FDA WARNING_LETTER - nextl3vel services group, llc - December 22, 2020

The FDA issued a Warning Letter to This Stuff Is Good For You, LLC, following reviews of their websites in September and December 2020. The company is marketing unapproved new drugs and misbranded drugs for human use, and unapproved new animal drugs and adulterated animal foods.

For human products, the FDA determined that all strengths and varieties of CBD products are unapproved new drugs under section 505(a) of the FD&C Act, and misbranded drugs under section 502(f)(1) due to inadequate directions for use. Specific concerns include marketing CBD products for children (e.g., "CBD FOR CHILDHOOD ADD/ADHD"), CBD Vape products due to inhalation risks, and reLeaves Vision+ 20mg CBD Eye Drops due to potential for irreversible eye damage. Additionally, certain CBD-containing products promoted as conventional human foods (e.g., CBD Sleep Syrup, CBD Vegan Gummy’s, Chronic Candy products) are considered adulterated under section 301(ll) and 402(a)(2)(C)(i) because CBD and melatonin (an ingredient in CBD Sleep Syrup) are unapproved food additives and not generally recognized as safe (GRAS).

For animal products, reLeaves 40mg CBD Pet Shampoo, reLeaves Full-Spectrum CBD Dried Dog Treat Cookies, and reLeaves CBD Broad/Full Spectrum Tinctures are unapproved new animal drugs under