As previously reported on this blog, the Agriculture Improvement Act (also known as “the 2018 Farm Bill”) removed hemp from the Controlled Substances Act, which means it is no longer an illegal substance under federal law.  However, the 2018 Farm Bill does not affect FDA’s authority to regulate derivatives of cannabis (e.g., CBD) or other hemp products, or change the regulatory requirements for such materials in FDA-regulated products like food, dietary supplements, cosmetics, or drugs.  As previously mentioned, FDA released a statement clarifying their position on the use of cannabis or cannabis-derived compounds in food and dietary supplements.  In sum, it is still illegal to sell a food or dietary supplement that contains added CBD or THC in interstate commerce.

In a January 15, 2019 letter to FDA Commissioner Scott Gottlieb, Senators Ron Wyden (D-OR) and Jeff Merkely (D-OR) urged the Commissioner to update federal regulations governing the use of certain hemp-derived ingredients in food, beverages, and dietary supplements. The Senators state that “outdated regulations limits producers from taking full advantage of the industrial hemp market by, for example, prohibiting food products containing CBD from being sold across state lines.”  The Senators note there has been increasing widespread public interest in the production and use of CBD, and that farmers in both Oregon and nationwide are poised to make substantial economic gains should the regulations be updated.

As of the time of this blog’s publication, the government has been partially shutdown for 33 days. The Senators recognize that FDA is therefore operating with limited staff, and thus conclude the letter with a request for FDA’s response to the following set of questions within 30 calendar days of the government reopening: