FDA GUIDANCE CREATES CLEAR LINE BETWEEN NATURAL KRATOM AND 7-OH PRODUCTS

The relationship between kratom and the Food and Drug Administration (FDA) has been a back-and-forth for over a decade. 

As the science around the plant has developed, it appears that tug of war may be pulling firmly in the direction of those who support natural kratom products.

In recent months, the FDA has taken concrete steps in favor of natural kratom products while speaking out against bad actors and products that have put a negative spotlight on the industry. That switch in stance by the FDA echoes the guidance and warnings of industry insiders, who have tried to make it clear that regulation is the correct path forward for kratom. 

Now, the question is how quickly local leaders, state medical boards and others in the regulatory sphere can latch onto those developments from the FDA instead of relying on past guidance to target natural kratom products.  

The change in tactics from the FDA was made official last July when the agency held a press conference to announce its intent to target 7-hydroxymitragynine (7-OH) and create a carve-out for natural kratom products. That action came after prevailing science showed that 7-OH, an alkaloid that occurs in trace amounts in natural kratom, was a dangerous opioid substitute when artificially enhanced and synthesized beyond what naturally occurs in kratom leaf. 

Along with the announcement that the FDA would be looking to make 7-OH a Schedule I substance, the agency released a report to “educate the public about the health concerns of 7-OH and its distinction from the natural kratom leaf.” At the same time, FDA Commissioner Marty Makary sent a letter to fellow physicians about the distinct difference between 7-OH and products derived from natural kratom leaf. 

Makary acknowledged that 7-OH is a naturally occurring element in the kratom plant, but made it clear that healthcare providers and the legal system should make the same distinction as the FDA. 

“(Natural kratom leaf) is not our focus. Our primary concern is the concentrated form of 7-OH,” Makary said in the letter. “These concentrated products are far more dangerous than traditional kratom leaf products.” 

In the report issued by the FDA about the risks associated with 7-OH, the agency went into detail about the difference between natural leaf kratom and those that are artificially enhanced or synthesized with elevated levels of 7-OH. 

Using “chemical, pharmacological, and epidemiological data on 7-OH,” as well as surveillance data from federal programs, the FDA determined that the “pharmacological profiles, abuse liability, and emerging patterns of non-medical use establish 7-OH as a dangerous substance.” While the report acknowledges that 7-OH is present in natural leaf kratom, extensive data and examples cited make it clear that the products that pose a risk to public health are those with artificially enhanced levels of 7-OH. 

On a scientific level, the danger of 7-OH products comes from the way those products impact the opioid receptors in the brain. The FDA report concludes that 7-OH “acts as a full mu opioid agonist” and labels mitragynine, the primary alkaloid in natural kratom products, as a partial agonist of that same receptor. In certain studies, the FDA highlighted the fact that 7-OH “displayed approximately 13-fold greater potency than morphine and 46-fold greater potency than mitragynine.” 

That chemical distinction is why the FDA report concludes that “7-OH may expose individuals to similar risks as classical opioids, including respiratory depression.” Respiratory depression is the cause of opioid-induced death. 

When it comes to natural leaf kratom, the report highlights historical usage of kratom leaves and the alkaloid makeup of the teas and dry leaf products consumed in Southeast Asia. Based on testing and historical data, the FDA report clarified that 7-OH constitutes only 2% of the total alkaloid composition in natural products. Still, it cited a study where seven of the eight products were found to have levels of 7-OH that were “109-509% higher than expected.”

Due to those elevated levels of 7-OH, the report claims that “many of the products available today, which are often associated with or advertised as kratom, no longer resemble botanical kratom.” That is why the FDA has drawn a clear line between natural leaf kratom products and those with elevated levels of 7-OH. 

The report concludes: “Current regulatory gaps have enabled widespread availability of (7-OH) products despite their opioid-like properties and necessitate immediate policy intervention to address this emerging threat to American public health.”

The FDA’s distinction between natural leaf kratom vs. 7-OH still has not stopped a handful of local authorities from putting all kratom products in their crosshairs. 

Recent actions by the California Department of Public Health (CDPH) and the Ohio Board of Pharmacy have targeted kratom, and will ultimately be decided by the legislatures in those states. In California, the CDPH has seized products from the shelves regardless of whether or not the products contain 7-OH or natural leaf kratom. 

Ohio took a more measured approach and created an exception for natural kratom in an emergency rule that made certain products illegal; however, Gov. Mike DeWine has indicated that the state may try to ban all kratom products if the emergency rule is turned into law. Both DeWine and the CDPH have cited the FDA’s guidance as the reason for their actions, despite not adhering to Makary’s guidance on natural leaf kratom. 

Advocates in both states have made it clear that the FDA’s stance on kratom favors natural leaf products and are backing efforts to regulate dangerous kratom products out of the market.