USA – FDA Begins Plotting Pathway for Cannabis Product Approvals

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday announced that the agency is looking into developing a regulatory pathway for cannabis and cannabis-derived products, including cannabidiol (CBD), in response to recent legislative changes to how certain types of cannabis are scheduled under the Controlled Substances Act (CSA).


Last year, the Agriculture Improvement Act, also known as the Farm Bill, defined hemp as cannabis that contains less than 0.3 percent delta-9-tetrahydrocannabinol (THC) and removed hemp from the list of controlled substances under the CSA.

Around the same time, FDA approved the first cannabis-derived drug, GW Pharmaceuticals’ Epidiolex (cannabidiol), to treat seizures that present with two rare forms of epilepsy.

Additionally, while other forms of cannabis remain listed as Schedule I drugs, some 30 states and the District of Columbia, Guam and Puerto Rico have legalized the medical use of marijuana, and ten of those states and the District of Columbia have approved recreational marijuana use.

The trend toward state level legalization and the removal of hemp from the CSA has led to a proliferation of cannabis and cannabis-derived products on the market, with major pharmacies announcing plans to carry CBD products. Many of these products have been sold as foods and dietary supplements, while some have been marketed with unsupported medical claims…