After months of waiting, the U.S. Food and Drug Administration released a report on CBD regulations without really saying much that isn’t already known. These are four of the main takeaways from the report.
Nearly five months after expected, the U.S. Food and Drug Administration has released information on the progress the agency has made concerning cannabidiol (CBD).
On March 5, Food and Drug Administration Commissioner Stephen M. Hahn announced the agency was providing updates on developing CBD regulations, “including several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity.”
While the new report offers some insight into the FDA process, it left the public and the industry guessing. Here are the four main takeaways from the new FDA report on CBD.
FDA Hasn’t Made Any Decisions Yet
If you were hoping for clear rulemaking for CBD, you’ll have to wait a bit longer. FDA has yet to make final decisions on the rules and regulations of the hemp CBD industry. The agency announced it is still actively reviewing pathways for CBD marketing and developing guidelines.
“Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities while FDA takes potential steps to establish a clear regulatory pathway,” FDA wrote in its report.
“There’s not much cause for celebration,” said the U.S. Hemp Roundtable, which funds the U.S. Hemp Authority, the first-ever quality certification program for CBD products. “FDA continues to kick the can down the road, claiming that more study is needed before it takes action.”
FDA will continue to update online resources for the public and keep multiple lines of communication open with government and industry leaders, as well as researchers. The agency will also re-open a public docket for comments indefinitely.
FDA Says It Still Lacks Research
Hahn noted that there are still many questions about “the science, safety, and quality” of CBD left to be investigated by the agency. The statement also confirmed that FDA at this time is not clear on the safety of CBD products when taken with other medications or for certain populations such as children, senior citizens, and pregnant women.
“This does not mean that we know CBD is unsafe to these populations or under these circumstances, but given the gaps in our current knowledge, and the known risks that have been identified, we also are not at a point where we can conclude that unapproved CBD products are safe for use,” Hahn stated.
Hahn acknowledged that CBD research is limited since all cannabis was classified as a Schedule I controlled substance prior to the passage of the 2018 Farm Bill that legalized domestic hemp and its derivatives.
The agency said that it is actively working to identify and review the data on CBD that is available.
FDA Acknowledges “High Level of Interest” for CBD
The report notes the high demand for CBD and acknowledges the urgent need for regulations.
“We recognize the significant public interest in CBD and we must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety and quality of many of these products,” Hahn stated in the news release.
“We are committed to working efficiently to further clarify our regulatory approach to these products – as always, using science as our guide and upholding our rigorous public health standards.”
In July 2019, FDA officials announced that the agency was going to expedite its work to address rules and regulations on CBD and release a progress report by summer/early fall of 2019. Many concerned state and federal government leaders have urged the FDA to move more quickly.
In December, a provision in the federal spending bill mandated that FDA release a report on CBD regulations within 60 days. That deadline passed last month. The spending bill also allocated $2 million for FDA efforts to develop regulations for hemp-derived CBD.
FDA Will Focus on Enforcing Action Against Bad Actors For Now
Moving forward, FDA will be monitoring the CBD marketplace. According to the statement, the agency will take appropriate action against unlawful CBD products that pose a risk of harm to the public. Those specifically named were products marketed with false claims or statements such as omitted ingredients, incorrect statements about the amount of CBD.
FDA has already issued warnings to some CBD companies for making unsubstantiated claims about the effects and benefits of CBD.
CBD in the U.S.
With the passage of the 2018 Farm Bill, a new frontier opened up for the versatile hemp plant. The bill made hemp legal for commercial production and led to a booming hemp-derived CBD industry, anticipated to reach $22 billion by 2022
CBD is a non-intoxicating compound found in cannabis, both marijuana and hemp. Check out our CBD information page to gain a better understanding of CBD’s potential benefits and uses.
Stay up to date with the latest cannabis policy, business, and scientific research by checking back in at our cannabis news page.