Nearly 4 years after the passage of the 2018 Farm Bill, which appeared to be the moment the CBD industry and its retail partners had been waiting for, there is still not a clear answer to how the FDA intends to regulate CBD products in the US. This has put a massive burden on the industry, with many major retailers still hesitant to sell CBD ingestible products.
Over recent months, many members of Congress have been putting increased pressure on the FDA to follow through on their promise to provide a regulatory pathway to sell and market CBD products.
In a September 19 letter to the FDA Commissioner, four members of Congress expressed their disappointment in the agency's failure to follow through on promises made nearly four years ago to clarify how they intend to regulate CBD products.
In their letter to FDA Commissioner Robert Califf, M.D., Congresspeople Griffith and Guthrie criticized the agency's approach to CBD, saying it "...has created unnecessary uncertainty in the marketplace around these products,” and highlighted, “The United States currently has a robust but largely unregulated CBD market, which leads to an unsafe marketplace for consumers.”
Legislators and industry advocates recognize that the agency has had challenges coming up with framework for regulating CBD. In response, they have continued to push common-sense legislation that will give the agency a head start and simplify their role in regulating these products.
There are currently two pieces of well-supported legislation that could help move us closer to FDA clarity and finally allow the CBD industry to reach its full potential.
H.R. 6134 is focused on the regulation of CBD as a food rather than as a dietary supplement. A separate bill focused on CBD in dietary supplements, H.R. 841—otherwise known as the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021—has garnered over 40 co-sponsors, including most recently Rep. Dina Titus (D-Nevada). The chairman of the House Agriculture Committee, Rep. David Scott (D-Georgia), co-sponsored the bill in August.
While those of us in the industry are hopeful that these bills will move things forward, we are also optimistic that Congress is putting increased pressure on the FDA to follow through on the responsibilities assigned to the agency in the 2018 Farm Bill.
“Rather than denying new products from coming to market, the FDA must take action and establish a clear set of standards for companies to adhere by, especially since these products are already being sold in states across the nation,” Griffith and Guthrie wrote to Califf in the Sept. 19 letter.
Another promising development is the recent appointment of Norman Birenbaum, a veteran cannabis regulator in New York and Rhode Island, as a senior public health advisor to the FDA. "With his expertise in policy analysis and legislative outreach related to cannabis and cannabis-derived products, Norman is excited about creating the high-value partnerships needed for FDA’s outreach throughout the health care community, including with patients and patient advocacy groups," Douglas Throckmorton, M.D., deputy center director for regulatory programs with FDA's Center for Drug Evaluation and Research (CDER), shared in an email to FDA staff.
Some industry stakeholders are hopeful that Birenbaum's hiring signals a path forward for hemp-based CBD.
In a statement on the U.S. Hemp Roundtable's website, Jonathan Miller, the group's general counsel, stated, “After four years of inaction, we are hopeful that the appointment of Norman Birenbaum by the FDA signals a positive step forward for the regulation of hemp-derived cannabinoids such as CBD.”
Overall, it appears as though the future of CBD is finally looking brighter. Increasingly, lawmakers at the federal and state level are beginning to realize that this relatively harmless substance is not a danger to public health and should not be subject to foggy regulation. Hopefully, we will see our nation's leaders continue down this path by providing further clarity on the legality of both industrial hemp and its derivatives such as CBD.
If you are interested in following these efforts, or would like to contact your representatives to urge them to support active hemp advancement legislation, visit the U.S. Hemp Roundtable's Action Center.
03, Josh Long | Oct. “Lawmakers Keep Pressing FDA on CBD Regulations.” Natural Products INSIDER. New Hope, October 3, 2022. https://www.naturalproductsinsider.com/herbs-botanicals/lawmakers-keep-pressing-fda-cbd-regulations