Four top scientists agree that the FDA should regulate Kratom to guarantee its quality, purity and consistency. If not a black market will develop that would put consumers at risk.

29 April 2018
Four top scientists  agree that the FDA should regulate Kratom to guarantee its quality, purity and consistency. If not a black market will develop that would put consumers at risk.

A number of scientists including Jack Henningfield, an adjunct professor of behavioural biology at Johns Hopkins University School of Medicine and Vice President of research in the areas of health policy and abuse liability for Pinney Associates, have come together and blasted the FDA policies on Kratom. They said that Kratom has also been unfairly slandered in the wake of the recent Salmonella health warnings and product recalls. They were also very critical on Denver’s current prohibition of Kratom and suggest that making such laws will only force people to source their products from underground and illegal sources which would eventually lead to tragedy.

 

A Kratom Tree, Mitragyna speciosa

 Mitragyna speciosa. The Kratom Tree Native to South East Asia.

Henningfield states “Former opioid addicts who've successfully used kratom to kick their habit are reporting they are terrified of losing access to the product. These people fear going back to opioids if kratom is banned, and any of us in addiction medicine know that fear is justified. It's predictable that many will go back to opioids and some will die."

Mitragyna speciosa is safe 

Oliver Grundmann is a clinical associate professor at the University of Florida's College of Pharmacy.

 

This event was provided by the non-profit organization People Plants & Health.  

Other participants included Michael McGuffin, executive director of the American Herbal Products Association along with Paula N. Brown, director of applied research and Canada research chair for the BC Institute of Technology and adjunct professor of biology at the University of British Columbia and Oliver Grundmann, a clinical associate professor with the College of Pharmacy at the University of Florida.

Mitragyna speciosa

Oliver Grundmann is a clinical associate professor at the University of Florida's College of Pharmacy.

All four experts delivered the same basic message: Rather than outlawing kratom or treating it similarly to narcotics such as heroin and cocaine, the FDA and other agencies in the federal government should regulate it to guarantee its quality, purity and consistency and if they don't, a black market will develop that would likely put consumers at greater risk.

"When the FDA declared that kratom is an addictive, narcotic-like substance that's dangerous, it's not surprising that Denver officials would come up with their own kratom rules. I am aware that many health professionals with different agencies are considering what to do, and they're scratching their head and getting mixed messages.... In the few states where it's banned, people get it from elsewhere, and if it's banned nationally and criminalized, the only place to go is criminal sources. And that's a deadly, scary option." Stated Jack Henningfield.

Grundmann discussed a survey he conducted two years ago with thousands of kratom users. "I can tell you that part of the responses I received came from Colorado, he noted. I can't tell what part of that population was using kratom to mitigate withdrawal symptoms from either illicit drug use or prescription opioid use. But I would obviously share the caution or the concern that Dr. Henningfield feels that users who have been using kratom to mitigate withdrawal symptoms or [have] felt relief from symptoms of opioid use are now at a loss."

“As a result of the Denver human-consumption ban”, Grundmann went on, “such individuals might have to switch back to prescription opioids or turn back to illicit use  or they are obtaining kratom from other states or a source like the Internet, which obviously isn't regulated in the same manner. And that's a concern. I don't see any benefit in regulating it at this point on a state-by-state level, and I hope that eventually Denver and the states will try to find a way forward based on science  on what science tells us."

Michael McGuffin added "The idea of having to understand 51 regulations one from the FDA and then the fifty states is not tenable. That's why we're strongly supportive of appropriate regulations and would discourage state-by-state approaches in the interest of maintaining order in the use of this herb that's being used in all fifty states. We advocate for strong federal management and regulation."

Paula Brown said, "This really brings me back to my concern about the advisories issued by the FDA. The science out there doesn't support the assertion of the risks associated with kratom. This is a plant used for more than a century to reduce stress and anxiety, to boost energy and reduce minor pain  and there are few alternatives for reducing minor pain outside of Ibuprofen and Acetaminophen. From my perspective, you're talking about a traditionally used herb that is in the marketplace, and it's in the best interest of public health to make sure these products aren't adulterated and contaminated."

Henningfield supported the efforts made by the FDA in conjunction with the Centers for Disease Control and Prevention to target salmonella-infected kratom. "That's when we need the FDA," he said. But in his view, using this situation as an excuse to justify prohibiting kratom in general would be as wrong as banning all sales of chicken or eggs after a salmonella infection.

The abuse and addiction potential was thoroughly discussed by the scientists. Although Mitragynine the main alkaloid responsible for Kratom’s effects binds to the same receptors as heroin and fentanyl, it is infinitely less addictive than those substances. Henningfield pointed out that "We basically rank substances on their addictiveness and harmfulness. That's part of the scheduling process" established by the Drug Enforcement Administration. For instance, certain over-the-counter cough medicine does cause addiction in some people and does cause serious harm. You could schedule it, but it makes more sense not to schedule it. Nicotine gum meets some criteria for addiction, and some people become addicted to it  but most of the people were already cigarette smokers."

Henningfield went on to say "it's not as simple as all or none. ... Kratom's potential for addiction and harm is relatively low compared to opioids and other products and other substances. For example, narcotic-like opioids can cause powerful euphoria, as well as respiratory depression and death. We don't see that in kratom not even in Southeast Asia, where it literally grows on trees. People don't smoke it there.”

He also very interestingly points out that "the most widespread addiction on the planet is to caffeine." This is an appropriate reference because kratom is closely related to coffee being in the family. "We consider that a relatively benignly addictive substance. You could get stimulated and wake up with cocaine or amphetamines, but most of us believe caffeine is a better way to do it. If you drink it every day, you're probably at some level of dependence. But when it comes to opioids versus kratom, that's a no-brainer."

Grundmann, referencing the same survey, said, "it is quite obvious that the risk of dependency development for kratom is low compared to many other drugs. As Dr. Henningfield pointed out, if we rank a drug or substance in general on a scale of how likely is somebody to get addicted or dependent on it, then kratom is likely to end up on the lower end of that. But there are various components that lead somebody to become dependent on a drug...and for somebody who was dependent on alcohol or wanted to use kratom to mitigate withdrawal symptoms from alcohol dependence, this might not be the ideal way to go about it."

Early evidence suggests that kratom seems to be working quite well for withdrawal symptoms from opioids but we would really need larger studies that are better organized and better controlled to give us more evidence. And if research on kratom is restricted, those studies couldn't be conducted. That's the fear we have as researchers moving forward." Said Grundmann.

 



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