FDA extends deadline for submitting comments on cannabis

As many in the hemp industry already know, the U.S. Food & Drug Administration (FDA) is in the process of determining appropriate regulations for products containing cannabis, including hemp-derived CBD. On May 31st the FDA held a public hearing to collect feedback from industry and consumer stakeholders on this topic. As noted by the Hemp Industries Association (HIA) in a newsletter late last month, most of the over 3,000 comments received so far contain anecdotal testimony that are missing the scientific data needed for the FDA to make scientifically-informed decisions on how to regulate cannabis-derived products in the marketplace in a manner that best protects public safety. Data sought by the FDA includes:

  1. Any safety data on special human populations (e.g., children, adolescents, pregnant and lactating women) or animal populations (e.g., species, breed, or class).

  2. Any safety data on overlap of therapeutic dose levels from approved drug products and potential exposure from other uses (e.g., from food, dietary supplements, cosmetics).

  3. What margin of exposure would represent an appropriate and safe level from anticipated cumulative exposure?

  4. Safety data to support the safe use of CBD in general food use (including dietary supplements).

  5. Adverse events data, number of bottles sold, serving size (CBD amount) and any other information to support safety

If you or your company has any of the above data, please submit a comment to the FDA, which recently extended the comment submission deadline to July 16th.

Click here to learn more about the May 31st public hearing, including seeing the video recording and transcript, and here for a overall summary of the FDA’s position.

Kris Plunkett