Is kratom legal at the federal level in the US?

Yes — kratom is legal at the federal level in the United States as of 2026. It is not a scheduled controlled substance under the Controlled Substances Act, and the DEA has not classified its alkaloids as scheduled drugs. However, the FDA has not approved kratom as a dietary supplement and has issued multiple advisories about it. State-level laws vary significantly: kratom is illegal in a handful of states (Alabama, Arkansas, Indiana, Louisiana, Vermont, Wisconsin) and is regulated under KCPA-style consumer protection laws in many others.

Why hasn't the FDA approved kratom?

The FDA's position is that kratom does not meet the dietary supplement framework under the Dietary Supplement Health and Education Act because it has not been demonstrated to be safe under DSHEA's 'reasonable expectation of safety' standard, and because kratom alkaloids interact with opioid receptors. The FDA has issued import alerts allowing seizure of imported kratom shipments and has warned consumers about adulterated and contaminated products. The agency does not, however, have enforcement authority to ban kratom at retail without scheduling or new legislation.

Did the DEA try to ban kratom?

Yes — the DEA proposed scheduling mitragynine and 7-hydroxymitragynine as Schedule I controlled substances in August 2016, which would have effectively banned kratom nationwide. After unprecedented public pushback (over 130,000 public comments, congressional letters from over 50 lawmakers, and a 142,000-signature White House petition), the DEA withdrew the proposal in October 2016 and referred the matter to the FDA for further review. No federal scheduling action has been taken since.

What has the FDA done about synthetic 7-OH products?

The FDA issued a public consumer alert in 2025 specifically targeting concentrated 7-hydroxymitragynine products — tablets, gummies, and shots that contain 7-OH at concentrations far above natural-leaf levels. The agency cited dependence and overdose risk and issued warning letters to several manufacturers. Most KCPA-style state laws now explicitly cap 7-OH at 1–2% of total alkaloid content, which functionally bans the synthetic concentrates while preserving access to natural-leaf products. See our synthetic 7-OH explainer for the full breakdown.

Could the FDA ban kratom in the future?

The FDA itself does not have authority to ban kratom outright; that would require either DEA scheduling action or new federal legislation. The FDA can however continue to issue import alerts, warning letters to manufacturers, and consumer advisories — all of which it has been doing. The most likely federal scenario in 2026 is continued advisory pressure plus targeted action on synthetic 7-OH products, with state-level KCPA legislation continuing to be the actual operational regulatory framework.

What does 'FDA disclaimer' on kratom labels mean?

Because kratom is not an FDA-approved dietary supplement, every reputable kratom product label includes the standard supplement disclaimer: '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.' This is required FTC/FDA practice for any product marketed in the supplement space without FDA-approved health claims, and its absence on a product label is a red flag that the manufacturer is operating outside basic regulatory norms.

Regulation · 10 min read · May 9, 2026

Kratom and the FDA: A 2026 Guide to the Federal Regulatory Picture

Kratom is not federally illegal in the US, but the FDA has never approved it as a dietary supplement and continues to issue advisories. Here's exactly where the federal picture stands in 2026 — what the FDA has done, what it hasn't, what the DEA's position is, and how state regulation fills the federal vacuum.

Frequently Asked Questions

Is kratom legal at the federal level in the US?: Yes — kratom is legal at the federal level in the United States as of 2026. It is not a scheduled controlled substance under the Controlled Substances Act, and the DEA has not classified its alkaloids as scheduled drugs. However, the FDA has not approved kratom as a dietary supplement and has issued multiple advisories about it. State-level laws vary significantly: kratom is illegal in a handful of states (Alabama, Arkansas, Indiana, Louisiana, Vermont, Wisconsin) and is regulated under KCPA-style consumer protection laws in many others.
Why hasn't the FDA approved kratom?: The FDA's position is that kratom does not meet the dietary supplement framework under the Dietary Supplement Health and Education Act because it has not been demonstrated to be safe under DSHEA's 'reasonable expectation of safety' standard, and because kratom alkaloids interact with opioid receptors. The FDA has issued import alerts allowing seizure of imported kratom shipments and has warned consumers about adulterated and contaminated products. The agency does not, however, have enforcement authority to ban kratom at retail without scheduling or new legislation.
Did the DEA try to ban kratom?: Yes — the DEA proposed scheduling mitragynine and 7-hydroxymitragynine as Schedule I controlled substances in August 2016, which would have effectively banned kratom nationwide. After unprecedented public pushback (over 130,000 public comments, congressional letters from over 50 lawmakers, and a 142,000-signature White House petition), the DEA withdrew the proposal in October 2016 and referred the matter to the FDA for further review. No federal scheduling action has been taken since.
What has the FDA done about synthetic 7-OH products?: The FDA issued a public consumer alert in 2025 specifically targeting concentrated 7-hydroxymitragynine products — tablets, gummies, and shots that contain 7-OH at concentrations far above natural-leaf levels. The agency cited dependence and overdose risk and issued warning letters to several manufacturers. Most KCPA-style state laws now explicitly cap 7-OH at 1–2% of total alkaloid content, which functionally bans the synthetic concentrates while preserving access to natural-leaf products. See our synthetic 7-OH explainer for the full breakdown.
Could the FDA ban kratom in the future?: The FDA itself does not have authority to ban kratom outright; that would require either DEA scheduling action or new federal legislation. The FDA can however continue to issue import alerts, warning letters to manufacturers, and consumer advisories — all of which it has been doing. The most likely federal scenario in 2026 is continued advisory pressure plus targeted action on synthetic 7-OH products, with state-level KCPA legislation continuing to be the actual operational regulatory framework.
What does 'FDA disclaimer' on kratom labels mean?: Because kratom is not an FDA-approved dietary supplement, every reputable kratom product label includes the standard supplement disclaimer: '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.' This is required FTC/FDA practice for any product marketed in the supplement space without FDA-approved health claims, and its absence on a product label is a red flag that the manufacturer is operating outside basic regulatory norms.

Synthetic 7-OH Products: What They Are, Why They're Banned, and How to Spot Them — Products marketed as 'kratom' that are actually concentrated 7-hydroxymitragynine are the single largest safety problem in the kratom market today. Here's the chemistry, the regulatory response, and the label red flags that tell you what's really in the bottle.
What Is the Kratom Consumer Protection Act? A 2026 Guide — The KCPA is the kratom industry's flagship consumer-safety law — setting age limits, labeling rules, and contamination thresholds. Here's what it does, which states have passed it, and why it matters when you buy kratom.
Kratom Dosage Guide — Beginner doses and dose-by-weight chart for safe use.
Lab Results Library — Every batch's third-party Certificate of Analysis.