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.
By: Dae Y. Lee, Pharm.D., Esq., CPBS
Recent events signal the need for CBD manufacturers to have a clear game plan to address legal uncertainty and confusion by law enforcement and prosecutors. New York prosecutors recently dropped felony marijuana possession charges against a New York-based CBD manufacturer. The manufacturer was arrested in November for allegedly receiving 106 pounds of marijuana. However, the shipment contained hemp plants. Notably concerning, the shipment included documents verifying that the hemp contained 0.06% THC, which is lower than the 0.3% threshold set forth by the Agriculture Improvement Act of 2018 (2018 Farm Bill). Of note, any cannabis plant that contains more than 0.3 % THC would be considered non-hemp cannabis under federal law and would thus face no legal protection under the 2018 Farm Bill.
Law enforcement’s wrongful seizure demonstrates a lack of knowledge and understanding of CBD, which may lead to business interruption and financial loss. Stakeholders should make sure they have a Plan of Action to address wrongful seizure and surrounding criminal issues, as well as appropriate commercial insurance coverage to mitigate the economic risks.
New York is clearly making efforts to address uncertainty through legislation. New York Governor Cuomo signed a comprehensive hemp bill this month that allows and sets up a regulatory framework for the growth, sale, distribution, transportation, and processing of industrial hemp and hemp extracts including CBD in the state. Stakeholders should understand the contours of this new law.
Regulation of hemp and its derivative products remains mired in a jumble of conflicting state and federal law. Stakeholders, ranging from manufacturers to retailers, must remain compliant. If your company handles hemp and its derivatives, contact Frier Levitt today to speak to an attorney.
Cannabidiol (CBD) products have seemingly flood the market, suddenly springing up in many places. This has lead pharmacies, natural health food stores and other retailers to discuss new strategies to position themselves in the developing market of CBD. However, recent market saturation and uncertain regulatory oversight have caused massive confusion of whether these products are legal or not.
In this recorded webinar, Ron W. Lanton, Esq., Executive Director of Frier Levitt Government Affairs, explores several issues around CBD, including:
• CBD vs. THC
• An examination of current state and federal CBD and Marijuana policies
• A discussion of current administration viewpoints, including the FDA and DEA
• Other related business trends
Viewers of this webinar will be able to:
• Understand relevant CBD terms
• Comprehend the current viewpoints CBD and Marijuana policies and business trends
• Pinpoint the relationship of the FDA and DEA on CBD