FDA WARNING_LETTER - Hope Botanicals, LLC - May 26, 2022

On May 26, 2022, the FDA issued a Warning Letter to Hope Botanicals, following a review of their website and social media in May 2022. The FDA determined that Hope Botanicals markets unapproved new animal drugs and unapproved new human drugs containing CBD, and adulterated human and animal foods.

Specifically, products like "CBD Horse Pellets," "Peppermint Flavor Horse Formula," "Happy Horse Bites," "CBD Liniment Gel," "Natural Flavor Pet Formula," and "Beef Flavored Soft Chews" are deemed unapproved new animal drugs, unsafe under 21 U.S.C. 360b(a), and adulterated under 21 U.S.C. 351(a)(5). Claims on the company's website and social media, including testimonials, indicate intended use for disease treatment in animals (e.g., arthritis, pain, anxiety, cancer). The FDA is particularly concerned about CBD products for food-producing animals due to potential residues in human food.

For human use, "Broad Spectrum Tincture," "Super Full Spectrum Tincture," "Phytocannabinoid-Rich Broad Spectrum Hemp Oil Softgels," and "Broad Spectrum Nano CBD Salve" are unapproved new drugs, violating 21 U.S.C. 355(a) and 331(d), and misbranded under 2