Botanical Kratom Leaf vs. Concentrated 7-OH: What the 2026 Rules Actually Say

Last reviewed: August 28, 2026. Regulations can change quickly. This educational guide is not legal or medical advice. Always check the controlling federal, state and local sources before buying, selling, shipping or possessing a product.

The short answer

Botanical kratom leaf and a concentrated 7-hydroxymitragynine product should not be treated as interchangeable categories.

The kratom plant, Mitragyna speciosa, naturally contains multiple alkaloids. Mitragynine is generally described as its principal alkaloid, while 7-hydroxymitragynine—usually shortened to 7-OH—can occur naturally in smaller amounts. Commercial products may also contain 7-OH at enhanced concentrations, added 7-OH, or compounds produced through chemical or semi-synthetic processes.

That difference now matters directly under federal and Colorado law:

• The federal government has begun a temporary-scheduling process aimed at 7-OH above specified thresholds, not an across-the-board scheduling of all botanical kratom leaf.
• A separate federal order took effect on August 26, 2026, placing mitragynine pseudoindoxyl, MGM-15 and MGM-16 in Schedule I.
• Colorado law separately prohibits synthesized or semi-synthesized kratom alkaloids and products exceeding the state’s 7-OH limit, along with imposing age, labeling, storage and product-form restrictions.

Headlines that say only “kratom ban” leave out these distinctions. The correct question is: Which substance, in what product form, at what concentration, under which jurisdiction, and on what date?

Four categories that should not be blended together

1. Botanical kratom leaf

This generally refers to dried or powdered material from the leaves of Mitragyna speciosa. It contains naturally occurring plant alkaloids, including mitragynine and trace amounts of 7-OH.

Calling a product “natural” does not prove that it is uncontaminated, lawful everywhere or appropriate for a particular person. It also does not establish FDA approval. It simply describes the source or form of the material.

2. Botanical extracts and concentrates

An extract is processed to concentrate selected constituents from plant material. Extracts can vary widely in composition and concentration. A product may report total alkaloids, mitragynine, 7-OH or a serving-level amount, but those measurements are not interchangeable.

An extract is not automatically a synthetic product. However, processing history, chemical transformation, the final 7-OH concentration and the product’s dosage form can affect how a regulator classifies it.

3. Enhanced or added 7-OH products

These products contain 7-OH at levels materially different from ordinary botanical leaf, often in tablets, shots, gummies, strips, powders or other concentrated formats. FDA’s enforcement statements have focused on products containing added 7-OH or enhanced levels of 7-OH, rather than naturally occurring trace levels in leaf. FDA states that 7-OH is not lawful as a dietary ingredient and cannot lawfully be added to conventional foods. FDA warning-letter announcement.

4. Related synthetic or chemically transformed compounds

Federal regulators have separately identified:

• mitragynine pseudoindoxyl, sometimes abbreviated MP;
• MGM-15, also described in the federal order as dihydro-7-hydroxymitragynine; and
• MGM-16, described in the federal order as a fluorinated 7-OH-related substance.

These are not simply another color or strain of kratom powder. Since August 26, 2026, they have been temporarily controlled as Schedule I substances at the federal level. Federal Register temporary order.

What happened federally in 2025 and 2026?

The federal record is easiest to understand as a sequence.

July 2025: FDA warning letters and scheduling recommendation

On July 15, 2025, FDA announced warning letters to firms marketing 7-OH products. The agency said its focus included concentrated products such as tablets, gummies, drink mixes and shots. FDA also stated that there are no FDA-approved drugs containing 7-OH. FDA announcement.

On July 29, 2025, FDA announced that it was recommending federal scheduling action involving certain 7-OH products. That recommendation did not itself create a final DEA scheduling order. FDA scheduling announcement.

July 6, 2026: DEA publishes two notices of intent

DEA published one notice addressing 7-OH above a specified threshold and another addressing MP, MGM-15 and MGM-16.

The 7-OH notice described the proposed covered threshold as:

• botanical Mitragyna speciosa material containing more than 0.050% 7-OH on a dry-weight basis; or
• certain alternative articles containing more than 0.050% by the applicable weight or volume measurement, or more than 1.00 milligram of 7-OH in the article.

The notice describes alternative articles as including synthetic articles and certain processed forms such as extracts, concentrates, processed edibles or pressed pills. Read the complete definitions before applying the numbers to any specific product. Federal Register 7-OH notice of intent.

The 0.050% figure and the 1.00-milligram figure answer different measurement questions. A percentage describes concentration; milligrams per article describe a total amount in the article. A product can require both calculations.

August 26, 2026: the related-compounds order takes effect

DEA’s final temporary order for MP, MGM-15 and MGM-16 became effective on August 26, 2026. The order states that unauthorized retail sale and possession of these Schedule I substances are unlawful under the Controlled Substances Act. The temporary order remains effective for two years, with a possible one-year extension while the regular scheduling process proceeds. Federal Register order.

Status of the separate 7-OH threshold action

As of this page’s August 28, 2026 review, the official Federal Register record located for 7-OH above the specified threshold is the July 6 notice of intent. That notice says control takes effect only when DEA publishes a separate temporary scheduling order. Do not describe the notice itself as a final order, and recheck the Federal Register before every update, sale or shipment decision.

FDA’s July 13, 2026 update likewise described the 7-OH threshold action as a scheduling process aimed at concentrated and synthetic products rather than natural leaf containing only naturally occurring trace levels. FDA 7-OH update.

What Colorado law adds

Colorado’s enacted SB25-072 creates requirements that are separate from the federal process. The Colorado General Assembly’s enacted summary says the law prohibits, among other things:

• sales to people under 21;
• products that are adulterated;
• products containing synthesized or semi-synthesized kratom alkaloids;
• products with 7-OH greater than 2% of the product’s alkaloid composition;
• products presented as confections, mimicking candy or appealing to children;
• combustible or vaporization-intended kratom products;
• products missing required label information; and
• retail display or storage that allows access by people under 21.

The law treats prohibited conduct as a deceptive trade practice subject to enforcement under the Colorado Consumer Protection Act. Colorado SB25-072 enacted summary.

Colorado’s 2%-of-alkaloid-composition measure is not the same measurement as the federal notice’s 0.050%-of-product-weight and 1-milligram-per-article criteria. A laboratory report must identify its denominator and units clearly enough to apply the correct rule.

Why “under 2%” is not a complete compliance answer

People sometimes repeat a single number as if it answers every legal question. It does not.

A result below 2% of the alkaloid fraction may address one Colorado criterion, but it does not by itself prove:

• compliance with a federal weight-based or article-level threshold;
• absence of synthesized or semi-synthesized alkaloids;
• compliance with age, labeling or product-form rules;
• compliance in another state or locality;
• that the batch is free of contaminants; or
• that the product is FDA approved.

Compliance analysis begins with the product’s identity and complete laboratory results. It does not end with a screenshot of one favorable number.

How to read the 7-OH line on a laboratory report

Before deciding what a result means, check five things.

1. Product and batch identity

The report should match the lot or batch on the package. A result for a different lot is not reliable evidence about the package in hand.

2. Product form

Is the sample leaf powder, an extract, a liquid, a pressed tablet, a gummy, a shot or another article? The federal notice distinguishes botanical material from alternative articles.

3. Unit

Look for percent by dry weight, percent weight/weight, weight/volume, milligrams per gram, milligrams per serving or milligrams per article. Do not treat these as synonyms.

4. Denominator

“Percent of the product” and “percent of the total alkaloid fraction” are different ratios. The laboratory or manufacturer should be able to show the calculation.

5. Detection and reporting limits

“ND” usually means not detected under the method’s reporting conditions; it does not necessarily mean absolute zero. Find the limit of detection, limit of quantitation or reporting limit when those details are provided.

For a full walkthrough, link this section to Kiody’s How to Read a Kratom Certificate of Analysis guide.

What responsible retailers should do now

This section is an educational operational checklist, not legal advice.

1. Separate product categories. Do not market enhanced 7-OH, MP, MGM-15 or MGM-16 as ordinary botanical leaf.
2. Remove controlled compounds. Do not sell or possess MP, MGM-15 or MGM-16 without the federal authorization required for Schedule I substances.
3. Verify each active batch. Match product, lot, product form, 7-OH result, units and measurement basis.
4. Review every label. Confirm age language, identity, ingredients, manufacturer information and Colorado-specific requirements.
5. Control customer access. In Colorado, keep products inaccessible to people under 21 in retail settings.
6. Avoid candy-style presentation. Review names, shapes, graphics and formats that could appeal to children.
7. Check every destination. Federal rules do not replace stricter state or local laws.
8. Archive proof. Retain reports, labels, supplier records, lot records and the government sources used for each compliance decision.
9. Date every legal page. A regulation tracker without a last-reviewed date can mislead customers.
10. Escalate unclear products. If a supplier cannot explain the chemistry, processing history or laboratory units, pause the product rather than guessing.

What customers should look for

A customer should be able to identify:

• whether the product is leaf, extract or another concentrated format;
• the complete ingredient list;
• the amount and unit used for any alkaloid claim;
• a matching lot or batch report;
• the seller’s age policy;
• a real contact channel for quality questions; and
• a dated legal-status page linking to primary government sources.

Be cautious when a product uses phrases such as “legal everywhere,” “same as natural leaf,” “FDA approved,” “safe alternative” or “works like” a prescription medication. Those statements may hide important legal, chemical or health distinctions.

Frequently asked questions

Is all kratom federally banned?

No. The cited 2026 federal actions do not amount to a simple across-the-board scheduling of all botanical kratom leaf. One action is a notice concerning 7-OH above specified thresholds; the final August 26 order separately controls MP, MGM-15 and MGM-16.

Is 7-OH naturally present in kratom?

It can occur naturally in trace amounts. That fact does not make a concentrated, enhanced or synthetic 7-OH product equivalent to ordinary leaf.

Did DEA make MP, MGM-15 and MGM-16 illegal?

DEA temporarily placed them in Schedule I effective August 26, 2026. Unauthorized handling, retail sale and possession are subject to the Controlled Substances Act.

Is the proposed federal limit simply one milligram?

No. The July 6 notice describes multiple criteria based on product type, concentration and total amount. The greater-than-1.00-milligram criterion applies within the notice’s definition of certain alternative articles and must be read together with the percentage criteria.

Does Colorado use the same threshold as the federal notice?

No. Colorado’s enacted rule includes a 2%-of-alkaloid-composition limit and a prohibition on synthesized or semi-synthesized kratom alkaloids. The federal notice uses different measurements and definitions.

Does a passing COA make a product legal everywhere?

No. A COA supplies test results for a sample. Legal status also depends on product form, ingredients, processing, labeling, age restrictions, location and current law.

Can a company claim a 7-OH product treats pain, anxiety or withdrawal?

Companies should not make disease-treatment claims for products that have not been approved as drugs. FDA states that there are no FDA-approved drugs containing 7-OH. People seeking treatment should speak with a licensed health professional.

Primary sources

1. U.S. Drug Enforcement Administration, Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I — Notice of Intent, July 6, 2026.
2. U.S. Drug Enforcement Administration, Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15 and MGM-16 in Schedule I, effective August 26, 2026.
3. U.S. Food and Drug Administration, Hiding in Plain Sight: 7-OH Products, updated July 13, 2026.
4. U.S. Food and Drug Administration, FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine, July 15, 2025.
5. Colorado General Assembly, SB25-072 Regulation of Kratom, enacted May 29, 2025.