Bipartisan congressional lawmakers recently sent a pointed letter to the head of the Food and Drug Administration (FDA), complaining about 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 CBD Product Safety and Standardization Act was filed in December 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 late last month in a letter that was released on Wednesday.
FDA’s response “does not address provisions of our bill drafted specifically to address product safety, and is a completely insufficient response at this moment when cannabidiol (CBD) products are proliferating around the country,” Reps. Kathleen Rice (D-NY), Morgan Griffith (R-VA), Angie Craig (D-MN) and Dan Crenshaw (R-TX) wrote.
Despite being given regulatory authority over hemp and its derivatives under the 2018 Farm Bill, “FDA has refused to act on that authority, allowing a marketplace where dangerous products, like those containing delta-8 THC, are often indistinguishable from products that meet strict standards for quality, dosage, packaging, and sale established by state regulators who have stepped in to fill the regulatory void.”
The lawmakers are asking FDA to go back to the drawing board and provide revised technical assistance that more specifically addresses these concerns and directly speaks to the relevant provisions of their bill.
Because FDA has so far declined to take action to allow the marketing of hemp derivatives in food and beverages, states have increasingly stepped in to fill the regulatory gap, with about two dozen having enacted rules for the cannabinoids that are widely available in markets across the country.
“These state regulations are a direct result of FDA’s inaction, lack of clarity, and refusal to engage meaningfully on this issue,” the August 24 letter to FDA Commissioner Robert Califf says. “However, we believe that FDA can and should reverse course and learn from these state governments—working with them to determine how a federal framework could be designed to eliminate the unsustainable and inefficient patchwork of state regulations.”
The @HempRoundtable applauds @RepKathleenRice @RepAngieCraig @RepMGriffith & @RepDanCrenshaw for a clear, comprehensive critique of the @US_FDA's TA on H.R. 6134! We hope it prompts the @US_FDA to act on the establishment of a regulatory framework for #hemp-derived #CBD products. https://t.co/fOTttIwn0t
— US Hemp Roundtable (@HempRoundtable) September 15, 2022
At a House Appropriations subcommittee hearing in May, 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.”
But as more months have gone by without an update, the bipartisan lawmakers have grown increasingly frustrated—and they demanded answers from FDA within 30 days of receiving the letter, which would put the deadline at the end of next week. They said, at a minimum, the agency should be providing enforcement guidelines for the hemp cannabinoid market.
The lawmakers said that they “worked hard to craft a bill that would provide the agency with tailored authorities to address the concerns FDA has raised in order to establish a workable, responsible framework for the regulation of hemp-derived CBD in conventional food products.”
Under their bill, FDA would be required 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,” according to the text of the legislation.
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“We were genuinely hopeful that, even if some in the agency disagreed with the particulars, you, as Commissioner, would have viewed our legislation as an opportunity to jumpstart a productive dialogue and make up for lost time,” the sponsors wrote.
Here’s what the lawmakers asked FDA to produce by next week:
1. A new [technical assistance, or TA] document that addresses the actual text and construct of our bill.
2. A redline to our legislative language, or new legislative language, that establishes a pathway for CBD to be legally marketed in food products and provides the appropriate safety considerations.
3. A public charge to the Reagan Udall Foundation that, as part of the internal review of CFSAN they are conducting per your request, TA processes (including clearance processes) be assessed as part of the report, using CBD as an example.
4. An update on any ongoing work at the agency to develop an enforcement discretion policy articulating specific circumstances in which the agency will prioritize enforcement actions against CBD products. If no work is ongoing, please provide an explanation for why not.
5. Answers to the following questions:
a. What are the specific discrete scientific questions FDA is seeking answers to before issuing regulations to permit CBD in food and other products?
i. What actions has FDA taken to present these questions to the scientific community?
ii. What other actions has FDA taken to obtain answers to these questions?
iii. Does FDA have answers to these questions for every other food ingredient and dietary supplement ingredient on the market? If not, please explain the difference in standards.
b. Has FDA spoken with any state and international regulators to learn about the information and policy considerations used to set regulations for CBD-containing food products in these jurisdictions? If so, please provide the participants and dates of these meetings and the agendas. If not, please provide the rationale for not doing so.
Stakeholders have strongly encouraged FDA to live up to its authority and provide guidelines and clarity for the industry. U.S. Hemp Roundtable, which posted the letter, launched an online portal for supporters to send messages to their representatives about the need to enact the bipartisan CBD bill.
With respect to the lawmakers’ request that FDA provide, “at a minimum,” enforcement guidelines for the marketplace, the agency has taken some modest actions against certain CBD companies in recent years.
In May, for example, the agency simply sent warning letters to four cannabis companies for allegedly making unsanctioned claims about the medical benefits of CBD products they’ve marketed for animals.
FDA also recently warned consumers about marijuana-infused copycat food products that resemble popular brands and the risks of accidentally ingesting THC, particularly for children.
The agency separately issued its first set of warnings to companies over the allegedly illegal sale of products containing the increasingly popular cannabinoid delta-8 THC.
It sent five warning letters to companies that are marketing products with the intoxicating compound and making what the agency says are unsanctioned claims about their therapeutic potential.
In May, a top Republican on a key congressional committee also called on leadership to schedule a hearing to hold FDA accountable for its lack of action to set regulations for CBD and delta-8 THC products.
Read the letter to FDA about CBD regulations below:
Photo by Kimzy Nanney.