FDA WARNING_LETTER - Noli Oil, LLC - November 25, 2019

The FDA issued a Warning Letter to Noli Oil on November 22, 2019, following a September 2019 review of their website and social media. The Agency determined that Noli Oil markets numerous cannabidiol (CBD) products, including oils, balms, gels, gummies, caramels, softgels, and various creams and soaps, as well as pet products like dog treats and pet oil. The FDA found that Noli Oil's human CBD products are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act, as they are marketed with therapeutic claims. These products are also misbranded under section 502(f)(1) because their labeling lacks adequate directions for use. Furthermore, human food products containing CBD (gummy bears, caramels, watermelon rings) are considered adulterated and their introduction into interstate commerce is a prohibited act under section 301(ll) of the FD&C Act, as CBD is an unapproved food additive and not generally recognized as safe (GRAS). Similarly, Noli Oil's "Dog Treats (Beef Flavored)" and "Pet CBD Oil" are unapproved new animal drugs, unsafe under section 512(a), and adulterated under section 501(a)(5) due to therapeutic claims. Marketing CBD in animal food is also a prohibited act under 301(ll) and renders the food adulterated as CBD is not a GRAS animal food additive. Noli Oil must promptly correct these violations and respond within fifteen working days, detailing corrective actions and prevention measures. Failure to comply may result in legal action, including product seizure or injunction.