In 2016, the Drug Enforcement Agency (DEA) issued a Notice of Intent to temporarily schedule mitragynine and 7-hydroxymitragynine, the two primary alkaloids found in kratom, as Schedule 1 substances. This Notice of Intent was subsequently withdrawn on October 31, 2016; however, since then we have been led to believe that kratom was still under constant investigation.
On January 28th, 2021, it was discovered that this was not the case and that the Department of Health and Human Services, HHS) had rescinded the request for classification of kratom as a Schedule I drug all the way back in 2018.
To be classified as a Schedule I drug, a substance must have “no currently accepted medical use and a high potential for abuse.” However, before the DEA can schedule a substance, the Attorney General has to request an evaluation and recommendation from the Secretary of Health and Human Services.
In 2018, Brett Giroir, the Assistant Secretary of Health, said, “I now conclude that while mitragynine and 7-hydroxymitragynine have many properties of an opioid, scheduling these chemicals at this time in light of the underdeveloped state of the science would be premature.
For example, one recently published peer reviewed animal study indicated that mitragynine does not have abuse potential and actually reduced morphine intake.” He went on to state several consequences of immediately adding kratom to the list of Schedule I substances. Among those, he said that the scheduling could lead to “intractable pain,” a risk of switching to highly lethal opioids, and the stifling of research.
The fact that these recommendations came in August of 2018, but were just made available to everyone in 2021, means that the FDA deliberately hid this fact for well over two years. By withholding these facts, the FDA misled policy makers and the media. In turn, research was oppressed, medical professionals retracted support, and lawmakers and law enforcement groups were duped.
Six states followed the federal government by banning the sale of kratom and additional local governments followed suit. This left consumers without the beneficial plant that, in some cases, was the only substance that truly helped them.
Many of these kratom bans pointed directly to the imminent threat of scheduling kratom, which has been false since 2018. In addition, false news reports and information may have kept consumers from benefiting from kratom due to unsupported fear of the natural plant.
The fight is not over. As Dr. Jack Henningfield, Vice President, Research and Health Policy at Pinney Associates, stated, “Our nation needs FDA in the game, setting standards for kratom product purity and everything else it routinely does for dietary supplements and even kratom’s botanical cousin, coffee beans and ground coffee.
Fortunately, four states have already begun to blaze this trail with their own consumer protection regulatory frameworks, and many companies are working with the American Kratom Association on voluntary good manufacturing practices, so FDA does not need to start from scratch.” In addition, there needs to be an increase in awareness and research so that people can properly benefit from kratom. The American Kratom Association backs such initiatives and aims to support kratom consumers, educate all Americans, amplify the positive stories of kratom, and generate awareness.