Bipartisan congressional lawmakers have refiled a pair of bills meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food and beverage additives.
The two measures that were filed on Friday—the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act and the CBD Product Safety and Standardization Act—are being sponsored by Reps. Morgan Griffith (R-VA) and Angie Craig (D-MN).
Earlier versions of the bills were filed last Congress and ultimately did not advance, but advocates and industry stakeholders feel that the Food and Drug Administration’s (FDA) recent announcement that it wouldn’t be taking steps to regulate CBD will put pressure on lawmakers to act this time around.
FDA “has dragged its feet in properly regulating CBD and hemp-derived products on the market, creating confusion about its legal uses,” Griffith said in a press release on Friday. “Americans need better guidance and that is why I have introduced these two pieces of legislation, which will create a pathway for regulation in both the food and dietary supplement spaces.”
The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act would mandate that hemp, hemp-derived CBD and other derivatives from the federally legal cannabis plant would be made lawful as dietary supplements under the Federal Food, Drug, and Cosmetic Act (FDCA).
The CBD Product Safety and Standardization Act, meanwhile, would require FDA to develop rules and hold a public comment period on the maximum amount of hemp-derived CBD that could be added to a food item or beverage per serving, labeling and packaging requirements and the “conditions of intended use,” the text of the legislation states.
“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. “That’s why I’ve partnered with Rep. Griffith on these bipartisan bills to better regulate CBD products, keep consumers safe and ensure our hemp farmers and businesses have the support they need.”
FDA announced in January that it would not be creating rules to allow the marketing of CBD as dietary supplements or food items, leaving the massive industry without regulations despite repeated calls for administrative action from lawmakers, advocates and stakeholders.
Following a “careful review” of the non-intoxicating cannabinoid, FDA said it reached the conclusion that the existing regulatory pathways that are in place for other dietary supplements and food additives will not work for CBD. Instead, the agency said that wants to “work with Congress on a new way forward.”
“The FDA has made it clear that legislative action by Congress is needed to solve its CBD regulatory problem and these two bi-partisan bills re-introduced by Reps. Griffith and Craig serve as the solution,” 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.”
FDA’s announcement came days after the agency released finalized guidance that focuses on developing cannabis-based drugs and outlined the process and unique considerations for scientists when it comes to hemp and marijuana.
Meanwhile, House Oversight and Accountability Committee Chairman James Comer (R-KY), said in January that he was preparing to confront FDA over their failure to enact regulations for hemp-derived products like CBD.
FDA has faced increased pressure from bipartisan lawmakers and industry groups to do something about the issue since hemp and its derivatives were federally legalized under the 2018 Farm Bill.
Top officials in the agency have previously signaled that they felt it may take work from Congress to adequately regulate CBD.
Griffith and Rep. Brett Guthrie (R-KY) sent a letter to FDA Commissioner Robert Califf last year, demanding answers over the continued lack of regulations for CBD for those purposes.
Griffith and other bipartisan lawmakers sent a separate, related letter to the FDA commissioner in August. They expressed frustration over the “completely insufficient response” the agency provided in response to their bill calling for hemp-derived CBD to be permitted and regulated as a food additive.
After the earlier version of the CBD Product Safety and Standardization Act was filed in late 2021, the sponsors sought technical assistance from FDA to advise on key provisions. But four months after they sent the inquiry, FDA returned a “one-page” response that was “simply a reformatting of a document provided to Congress over two years ago,” the lawmakers said
At a House Appropriations subcommittee hearing last year, FDA’s Califf recognized that the agency had moved slowly with rulemaking for CBD in the food supply, stating that the situation “looks pretty much the same in terms of where we are now” as compared to when he first worked on the issue in 2016.
He said the FDA has taken steps to research the safety profile of cannabinoids to inform future rules, but he also punted the criticism about inaction to Congress, saying he doesn’t feel that “the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward.”
“We’re going to have to come up with something new,” Califf said. “I’m very committed to doing that.”
FDA also recently touted its role helping a state agency crack down on a company selling delta-8 THC gummies that they said are linked to “serious adverse events.”
In November, the agency sent warning letters to five companies that sell foods and beverages containing CBD.
The agency didn’t specify why it targeted those particular five companies out of the many more that market similar cannabidiol-infused consumables, but it said that they sell products “that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.”
All of this comes in the background of a major task for FDA: Conducting a scientific review into marijuana, at the direction of President Joe Biden, to aid in an assessment of its federal scheduling. FDA’s recommendation won’t be binding, but officials say they expect DEA to product a scheduling recommendation that’s consistent with their findings about its risks and benefits.
Also this month, bipartisan congressional lawmakers introduced a new bill that seeks to end what they say is a “discriminatory” federal policy that bars people with prior felony drug convictions from owning or leading legal hemp businesses. (Full Story)