Tag: kratom

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).

Keep reading

Industry group calls for FDA regulation of Kratom

Kratom, the tropical tree native to Southeast Asia, isn’t lawfully marketed in the U.S.— not as a drug product, a dietary supplement, or a food additive in conventional food. However, products prepared from kratom leaves are available in the U.S. through sales on the Internet and at brick-and-mortar stores. 

Kratom is often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal.

According to the American Kratom Association, the U.S. Food and Drug Administration is putting consumers at risk because it refuses to regulate kratom properly.  

Mac Haddow, the association’s senior fellow on public policy, says: “Since the FDA  treats all kratom products as the same, consumers have to navigate an increasingly complex marketplace alone.”

Keep reading

Top Federal Health Official And Former White House Drug Czar Brief Congress On Kratom As Advocates Push For Bipartisan Reform Bill

A top federal health official and a former White House drug czar were among the featured speakers at a recent kratom-focused congressional briefing, laying out research priorities for the plant and broadly promoting alternative approaches to drug criminalization.

Last week’s event, organized by the American Kratom Association (AKA), was meant to give a science-based overview of kratom issues for congressional staff and stakeholders as bipartisan lawmakers work to advance a bill to federally regulate the substance, which is currently unscheduled and anecdotally used for pain relief, curbing withdrawal symptoms and other purposes.

National Institute on Drug Abuse (NIDA) Director Nora Volkow started by saying that while she always wants policy to be grounded in science, she’s come to understand that data is “not necessarily sufficient or enough.”

In the case of kratom, she said, “unfortunately, we don’t know much,” which is why NIDA is committed to expanding research into its potential risks and benefits. For example, she said health agencies have “invested significant resources” to synthesize the main compound of kratom so that researchers can conduct clinical trials investigating how it can be used for pain management and also “for the treatment of drug addiction.”

Keep reading

Indonesia’s President Urges Biden To Lift FDA’s Kratom Import Restrictions, Advocacy Groups Say

In a meeting with President Joe Biden this week, the president of Indonesia urged the administration to lift a Food and Drug Administration (FDA) alert that broadly restricts imports of kratom to the U.S., according to a pair of advocacy groups.

Indonesia is one of the primary international exporters of kratom, a plant native to Southeast Asia that’s used for pain relief, managing the symptoms of opioid withdrawal and other purposes. The plant is currently unscheduled under U.S. law, but FDA issued an import alert in July that has seriously limited kratom imports from Canada, Indonesia, Malaysia and the Philippines.

Indonesian President Joko Widodo met with Biden for a bilateral meeting at the White House on Monday. According to the American Kratom Association (AKA) and the Kratom Coalition, Widodo used the opportunity to request administrative action to remove the FDA restrictions, emphasizing the economic and environmental consequences of the current kratom import policy for Indonesia.

The White House referred Marijuana Moment’s request for comment to the National Security Council (NSC). A spokesperson for NSC said they have “nothing to add on the Leaders’ conversation beyond the joint statement and fact sheet released on Monday” that do not explicitly mention kratom.

Keep reading

Federal Lawmakers Are Preparing To Reintroduce Legislation To Regulate Kratom Amid Pushback To FDA-Proposed Ban

As federal lawmakers prepare to reintroduce a bill to regulate kratom, a former Trump administration drug czar stressed the need to beat back “misinformation” from the Food and Drug Administration (FDA), which has attempted to ban the substance in the U.S. and abroad.

Members of the American Kratom Association (AKA) said during a webinar Tuesday that they expect federal legislation to regulate the drug “will be filed shortly” in Congress and could be taken up later this session.

The text of the forthcoming bill “will be word-for-word the same” as congressional legislation introduced last session, said Mac Haddow, a senior fellow at AKA. The title, however, will be updated to the Kratom Consumer Protection Act, a nod to model legislation that AKA has been lobbying for at the state and federal levels.

Sponsors will include, on the Senate side, Sens. Mike Lee (R-UT) and Cory Booker (D-NJ), who also sponsored last session’s bill, the Federal Clarity for Kratom Consumers Act. In the House, lead sponsors will be Reps. Mark Pocan (D-WI) and Jack Bergman (R-MI). Pocan sponsored last year’s bill in the House, while Bergman is a new addition.

The forthcoming legislation’s bipartisan sponsorship in each chamber—specifically pairing a “very liberal” elected official with a “very conservative” one—is designed to highlight “that this is not a partisan issue,” Haddow said. “This is about good policy.”

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.

Neither chamber took action on the proposal last session, but AKA expects more traction—and more sponsors—on this year’s bill.

Keep reading

Former Trump Drug Czar Says Top Federal Officials Stopped FDA From Scheduling Kratom Amid Concern About Agency’s ‘Bias’

As the U.S. Food and Drug Administration (FDA) under the Trump administration prepared to propose federal restrictions on kratom, a number of top officials intervened, criticizing the agency’s “bias” and stopping it “on the spot” from moving ahead with scheduling, a former White House drug czar said in a new interview.

“They did not give—did not have—the entire facts. They didn’t have the science,” said Jim Carroll, who served as director of the Office of National Drug Control Policy, or drug czar, under President Donald Trump from 2018 to 2021. “FDA did not paint the entire picture. Maybe they didn’t have the entire picture, but everyone else did.”

Carroll, who now works as a private lawyer and consultant, made the comments during a discussion with Mac Haddow, senior fellow at the American Kratom Association (AKA), during the National Conference of State Legislatures summit in Indianapolis earlier this month.

The former White House official said that as the Trump administration was considering whether to schedule kratom under the Controlled Substances Act, around 2018, FDA gave a presentation to his office that misstated the drug’s risk profile and potential benefits.

The agency was “talking about kratom being an opioid. We know that’s wrong, it’s flat-out wrong,” Carroll said. “They said that it’s highly addictive. Johns Hopkins [and] other medical, independent researchers have said it’s no more addictive than a cup of coffee in the morning, which I had before this interview.”

Keep reading

Innocent Man Beaten to Death in Jail After Being Sentenced to a Decade for Having Kratom

Last week, the Free Thought Project delved into the deeply unsettling story of Shaina Brown, an Alabama resident facing a potential life sentence over the mere possession of kratom. In our coverage, we touched upon the tragic case of Marshall Price, another victim of the merciless war on drugs. This week, we continue our exposé by shifting our focus to Price’s case, highlighting the gruesome realities of this ongoing war on a widely beneficial plant.

Before moving into the details of Marshall’s story, it is important to point out the massive disinformation campaign waged by the media and the government over this plant. A recent story out of Florida is gaining traction and serves as a perfect example of this propaganda after a judge awarded the family of Krystal Talavera $11 million in a lawsuit. Talavera, who had life-threatening pre-existing conditions, died after ingesting a substance in a baggy that had “Space Dust” written on it with a sharpy. This is “kratom,” according to the media, which is unwilling to do even 30 seconds of research to find out the truth.

The court ruled that Talavera died from kratom, and the media ran with it. But this was simply not the case. Talavera ingested a highly potent and concentrated alkaloid extract of the kratom plant, not kratom leaves. This is the equivalent of extracting lethal doses of caffeine from the coffee bean and calling it “coffee.”

Keep reading

Innocent Woman Facing Life in Prison for Legally Purchasing Kratom & Driving 200 Feet Into Alabama

In a disgusting display of what’s fundamentally wrong with America’s drug war, Shaina Brown, an entirely innocent woman, who harmed no one, finds herself locked up behind bars, slapped with an egregious $1,000,000 bail, later lowered to a still absurdly high $250,000, all for the mere possession of a plant she bought legally, just 200 feet away from where she was arrested. The plant in question? Kratom, a botanical supplement that has been vilified by a select few states and the federal government, despite it being perfectly legal in the majority of the US, including where Brown had initially bought it. It is also extremely safe when consumed properly.

To show just how insidious the state’s war on kratom actually is, we compared some of the recent bail amounts in Escambia County to Shaina’s case. Folks with crimes like strangulation, assault, battery, murder, and sexual abuse all have lower bonds than Shaina.

According to local law enforcement, the arrest happened in the dead of night on April 1, 2023, after Brown crossed over the unmarked state line from Florida, where Kratom is legal, into Alabama, where it is not. For those who may be unaware, kratom is ground-up tea leaves that are consumed by millions worldwide for its therapeutic benefits. Shaina’s mistake? Unknowingly bringing it into a state that has criminalized it.

Now, Brown faces the grim reality of the drug war in America. A plant purchased legally turns into a Schedule 1 substance the moment she crosses that imaginary line drawn on a map, transforming her, in the eyes of Alabama law, from a law-abiding citizen to a felon, with potential charges carrying a sentence of 10 years to life in prison.

The charges are shocking, especially considering Shaina’s history of minor offenses: a solitary speeding ticket and a cold check written in 2014 for under $500. A woman who isn’t a hardened criminal is now facing the prospect of losing years of her life, all for unknowingly “trafficking” tea powder in Alabama.

What’s most chilling about these proceedings is the manner in which they’re carried out. Juries are informed that the defendants are charged with possession or trafficking of a Schedule 1 substance, but they’re not told that this substance is Kratom. This omission paints an unfair picture, aligning defendants like Shaina with the likes of hardened criminals involved in the trade of far more dangerous and illicit substances like fentanyl.

Keep reading

American Medical Association Promotes Psychedelics Research, Opposes Kratom Criminalization And Affirms Support For Marijuana Drug Testing

The American Medical Association (AMA) has adopted a series of new drug policy positions, including advocating for psychedelics research, opposing the criminalization of kratom, calling for an end to the sentencing disparity between crack and powder cocaine and supporting the continued inclusion of marijuana metabolites in employment-based drug tests.

The organization’s House of Delegates, which met last month to consider numerous resolutions, also declined to approve an additional measure to revise its stance on marijuana in a way that would have maintained its opposition to legalization while implicitly recognizing the benefits of regulating cannabis products—instead opting to continuing its advocacy for prohibition without the newly proposed regulatory language.

This comes about a year after AMA delegates voted to amend its policy position to support the expungement of past marijuana convictions in states that have legalized the plant.

At the most recent meeting, the body tackled several different areas of drug policy.

The American Kratom Association (AKA) cheered the adoption of a new resolution that says people “who are using kratom only for personal use should not face criminal consequences”—though the measure also says that the substance should be “evaluated by the relevant regulatory entities for its appropriateness for sale and potential oversight via the Controlled Substances Act, before it can be marketed, purchased, or prescribed.”

Keep reading