The U.S. Food and Drug Administration (FDA) re-opened a docket this week seeking scientific data and information about products containing cannabis or cannabis-derived compounds such as cannabidiol (CBD). This move is intended to help close the agency's knowledge gaps surrounding CBD, part of the FDA's comprehensive approach to CBD oversight discussed in an alert issued earlier this week.

Originally, the docket opened on April 3, 2019 in advance of an FDA public meeting to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. The May 31, 2019 public meeting was widely attended by representatives from academia, agriculture, consumers, health professionals, manufacturers, retailers and distributors, patient groups, and public safety groups, as well as the FDA commissioner at the time. Following in the footsteps of his predecessor, the current FDA commissioner has taken the reins on CBD regulation, focusing on public education, selective enforcement, and scientific data accumulation.

As reported in yesterday's Federal Register notice, the public docket has been re-opened "[i]n light of the continued interest and increased research activity in this space, as well as the need for additional scientific data on this topic." The notice details the specific topics and types of data that the FDA is soliciting, which are summarized at a high-level below:

• The risk of liver injury from CBD;
• Toxicities of some of the active metabolites of CBD;
• Impact of CBD on the male reproductive system;
• Effect of CBD co-administration with other medicines, alcohol, dietary supplements, tobacco products, and herbal products;
• Impact on neurological development;
• Sedative effects of CBD;
• Transdermal penetration and pharmacokinetics of CBD;
• Clinical studies (including real world data/evidence) to address safety questions related to long-term sustained or cumulative exposure to CBD, including in vulnerable populations such as children, the elderly, and women who are pregnant or breastfeeding;
• Long-term (chronic) repeated dose toxicity studies in appropriate animal models, evaluating the most relevant toxicological end points;
• Clinical studies on the effect of different routes of CBD administration;
• Effect of CBD on pets and food-producing animals;
• Studies to characterize the potential for bioaccumulation of CBD over long-term exposure; and
• Effect of CBD on the eye.

Currently, more than 4,000 comments are available in the docket since it was opened in April 2019. Readers are encouraged to evaluate the potential impact of the comments as submissions made to the docket will likely serve as part of an administrative record to help inform the agency's regulatory oversight and continued evaluation of cannabis and cannabis-derived compounds.