By Robert Claiborne, Dascher Pasco & Bryan Haynes, Troutman Pepper Hamilton Sanders LLP
Did the FDA violate the Constitution when it issued its rule Deeming Tobacco Products to Be Subject to the Federal Food, Drug, & Cosmetic Act, 81 Fed. Reg. 28,973 (May 10, 2016) (the “Deeming Rule”)? No, according to a recent decision from the U.S. Court of Appeals for the D.C. Circuit.
On Thursday, July 30, 2020, Democratic Senator Tina Smith (D-MN) filed a new bill to federally legalize marijuana. The bill, titled the “Substance Regulation and Safety Act,” would “decriminalize and deschedule cannabis” and provide for its regulation by removing both marijuana and tetrahydrocannabinols from the Controlled Substance Act and giving the Food and Drug Administration the authority to regulate cannabis products in the same manner, and to the same extent, as FDA regulates tobacco products.
On Tuesday, July 21, 2020, the U.S. Food and Drug Administration (FDA) issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry.” While it contains little “new news,” the draft guidance describes FDA’s current thinking on several topics relevant to clinical research related to development of drugs containing cannabis or cannabis-derived compounds, including sources of cannabis for clinical research, information on quality considerations and recommendations regarding calculating delta-9 tetrahydrocannabinol (THC) levels. The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities.