U.S. lawmakers re-introduced two bills that would establish a legal framework for hemp-derived cannabinoids, hoping to revive a rulemaking process that has been slow to unfold.
The measures would mandate that CBD and other cannabinoids from hemp be made lawful as food and food ingredients, and establish regulations for such products.
Congress is under growing pressure to lay a pathway for CBD – which is on the market throughout the U.S. but unregulated – especially after the U.S. Food and Drug Administration (FDA) declared earlier this year that it can’t manage such products under the agency’s current structure. FDA called on Congress to establish legal clarity.
“These reforms are a long time coming,” said Sanford Stein of Chicago-based Cannabis Law. “The FDA has been treating hemp like a new drug, not a food supplement or dietary aid.”
‘Demand-led’ policy
The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act (H.R. 841), originally introduced Feb. 4, 2021, would make CBD and other derivatives from the hemp flower legal as dietary supplements under the Federal Food, Drug, and Cosmetic Act (FDCA).
The CBD Product Safety and Standardization Act would require FDA to develop rules regarding the maximum per-serving amounts of CBD that could be in foods and beverages, and set requirements for labeling and packaging as well as the “conditions of intended use.” That measure, H.R. 6134, was first introduced Dec. 2, 2021.
The proposed laws have so far failed in Congress. The revived measures are sponsored by Reps. Morgan Griffith, a Virginia Republican, and Angie Craig, a Democrat from Minnesota, reflecting support among both political parties.
“Bipartisan Congressional sponsorship shows just how far political influence has reached. Public demand often leads policy. That is happening here,” Stein said.
Safety concerns
FDA currently recognizes CBD as a drug, technically barring it from use in foods or being marketed as a dietary supplement. In its January announcement, the agency said that not enough is known about CBD products to regulate them as foods or supplements as it urged lawmakers to step in.
FDA has repeatedly cited studies that say CBD could harm the liver and male reproductive system, and said little is known about how it interacts with drugs, and its effects on children and pregnant women. The agency has also expressed alarm over delta-8 THC products, which are made from hemp-derived CBD, calling the rapid growth of such products “extraordinarily concerning.”
But the agency has provided little support for CBD research, and has spent most of its efforts thus far cracking down on vendors with repeated waves of warning letters over marketing claims and tainted products.
“In Minnesota, we’ve seen firsthand that our local governments and small businesses need more guidance when it comes to CBD and hemp-derived products,” Craig said, suggesting passage of the measures would “keep consumers safe and ensure our hemp farmers and businesses have the support they need.”
Inaction ‘devastating’
FDA has authority over CBD and other hemp-derived cannabinoids under provisions in the 2018 U.S. Farm Bill; that authority extends over all forms of cannabis compounds under the FDCA and the Public Health Service Act.
“The FDA has made it clear that legislative action by Congress is needed to solve its CBD regulatory problem,” U.S. Hemp Roundtable General Counsel Jonathan Miller said in a press release.
“The FDA’s inaction over the past four years has had a devastating impact on U.S. hemp growers, and has left thousands of unregulated products on the marketplace, raising health and safety concerns for consumers,” Miller said.