New Leaf Pharmaceuticals, LLC – FDA Warning Letter, Dec 22, 2020

The FDA issued a Warning Letter to New Leaf Pharmaceutical after reviewing its website and Facebook page in July and December 2020, identifying that the company was marketing "RHINODOL CBD" nasal spray products as unapproved new drugs and misbranded drugs. The products are deemed unapproved new drugs under sections 505(a) and 201(p) of the FD&C Act (21 U.S.C. 355(a), 321(p)) because they are not generally recognized as safe and effective for their intended uses, and no FDA-approved applications are in effect. The introduction of such drugs into interstate commerce violates section 301(d) (21 U.S.C. 331(d)). Additionally, the products are misbranded under section 502(f)(1) (21 U.S.C. 352(f)(1)) because their labeling fails to bear adequate directions for use, as required by 21 CFR 201.5, for conditions not amenable to self-diagnosis. Introducing misbranded drugs violates section 301(a) (21 U.S.C. 331(a)). The FDA highlighted public health concerns due to the intranasal administration route. New Leaf Pharmaceutical must take prompt action to address these violations and notify the FDA within fifteen working days, detailing corrective steps and preventative measures. Failure to comply may result in legal action, including seizure and injunction.