FDA Re-Opens Public Comments On CBD Regulation

As the U.S. Food and Drug Administration continues to craft CBD regulation, the agency hopes the public will offer additional feedback particularly scientific data on CBD safety.

Officials from the United States Food and Drug Administration (FDA) are seeking more public feedback on cannabidiol (CBD) and have re-opened a public comment period from April 2019 to gather more information.

“To provide a public and transparent way for stakeholders to provide new and emerging information to us in real time as it becomes available, we are reopening the comment period and extending it indefinitely to allow interested parties to continue to comment,” FDA officials wrote.

“We are particularly interested in data that may help to address uncertainties and data gaps related to the safety of cannabidiol (CBD).”

This is the second time that FDA requested public input on CBD. Thousands of people submitted comments in the first go-around last year.

FDA submitted a mandatory progress report to Congress last week, notifying lawmakers of the status of its CBD rulemaking efforts. The report included information on how the federal agency is exploring pathways to allow CBD to be marketed as a dietary supplement. In addition, FDA announced it is actively developing enforcement discretion guidance for CBD businesses.

What FDA Wants to Know About CBD

A section of the federal register notice aims at gaining specific feedback about CBD safety and scientific evaluation. FDA is requesting feedback on the following:

  • Potential impact of CBD on the liver.
  • Potential toxicities of some of the active metabolites of CBD.
  • Potential impact of CBD on the male reproductive system.
  • Potential effect of CBD co-administration with other medicines, alcohol, dietary supplements, tobacco products, and herbal products.
  • Potential impact on neurological development.
  • Potential impact of CBD on driving performance and ability to operate heavy machinery.
  • Potential impact of CBD on the human eye.
  • Potential impact of CBD on pets and food-producing animals.
  • Potential impact of long-term exposure to CBD.
  • Potential impact of long-term sustained or cumulative exposure to CBD in vulnerable populations such as children, the elderly, and women who are pregnant or breastfeeding.

FDA officials are looking for more scientific data from the public as well as seeking new ways to conduct research. Those ways include a grant for FDA’s National Center for Toxicological Research to conduct a study on the effects of CBD exposure during pregnancy, as well as a research study to evaluate the levels of CBD and THC in a sample of cosmetic products to evaluate sensitization of THC and CBD topically, and dermal saturation.

“As data become available that are high-quality, reliable and relevant to our evaluation of CBD products that fall under the FDA’s purview, we will be able to refine – and, perhaps in some cases, revise – our thinking and approaches,” FDA Commissioner Stephen M. Hahn said in a March 5 press release.

How to Submit Your CBD Comments

FDA officials are offering a new option for those providing comments by opening a way for the public to provide confidential submissions. Using this path of commenting allows those submitting feedback an alternative to placing their personal information out there to be viewed by the public.

You can submit a comment to the federal register on “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds,” here.

The comment period is open indefinitely.

FDA Feels Pressure About CBD

Since the passage of the 2018 Farm Bill, hemp-derived CBD products have lined shelves of gas stations and grocery stores, all without official evaluation from FDA. Roughly one in seven Americans now use CBD products. With many labels claiming certain health benefits, lawmakers and stakeholders have placed pressure on FDA to craft regulations that would provide the public guidance on CBD.

In July 2019, FDA officials announced they would be expediting work to provide answers on CBD. The announcement included a promise that the federal agency would provide a progress report by the end of summer/early fall. That deadline came and went without any new developments from FDA.

FDA Commissioner Hahn faced questions on CBD regulations at a congressional hearing last week. He reiterated the need for additional research before any final decisions are made.

“We have a knowledge gap, sir, that makes it difficult for us to know how to proceed in several areas,” Hahn said.

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