FDA & Product Rules

DEA Resets Its 7-OH Kratom Threshold as States Split Over Leaf Sales

DEA filed a notice on October 9 that would schedule 7-OH and mitragynine pseudoindoxyl above 1 milligram per gram or a set ratio to mitragynine, replacing its July 0.050 percent proposal, while MGM-15 and MGM-16 stay in Schedule I and Tennessee, Massachusetts, Rhode Island, and Pennsylvania draw different state lines for kratom sellers.

E-commerce 4 Internet Marketers Editorial

Illustration of a parcel driver pausing at a blank crossroads sign on an October morning while a farmer across the road points him in a different direction.

The Drug Enforcement Administration (DEA) on October 9 filed a new notice of intent that would temporarily place 7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl in Schedule I whenever either compound, or the two combined, crosses a new threshold of 1 milligram per gram or a set ratio to mitragynine. The notice, posted for public inspection and scheduled to run in the Federal Register on October 14, 2026, replaces the 0.050 percent threshold DEA proposed in July. DEA says it is withdrawing that July notice in a separate document.

For online kratom and botanical sellers, the federal line on what counts as a controlled substance has now moved twice in three months, and state law is drawing its own lines. Tennessee banned kratom outright on July 1. Massachusetts placed every form of kratom in Schedule I under state law on August 28. Rhode Island opened a licensed market for adults 21 and older on April 1 but bars delivery to consumers, and the Pennsylvania House passed a bill on October 5 that would cap 7-OH at 0.5 percent of a product’s total alkaloids.

What DEA scheduled on August 26

Three semisynthetic compounds are already federal Schedule I substances. DEA’s temporary scheduling order at 91 FR 54948 (Docket No. DEA-1644) placed mitragynine pseudoindoxyl, MGM-15 (dihydro-7-hydroxymitragynine), and MGM-16 in Schedule I effective August 26, 2026, until August 26, 2028. That order carries no threshold, so any amount counts.

The order says retail sales of Schedule I substances to the public are not allowed under the Controlled Substances Act (CSA), and that anyone who cannot or does not want to obtain a Schedule I registration must surrender existing stock. DEA describes the products it found as chewable tablets, powders, and liquid shots sold online and in gas stations, corner shops, and vape shops, often in bright packaging and sometimes labeled “sold strictly for laboratory, botanical, and research purposes only” and “not intended for human consumption.”

The kratom plant itself and mitragynine, its main alkaloid, are not federally scheduled. A Congressional Research Service legal sidebar updated October 6 put it plainly: absent a final scheduling action by DEA or Congress, “7-OH is not a controlled substance.”

How the 7-OH threshold changed between July and October

DEA’s first 7-OH notice, published July 6 at 91 FR 40917 (Docket No. DEA-1570), would have scheduled kratom leaf material containing more than 0.050 percent 7-OH by dry weight. For synthetic products and processed forms such as extracts, concentrates, edibles, and pressed pills, the cutoff was 0.050 percent or more than 1.00 milligram of 7-OH in the article. DEA said the order would come no earlier than August 5. It never issued one.

The Department of Health and Human Services (HHS) opened a request for information on that threshold the same day, with comments due July 31, and on August 26 extended the deadline to September 10 after a request for more time.

The October notice adopts a threshold that, according to the document, Assistant Secretary for Health Brian Christine recommended in an October 8 letter. 7-OH and mitragynine pseudoindoxyl would be controlled when either one alone, or both combined, meets one of two tests:

  • Concentration. More than 1 milligram per gram for powders, capsules, and other solids, or more than 1 milligram per milliliter for liquids.
  • Ratio. The mass of mitragynine in the product, divided by the mass of 7-OH, mitragynine pseudoindoxyl, or the two combined, is less than 100.

One milligram per gram works out to 0.1 percent by weight, double the July figure, and the July cap of 1.00 milligram per article does not appear in the new text. DEA’s notice says the new threshold “would permit certain products to remain in the marketplace without being subject to schedule I controls,” and adds that “neither HHS nor DEA has made a finding that these substances are safe to use at below-threshold levels.” The order can be published no earlier than 30 days after the notice appears, which would make November 13 the earliest date.

The change also affects mitragynine pseudoindoxyl, which has been controlled at any amount since August 26. DEA says that order stays in force until the new threshold-based order is published and the August order is withdrawn. A companion notice filed the same day would reissue the Schedule I listing for MGM-15 and MGM-16 “without change,” a step DEA calls technical and procedural, so those two remain controlled at any amount.

Four states, four different rules

Tennessee. House Bill 1649, known as Matthew Davenport’s Law and enacted as Public Chapter 950, was signed May 15 and took effect July 1, 2026. It makes knowing possession of kratom a Class A misdemeanor and manufacturing, delivering, or selling it a Class C felony. The bill defines kratom to include any part of the plant containing mitragynine or 7-OH, leaf extracts, and synthetic alkaloid derivatives, so leaf products fall inside the ban.

Massachusetts. Gov. Maura Healey announced on August 13 that Department of Public Health Commissioner Robbie Goldstein had issued an emergency order placing “all forms of kratom” in Schedule I under state law. The state’s kratom page says the order, 105 CMR 726.000, took effect August 28 and lasts up to one year, and that it lets local boards of health remove kratom products from stores. Stateline described the action as a governor’s executive order; the state’s own documents describe it as a commissioner’s emergency order.

Rhode Island. The Rhode Island Kratom Act (2025 Public Laws chapter 446) took effect April 1, 2026, and Stateline describes Rhode Island as the first state to replace a statewide kratom ban with a regulated market. Licenses come from the Rhode Island Department of Health. Buyers must be 21 and show photo ID, and products may not contain synthetic alkaloids, more than 1 percent 7-OH by share of total alkaloids, more than 0.5 milligrams of 7-OH per gram, or more than 1 milligram of 7-OH per serving. The part that matters most for e-commerce is section 11-9-13.23: kratom may be sold at retail only at a licensed fixed location, and “delivery of kratom and kratom products to retail purchasers is prohibited.” The law defines a retailer to include sellers outside the state.

Pennsylvania. House Bill 2657 passed the House 202 to 0 on October 5 and now goes to the Senate. As amended, it would ban “synthetic kratom products,” defined to include anything with 7-OH above 0.5 percent of total alkaloid composition or more than 10 parts per million of mitragynine pseudoindoxyl. Processors and retailers of natural kratom would register with the Department of Health, sales to anyone under 21 would be banned, and retailers would have to scan IDs. Stateline’s October 5 report described the bill as having cleared a House committee the week before. The full House vote came that afternoon.

Those four sit inside a wider split. Stateline, citing the Rockefeller Institute of Government, reported that 14 states ban or schedule kratom, 13 set potency limits, and 24 have sales restrictions, with overlap among the groups.

Analysis: what kratom stores will need to show

The federal and state rules measure different things. DEA’s proposed tests use milligrams per gram and a mitragynine ratio. Rhode Island uses a share of total alkaloids, milligrams per gram, and milligrams per serving. Pennsylvania’s bill uses a share of total alkaloids and parts per million. A certificate of analysis (COA), the lab report tied to a production lot, that reports only total alkaloids or only mitragynine cannot answer most of those questions. Sellers will be better placed with COAs that list 7-OH and mitragynine in milligrams per gram, mitragynine pseudoindoxyl at a low detection limit, and results for MGM-15 and MGM-16, each tied to a lot number on the product page.

The state rules also call for blocks at the shipping-address level rather than product-by-product edits. Tennessee and Massachusetts reach leaf products as well as concentrates, and Rhode Island’s delivery ban applies even to a compliant, licensed product. Stores that keep state restrictions in shipping rules can work from EC4IM’s guide to encoding state shipping ban matrices in cart rules, and Shopify merchants should recheck those blocks as their stores move to market-driven shipping.

Catalog cleanup is already overdue for any listing that names mitragynine pseudoindoxyl, MGM-15, or MGM-16, which have been controlled at any amount since August 26. DEA’s August order quotes the research-use labels it found on those products, much as FDA did when it sent warning letters to peptide vendors that relied on the same wording.

Payments are where the leaf-versus-concentrate line is likely to come up next. Stripe’s prohibited businesses list, for example, bars “any illegal products and services” and “substances designed to mimic illegal drugs.” A store that lists plain leaf powder beside 7-OH tablets on the same domain gives an underwriter little reason to separate the two. DEA and HHS have now put that distinction into the threshold text itself, and a lab report that shows where each SKU falls against it is a document a risk reviewer can check.

What remains unknown

DEA has not said when it will issue the 7-OH order, only that it cannot come before the 30-day notice period ends. The separate withdrawal of the July notice had not appeared on the Federal Register’s public inspection list as of the morning of October 10. The Pennsylvania Senate has not acted on HB 2657, and the Massachusetts order runs for up to one year unless the state takes further action. Congress is also weighing bills, including the End Gas Station Heroin Act (S. 5383 and H.R. 10272), that CRS says would add 7-OH and mitragynine pseudoindoxyl to Schedule I by statute with exceptions for compounds that occur naturally in kratom.

Taken together, DEA’s October filing would raise the concentration figure in the 7-OH line it proposed in July, add a mitragynine ratio test, and move mitragynine pseudoindoxyl, now controlled at any amount, onto the same threshold as 7-OH, while MGM-15 and MGM-16 stay controlled at any amount. States are moving in different directions, from Tennessee’s leaf ban and Massachusetts’ emergency scheduling to Rhode Island’s licensed counters and Pennsylvania’s pending potency cap. For online sellers, that leaves three jobs: removing scheduled compounds from the catalog, blocking shipments to states that ban the category or forbid delivery, and keeping lab reports that measure 7-OH, mitragynine, and the semisynthetics in the units regulators now use.

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