The 0.05% / 1 mg 7-OH DEA Threshold, Explained

If you sell or stock 7-OH products, one number now defines what is regulated and what is not. This is a plain-language, citation-backed breakdown of the threshold itself. It is regulatory information only, not legal advice, and it makes no claims about any product's effects.

What is the 7-OH threshold?

The threshold is the quantitative test the DEA uses to define which materials are captured by its proposed temporary scheduling action. It appears in the Notices of Intent filed July 1, 2026 and published in the Federal Register on July 6, 2026 (docket DEA-1570; 91 FR 40917). A material is "in" if it meets either of two tests: a concentration test (over 0.050% 7-OH) or a per-article mass test (more than 1.00 mg of 7-OH). Meeting either one is enough.

A related HHS Request for Information (HHS-OASH-2026-0232; 91 FR 41049) is open, with comments due July 31, 2026. That RFI may further refine the threshold, so the exact figures could shift before the action becomes final.

How is 0.050% measured?

The 0.050% figure is a concentration expressed by weight or volume, written as w/w (weight of 7-OH per weight of product), w/v, or v/v depending on the product's form. For dry plant material it is measured by dry weight. In practical terms, 0.050% means 7-OH makes up more than five hundredths of one percent of the material being tested. A laboratory Certificate of Analysis (COA) is how a product's 7-OH concentration is documented.

What does "1 mg per article" mean?

The second test is an absolute quantity, not a concentration. If a single package or article contains more than 1.00 mg of total 7-OH, it is captured — regardless of how large the article is or how dilute the concentration might be. "Per article" means per finished unit as sold: a single tablet, a single bottle, a single shot, a single package. Because this is a mass ceiling rather than a percentage, even a low-concentration product can exceed it simply by being large enough.

Which products does the threshold capture?

The Notices of Intent name synthetic and further-processed material explicitly: extracts, concentrates, edibles, beverages, and pressed pills or tablets. As a practical matter, essentially all concentrated 7-OH tablets, powders, and shots exceed 1.00 mg of 7-OH per article, so they fall inside the threshold on the mass test alone. Retailers reviewing inventory should look at each SKU's COA for both its 7-OH concentration and its total 7-OH per unit.

Is natural kratom leaf included?

Generally, no. Natural kratom leaf contains only trace amounts of 7-OH — well below 0.050% by dry weight — so unprocessed leaf typically falls outside the threshold and is excluded. The distinction the DEA is drawing is between the low-trace 7-OH found naturally in the plant and the concentrated or synthetic 7-OH found in processed products. As always, a product's own COA is the authority on where it sits relative to the line.

What about MGM-15 and MGM-16?

Alongside 7-OH, several related compounds are named for scheduling under a separate docket, DEA-1644: mitragynine pseudoindoxyl, MGM-15 (dihydro-7-hydroxymitragynine), and MGM-16 (9-fluoro-7-hydroxymitragynine). These are listed as distinct substances rather than being governed by the 0.050% / 1 mg threshold that applies to 7-OH itself. Retailers carrying products marketed around these compounds should track that docket separately.

When does this take effect?

This is a temporary scheduling action issued under 21 U.S.C. 811(h). Based on the Notices of Intent, the earliest effective date is approximately August 5, 2026. Because the HHS RFI comment window runs through July 31, 2026, the specifics may still change; treat every date and figure here as the current published position, not a settled final rule.

What retailers and wholesale buyers should do

Pull the COA for every 7-OH SKU you carry and check two numbers: the 7-OH concentration (is it over 0.050%?) and the total 7-OH per finished article (is it over 1.00 mg?). If either is true, that product is inside the threshold as currently written. 7ohBlack maintains lab documentation for its wholesale catalog — see our COA library and wholesale program. Retail buyers can find consumer products and lab documents at Favor'd Alkz.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. For adults 21 and older, where legal.

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