Science and Research Should Take Precedence Over Alarmist Kratom Bans
City of Newport Beach Kratom Ban Puts Politics Over Science
Kratom, whose scientific name is Mitragyna speciosa, is a tropical evergreen tree in the coffee family that is native to Southeast Asia. Due to its mood-enhancing and productive enhancement properties, products including the ingredient have surged in popularity in recent years.
It is estimated as many as 15 million people in the U.S. use kratom as a herbal supplement. It's not just a botanical product; it's a lifeline for many. It has helped countless individuals with occasional stress and anxiety and mood and productivity enhancement.
Products with kratom as an ingredient are legal to buy and consume in California. However, bans have been instituted in individual cities of San Diego, Oceanside, and, as of last week, Newport Beach.
The Global Kratom Coalition is opposed to this most recent ban. Instead we urge local elected leaders to consider a common sense approach relying on facts, science, and well considered regulations that serve to protect consumers while maintaining access to natural alternatives.
Everyday our members interact with dozens of kratom consumers. Story after story proves that responsible use of these products can have an outsized impact on quality of life and provide an alternative to more widely used substances that do not agree with their personal consumption choices.
It is our desire that local and state governments consider the adverse impact this might have on consumer segments who rely on kratom products as part of their wellness routines. We also urge local governments to consider the real-world implications that emanate from a localized ban; consumers do not stop taking the product, they just find alternate ways to purchase it.
Councilmember Lauren Kleiman, who put forward the ban, admitted as much when she stated that ‘in the meantime, there are plenty of other opportunities to access product outside of the city for residents that would like to purchase it’. This begs the question as to what a localized ban achieves beyond affecting local businesses who sell kratom, and inconveniencing local residents who choose to use kratom.
The fact is, localized bans do not change consumption habits, as consumers may simply travel outside the ban lines to obtain their products, and law enforcement loses control of the problem (if there is, in fact, a problem at all).
Kleiman also relied on outdated data, claims and sources to determine that kratom is unsafe. In fact, the U.S. Food and Drug Administration (FDA), one of the most cited kratom critics, recently acknowledged that they are yet to determine that kratom is dangerous. On February 8, 2024, when called by a Federal Judge to present witnesses and testimony under oath in a case in the Southern District of California at a hearing on whether kratom is dangerous, the FDA refused to attend the hearing or even provide under oath any documents or testimony to the Court. "They [FDA] have refused to provide us with witnesses or documents to support our position… The reason they gave was that they have not yet made a determination regarding whether kratom is dangerous.”
In place of banning kratom, here are some more productive regulatory ways to ensure kratom is safe and available.
Use common sense regulations to maintain access and ensure consumer safety, consumers and industry need clarity and certainty. To get there, we need common sense, science backed regulations. Based on science and research, regulations are critical to a safe and prosperous industry. The Global Kratom Coalition is advocating for regulations designed to ensure that consumers have access to kratom products that are safe. These regulations include clear labeling standards, manufacturing standards and protections against the adulteration of kratom products.
Model regulations provide a framework for businesses to operate within, outline guidelines on consumer protection and product safety. State-level regulations, such as those proposed in Oklahoma by Sen. Dana Prieto, R-Tulsa, authored legislation along with Rep. Daniel Pae, R-Lawton (HB 3574), play a crucial role in ensuring companies can effectively serve their customers while maintaining ethical standards and compliance. The Oklahoma regulations further prevent adulteration, and strengthen manufacturing, labeling and packaging requirements.
Follow more recent moves by the FDA who is shifting to use science and facts. As state’s like California further consider how to regulate the industry - which is absolutely necessary - regulators should follow the lead of the U.S. Food and Drug Administration (FDA) and their aim to use science and facts to drive policy recommendations. In late February 2024, the FDA committed to pursue fact based product arguments that influence regulations. Regulations based on science and facts ensure that decisions are grounded in evidence, promote safety, and encourage efficiency.
Consider future data and leadership coming from the FDA. Clinical research is necessary to expand understanding of kratom consumer safety, guide regulatory decision-making, and impact global health. FDA also recently appointed James “Jim” Jones, the first-ever Deputy Commissioner of the Human Foods Program. Jones, a renowned food expert, is well positioned to encourage the agency to produce robust scientific data that evaluates the efficacy and safety of kratom.
As noted at the recent 3rd Kratom Symposium, the scientific community strongly encourages further research on the various forms of kratom to help firmly establish, clarify, or dispel inaccuracies. The FDA’s recent leaf kratom Single Ascending Dose (SAD) study and upcoming Human Abuse Potential (HAP) are critical components of the clinical research needed in this space.
The SAD study aims to learn about the safety, pharmacokinetics (what the body does to the substance), and pharmacodynamics (what the substance does to the body) of leaf Kratom. This SAD research will help determine the optimal dose range for further clinical development by identifying the maximum tolerated serving and assessing kratom's effect at various serving levels. Additionally, the single ascending dose data will provide valuable data on leaf kratom’s safety profiles, guiding subsequent dose selection for further clinical trials and public statements on kratom. Initial SAD results are expected to be released in late 2024.
The FDA has also released a request for proposal for Human Abuse Potential (HAP) research. The HAP research will evaluate kratom through controlled laboratory studies and observational research, which can provide critical insights into its addictive properties and abuse liability, informing regulatory decisions on how kratom should be adequately regulated in the U.S.
FDA with state legislators and regulators can create much greater certainty. Research will be critical for the question marks that the FDA has had in relation to kratom's risk profile. These findings could be an industry and consumer game changer.
Level-set with comparative data
Our own analysis of Poison Center Calls from 2017 to 2022 demonstrates the relative risks of other substances compared to kratom.
This graph presents total call numbers for each of multiple substances including kratom.
When normalized by 100,000 users (see “Calls per 100K Users”), it is still apparent that kratom calls are still relatively low when compared to other widely used and accepted substances that are freely marketed and sold in the US.
There were only 18 calls that resulted in death after kratom ingestion, whereas opioid calls that resulted in death were almost 1,790 in the same 6-year period (see “Calls Resulting in Deaths”).
All of this data and upcoming research show that knowledge of kratom and its benefits are headed in the right direction. However, alarmist reactions from local elected officials is a step in the wrong direction. It is the desire of the Global Kratom Coalition for lawmakers and state-level regulators to create and enforce common sense regulations based on facts.
