Dr. Abernethy announced via Twitter the “FDA is extending the public comment period until 7/16 to submit scientific data/info on products containing cannabis & cannabis-derived compounds. Information that’s collected will assist our ongoing, science-based work related to these products:”
The extension of the comment period was made at the request of people at the public hearing held by the FDA on May 30. “The requests conveyed concern that the current 60-day comment period does not allow sufficient time to develop meaningful or thoughtful responses to the questions that appeared in the notice requesting data and other evidence in support of answers,” read the notice in the Federal Register on Thursday, June 20.
The FDA, in an update published June 14, reiterated its current views about the regulation of cannabis products and hemp-derived CBD products. However, the agency also recognizes there are still many unanswered questions about the science, safety, and quality of products containing CBD.
The FDA says there is limited available information about CBD, including about its effects on the body. The agency is working to learn more about the safety of CBD and CBD products, specifically:
1. The effects CBD could cause in the body, such as toxicity to the liver, when someone ingests CBD regularly over a long period of time.
2. The cumulative exposure to CBD if people access it across a broad range of consumer products. In other words, what are the cumulative effects if someone consumes food products with CBD and uses a topical lotion containing CBD and takes other CBD-based products on the same day? What if you use these products daily for a week or a month?
3. The effects of CBD on special populations (e.g., the elderly, children, adolescents, pregnant and lactating women) or types of animals (e.g., species, breed, or class).
4. The safety of CBD use in animals (e.g., species, breed, or class) including pets.
It is hoped that the public will respond to the FDA’s request for comments. There is still a lot of information to be obtained – like scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
As Cannabis Wire reminds consumers, “it could take the agency years to fully craft these CBD regulations.”