On October 31, 2019, the United States Department of Agriculture (USDA) published an interim final rule (IFR) on domestic hemp production. This rule establishes a regulatory framework for USDA oversight of domestic hemp production in accordance with the 2018 Farm Bill.  While many questions remain about how the federal government, including the U.S. Food and Drug Administration (FDA), will regulate hemp-derived products, including cannabidiol (CBD) cosmetics, dietary supplements, and food products, we’ve addressed below the most important takeaways from the IFR with regard to the provisions that would apply to the farmers who are growing hemp.

Scope of Interim Final Rule

The scope of the IFR is limited to the production, sampling, testing, and disposal of hemp plants. The 2018 Farm Bill and the IFR’s requirements (licensing, etc.) apply to hemp producers, and the regulations define producers as, essentially, farmers that grow (or cultivate) hemp plants for market. In other words, the USDA is not regulating the processing, manufacture, testing, or
marketing of hemp-derived products (including CBD products) through the IFR. FDA retains authority over the manufacturing and marketing of CBD, and other cannabinoid-containing pharmaceuticals, foods, dietary supplements, and cosmetics, and the federal Drug Enforcement Administration (DEA) retains jurisdiction over any plants or products that contain greater than 0.3% THC on a dry weight basis. USDA also reiterates that states may not prohibit the transportation or shipment of hemp produced in accordance with the IFR (and the 2018 Farm Bill) or the 2014 Farm Bill.

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Photo of Martin Hahn Martin Hahn

Partner, Washington, DC

Martin Hahn uses his background in food technology and his comprehensive understanding of the laws governing the food industry to navigate clients through the myriad regulatory and business issues impacting the industry from farm to table. He recognizes the demands…

Partner, Washington, DC

Martin Hahn uses his background in food technology and his comprehensive understanding of the laws governing the food industry to navigate clients through the myriad regulatory and business issues impacting the industry from farm to table. He recognizes the demands placed on his clients and finds innovative and creative solutions, particularly when responding to observations raised by regulators  during inspections. Whether the issue involves obtaining the authorization of a new food or dietary ingredient, complying with manufacturing requirements, labeling or advertising, product recalls, or enforcement, Martin serves as an effective advisor and advocate.

Martin’s career has touched on almost every issue impacting the food industry. He has a comprehensive understanding of the laws affecting the labeling and advertising of foods, dietary supplements, infant formulas, medical foods, and foods for special dietary use. He helps clients anticipate new trends and develop the data that is needed to distinguish their products from others on the market. With his understanding of science and technology in the food industry, Martin provides assistance in obtaining regulatory authorizations to market new food ingredients, food packaging materials, and dietary ingredients. He also assists clients in responding to proposed regulations and draft guidance, as well as, tracks and keeps his clients apprised of the latest trends in class action law suits and helps clients anticipate new regulatory initiatives.

Martin grew up on a farm and worked in food processing plants before going to law school. His hands-on experience in the field and degree in food technology allow him to better understand the challenges his clients face in complying with the laws impacting food manufacturing. He understands Hazard Analysis Critical Control Point (HACCP) and the regulations under the Food Safety Modernization Act (FSMA).

Photo of Samantha Dietle Samantha Dietle

Associate, Washington, DC

Sam Dietle provides practical legal solutions and regulatory guidance to all segments of the food industry, including manufacturers, restaurants, retailers, animal producers and processors, and their trade associations.

She advises clients on federal and state regulatory issues that arise throughout…

Associate, Washington, DC

Sam Dietle provides practical legal solutions and regulatory guidance to all segments of the food industry, including manufacturers, restaurants, retailers, animal producers and processors, and their trade associations.

She advises clients on federal and state regulatory issues that arise throughout the entire food supply chain, including labeling and advertising compliance and claim substantiation issues, enforcement actions by the Food and Drug Administration (FDA) and United States Department of Agriculture (USDA), litigation support, and drafting comments on proposed regulations and agency guidance. Sam also counsels clients in consumer products industries on compliance with Consumer Product Safety Commission (CSPC) requirements.

Prior to joining Hogan Lovells, Sam advised food packaging companies on FDA premarket requirements and regulatory compliance matters. Sam also worked with electronic cigarette companies as FDA began to regulate this industry. While in law school, she served as a judicial intern in the U.S. Court of Federal Claims, working on vaccine injury claims cases.