FDA Extends Public Comment Period on CBD
On April 3, 2019, the U.S. Food and Drug Administration opened a public comment period to discuss agricultural hemp and CBD. The purpose of this public comment period is to:
Obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds Docket N0 FDA-2019-N-1482
An Extended Deadline – July 16, 2019
The original ending date for this public comment period was today, July 2 2019, however it has been extended through July 16, 2019 @ 11:59pm EST.
We encourage anyone with pertinent scientific information about CBD to submit a written statement to the FDA before the deadline.
How to Submit Written Comments on CBD to the FDA
All submissions received must include the Docket No. FDA-2019-N-1482 for “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments.”
Comments may be submitted to: https://www.regulations.gov/docket?D=FDA-2019-N-1482
For written/ paper submissions, submit comments to:
Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852
Comments post-marked on July 16th will be considered valid submissions.
FDA Needs Scientific Data
Please note FDA is not looking for anecdotal comments regarding CBD. They are looking for scientific data, particularly on the following:
Any safety data on special human populations (e.g., children, adolescents, pregnant and lactating women) or animal populations (e.g., species, breed, or class).
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).
What margin of exposure would represent an appropriate and safe level from anticipated cumulative exposure?
Safety data to support the safe use of CBD in general food use (including dietary supplements).
Adverse events data, number of bottles sold, serving size (CBD amount) and any other information to support safety
To read the full FDA notice of public hearing, including more specifics on what types of information they are looking for, click here. This is also where you can find detailed instruction on providing confidential testimony as well as directions to turn in your written submission in person if you prefer.
If you have further questions about the FDA, hemp or CBD products as they pertain to your business, feel free to contact EARTH Law, LLC to make an appointment.