On February 27, 2019 both the Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”) provided new insights and guidance related to their proposed regulatory processes for hemp under the 2018 Farm Bill. I will summarize these agency statements below, and give some context for what hemp and CBD businesses can expect in the near term.
The USDA posted a webpage titled Hemp Production Program (“Program Update”). The 2018 Farm Bill directs the USDA to create regulations and guidance to implement a program for hemp cultivation in the US. The USDA has started to gather information to begin the process of rulemaking. The USDA will use this information to “formulate regulations that will include specific details for both federally regulated hemp production and a process for the submission of State, and Indian tribal plans to USDA.”
The Program Update states that the USDA’s goal is to have regulations in place by fall of 2019 to accommodate the 2020 planting season. The Program Update also indicates that cultivators should operate under the 2014 Farm Bill for the 2019 planting season. The 2018 Farm Bill extension of the 2014 authority expires 12 months after USDA has established the plan and regulations required under the 2018 Farm Bill. The USDA will hold a listening session on hemp production in the form of a webinar on March 13, 2019, at a to-be-determined time.
FDA Commissioner Dr. Scott Gottleib provided testimony to the House Committee on Appropriations on the FDA’s status of operations. Kyle Yaeger of Marijuana Moment, reported on the testimony moments after Gottleib stood down. According to Gottleib, the FDA understands that “Congress wants there to be a pathway for CBD to be available.” Gottleib qualified this by saying that CBD access is not a straightforward issue because CBD has already been investigated and approved as a drug, Epiodiolex, which generally means CBD cannot be added to food. This is where things get interesting.
Gottleib stated that CBD products could be available “in a high concentration, pure formulation as a pharmaceutical product” and “at a different concentration as a food product or dietary supplement.” This only adds to the rumors that the FDA may distinguish hemp extracts by those that include the full array of cannabinoids found in the plant (“full spectrum extracts”) and those that have isolated CBD alone (“CBD isolate”). At this point, that distinction is just conjecture, but Gottleib’s recent statement is an indicator that FDA is at the very least considering this distinction. For more information on this and the Red Yeast Rice case that has lead to the widespread industry speculation, please see the following:
- A Shift in Nomenclature for Hemp-CBD Products
- The FDA’s Stance on Hemp Derived CBD as a Dietary Supplement (Part 1) and (Part 2)
Gottleib went on to say that “We believe it does have therapeutic value and has been demonstrated [. . .] but I will tell you this is not a straightforward process. There’s not a good proxy for us doing this through regulation.” Gottleib is right. CBD doesn’t fit in nicely to the FDA’s general framework. That is one of the reasons why we write so frequently on CBD and the FDA.
Gottleib also noted that the FDA will hold a public hearing on hemp and CBD in April. That hearing is sure to draw a TON of interest, so stay tuned for that.
These recent updates from the FDA and USDA are not groundbreaking, but they do provide some new information, including when and how the public can provide input into the critical rulemaking process. We will continue to monitor FDA, USDA and other federal agencies as they figure out how to regulate legal hemp.
Read this full story…..: USDA and FDA Shed Light on Hemp and CBD