AKA Sharpens Criticism Of 'Opioid' Finding In FDA's Report To DEA

25 August 2018
AKA Sharpens Criticism Of 'Opioid' Finding In FDA's Report To DEA

Executive Summary

American Kratom Association realizes FDA could have significant influence on DEA decision on whether to schedule kratom constituent ingredients as controlled substances. The association and experts on kratom say FDA's, which concluded that mitragynine and 7-hydroxymitragynine are opioids and use of kratom is dangerous, contains numerous inaccuracies and incorrect conclusions.

The clock is ticking on kratom remaining available in the US, proponents for the botanical ingredient say, unless the Drug Enforcement Administration rejects FDA's findings about its safety and chemical profile.

The American Kratom Association anticipates that FDA will have significant influence on DEA's decision on whether to schedule kratom constituent ingredients mitragynine and 7-hydroxymitragynine as controlled substances. Scheduling those substances would shut down US sales of products containing kratom, which is extracted from a tropical deciduous and evergreen tree in the same biological family as coffee and native in Southeast Asia and currently is used by 3m to 5m consumers.

However, the association and researchers who are experts on kratom say FDA's 2017 report, which concluded that mitragynine and 7-hydroxymitragynine are opioids and that use of kratom is dangerous, contains numerous inaccuracies and incorrect conclusions.

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"The time's come for the Congress of the United States and the DEA to stand up and say, 'We want good evidence'," said C.M. "Mac" Haddow, an Upstream Consulting principal and a senior fellow on policy at AKA, during an Aug. 21 media briefing the trade group conducted to discuss its evaluation of FDA's research.

"We're requesting that the government follow the science," said AKA President David Herman.

In addition to FDA's study on kratom, DEA is conducting its own analysis and will evaluate those results before making its scheduling call, said an agent representing DEA.

Although AKA asserts that DEA is under pressure from FDA to prohibit sales of products containing mitragynine and 7-hydroxymitragynine through Controlled Substances Act scheduling, DEA does not say that it is expediting its decision.

As far as when it's expected, the agent said DEA is not required to make its decision by a certain date because kratom is not deemed a substance subject to FDA's drug product oversight authority. DEA faces a 90-day deadline for scheduling decisions when the relevant substance is considered a drug.

"There's not a hard deadline for when we have to finish our analysis for kratom," the agent said.

DEA initially proposed temporarily scheduling kratom before receiving comments as well as FDA's analysis and conducting its own, but questions from consumers, industry stakeholders and members of Congress waylaid the proposal. The agency in October 2016 withdrew it and commenced a notice-and-comment process to guide its decision without temporarily scheduling the herb's mitragynine and 7-hydroxymitragynine constituents. (Also see "DEA Takes Comments On Kratom, But Keeps Eye On Scheduling" - Rose Sheet, 14 Oct, 2016.)

FDA stands by its research and its findings. "The FDA has done an exhaustive review of adverse event reports, clinical literature, and other sources of information related to kratom and is deeply concerned about the drug’s risks and its potential for abuse. Kratom is an opioid and has the addictive features of opioid drugs. In the setting of an opioid epidemic, FDA has deep concerns about the potential for kratom to fuel the addiction crisis," an agency representative said in an email.

FDA Follows 'Story' Or Science?

Like Haddow and Herman, Jane Babin, a kratom expert who evaluated FDA's report for the trade group, criticized the agency's work. FDA has "abandoned the true science in pursuit of its own story. That has a lot of implications," said Babin, a University of San Diego School of Law professor and a molecular biology researcher at Purdue University.

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AKA contends that although FDA stated in its November 2017 report to DEA that 44 deaths had been linked to kratom over a seven-year period, the agency based those findings on reports that kratom was found in the blood of the decedents, not on autopsy reports that identified kratom use as the cause of death. (Also see "FDA's Opioid Label For Kratom Called Misbranding By Marketers" - Rose Sheet, 7 Feb, 2018.) FDA since has reported that 64 deaths were reported referencing kratom use, but allowed that 17 were later classified as not linked to the ingredient.

"We should be able to trust our government to bring us objective information about the subjects within their purview," said Babin, who has collaborated with AKA pro bono.

She suggested that by "picking and choosing" data and other information about adverse event reports and other materials that refer to kratom, FDA created its "story of kratom being an opioid to substantiate the story that it's dangerous."

FDA's representative said the 64 deaths involving kratom were reported in AERS received by the agency between January 2011 and April 30, 2018. FDA determined that 47 of the deaths may be kratom-related, but also found "that 17 of the 64 deaths reported (some of which were reported as suicides), were not likely caused by kratom," the representative said. 

"These deaths are just one measure of kratom’s risk. They don’t account for the many people who may become initiated on, and addicted to, opioids because of the easy access to kratom," the representative added. 

Coffee Closest Comparison?

Kratom, however, is no more dangerous than coffee, which is extracted from a similar plant, says Oliver Grundmann, a researcher and a medicinal chemistry professor at the University of Florida College of Pharmacy.

FDA is accurate in saying that mitragynine and 7-hydroxymitragynine bind with opioid receptors in the brain, but the agency's reference was incomplete because those substances don't cause an opioid-like reaction, Grundmann said. Some drug ingredients available OTC in the US, such as diarrhea remedy loperamide and cough suppressant dextromethorphan, also bind with opioid receptors, he said.

Those ingredients, like kratom constituents, don't have the same effect as pharmaceutical or illicit drugs intended to react with opioid receptors. "Just because there is an interaction with opioid receptors, the quality or what the consequences of that interaction are can be quite different," Grundmann said.

And like coffee, kratom can be habit forming but is not dangerous if used as intended, he said. Mild headaches probably occur for three to four days following cessation of regular kratom use. "Considering that kratom belongs to the same plant family as coffee, it is not surprising that there is some possibility for dependence," Grundmann said.

AKA Wants Meeting

Marketers and other kratom proponents says the herbal ingredient, identified as mitragyna speciosa and available in powders, capsules or pills and beverages, has been used in the US since long before the October 1994 grandfather date for dietary ingredients to be eligible for use in supplement products without being notified to FDA as new and being subject to the agency's decision on whether safety for an intended use is established. They say the herb is safe to use at any dosage, but separate alkaloids of the extract could be unsafe if used in high dosages or consumed in formats unlike traditional kratom. (Also see "Failed NDIs, FDA's Opioid Concerns Don't Stop Kratom Supplement Sales" - Rose Sheet, 17 Aug, 2018.)

FDA's conclusions on four NDI notifications for M. speciosa and for other kratom constituent ingredients submitted so far is that safety is not shown for intended use in dietary supplements.

AKA counters that when kratom's alkaloid structure is altered and its ingredients become more purified or concentrated during processing for use in some supplement formulations, an NDI notification could be necessary, but kratom leaves ground or chopped for use in beverages or in capsules are not NDIs.

After publishing its white paper on FDA's findings, AKA asked the agency and the National Institute on Drug Abuse for a joint meeting to resolve what it says are conflicts in the science about the botanical and develop public health policy allowing its continued use in supplement. The Pittsburgh-based association has not received a reply from either agency. (Also see "Kratom Group Contests FDA's Opioid Finding, Requests Joint Meeting With NIDA" - Rose Sheet, 16 Aug, 2018.)

The association previously contacted NIDA, after FDA submitted its report to FDA, asking for help to convince FDA to reconsider its warning that the ingredient is unsafe. AKA told the NIH agency that rather than provide opioid-like effects for users, and potentially lead them to using pharmaceutical or illicit opioids, kratom supplements can help narcotic addicts through withdrawal. (Also see "Kratom Experts Seek NIDA As Ally To Show Herb's Safety And Benefits" - Rose Sheet, 27 Nov, 2017.)


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