The U.S. Department of Agriculture (“USDA”) has announced a notice of comment period extension on the Hemp Production Program Interim Final Rule allowing hemp stakeholders to submit comments until January 29, 2020. By way of brief background, the Agriculture Improvement Act of 2018 (“2018 Farm Bill”) required USDA to establish the Program, which attempts to clarify the regulatory frame for States and Indian Tribes for the domestic production of hemp.
The Rule outlines provisions for the States and Indian Tribes to submit hemp plans for USDA approval. It also establishes THC testing protocols, interstate transportation, licensing protocols, and eligibility rules for federal programs (e.g., loan and crop insurance programs). More specifically, by and through the Rule, USDA is imposing strict sampling and testing requirements to ensure that the hemp does not contain THC exceeding 0.3%. However, farmers would not be considered in violation of the Rule unless the hemp crops contain THC exceeding 0.5%. Notwithstanding this, farmers are required to dispose any hemp crops with 0.3% – 0.5% THC. Furthermore, the Rule allows hemp to be transported across state lines even in the instances where the state does not authorize hemp production. Of note, states may enact stricter regulations impacting the production, transportation, and sale of the hemp and its derivatives.
As indicated above, the Rule provides much needed guidance to producers and farmers. However, it does not have any bearing on the FDA’s regulation on the hemp and its derivatives in food, beverage or dietary supplements. In other words, stakeholders in the hemp industry must comply with not only FDA and USDA regulations but also state laws that are often not in line with the federal regulations. Moreover, the Rule does not address several key issues including, but not limited to, seed certification, total THC testing instead of the delta-9 tetrahydrocannabinol testing, and the potential issues arising from testing out of only Drug Enforcement Administration registered labs.
With the exponential growth in the hemp industry and the growing regulatory concerns, Stakeholders should review the Rule in detail and submit comments to USDA. Frier Levitt assists state and national associations around the country in drafting proposed legislation. Our “request for comment” work has played a prominent role on important national issues. If you want to learn more about the Interim Final Rule or would like to submit comments before January 29, 2020, contact Frier Levitt today. Time is of the essence.
On May 31, 2019, the Food and Drug Administration (FDA) held a widely anticipated public hearing to gather information on the use of cannabis and cannabis-derived compounds, including cannabidiol (CBD), in consumer products such as foods, dietary supplements and cosmetics. Although FDA did not reveal any new regulatory pronouncements, the hearing marks an important initial step in the Agency’s on-going evaluation of a potential evidence-based regulatory pathway for such products.
At the hearing, Acting Commissioner Dr. Ned Sharpless delivered opening remarks and reiterated that recent changes to federal and state law, and the explosion of CBD products in the marketplace, have not affected FDA’s view that CBD cannot be lawfully added to any FDA-regulated consumer product. While the Agriculture Improvement Act of 2018 (the “Farm Bill”) generally legalized CBD derived from hemp (defined as cannabis with THC content below 0.3% by dry weight), the Farm Bill explicitly preserved FDA’s authority to regulate foods, drugs, dietary supplements and cosmetics containing CBD. Dr. Sharpless said critical questions remain about the safety of widespread CBD use and the Agency will carefully evaluate whether evidence supports the broad use of CBD in FDA-regulated products.
Echoing his predecessor Dr. Scott Gottlieb, Dr. Sharpless noted that FDA is primarily concerned with over-the-counter CBD products that claim to prevent, diagnose, mitigate, treat or cure serious diseases such as cancer. While FDA enforcement to date has focused on CBD products making egregious disease claims, Dr. Sharpless noted that FDA does not have a policy of enforcement discretion with respect to any CBD products.
Over 100 people testified at the hearing from a broad range of interest groups including academia, health professionals, agriculture, manufacturers, retailers, distributors, consumer groups, patients, state governments, public safety organizations, and legal professionals. Speakers discussed a wide array of uses for CBD products and provided anecdotal and scientific conclusions regarding CBD use. Several speakers described the current CBD market as the ‘Wild West’ and emphasized the need for instituting quality assurance and good manufacturing standards. Many speakers also addressed the difficulty of testing CBD products in the current legal environment and how that hinders the creation of quality CBD products.
Comments to the FDA docket may be submitted until July 2, 2019.
If you need assistance navigating the unsettled and complex regulatory environment for cannabis-derived products including CBD, or if you are interested in submitting comments to the docket, contact Frier Levitt Government Affairs today.