On August 24th, Legislators sent a letter to the head of the Food and Drug Administration (FDA) in regards to a “completely insufficient response” to their proposed bill permitting hemp derived CBD as a food additive.
FDA’s Lack of Technical Assistance
Since Congress filed the CBD Product Safety and Standardization Act in December 2021, the FDA was sought out for technical assistance to assess the bill. After waiting for four months, the FDA gave a one page response that was described by lawmakers as “simply a reformatting of a document provided to Congress over two years ago.” The 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.”
As far as the FDA is concerned, their stance on the hemp market remains consistent with their regulatory authority over hemp and its derivatives in the 2018 Farm Bill. Since 2018, there has been little action by FDA regulation. Now, legislators are asking the administration to reconsider their position and come up with an adequate response that addresses the relevant concerns regarding public safety.
States Regulate Hemp in Absence of FDA
The FDA has so far remained silent on the issue, forcing states to take it upon themselves to create their own laws to regulate the hemp-derived cannabinoids. Now, about two dozen states have some form of regulation over hemp and its derivatives.
In the letter sent to the FDA head commissioner Robert Califf, lawmakers argued that “these state regulations are a direct result of FDA’s inaction, lack of clarity, and refusal to engage meaningfully on this issue. However, we believe that FDA can and should reverse course and learn from these state governments – working with them to determine the unsustainable and inefficient patchwork of state regulations.”
Last May, FDA’s Califf admitted that the state of CBD food regulations on a federal level have moved slowly, even going so far as to say that everything “looks pretty much the same in terms of where we are now” since 2016. Califf also claims 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 Must Provide Hemp Guidelines by Next Week
With the deadline of the letter due in 30 days, a reply from FDA is due at the end of next week. With several questions unanswered, bipartisan lawmakers insist that the agency should a least provide guidelines to enforce the hemp cannabinoid market. Congress 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.
“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.
FDA is at a Critical Point in Hemp Market Regulations
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.
