FDA Reopens Cannabis Docket

FDA has reopened the comment period indefinitely for its public hearing on products containing cannabis or cannabis-derived compounds.In doing so, FDA is seeking scientific data and information on cannabis and cannabis-derived compounds, particularly cannabidiol (CBD).

On May 31, 2019, FDA hosted a public hearing on “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds” and established a public docket to obtain information related to cannabis and cannabis compounds.The initial docket closed on July 16, 2019.Since then, FDA has issued a report to Congress providing an update on the Agency’s evaluation of potential regulatory pathways for CBD products and a description of how FDA expects to proceed moving forward.The report described how FDA is continuing to evaluate CBD and how FDA seeks more information on CBD safety. 

Consistent with its report to Congress, FDA has reopened the comment period for the public hearing on cannabis and extended it indefinitely to allow interested parties to comment and provide relevant data.FDA is “particularly interested in data that may help to address uncertainties and data gaps related to the [sic] CBD.”

These data gaps include:

• The risk of liver injury from CBD;
• Toxicities of active metabolites of CBD;
• Impact of CBD on the male reproductive system;
• Effect of CBD co-administration with other substances;
• Impact of CBD on neurological development;
• Sedative effects of CBD;
• Transdermal penetration and pharmacokinetics of CBD;
• Clinical studies to address safety associated with long-term use of CBD;
• Long-term repeated dose toxicity studies on CBD;
• Clinical studies on the effect of different routes of administration for CBD;
• Effect of CBD on pets and food-producing animals;
• Studies to characterize the potential for bioaccumulation of CBD; and

• Effect of CBD on the eye.

Stakeholders possessing data and information on these issues should consider submitting comments to the docket to help advance FDA’s considerations of the potential for establishing a clearer pathway to market for CBD products (in addition to the new drug approval pathway).

As Covington is advising clients on federal and state legal landscapes surrounding products containing CBD, we are creating a CBD mailing list for clients and friends of the firm. If you are interested in receiving related communications, sign up here.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice below.