The industry did not have to wait long to hear from Congress and FDA following the May 31, 2019 public hearing on the safety and sale of products containing industrial hemp-derived compounds, including CBD. First, on June 3, 2019, the House Appropriations Committee (the Committee) published a report to accompany its spending bill for fiscal 2020, expressing concerns about the proliferation of foods and dietary supplements “containing cannabis and cannabis-derived products marketed in violation of the Federal Food, Drug & Cosmetic Act (FDCA).”1 The Committee stated that such products pose potential health and safety risks to the public and noted FDA’s authority (as set forth in the 2018 Farm Bill) to take action regarding cannabis, including hemp and CBD.
The Committee urged FDA to “assert its commitment to identifying lawful federal regulatory pathways for CBD foods and dietary supplements if such pathways may include necessary public health and safety parameters that will protect the public health.” The Committee suggested FDA explore labeling requirements and limits on CBD and other cannabis-derived ingredients in products, based upon anticipated total exposure levels. The Committee further indicated that it expects FDA to preserve incentives to invest in research into CBD with the goal of better understanding CBD’s uses and potential benefits.
Thereafter, on June 14, 2019, FDA’s Working Group on CBD, led by Deputy Commissioner Amy Abernethy and Principal Associate Commissioner for Policy Lowell Schiller, issued a statement outlining the working group’s thinking, potential next steps for FDA, and outstanding questions from the public hearing.2 The statement reiterated FDA’s intent to take a science-based approach to any rules and regulations that it chooses to implement with respect to cannabis and cannabis-derived compounds, including CBD. The statement briefly outlined the current state-of-play for those products that fall within FDA’s jurisdiction, and provided insight into where FDA intends to go from here.
- Where things stand. FDA reiterated that before a product containing CBD is marketed as a drug, it must go through new drug approval. In addition, FDA stated that it remains currently illegal to put into interstate commerce a food containing CBD or to market CBD as, or in, a dietary supplement. Nevertheless, FDA acknowledged the substantial public interest in marketing and accessing CBD in food and dietary supplements and is exploring potential ways for CBD products to be lawfully marketed. FDA indicated that the statutory provisions currently prohibiting this practice do allow FDA to issue regulations creating an exception. FDA continues to have lingering questions about the risks to the public health posed by CBD but is exploring ways to address the regulation of CBD products.
- FDA hears you. FDA acknowledged that many industry stakeholders want a regulatory pathway to enable the lawful marketing of cannabis-derived products (including CBD) in food and dietary supplements, including clear safety standards; the need to support research evaluating the therapeutic benefits of CBD; the need for consistent terminology related to these products; and the need for industry standards for manufacturing of CBD products. FDA stated that it will continue to explore pathways for such regulation. FDA will do so in a way that protects public health, maintains incentives for cannabis drug development, and creates a robust administrative record that is needed to support the initiation of any rulemaking.
- Questions remain. FDA indicated that uncertainty remains as to the safety of CBD and that the public hearing did not resolve lingering questions regarding whether, among other things, CBD products are safe to consume daily; how CBD products impact vulnerable populations like children, the elderly and pregnant-women; and whether there are risks associated with long-term exposure to CBD products. FDA encouraged industry stakeholders to continue submitting comments to the public docket on safety, manufacturing, product quality, marketing, labeling, and the sale of products containing cannabis and cannabis-derived products.
Overall, FDA expressed a desire to thoughtfully approach rules and regulations regarding CBD but gave no indication regarding when it will take firm steps in that direction. In the meantime, FDA has extended by two weeks the deadline to submit written comments. The deadline is now July 16, 2019.3
We intend to monitor written comments submitted by the industry as well as any additional steps taken by FDA’s Working Group and Congress as a whole. We will continue to keep you informed on further developments. In the meantime, should you have any questions or concerns, please do not hesitate to reach out to the authors of this post or any member of Reed Smith’s Cannabis Law Team.
- Please note that, although the Committee’s report refers generally to “cannabis and cannabis-derived products,” it appears from the context that the Committee is concerned with industrial hemp, a form of cannabis, and not cannabis generally.
- “FDA is Committed to Sound, Science-based Policy on CBD,” Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner, and Lowell Schiller, J.D., Principal Associate Commissioner for Policy, June 14, 2019.
- Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Extension of Comment Period, 84 Fed. Reg. 28822 (June 20, 2019).
Client Alert 2019-161
