Kratom industry warns synthetic opioids should not be called ‘kratom’
“And then these amateur chemists got involved and started tinkering with the alkaloids in the natural plant and started to adulterate them, and that appropriately got kratom on the radar of both the DEA and the FDA,” he said.
In 2012, the FDA issued an import alert on kratom products, and the DEA sought to temporarily classify kratom’s primary alkaloids as Schedule I substances in 2016 before withdrawing the proposal following public comment.
The FDA maintains that kratom has not been approved for any medical use and has warned of some risks, including dependence, contamination and adverse events, while researchers continue to study both the plant and its individual compounds. (Getty Images)
More recently, the agencies have raised concerns about concentrated and chemically modified kratom products, including those containing high levels of 7-hydroxymitragynine (7-OH).
“What these bad actors have done is completely alter the composition of the natural kratom plant,” Haddow said.
“They rearranged the molecules. They’ve chemically synthesized them with high-concentration chlorine and baking soda and other nefarious production methods, so that they deliver what is in fact a signature opioid to consumers in the United States.”
Calls for stronger enforcement
The association’s focus now is on banning synthetic products and protecting the natural leaf, Haddow said.
“It is improper for any government agency across the country to be blaming natural leaf kratom for any adverse event that is properly attributable to a synthetic opioid,” he added, expressing his viewpoint.
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“If we were to take coffee and extract caffeine from it and then highly concentrate it to a level in which it is fatal and someone ingested it and died, we wouldn’t blame coffee — we would blame the bad actor that took and extracted that caffeine, because caffeine is in its natural form and coffee is not dangerous. The same is true for natural kratom.”
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Haddow said 7-hydroxymitragynine (7-OH) products — including Sudendoxyl and compounds known as MGM-15 and MGM-16 — should not be considered kratom.
“[They] are synthetic opioids, all of which should be enforced by both the federal and local law enforcement agencies,” he said.
“We advocate strongly for proper clarification of these dangerous products as opposed to natural kratom, which is literally helping people with their health and wellness and saving lives.”
Haddow cited an NIH-led study that is moving forward to evaluate whether purified mitragynine, the main alkaloid in the kratom plant, could help treat opioid use disorder.
Regulation over prohibition
Haddow said the association supports state regulations that require testing, labeling and age restrictions rather than outright bans.
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“Make sure the product formulations are safe, make sure the products are labeled correctly and make sure they’re age-restricted,” he urged. “21 and up should be the only people who have access to these products.”
“We need to regulate them, and as we represent consumers, we’re going to fight for that.”
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The FDA maintains that kratom has not been approved for any medical use and has warned of some risks, including dependence, contamination and adverse events, while researchers continue to study both the plant and its individual compounds.
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