FDA has issued a final guidance, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry.” This guidance provides the FDA’s current thinking on several topics relevant to clinical research related to developing drugs containing cannabis and cannabis-derived compounds. The agency said it is committed to supporting robust scientific research into understanding the therapeutic uses and safety of cannabis products and that it believes the drug-development and -approval process represents the best way to ensure safe, effective, and high-quality new medicines, including any drugs derived from cannabis, are available to patients needing appropriate medical therapy.
FDA yesterday issued marketing denial orders for 2 menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company: Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%. FDA said the company risks enforcement actions if they market or distribute these products in the U.S. The company can resubmit applications or submit new applications to address the deficiencies of these products, FDA added.