In a statement, Gottlieb said, “In recent years, we’ve seen a growing interest in the development of therapies and other FDA-regulated consumer products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD). This interest spans the range of product categories that the agency regulates. For example, we’ve seen, or heard of interest in, products containing cannabis or cannabis derivatives that are marketed as human drugs, dietary supplements, conventional foods, animal foods and drugs, and cosmetics, among other things. We also recognize that stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products.”
Interest in these products increased last December when Congress passed the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), which among other things, established a new category of cannabis classified as hemp that was removed from the Controlled Substances Act. At the same time, Congress explicitly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.
According to Gottlieb, FDA’s new steps to advance its consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products include: a public hearing on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety; the formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed, including a consideration of what statutory or regulatory changes might be needed; updates to the webpage with answers to frequently asked questions on this topic; and the issuance of warning letters.
More info: www.fda.gov