failure to comply may result in legal action, including product seizure and injunction. The response should be directed to Kimberly Dutzek, Compliance Officer, at the FDA"s Human Foods Program.