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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Congressional Committee Schedules Hearing To Press FDA On Lack Of CBD Regulations Next Week As Bipartisan Lawmakers File Bills To Address The Issue

A congressional committee has scheduled a hearing for next week focused on the Food and Drug Administration’s (FDA) refusal to enact regulations to allow for the marketing of hemp-derived CBD products. And bipartisan and bicameral lawmakers have separately reintroduced a bill to fill the regulatory gap.

The House Oversight and Accountability Subcommittee on Health Care and Financial Services scheduled the hearing—titled “Hemp in the Modern World: The Years long Wait for FDA Action”—for July 27.

Chairwoman Lisa McClain (R-MI) said in a press release on Thursday that “FDA has failed for too long to do its job to ensure the safety of legalized hemp-derived products.”

“Without these regulations, dangerous products could make their way to the shelves while safe and credible CBD products could be prevented from entering the market,” she said. “We are going to investigate why exactly the FDA has decided to ignore their regulation responsibilities related to CBD and other areas of jurisdiction. We need to ensure that the FDA is not setting what would be a dangerous precedent and using this as an opportunity to seek more authority and resources from Congress.”

Rep. James Comer (R-KY), who chairs the full committee, has sharply criticized FDA after the agency announced in January that it would not be developing CBD regulations, stating that there is not an available pathway to create such rules and it would require congressional action.

To that end, Sens. Ron Wyden (D-OR), Rand Paul (R-KY) and Jeff Merkley (D-OR), along with Rep. Earl Blumenauer (D-OR), separately filed legislation on Thursday that would remove regulatory barriers that FDA claims prevents it from allowing CBD sales in the food supply or as dietary supplements.

The Hemp Access and Consumer Safety Act, which was also introduced last Congress but did not advance, would exempt “hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp” from certain federal restrictions, while permitting officials to enact labeling and packaging rules.

—Marijuana Moment is tracking more than 1,000 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they don’t miss any developments.Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.—

“Despite being legally grown in the United States for nearly five years, hemp and hemp-derived CBD are still in a regulatory gray zone that puts consumers at risk and holds producers back,” Wyden said in a press release. “The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD.”

Merkley added that “our hemp farmers need updated CBD regulations to thrive.”

“FDA get it done!” he said.

Paul, for his part, said that CBD products and businesses “have earned their recognition in the marketplace, but the FDA, unfortunately, hasn’t treated them like any other food additive or dietary supplement.”

“The Hemp Access and Consumer Safety Act directs the FDA to regulate hemp products properly and provides a huge relief to hemp farmers, processors, and merchants,” the senator said.

Comer, meanwhile, said in April that his panel would be launching an investigation into the matter, and he requested that FDA turn over documents related to its decision not to regulated the cannabinoid. Even before the agency made that decision, the congressman expressed his intent to address the lack of rules.

Now lawmakers are gearing up to formally address FDA’s inaction at the subcommittee hearing.

Jonathan Miller, general counsel to the U.S. Hemp Roundtable, will be among those testifying at the meeting, the organization announced in a press release on Thursday.

Huge news! @HempRoundtable General Counsel @RecoveringPol will testify at a historic hearing on #hemp and #CBD before the @GOPoversight Subcommittee on Health Care and Financial Services. Join us on July 27th at 2 PM ET to witness this momentous event! https://t.co/sqB6ztAQUopic.twitter.com/Vvdd7KZa9W

— US Hemp Roundtable (@HempRoundtable) July 20, 2023

“I am honored to serve as a witness for this historic hearing to testify to the extraordinary challenges faced by hemp farmers and CBD consumers over the past five years,” Miller said. “I look forward to shedding light on the urgent need for clear regulations that ensure consumer safety and promote the growth of the hemp industry.”

Two other witnesses are listed to testify at the hearing next week: Rayetta Henderson, senior managing scientist at ToxStrategies, LLC and Richard Badaracco, a former Drug Enforcement Administration (DEA) special agent who now serves as the president-elect of the Kentucky Narcotic Officers Association and as a board member of the U.S. Hemp Authority.

The hemp industry took a major plunge in 2022, according to a report from the U.S. Department of Agriculture (USDA) that was released in April—and stakeholders say the FDA’s refusal to issue regulations for CBD products is largely to blame.

Bipartisan congressional lawmakers refiled a separate pair of bills in March that are also meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food and beverage additives.

FDA’s announcement that it wouldn’t be regulating CBD came days after the agency released finalized guidance that focuses on developing cannabis-based drugs and outlined the process and unique considerations for scientists when it comes to hemp and marijuana.

Meanwhile, the agency has received some bipartisan praise for releasing first-ever guidance on developing psychedelic medicines. At the same time, it is actively working to review the federal scheduling of marijuana under a directive from President Joe Biden last year.

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Federal Health Agency Issues CBD Warning, While Noting Dispensary Products May Be Safer Than Those Purchased Elsewhere

A federal health agency has published a new advisory on what it warns are the “potential harms, side effects, and unknowns” of CBD as more Americans use the popular cannabinoid. At the same time, the government body is also implying that products purchased from state-legal marijuana dispensaries may be safer than those found at gas stations and other retailers.

CBD has appeared on store shelves across the country following Congress’s legalization of hemp in the 2018 Farm Bill, and the Substance Abuse and Mental Health Services Administration (SAMHSA) advisory notes that “the popularity of CBD products continues to grow.” It points to an array of form factors—including CBD-infused topicals, fabric, food and beverages—now on the market at an estimated 270,000 retailers nationwide.

“It is critical that the general public be made aware of the potential harms associated with CBD use,” the agency said in an announcement about the advisory on Thursday, “and parents, in particular, should be advised not to let their children use non-FDA-approved CBD products.”

As many as 1 in 3 Americans reported using CBD products in 2020, the report says, citing a survey conducted by the prescription discount plan SingleCare. Given the widespread use, the agency warns, “The public should be aware of the misconceptions surrounding CBD products as well as the potential harms and risks associated with their use.”

Curious about the potential #risks and #harms of non-FDA-approved #CBD use? Check out SAMHSA’s new advisory: https://t.co/1wMjabVpHXpic.twitter.com/ITW5rTTmaV

— Miriam E. Delphin-Rittmon, Ph.D. (@SAMHSA_Leader) February 24, 2023

The brief advisory is not intended to be a comprehensive evaluation of CBD or its medical potential, with SAMHSA saying it “focuses on the risks and harms of CBD, especially those sold over the counter.”

Many of the dangers identified in the report—such as a lack of safety standards, poor accuracy in labeling and inconsistent quality control—result from the federally unregulated status of CBD products.

For instance, the SAMHSA advisory says that CBD concentrations “may be more or less than advertised and, because of a lack of quality control, the manufacturing process may introduce harmful biological and chemical contaminants, including the psychoactive [cannabinoid] THC.”

“The lack of safety standards, accuracy in labeling, and quality control,” the report continues, “may lead to additional concerns for unintended intoxication, particularly among children.”

Last month, FDA announced that it will not be creating rules to allow CBD to be marketed as a dietary supplement or food item despite repeated calls for administrative action from lawmakers, advocates and other stakeholders. Instead, the agency said that it wants to “work with Congress on a new way forward.” Officials also denied three citizen petitions requesting rulemaking for the marketing of CBD.

Other potential health and safety effects of CBD use, the SAMHSA report says, could include “adverse drug interactions, liver toxicity and reproductive and developmental effects.” It says more clinical research is needed to conclusively determine whether CBD products are safe and effective.

The advisory does not attempt to compare potential side effects of CBD to complications involved with prescription medications, for example opioids. A number of studies have indicated that easier access to regulated cannabis, which includes CBD products, can reduce patients’ reliance on opioids to treat conditions such as chronic pain.

So far the only FDA-approved CBD product is Epidiolex, a prescription medication that consists of purified CBD and is intended to treat a rare form of epilepsy in children.

Non-FDA approved products are marketed as a potential treatment for a wide range of other health conditions, only some of which are supported by research.

Citing survey data from 2019, the agency said that 40 percent of CBD users purchased products from marijuana dispensaries. About a third (34 percent) bought CBD from a different retail store, 27 percent shopped online and 12 percent obtained it from another source.

Cannabis retailers, which are typically licensed and heavily regulated at the state level, may offer better and more consistent CBD products than are available at national retailers, SAMSA said—a notable admission from the agency while marijuana dispensaries remain federally illegal.

“Although regulations and enforcement vary from state to state,” the advisory said, “CBD products purchased from dispensaries may be subject to some form of oversight and standardization.”

It also noted, however, that “products sold at cannabis dispensaries are not FDA-approved and may contain more than 0.3 percent THC, depending on the state’s definition of allowable CBD products.”

Consumers, businesses and even members of Congress have expressed frustration at the general lack of regulatory guidance on CBD from federal agencies. Last September, U.S. Reps. Morgan Griffith (R-VA) and Brett Guthrie (R-KY) sent a letter to FDA Commissioner Robert Califf demanding answers over the continued lack of regulations. Earlier this year, a key Republican lawmaker, Rep. James Comer (R-KY), pledged to take FDA officials to task with his new House chairmanship for failing to enact CBD regulations.

At DEA, meanwhile, officials recently weighed on on two other cannabinoids that can be derived from legally grown hemp: delta-8 THC-O and delta-9 THC-O, which are not naturally found in the cannabis plant but can be produced from other natural cannabinoids. DEA said that because the two cannabinoids “do not occur naturally in the cannabis plant and can only be obtained synthetically,” they do not fall under the definition of hemp and are therefore considered illegal controlled substances.

FDA also recently touted its role helping a state agency crack down on a company selling delta-8 THC gummies that they said are linked to “serious adverse events.”

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