FDA WARNING_LETTER - Holista LLC dba HolistaPet - April 29, 2025

The FDA issued a Warning Letter to Holistapet on April 7, 2025, after reviewing their websites and social media, which promote and sell various CBD-containing animal products. The agency determined that Holistapet's CBD products, including oils, pellets, treats, chews, and capsules for horses, dogs, and cats, are unapproved new animal drugs and adulterated animal foods. Specifically, the FDA found these products are intended to diagnose, treat, or affect animal body functions, classifying them as drugs under 21 U.S.C. 321(g)(1). Lacking FDA approval or index listing, they are unsafe (21 U.S.C. 360b(a)) and adulterated (21 U.S.C. 351(a)(5)), with their introduction into interstate commerce prohibited (21 U.S.C. 331(a)). Furthermore, products marketed as animal foods (e.g., pellets, treats) contain added CBD, which the FDA considers a drug with substantial clinical investigations. Introducing such animal food is a prohibited act under 21 U.S.C. 331(ll). CBD is also an unapproved food additive, as it is not generally recognized as safe (GRAS) for animal use (21 CFR 570.30) and lacks premarket approval. This renders the animal food unsafe (21 U.S.C. 348(a)) and adulterated (21 U.S.C. 342(a)(2)(C)(i)), with its interstate commerce prohibited (21 U.S.C. 331(a)). The FDA is particularly concerned about CBD products for food-producing animals due to safety risks for animals and human food. Holistapet must immediately cease selling unapproved CBD products for food-producing animals and respond in writing within fifteen working days, detailing corrective actions, or face legal action.