FDA Requests Comments for Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds

On April 3, 2019, the Food and Drug Administration (FDA) published a request for comments for scientific data and information about products containing cannabis or cannabis-derived compounds (84 Fed. Reg. 12969).

The Agriculture Improvement Act of 2018, Public Law 115-334 (the 2018 Farm Bill) changes certain Federal authorities relating to the production and marketing of hemp. These changes include removing hemp from the Controlled Substances Act, which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under Federal law.  Congress recognizes FDA’s important public health role with respect to all the products it regulates, and the 2018 Farm Bill explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act.

Based on the above, FDA seeks public comment on the health and safety risks, and the manufacturing and product safety concerns associated with products containing cannabis and cannabis-derived products.  The specific areas upon which FDA wishes public input and comment are outlined in the request for comment published in the Federal Register.

Advocacy is aware that many of the businesses that manufacture and distribute cannabis and cannabis-derived products are small.  We encourage affected small businesses to submit comments to the FDA about the safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis and cannabis-derived products.

The comment deadline is July 2, 2019.

  • Submit electronic comments here.
  • Submit written submissions in the following way: Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • Advocacy contact: Linwood Rayford at 202-205-6533.