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 bills follow on the heels of FDA’s recent announcement asking Congress to work with the agency to develop a regulatory framework for CBD.
Congressman Morgan Griffith (R-VA) and lead Democratic co-sponsor Congresswoman Angie Craig (D-MN) have introduced two pieces of legislation aimed at creating potential pathways for regulation of cannabidiol (CBD) products by requiring the Food and Drug Administration to regulate hemp-derived CBD.
Both bills would require FDA to utilize existing regulatory frameworks for CBD as dietary supplements and foods.
The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 would make hemp, cannabidiol derived from hemp, and other hemp-derived products lawful for use as a dietary supplement.
The CBD Product Safety and Standardization Act directs the FDA to regulate CBD as the agency would for other food and beverage ingredients by establishing requirements for quality and labeling, among other areas.
“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. 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. The U.S. Hemp Roundtable is grateful to Rep. Griffith for his steadfast leadership on behalf of the hemp industry, and we are proud to work closely with him, Rep. Craig and other original co-sponsors on this critical legislation that is integral for hemp farmers, CBD producers and consumers,” said Jonathan Miller, U.S. Hemp Roundtable General Counsel.
Background
Every five years, Congress passes legislation that sets national agriculture, nutrition, conservation and forestry policy, known as the Farm Bill.
Since the passage of the 2018 Farm Bill, which legalized the cultivation of hemp, the CBD industry has operated in regulatory limbo as the FDA repeatedly calls for more research on the safety and efficacy of CBD and issues warning letters in lieu of regulatory framework.
“The Food and Drug Administration has dragged its feet in properly regulating CBD and hemp-derived products on the market, creating confusion about its legal uses,” said Griffith. “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.”
“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,” said Craig. “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.”
Industry reaction
The wider industry sees these bills as a move in the right direction and remains optimistic that a roadmap for CBD is beginning to take shape.
“CRN applauds the introduction of the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 and remains committed to creating a legal pathway to market safe, non-psychoactive hemp-derived cannabinoids as dietary supplements. Over four years ago, Congress purposefully removed hemp-derived CBD from the Controlled Substances List to jumpstart a market, yet FDA refuses to recognize that directive. While FDA delays, a sizable market has grown for CBD—legal or otherwise. Americans know these products are safe because they have been taking them for years. Consumers don’t need a new regulatory scheme that will potentially limit consumer choice. They want access to the safe, innovative products to help them lead healthier lives that the Hemp and Hemp Derived CBD Consumer Protection and Market Stabilization Act will provide,” said Steve Mister, President of the Council for Responsible Nutrition (CRN).
“In the two and half years since this legislation was first introduced and following FDA’s recent passing of the buck to Congress on CBD dietary supplements, no substantive progress on establishing a lawful pathway for CBD dietary supplements has been made. This legislation would provide FDA the statutory authority the agency believes it requires to regulate CBD products as dietary supplements. It would also ensure that consumers have access to CBD dietary supplements that are clearly subject to FDA’s enforcement of the robust regulations that apply to all other herbal dietary supplements. The bill would codify the position AHPA adopted years ago recommending that manufacturers and marketers of CBD dietary supplements comply with all of the federal regulations that apply to such operations under the Dietary Supplement Health and Education Act and other relevant amendments to the Federal Food, Drug, and Cosmetic Act,” said Michael McGuffin, President of the American Herbal Products Association (AHPA).
“We are supportive of this legislation which is an important step forward in resolving the CBD conundrum given FDA’s recent signals that it could take years for the agency to finalize its position. Consumers need the assurance they can have continued access to safe and legal products,” commented Loren Israelsen, President of the United Natural Products Alliance (UNPA).
While previous versions of the bills were filed last Congress, they didn’t advance. So will this time around be different? It’s hard to say, but reintroducing these bills does add mounting pressure on lawmakers to take action.
“While it's good to see movement on the matter, given FDA’s responses to the same legislation the past two congresses, plus their recent statements on needing a new mechanism to regulate CBD/Hemp, it’s unclear that this will get traction and yield a pathway from FDA. We’re going to have to win the argument first before we can win the vote on this. Winning the argument means having legislation that puts FDA on the clock and accountable for setting a safe daily amount in foods and supplements (for CBD/hemp) using current authorities (i.e. labeling, GRAS, NDI) then there’s limited ways they (FDA) can push back. While some may raise concerns about FDA setting too low a level with such legislation, based on the current course of action, it’s likely to be either the agency sets a level at the direction of Congress or the current level, which is still zero, going forward,” said Daniel Fabricant, PhD, President, and CEO of the Natural Products Association (NPA).
All eyes on next Farm Bill
With the 2023 Farm Bill approaching, lawmakers on the US House and Senate agriculture committees will draft a new federal Farm Bill that will shape a number of programs for the next five years. While some may see the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 as mere gestures, the new bills could just be that extra push that the next Farm Bill needs to create a legal pathway for CBD.
The 2023 Farm Bill formally kicked off with field hearings in Michigan and Arkansas in 2022 and will continue throughout early 2023.
The Committee is currently accepting ideas and proposals for the 2023 Farm Bill, as well as feedback about the 2018 Farm Bill. Submissions are welcomed via this form or emailing FarmBill2023@ag.senate.gov.