Regulatory tracker
FDA kratom timeline.
The FDA has taken escalating regulatory action against kratom and its alkaloids since 2012. The July 29, 2025 announcement that FDA plans to restrict 7-hydroxymitragynine (7-OH) is the most significant enforcement action to date. Leaf kratom remains federally legal. This page tracks warning letters, import alerts, recalls, and scheduling announcements in reverse-chronological order. Sources: FDA.gov, Pharmacy Times, Venable Law analysis.
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2025-07-29
schedulingFDA announces plan to restrict 7-OH
FDA announced regulatory action to restrict 7-hydroxymitragynine (7-OH) products, including warning letters to multiple firms and preparation for scheduling action. Leaf kratom not affected by this announcement.
View source: FDA press announcement → -
2025-07-15
warningFDA issues warning letters to 7-OH manufacturers
FDA sent warning letters to firms marketing 7-hydroxymitragynine-containing products as unapproved new drugs. Products flagged included tablets, gummies, and concentrated extracts.
View source: FDA press release → -
2024-08-01
advisoryFDA renewed public health advisory
FDA reiterated its position that kratom should not be used to treat medical conditions and warned of adverse events associated with kratom use, including seizures and liver toxicity.
View source: FDA.gov kratom hub → -
2022-03-28
recallMultiple kratom recalls for salmonella
Recalls initiated across multiple kratom brands after positive salmonella test results in imported leaf material.
View source: FDA → -
2018-04-03
recallSalmonella outbreak linked to kratom
FDA investigated a multistate salmonella outbreak linked to kratom products. 28 states affected, 199 people sickened.
View source: FDA → -
2018-02-06
advisoryFDA Commissioner Scott Gottlieb statement on kratom
Then-FDA Commissioner Gottlieb issued a strong statement warning about kratom's opioid-like properties, citing 44 reported deaths associated with kratom use.
View source: FDA → -
2016-10-12
schedulingDEA withdraws Schedule I proposal
Following public outcry and pushback from scientists, advocates, and members of Congress, the DEA withdrew its intent-to-schedule notice for kratom alkaloids.
View source: DEA → -
2016-08-26
schedulingDEA announces intent to schedule kratom as Schedule I
DEA issued notice of intent to temporarily place mitragynine and 7-hydroxymitragynine in Schedule I of the Controlled Substances Act.
View source: Federal Register → -
2014-02-11
advisoryFDA import alert — kratom
FDA issued import alert 54-15 authorizing detention without physical examination of shipments of kratom and kratom products.
View source: FDA import alerts →