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, the European Union, and other jurisdictions around the world. We advise manufacturers, distributers, and suppliers of CBD, other cannabinoids, and hemp products globally by assessing licensing expectations, understanding the requirements for pharmaceutical trials under various authorities, complying with relevant packaging regulations, developing suitable product labeling, advising on marketing requirements, and evaluating and overcoming product export and import challenges. We counsel clients on the current Food and Drug Administration (FDA) regulatory status of these products across many applications, including food, dietary supplement, vape product (pens, delivery systems, and e-liquids), pet product, and cosmetic. We also advise clients on the use of these ingredient in non-FDA regulated products, such as textiles.
Keller and Heckman works closely with the FDA and similar international agencies to explore regulatory pathways to get CBD and similar products to market and keep them there. We utilize the expertise of our other practice groups, including Food and Drug, California Proposition 65, Pesticides, and Tobacco and E-Vapor, as well as our in-house scientists to provide clients with creative and streamlined regulatory strategies to navigate the entire product lifecycle, from scientific research to product development and manufacturing to global marketing and distribution. Our in-house scientists have expertise in a wide range of disciplines, including molecular biology, toxicology, genetic engineering, and chemistry.
- Provided guidance to a major packaging manufacturer regarding compliance issues related to marketing packaging for 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
- Provided analyses of federal and state legislative provisions concerning CBD, other cannabinoids, and hemp ingredients