UPDATED GUIDANCE FROM DEA TARGETS SYNTHETIC KRATOM ADDITIVES, SETS LIMITS FOR NATURAL PRODUCTS

Advocates for natural kratom leaf have pleaded with authorities to adhere to the science surrounding the plant when pushing policy.

Those wishes are finally being heard at the highest levels of government in the United States.

As part of an ongoing process to finally figure out a federal regulatory structure, the Drug Enforcement Agency (DEA) issued a pair of new notices “based on new scientific information and recommendations provided by the U.S. Department of Health and Human Services (HHS).” Those regulatory notices focus on kratom-adjacent products that have been deceptively marketed, with this latest wave of updates and adjustments based on science creating a clear path forward for natural leaf kratom while limiting access to synthetic derivatives of the plant.

The most important part of the updated guidelines is that the DEA added to a Notice of Intent surrounding 7-hydroxymitragynine (7-OH) that includes new limits established using data generated by HHS. Since 7-OH occurs in natural kratom leaf in trace amounts, the new guidelines will make sure that natural kratom products do not get swept up in federal regulations aimed at taking dangerous synthetic products off the market.

Singling Out Synthetics

United States Attorney General Todd Blanche made it clear in the press release surrounding the updated federal guidance: Not all ‘kratom’ products are created equal, and the Department of Justice (DOJ) will do whatever it takes to protect responsible kratom consumers.

“Dangerous and addictive opioids do not belong behind convenience store counters,” Blanche said. “Our nation’s children and communities deserve protection from harmful substances like 7-OH and other powerful synthetic drugs. The actions taken by the Department of Justice today reflect our commitment to keeping Americans safe and holding drug traffickers accountable.”

This process started in July, when the DEA announced its intent to target synthetically altered kratom alkaloids. That was followed up more than a month later, when federal authorities temporarily placed three kratom derivatives — MGPI, MGM-15 and MGM-16 — into Schedule I on Aug. 26.

Although the updated action has not formally placed 7-OH in Schedule I, the DEA’s Notice of Intent still makes clear that the alkaloid poses a threat to public safety. More importantly, the updated notice sets a specific standard to help other legislative bodies create limits and regulations that support natural leaf kratom while targeting synthetic additives.

The specified threshold for allowable amounts of 7-OH is based on a letter penned by the Assistant Secretary of Health and sent to the DEA administrator. Those recommendations cover both 7-OH and MGPI, and set the allowable limit for each substance or the combined amount if both are present. Per the letter from HHS, the limit is set at 1 milligram per gram for solid/powdered products, or 1 milligram per milliliter for liquid products.

Also included in the DEA’s update was a renewal of the Notice of Intent that placed both MGM-15 and MGM-16 into Schedule I temporarily. Both of those notices will be published in the Federal Register on or after Nov. 13, 2026.

Advocate-Approved Regulations

After years of pushing for science-backed solutions to kratom policy, the American Kratom Association (AKA) has applauded the federal government at every step of the journey toward regulating synthetic additives out of the market. Senior fellow Mac Haddow said that the steps taken by the DEA are a welcome change from the previous policy of pushing prohibition.

“The DEA and the Department of Justice deserve recognition for addressing the critical distinction between dangerous, chemically manipulated opioid products and natural kratom leaf,” Haddow said. “That distinction is essential to protecting consumers without imposing an unjustified ban on lawful botanical products.”

Although there are more steps to be taken to make the DEA’s action permanent, the AKA said these recent updates by federal authorities prove the point that advocates have been making for years: Reasonable, science-backed regulations can limit access to dangerous products while maintaining access for responsible kratom consumers.

“This is an important victory for science, sound public policy, and the millions of Americans who rely on responsibly manufactured natural kratom products,” Haddow said.

Furthermore, the establishment of limits and concentration caps is a step that the AKA has supported across the country. Limits on the amount of 7-OH and bans of other adulterants have been packed into a series of laws known as Kratom Consumer Protection Acts (KCPAs) and have been supported by the AKA and members of the medical community.

For years, advocates for natural leaf kratom have made the case to lawmakers to listen to the science and create targeted regulations that are aimed at promoting natural leaf kratom products. With the DEA’s updated guidance on kratom, local lawmakers now have a federal standard to rely on in making such determinations.

The recommendations from HHS also provide kratom advocates with backing from federal health regulators and align with the AKA’s stance on how kratom should be regulated.

“Federal drug policy should target the substances and product formulations that actually create the risk,” Haddow said. “It should not punish consumers or responsible manufacturers because a scheduling order fails to distinguish a deliberately manufactured opioid compound from the incidental trace constituents of a natural botanical product.”

For the latest on kratom legality and federal regulatory developments, visit our kratom legality map and kratom news page. Learn more about the AHPA’s policy warning against labeling 7-OH as kratom and how Super Speciosa became part of the groundbreaking FDA study that helped establish the science behind these distinctions.