Cannabis, Hemp, and Cannabinoids (CBD)

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:

  • Understanding the current FDA regulatory status of, and developing potential regulatory pathways for, the use of CBD, other cannabinoids, and hemp ingredients in foods, dietary supplements, vape products (pens and e-liquids), pet products, cosmetics, and other applications;
  • Assessing state licensing expectations;
  • Understanding the requirements for pharmaceutical trials under state, FDA, and DEA oversight;
  • Complying with federal packaging regulations affecting CBD, hemp, and cannabis products;
  • Evaluating challenges with the export and import of CBD, other cannabinoids, and hemp products;
  • Developing suitable product labeling for products in different categories;
  • Advising on the marketing requirements for CBD, other cannabinoids, and hemp products in other jurisdictions, including Europe and Canada; and
  • Considering uses of CBD, other cannabinoids, and hemp in non-FDA regulated products (such as textiles).

Representative examples of specific issues we have addressed include the following:

  • Provided guidance to a major packaging manufacturer regarding compliance issues related to marketing their product specifically for packaging marijuana, CBD, and hemp products, including edibles;
  • Evaluated the requirements for cannabinoid compounds intended for therapeutic benefit;
  • Advised a bottled water company regarding the information that would be needed to support a Generally Recognized as Safe (GRAS) claim for CBD in a CBD-infused bottled water product;
  • Advised on the regulatory status of CBD and hemp compounds derived from sources other than the Cannabis sativa L. plant; 
  • Advised major e-vapor manufacturers on legal, regulatory, and scientific matters regarding the use of CBD and related compounds in vape devices;
  • Advised a large convention organizer on the legality of CBD and hemp products on the show floor;
  • Offered guidance on labeling requirements, Good Manufacturing Practices, export regulations, and related issues;
  • Assisted clients in responding to Warning Letters and enforcement actions;
  • Advised clients on the enforcement tools available to FDA that it could use to take regulatory action against foods and/or dietary supplements that contain CBD or other cannabinoids; and
  • Provided analyses of federal and state legislative provisions concerning CBD, other cannabinoids, and hemp ingredients.

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@saalts.com for more information.




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