Federal regulators are now calling the supplement kratom an opioid. So, what’s the big deal?

Advocates for the drug say the reclassification of kratom by the Food and Drug Administration (FDA) may not be a big deal in and of itself. However, what the Drug Enforcement Administration (DEA) does with this information could be.

In an announcement last week, FDA Commissioner Dr. Scott Gottlieb denounced kratom in light of new research conducted by his agency. In particular, the organization identified 44 deaths since 2011 that agency officials say are attributable to kratom.

“This new data adds to our body of substantial scientific evidence supporting our concerns about the safety and abuse potential of kratom,” said Gottlieb. “There is no evidence to indicate that kratom is safe or effective for any medical use.”

The FDA presented their findings based on “novel scientific analysis using a computational model developed by agency scientists.”

They say this analysis provides even more evidence that kratom is in fact an opioid capable of producing dangerous side effects, including breathing difficulties.

Kratom is derived from the leaves of the Mitragyna speciosa tree native to Southeast Asia.

It has been at the center of an increasingly public feud between proponents who say the drug can help with opioid withdrawal and is safer than other pharmaceutical opioids.

Criticism of FDA position

Critics have been quick to point out what they see as flaws in the FDA’s announcement.

They say that the pharmacology of kratom is already well understood, which makes the FDA’s announcement confusing at best.

“What they are effectively doing is using computer modeling, which is a very preliminary method in drug discovery,” Andrew Kruegel, PhD, an associate research scientist in the department of chemistry at Columbia University in New York, told Healthline.

“It’s like the very first step of any kind of discovery effort, which is basically going backward from the point we’ve reached already with kratom alkaloids, which is now up to animal studies,” said Kruegel.

He emphasized that the opioid activity of kratom compounds, including the two most well-known, mitragynine and 7-hydroxymitragynine, has already been established.

A spokesperson for the FDA explained to Healthline that while this may be true, this is the first time that the agency has elected to use language specifically calling kratom an opioid.

Prior to this announcement, including a public health advisory from the FDA in November on the dangerous and potentially deadly side effects of kratom, the spokesperson said the organization had been doing a delicate dance in their position on the drug.

Previously, the FDA had used slightly different language in addressing kratom, saying instead that it “has similar effects to narcotics like opioids.”

Now, the organization’s position is clear:

“Based on the scientific information in the literature, and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids,” Gottlieb said in his statement.

Opioids differ greatly

But, not all opioids are created equally.

In a previous interview with Healthline, Kruegel explained why he calls kratom an “atypical opioid.”

The compounds in kratom work through different pathways in the brain than other opioids. Kruegel says this might make them safer.

“They can activate the brain in such a way that they provide pain relief without, or at least with less, respiratory depression,” he said. “You only get a partial response. That is also protective in terms of respiratory depression side effects.”

“Really there’s nothing out there approved that’s substantially similar to the kratom alkaloids,” added Kruegel.

But others, including professors interviewed by the Washington Post, have expressed concern that kratom may be addictive.

They also say that there just isn’t enough research available at this point to say that the drug is safe.

“I support the FDA on this. I really believe they have taken a cautionary stance, which is to protect the American public,” Bertha K. Madras, PhD, a professor of psychobiology at Harvard Medical School, told the Post.

What’s the motivation?

Advocates for kratom say that explicitly using the word “opioid” in connection with kratom and the seemingly odd timing of the FDA announcement this month are the latest moves to get the DEA to make the drug illegal.

In fall 2016, the DEA had planned to implement emergency scheduling of kratom to make it a Schedule 1 drug, putting it in the same category as marijuana and heroin.

Schedule I drugs are considered to have “no currently accepted medical use and a high potential for abuse.”

The DEA can use emergency scheduling in the case of drugs that present an “imminent hazard to the public safety.”

But, they backed down after pressure from grassroots supporters and users of kratom. Members of Congress also sent a signed letter to the DEA, urging the agency to delay scheduling until they received further scientific review and input from the public.

That may have been just a small victory for kratom advocates.

The DEA is still conducting their own investigation into kratom. An agency spokesperson told Healthline they do not have a timeline yet for when they plan to finalize kratom’s scheduling.

The spokesperson confirmed that the FDA’s assessment would be included in their decision, along with numerous other scientific and legal factors.

The FDA’s announcement creates a sort of Catch-22 for kratom — what Kruegel describes as a “guilty until proven innocent” mentality. If the DEA reschedules the drug based on the fact that it has no accepted medical uses, the ability to prove otherwise gets significantly harder.

If kratom were to be added to the DEA’s Schedule 1, it might signal the end of research on the drug because of increased costs and bureaucracy associated with using controlled substances.

Depending on who you ask, kratom is a desperately needed alternative to traditional painkillers… or just another opioid fueling America’s epidemic.