The federal Food & Drug Administration Commissioner, Scott Gottlieb, recently issued a press release about Hemp and Hemp CBD. Back in December, the FDA had declared that they still have authority over Hemp CBD additives to drugs, foods, and dietary supplements, despite the 2018 Farm Bill removing Hemp from the Controlled Substances Act.
There has been an increase of Hemp CBD products nationwide since the 2018 Farm Bill passed and the FDA has been attempting to figure out a way to issue the enforcement of these products.
On May 31, 2019, the FDA will be holding a public hearing where they will be attaining input from the public to help with the regulation of Hemp CBD. The FDA will also be looking into creating possible avenues for conventional foods and dietary supplements containing CBD to be lawfully marked. The FDA will be making “working groups” for this exploration.
Operators who the FDA may think have made shocking or extreme medical statements about Hemp CBD products are being issued three more warning letters. The FDA also recently updated its Q&A, some of the questions covered are for review below, for a detailed version visit FDA Regulation of Cannabis and Cannabis-Derived Products
How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?
At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334, (the 2018 Farm Bill) was signed into law on Dec. 20, 2018. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” These changes include removing hemp from the CSA, which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law.
The 2018 Farm Bill, however, explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act (PHS Act). FDA treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of whether the cannabis or cannabis-derived compounds are classified as hemp under the 2018 Farm Bill.
Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?
The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.
When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.