FDA WARNING_LETTER - ATLRx, Inc. - May 04, 2022

On May 4, 2022, the FDA issued a Warning Letter to Chase Slappey regarding products sold on www.atlrx.com and associated social media. The FDA's February 2022 review found that the company markets various human and animal products containing CBD or Delta-8 THC, making unapproved drug claims.

Violations include: - **Unapproved New Human Drugs:** Products like "Delta 8 Terpene Gummies," "CBD Sleep Gummies," and "CBD Oil Tincture" are marketed with drug claims (e.g., for pain, anxiety, sleep) but lack FDA approval, violating sections 505(a) and 301(d) of the FD&C Act. - **Misbranded Human Drugs:** These human CBD/Delta-8 THC products are misbranded under section 502(f)(1) due to inadequate directions for use, as they address conditions not amenable to self-diagnosis/treatment. - **Adulterated Human Foods (CBD/Delta-8 THC):** Products like "CBD Sleep Gummies" and "Delta 8 Chocolate" are considered adulterated under section 402(a)(2)(C)(i) because CBD and Delta-8 THC are unapproved and unsafe food additives. Introducing food with added CBD is also a prohibited act under section 301(ll). - **Unapproved New Animal Drugs