Increasing consumer interest in cannabis-derived ingredients has led to an explosion of the use of the non-intoxicating cannabinoid, cannabidiol (CBD) in a wide variety of products, including drugs, foods, dietary supplements, personal care products, and cosmetics for both human and animal use. While CBD-containing products continue to proliferate – online and in stores across the globe – regulators have struggled to keep pace with the marketplace, and are now starting to examine and exercise their enforcement authorities over CBD-containing products.

Confusing matters further, numerous media outlets have reported that CBD is now “legal.” In the U.S., the recent passage of the 2018 Farm Bill clarified that hemp, and hemp-derived ingredients including CBD, are not Schedule I substances under the Controlled Substances Act. While this change brought much-needed clarity to the legal distinction between Cannabis that is considered non-controlled hemp and Cannabis that is illegal marijuana, hemp-derived CBD remains subject to regulation by several regulatory agencies at both the federal and state level.

FDA has taken the view CBD cannot be marketed as an ingredient in foods or dietary supplements under the exclusionary clauses of the statute that prohibit a substance from marketing as a food or dietary supplement if it was first studied as an investigational new drug. States such as Maine recently started enforcing the FDA position by taking market action against CBD-containing food and dietary supplements."

The uncertainty and complexity around the use of CBD in foods, dietary supplements, and cosmetics is not unique to the U.S. In the U.K., where a booming marketplace for CBD-containing products has also emerged, the Food Standards Authority (FSA) recently determined that CBD is a novel food ingredient and is advocating for removal of CBD-containing foods from the marketplace until CBD is approved as a novel food.

The ever-changing landscape for CBD underscores the need for companies to closely monitor regulatory developments and conduct appropriate diligence before commercialization of a product in their market.

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