FDA WARNING_LETTER - The Dragontree Apothecary LLC - August 21, 2019

The FDA conducted an inspection of Dragontree Apothecary LLC from August 12-21, 2019, identifying serious violations of the Federal Food, Drug, and Cosmetic Act. The company's products, including CBD Inflammation Relief, CBD Headache Relief, and CBD Sleep Support, are deemed unapproved new drugs and misbranded. The FDA states CBD products cannot be dietary supplements due to their status as active ingredients in approved or investigated drug products.

The company's websites and product labels contain claims that classify products like Cold & Flu Relief, Anxiety Relief, and various Muscle Melt items as unapproved new drugs because they are not generally recognized as safe and effective for their intended uses (e.g., treating disease, affecting body structure/function). The Inflammation Relief product is also misbranded for lacking adequate directions for layperson use, as it addresses conditions requiring professional supervision.

Furthermore, the dietary supplement products are adulterated under CGMP regulations (21 CFR Part 111). Violations include failing to establish specifications for components and finished products (21 CFR 111.70), not preparing and following written master manufacturing records (21 CFR 111.205(a)), and failing to establish and follow written procedures for quality control operations (21 CFR 111.103) and product complaints (21 CFR 111.553). The firm's response regarding hiring a