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).

FDA Deputy Commissioner Signals Shift in FDA Policy on #Kratom and #CBD Regulation. new FDA study finds “kratom appears to be well tolerated at all dose levels.” Read & download full doc https://t.co/mZltcHFxv7pic.twitter.com/AN3UpH7IR7

— American Kratom Association (@TheKratomAssn) February 27, 2024

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.

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Photo courtesy of Kimzy Nanney.

Bipartisan Lawmakers In Congress Introduce New Bill To Regulate Kratom Nationwide

Federal lawmakers have introduced legislation that would regulate kratom products across the country, renewing a similar push made late last session. The proposal, now titled the Kratom Consumer Protection Act, is expected to have bipartisan support in both chambers.

On the Senate side, the measure is sponsored by Sen. Mike Lee, a Utah Republican. Sen. Cory Booker (D-NJ), is expected to sign on as a cosponsor after Congress returns to work next week, advocates say. Booker was also a sponsor of last year’s legislation, which at the time was called the Federal Clarity for Kratom Consumers Act

In the House, meanwhile, the newly filed measure is sponsored by Reps. Mark Pocan (D-WI) and Jack Bergman (R-MI).

Aside from the new title, the elements of the proposal are the same, said Mac Haddow, a senior fellow on public policy for the American Kratom Association and a lead proponent for the bill in Congress.

“A properly regulated kratom marketplace will ensure consumer access to safe kratom products that are properly manufactured and labeled to inform consumers on how kratom can be safely used,” he said in an email to Marijuana Moment.

Haddow thanked the legislation’s sponsors for recognizing “that consumers need to be protected from a completely unregulated kratom marketplace where adulteration occurs frequently that puts consumers at significant risk of adverse events and death from irresponsible products laced with dangerous substances.”

On social media, Haddow called the legislation’s introduction “the start of a very important initiative for the American Kratom Association and every consumer advocate for kratom in the United States.”

“We hope you and every consumer advocate will join us in order to make this landmark legislation correct the path that the [Food and Drug Administration] has started on to try to ban kratom and instead regulate it properly in order to assure that Americans have the freedom to responsibly and safely use kratom products in the future,” he continued.

Exciting news! #kratom#federalkcpa#consumerprotection@HaddowMacpic.twitter.com/j8psxvvL3x

— American Kratom Association (@TheKratomAssn) October 7, 2023

If the bill becomes law, it would require FDA to take further steps to evaluate the health and safety of kratom and would also prohibit the agency from regulating kratom products in a way that’s more restrictive than regulations for food or dietary supplements.

Specifically, the proposal would prevent the U.S. Department of Health and Human Services (HHS) from imposing requirements for kratom that are more restrictive than allowable under the federal Food, Drug, and Cosmetic Act (FDAC).

It further stipulates that the department could not “treat kratom, or any product derived from or containing kratom, as an adulterated dietary supplement” or “require kratom to undergo requirements for notification as a new dietary ingredient.”

“The [HHS] Secretary may not issue, implement, or enforce an import alert for a kratom or kratom-derived product unless the Secretary determines that there is a history of such kratom or kratom-derived product being adulterated,” another section states.

It also says that nothing about the federal legislation is intended to “preempt” the laws of states, a growing number of which have enacted or considered measures to protect and regulate kratom access.

Under the legislation, the HHS secretary would additionally need to convene at least one public hearing to address the scientific data on the public health risks and benefits of the plant. The hearing would have to include input from “leading scientific researchers” and consider topics such as the number of Americans who use kratom, substance misuse potential and more. HHS would be required to open a public docket for at least 30 days for people to weigh in ahead of the hearing.

Additionally, a “Kratom Research Task Force” would be established under HHS in order to “coordinate kratom-related research conducted or supported by the Federal Government.”

The task force would need to submit a report to Congress and the HHS secretary within 90 days of enactment, detailing “all federally-funded kratom-related research that has begun or been completed.” Each quarter thereafter, the panel would need to update Congress on the status of kratom research, including an analysis.

“The Kratom Research Task Force shall convene public meetings with appropriate experts and stakeholders to increase public awareness concerning the current state of kratom-related research,” the text of the bill says. The task force would be dissolved two years after submitting the initial report.

Neither chamber took action on the proposal last session, but Haddow said in August that supporters expect more traction—and more sponsors—on this year’s kratom bill.

In terms of the bill’s sponsors, he explained at the time, pairing a “very liberal” elected official with a “very conservative” one is designed to highlight “that this is not a partisan issue” but instead “about good policy.”

Booker’s office did not immediately respond to an email seeking confirmation of his intent to sponsor the new bill.

The new bills, S.3039 and H.R.5905, are meant to safeguard consumer access amid efforts by the Food and Drug Administration (FDA) to ban kratom, which is used to manage anxiety and stress and to mitigate opioid withdrawal symptoms. FDA has supported banning the substance in the U.S. and abroad.

Critics have said FDA misstated the facts on kratom to overstate its health risks, for example by failing to distinguish between health hazards associated with kratom itself and those caused by adulterants found in unregulated kratom products.

Former Trump White House drug czar Jim Carroll, for example, said that an FDA presentation to his office in 2018 presented “an incomplete picture of the facts that were out there,” suggesting that kratom had no redeeming value and carried serious risks of injury and death.

Among the myths FDA perpetuated, he said, was the idea that kratom had been linked to a significant number of deaths, when in fact those deaths were later attributed to hazardous contaminants in kratom products.

“FDA did not paint the entire picture,” Carroll said at a separate event earlier this year, at which he detailed efforts by federal officials to stop FDA from trying to schedule kratom under the federal Controlled Substances Act (CSA). “Maybe they didn’t have the entire picture, but everyone else did.”

As the American Kratom Association (AKA) has worked to push back against FDA efforts to ban the substance, much of the organization’s focus has been on state-level reforms.

Haddow said in August that so far 11 states have passed some version of the Kratom Consumer Protection Act (KCPA), model legislation supported by AKA. In some cases, lawmakers even rolled back bans on kratom products and instead embraced regulation.

AKA’s model legislation for states sets a minimum age of 18 to buy kratom products (though some states have made it 21), prohibits the addition of adulterants or “any synthetic or artificially elevated alkaloid content,” requires that manufacturers register with the proper regulatory authority and creates standards around packaging and labeling.

Pocan, the House sponsor of this new congressional legislation, has been a particularly strong voice advocating for kratom research, emphasizing its therapeutic potential.

At a congressional hearing last year, for example, he expressed appreciation for the National Institute on Drug Abuse (NIDA) for funding research into the plant, stating that kratom has “helped many people to get off of opioids.”

The National Institutes on Health (NIH) also hosted a meeting last year to explore the therapeutic potential of the “controversial tree,” with an expert providing an overview of the science of kratom and what role it could play in mitigating the overdose crisis.

On the international level, the United Nations World Health Organization (WHO) decided in 2021 not to recommend that kratom be globally prohibited in a victory for activists.

While the decision was based on a scientific review of the risk of dependence, abuse potential and therapeutic applications of kratom, advocates touted the fact that about 80,000 people submitted comments to the panel, sharing their perspectives and experiences with the plant-derived substance.

As it stands, kratom is not scheduled under the federal Controlled Substances Act (CSA) or under international drug treaties to which the U.S. is a party. FDA has considered putting restrictions on the substance, but it has faced resistance and has been unable to do so at this point.

In July, the American Medical Association, in adopting a new slate of drug policy positions, said that people “who are using kratom only for personal use should not face criminal consequences.” The group added, however, that the substance should be evaluated by authorities “for its appropriateness for sale and potential oversight via the Controlled Substances Act, before it can be marketed, purchased, or prescribed.”

In 2021 Lee and Pocan sent a letter to the secretary of HHS and the country’s United Nations ambassador last year, imploring the officials to resist efforts to impose an international ban on kratom.

In 2020, the federal Agency for Healthcare Research and Quality (AHRQ) asked the public to help identify research that specifically looks at the risks and benefits of cannabinoids and kratom.

The Centers for Disease Control and Prevention (CDC) in 2020 separately received more than one thousand comments concerning kratom as part of another public solicitation.

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Photo courtesy of Wikimedia/ThorPorre.