The federal government just did something rare in supplement regulation: it drew a line that targets a dangerous opioid adulterant without sweeping away a natural botanical used in its natural leaf form. Action Alert!
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THE TOPLINE
- DEA’s proposed action targets highly concentrated, synthetic, or chemically enhanced 7-OH products—not traditional kratom leaf products containing only trace, naturally occurring levels of 7-OH.
- ANH supports this more precise approach because it distinguishes between natural botanicals and drug-like products engineered to deliver stronger opioid-like effects.
- Regulators must also address high-dose mitragynine extracts so bad actors cannot simply replace one risky product with another while continuing to exploit the kratom market.
Bad actors have been hijacking kratom’s name to sell concentrated, opioid-like products that bear little resemblance to the traditional botanical. For once, federal regulators may be drawing the right line: crack down on the dangerous adulterants without destroying access to the natural plant.
On July 1, 2026, the Drug Enforcement Administration announced its intent to temporarily place 7-hydroxymitragynine, or 7-OH, above a specified threshold into Schedule I of the Controlled Substances Act. DEA also moved to temporarily schedule three related synthetic substances: mitragynine pseudoindoxyl, MGM-15, and MGM-16.
This is a move in the right direction.
ANH has long warned that regulators too often use the worst actors in a product category as an excuse to attack the entire category. That is not what appears to be happening here. DEA and HHS have made clear that the action is aimed at highly concentrated, synthetic, or chemically enhanced 7-OH products, not natural kratom leaf products containing only naturally occurring trace levels of 7-OH. We applaud HHS Secretary Robert F. Kennedy Jr. and former FDA Commissioner Dr. Marty Makary (who helped spearhead this initiative) and hope this nuanced approach can be applied more broadly across the natural products sector moving forward.
A Dangerous Product Masquerading as Kratom
Kratom comes from the leaves of the Mitragyna speciosa tree, a botanical traditionally used in Southeast Asia. Its primary alkaloid is mitragynine. In natural leaf material, 7-OH occurs only in very small, trace amounts, while it can also be formed in the body following oxidation of mitragynine in the liver. As noted in FDA’s 2025 scientific report, 7-OH is has much greater affinity to opioid receptors than mitragynine and therefore larger, repeated exposures tend to both induce opioid-like, sedative effects, not dissimilar to morphine, while also increasing the potential for addiction.
None of these problems have been associated with traditional use of kratom leaf in Southeast Asia. It is the explosion of concentrated 7-OH, and more recently mitragynine pseudoindoxyl-based products, sold online and in gas stations, vape shops, convenience stores, and smoke shops in the form of tablets, gummies, shots, powders, capsules, and dissolvable strips that are at the root of all the problems with kratom in the USA.
FDA has warned that these products may contain enhanced or concentrated 7-OH levels and may be inaccurately labeled or marketed as “kratom.” DEA says these products often contain far more 7-OH than naturally occurring botanical kratom.
This is what smarter regulation should look like: protect consumers from deceptive, addictive, chemically manipulated products while preserving access to traditional botanicals.
For once, the federal government appears to be recognizing that a plant, an isolated alkaloid, and a semi-synthetic high-potency product are not the same thing.
The Line DEA Drew
DEA’s proposed threshold would cover botanical kratom material containing more than 0.050 percent 7-OH on a dry weight basis. It would also cover synthetic or further-processed alternative dosage forms, including extracts, concentrates, processed edibles, and pressed pills, when they contain more than 0.050 percent 7-OH or more than 1.00 milligram of 7-OH in the article.
FDA’s report states that concentrated 7-OH products are an emerging public health threat, citing opioid-like effects, dependence, withdrawal, and respiratory depression concerns. The report also notes that 7-OH has shown approximately 13-fold greater potency than morphine in one functional assay, a finding that helps explain why these products should never have been allowed to masquerade as ordinary supplements.
But There Is a Loophole
Here is the next problem: high-dose mitragynine.
Mitragynine is the dominant alkaloid in kratom, and research indicates that mitragynine is readily metabolized by CYP3A liver enzymes into 7-OH. If regulators remove high-7-OH products but ignore highly concentrated mitragynine extracts, bad actors may simply pivot.
That means FDA and HHS should not stop at 7-OH. They should, in our view, develop a science-based maximum mitragynine framework for finished products, especially concentrated extracts. This approach will prevent a marketplace shell game in which sellers replace one high-risk opioid-like product with another product designed to generate similar effects through a different pathway.
Kratom Is Used by Millions. Regulation Must Be Precise.
Kratom use in the United States has gained popularity. Survey research by Oliver Grundmann and colleagues reported a 9.1 percent active-use estimate among U.S. adults. Millions of Americans may be affected by how regulators handle kratom.
That is why blanket bans are the wrong answer.
Traditional kratom products, high-dose extracts, concentrated 7-OH, and synthetic derivatives require different regulatory treatment. A one-size-fits-all prohibition would punish responsible consumers and companies while doing little to address the real problem: adulterated, drug-like products sold under the cover of natural health.
Health Freedom Requires Guardrails Against Bad Actors
Health freedom does not mean allowing deceptive products to be sold to vulnerable consumers with no meaningful standards. Adults should retain access to natural health options, with truthful labeling, reasonable safeguards, and enforcement against fraud and adulteration.
FDA already has tools to act against illegal foods, drugs, and adulterated dietary supplements. DEA’s temporary scheduling action, if finalized, gives regulators another tool against concentrated synthetic 7-OH products. The challenge now is to use those tools effectively.
ANH will be watching whether HHS and DEA keep their promise not to sweep natural kratom into this action. We will also be watching whether FDA develops a rational standard for high-mitragynine products, because without one, this crackdown may simply shift the market rather than clean it up.
This is a welcome step. Now regulators must finish the job: ban the harmful, preserve the safe, and stop the cowboys from turning natural health products into unapproved opioid-like drugs.
Action Alert!
