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Facts

Source-linked 7-OH facts with specific denominators, evidence limitations, and dated regulatory context.

Updated

2 sources

Direct answer

These short claim blocks focus on 7-OH and link readers to the underlying record. Read the scope and date alongside each fact; a number without its denominator or study context can mislead.

Reading the facts

FDA's natural-leaf comparison uses 7-OH as a share of total alkaloids, not whole-leaf weight. FDA 7-OH scientific assessment

The October 14, 2026 Federal Register document is a notice of intent, not an effective 7-OH scheduling order. DEA October 14, 2026 notice of intent

For study limitations, read Science and Evidence. For the full dated legal context, read the Regulatory Tracker.

Sources

  1. FDA 7-OH scientific assessment
  2. DEA October 14, 2026 notice of intent

distinction

Natural kratom leaf contains only low or trace levels of 7-OH compared with concentrated 7-OH products.

FDA's 2025 assessment describes 7-OH as a minor kratom constituent and says natural kratom consistently shows less than 2% of total alkaloid content as 7-OH.

FDA 7-OH scientific assessment

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distinction

FDA summarizes typical botanical kratom 7-OH levels at about 0.01% to 0.04% by dry weight.

The FDA report cites contemporary data showing botanical leaf levels far below the concentrations seen in some retail 7-OH products.

FDA 7-OH scientific assessment

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distinction

Concentrated 7-OH products should not be treated as interchangeable with natural kratom leaf.

FDA's scheduling announcement says the agency was targeting concentrated 7-OH products and was not focused on natural kratom leaf products.

FDA scheduling recommendation press release

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distinction

FDA says enhanced 7-OH products likely involve chemical conversion of mitragynine because direct extraction from leaf would be economically impractical.

That distinction matters because a product marketed as kratom may contain a concentrated semisynthetic derivative rather than a leaf-like alkaloid profile.

FDA 7-OH scientific assessment

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potency

Matsumoto et al. reported about 13-fold greater 7-OH potency than morphine in a guinea-pig ileum contraction assay.

The paper's printed response values do not reproduce that ratio. FDA repeats the reported figure; it is not an independently verified multiplier or a human dosing rule.

FDA 7-OH scientific assessmentMatsumoto et al. 2004 7-OH pharmacology

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health-risk

FDA's 2025 report states that 7-OH produced respiratory depression in rodent studies.

The report highlights respiratory depression as a major opioid risk and cites preclinical evidence comparing 7-OH with morphine.

FDA 7-OH scientific assessment

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health-risk

FDA describes opioid-like withdrawal syndromes among reports tied to concentrated 7-OH exposure.

Withdrawal reports should be read alongside the limits of available human data; many reports are surveillance signals, not controlled clinical trials.

FDA 7-OH scientific assessmentFDA letter to health care professionals

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regulatory

There are no FDA-approved drugs containing 7-OH.

FDA also says 7-OH is not lawful in dietary supplements and cannot be lawfully added to conventional foods.

FDA scheduling recommendation press release

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regulatory

On July 15, 2025, FDA announced warning letters to seven companies marketing products containing 7-OH.

The announcement focused on concentrated 7-OH products such as tablets, gummies, drink mixes, and shots.

FDA 7-OH warning letters announcement

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regulatory

On July 29, 2025, FDA recommended scheduling action for certain 7-OH products under the Controlled Substances Act.

FDA said DEA has final scheduling authority and that rulemaking includes public comment before final scheduling action.

FDA scheduling recommendation press release

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regulatory

DEA, not FDA, has final authority over federal controlled-substance scheduling.

As of the FDA's July 29, 2025 announcement, DEA was reviewing the recommendation.

FDA scheduling recommendation press release

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regulatory

On December 2, 2025, FDA announced the seizure of about 73,000 units of 7-OH products valued at roughly $1 million from three Missouri firms.

FDA said the seized products included liquid shots and tablets containing concentrated 7-OH as an added ingredient.

FDA Missouri 7-OH seizure announcement

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help

SAMHSA's National Helpline is a free, confidential, 24/7 treatment referral and information service.

In the United States, call 1-800-662-HELP (4357) for treatment referral information related to mental health or substance use.

SAMHSA National Helpline

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help

The 988 Suicide & Crisis Lifeline is available 24/7/365 by call, text, or chat.

Use 988 for suicidal thoughts, mental health crisis, emotional distress, or alcohol and drug use concerns.

988 Suicide & Crisis Lifeline

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Related reading

Science and Evidence7-OH science: receptor pharmacology, withdrawal evidence, FDA materials, and limits in the evidence base.Regulatory Tracker7-OH regulatory developments: dated FDA, DEA, HHS, and state-level actions, with kratom leaf tracked separately.FAQ7-OH questions answered: how it differs from kratom leaf, dependence, withdrawal, regulation, and help resources.