Keller and Heckman is at the forefront of the rapidly evolving legal and regulatory landscape for cannabidiol (CBD), cannabis, and hemp products in the United States, European Union, and around the world. In 2018, the Agricultural Improvement Act of 2018 (also known as “the 2018 Farm Bill”) modified U.S. federal law relating to the production and marketing of “hemp,” defined as cannabis (Cannabis sativa L.), and derivatives thereof (e.g., cannabinoids, including CBD) with less than 0.3% on a dry weight basis concentrations of tetrahydrocannabinol (THC). The most significant change is that hemp is now excluded from the Controlled Substances Act, which means it is no longer under the jurisdiction of the Drug Enforcement Administration (DEA). However, food, dietary supplements, and other products made with CBD or other cannabis- or hemp-derived compounds are still subject to the Food and Drug Administration’s (FDA’s) authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Section 351 of the Public Health Service Act.
Because of our comprehensive and extensive experience dealing with regulation of food, dietary supplements, drugs, medical devices, tobacco, and e-vapor, Keller and Heckman attorneys and scientists are ideally positioned to advise companies in the hemp and CBD industries on myriad regulatory requirements for these novel products, in the United States and abroad. As part of this work, we have engaged and met with FDA to explore establishing regulatory pathways for CBD and similar compounds. In addition, Keller and Heckman utilizes the expertise of our food and drug, California Proposition 65, environmental, tobacco, chemical control, workplace safety and health, pesticides, product safety, transportation, and telecommunications practice groups to identify and address legal and regulatory issues across the entire supply chain and product life-cycle.
We provide legal and scientific support to CBD, other cannabinoids, and hemp manufacturers; and distributors and their suppliers with respect to legal and regulatory requirements including, but not limited to, the following areas:
Representative examples of specific issues we have addressed include the following:
The legal and regulatory landscape for CBD, cannabis, and hemp products is advancing quickly. Keller and Heckman’s attorneys and scientists are at the forefront of this developing industry. For more information, see Publications and News & Events to the right on this page, or visit the Keller and Heckman blogs listed below:
Please contact CBD@khlaw.com for more information.