FDA Official Says Agency Is ‘Actively’ Exploring CBD Regulations As It Continues To Monitor Kratom

The Food and Drug Administration (FDA) is “actively” exploring a potential regulatory framework for CBD, with plans to prioritize the issue in the next year, a top official says. Meanwhile, the agency is also investigating issues related to kratom.

FDA Deputy Commissioner for Policy, Legislation, and International Affairs Kimberlee Trzeciak discussed the agency’s cannabis and kratom interests during a webinar hosted by the Alliance for a Strong FDA this month.

Asked about issues that are “top of mind” for the agency in 2024 and where officials hope to engage with Congress, Trzeciak said that later this year or next year FDA wants to address setting up “an appropriate regulatory framework for CBD.”

Later in the conversation, the FDA official was asked specifically about how the agency is “prioritizing” its work on cannabis and kratom regulations, and she said officials are taking a number of factors into consideration as they work to address the substances.

“In almost every neighborhood you go to, you can see stores on the corners that are marketing CBD and kratom and others,” she said. “And one of the things that we have been thinking through here at FDA, using CBD as an example, is what does the regulatory framework for those products look like?”

“Based on what we know about CBD in particular, we do not think that those products would be able to meet the safety standards that we have in place for foods and dietary supplements today,” she said, referencing the agency’s position after it declined to enact regulations for the non-intoxicating cannabinoid that was legalized under the 2018 Farm Bill.

“What can we do in terms of regulatory tools to ensure that this product is going to be marketed that consumers are clearly aware of what the product is, what is in it and making sure that we have basic information about the marketplace?” Trzeciak said. “I like to think of it as the common regulatory tool that we have across the other products that we regulate.”

She added that FDA wants to “work with Congress on this effort,” including possible rulemaking around CBD product labeling and packaging.

“For example, how can we ensure that the agency knows if there are adverse events that are being reported, so we can identify those trends, making sure that the product is being manufactured or produced in a way that’s safe and quality?” she said.

Kratom reform advocates say the deputy commissioner’s comments represent a “shift” in the agency’s policy perspective on the issue. Historically, FDA hasn’t engaged in the kratom debate as actively as other agencies such as the National Institute on Drug Abuse (NIDA).

Meanwhile, FDA has faced criticism from hemp stakeholders and lawmakers over its prior decision not to regulate CBD, despite its prevalence in the marketplace. But it’s insisted that it will need additional congressional authorization in order to develop such regulations.

In a recent letter addressed to House Energy and Commerce Committee leaders, 28 state and national nonprofits focused on hemp and dietary supplements said that “the time for a hearing has never been riper” to examine regulatory pathways that FDA could enact to allow for the lawful marketing of hemp products for humans and animals.

The committee responded to FDA’s inaction last summer by putting out a Request for Information (RIF) from experts on the best path forward for regulating hemp, with hundreds of respondents sharing their perspective and recommendations.

With respect to congressional action, Sens. Ron Wyden (D-OR), Rand Paul (R-KY) and Jeff Merkley (D-OR), along with Rep. Earl Blumenauer (D-OR), filed legislation last July that would remove regulatory barriers that FDA claims prevents it from allowing the hemp marketing.

The House Oversight and Accountability Subcommittee on Health Care and Financial Services also held a hearing on FDA inaction over CBD last year, a first-of-its-kind meeting where bipartisan members strongly criticized the agency’s position.

Meanwhile, the National Association of State Departments of Agriculture (NASDA) is separately calling on Congress to increase the THC limit for legal hemp as one of their 2024 policy priorities.

The 0.3 percent THC limit for hemp that was imposed under the 2018 Farm Bill that federally legalized the crop has long been subject to criticism from stakeholders and lawmakers across the aisle. And one Justice Department researcher recently called into question the rationale for the restriction, suggesting it was arbitrarily decided based on a 1950s-era article that was adopted into federal statute.

The Congressional Research Service (CRS) recently outlined how differing policy priorities among industry stakeholders could complicate the task of updating the next farm bill’s hemp provisions, but there are several areas of agreement within the top industry groups.

One of those shared interests is amending the law to raise the THC limit to one percent for compliant hemp—a proposal that was also addressed in a standalone bill from Rep. Chellie Pingree (D-ME) in 2022.

It’s unclear if congressional lawmakers will ultimately tackle the Farm Bill this year. The 2018 version was set to expire at the end of last year, but it was extended under a bill President Joe Biden signed.

Meanwhile, FDA has also been engaged in other drug policy reform debates amid an ongoing federal review into marijuana scheduling, which prompted the agency to recommend. moving cannabis from Schedule I to Schedule III of the Controlled Substances Act (CSA).

FDA recently highlighted its scientific review into marijuana—a process that involved a comprehensive analysis of research, as well looking at hundreds of posts on social media platforms to see how consumers described cannabis’s therapeutic impact.

Earlier this month, FDA officials also joined scientists at a public meeting on next steps for conducting research to develop psychedelic medicines.

The meeting came months after FDA issued historic draft guidance on psychedelics studies, providing scientists with a framework to carry out research that could lead to the development of novel medicines.

To that end, FDA also recently accepted an application to review MDMA-assisted therapy as treatment option for post-traumatic stress disorder (PTSD), agreeing to carry out the analysis on an expedited basis.

Photo courtesy of Kimzy Nanney.