Kratom and the FDA: A Timeline of Regulatory Actions from 2014 to 2026

The relationship between kratom and the U.S. Food and Drug Administration (FDA) has been one of the most consequential and contentious stories in the modern botanical supplement industry. For over a decade, the FDA has taken a series of regulatory actions targeting kratom—ranging from import alerts and public advisories to attempted scheduling recommendations—while millions of Americans have continued to use kratom and advocacy organizations have pushed back with scientific evidence and grassroots mobilization. Understanding this regulatory history is essential for any informed kratom consumer. Here is a comprehensive timeline of key FDA actions and the kratom community’s responses from 2014 through early 2026.

2014: Import Alert 66-41

The FDA’s modern campaign against kratom effectively began in 2014 with the issuance of Import Alert 66-41, which authorized U.S. Customs and Border Protection to detain kratom shipments at ports of entry without physical examination. The import alert allowed the FDA to seize kratom products being imported into the United States, citing concerns that kratom was being marketed as an unapproved drug with unsubstantiated health claims.

This was a significant escalation. Prior to 2014, kratom had been quietly imported and sold in the U.S. for years with relatively little federal attention. The import alert signaled that the FDA was actively monitoring the kratom trade and prepared to use its regulatory authority to restrict the flow of kratom into the country.

The practical impact of Import Alert 66-41 was uneven. While some shipments were seized, the alert did not constitute a ban on kratom importation. Many shipments continued to enter the country, particularly through established supply chains. However, the alert created legal uncertainty for importers and vendors and served notice that the FDA considered kratom a product of regulatory concern.

2016: The DEA Scheduling Attempt

Perhaps the most dramatic chapter in kratom’s regulatory history came in August 2016, when the Drug Enforcement Administration (DEA) announced its intent to temporarily place kratom’s two primary alkaloids—mitragynine and 7-hydroxymitragynine—into Schedule I of the Controlled Substances Act. Schedule I is the most restrictive category, reserved for substances with “no currently accepted medical use and a high potential for abuse,” and includes drugs like heroin, LSD, and MDMA.

The DEA’s announcement cited the FDA’s evaluation of kratom as a basis for the scheduling action. The proposed effective date was September 30, 2016.

What happened next was unprecedented. The kratom community launched a massive grassroots response:

• Over 140,000 people signed a petition on the White House’s “We the People” platform opposing the scheduling
• A bipartisan group of 51 members of the U.S. House of Representatives signed a letter to then-DEA Acting Administrator Chuck Rosenberg, urging the agency to withdraw its notice of intent
• Nine U.S. senators sent a similar letter to the DEA
• Scientists and researchers submitted a letter arguing that scheduling would impede valuable research
• The American Kratom Association (AKA) coordinated advocacy efforts and legal strategy

On October 12, 2016, the DEA took the extraordinary step of withdrawing its notice of intent to schedule kratom—the first time in the agency’s history that it had reversed course on a proposed scheduling action due to public opposition. The DEA instead opened a public comment period, which received over 23,000 comments, the vast majority opposing scheduling.

2017–2018: FDA Intensifies Its Campaign

Following the DEA’s withdrawal, the FDA under Commissioner Scott Gottlieb stepped up its own campaign against kratom. Key actions during this period included:

November 2017: FDA Public Health Advisory

The FDA issued a formal public health advisory regarding “risks associated with kratom,” citing reports of deaths in which kratom was detected. The advisory stated that the FDA was “aware of 36 deaths associated with the use of kratom-containing products.” Critics, including the AKA, challenged these death attributions, noting that the vast majority of cited cases involved polydrug use (the concurrent use of multiple substances) and that no deaths had been conclusively attributed to kratom alone in the absence of other substances or pre-existing conditions.

February 2018: FDA Recommends Scheduling to DEA

In February 2018, the FDA made a formal recommendation to the DEA that kratom be classified as a Schedule I controlled substance. Alongside this recommendation, the FDA released a scientific analysis using its PHASE (Public Health Assessment via Structural Evaluation) computational model, which the agency claimed demonstrated that kratom’s chemical compounds were structurally similar to controlled opioid substances.

This PHASE analysis was immediately and vigorously challenged by independent scientists. Notably, Dr. Jack Henningfield, a prominent pharmacologist from Johns Hopkins University who had been engaged by the AKA to conduct an independent scientific review, published a detailed critique arguing that the FDA’s computational model was fundamentally flawed for evaluating complex botanical substances with multiple active compounds. Dr. Henningfield’s analysis, along with an eight-factor analysis examining kratom’s potential for abuse (the standard DEA framework for scheduling decisions), concluded that kratom did not meet the criteria for Schedule I classification.

2018: Salmonella Outbreak

In early 2018, the CDC identified a multi-state salmonella outbreak linked to contaminated kratom products, affecting nearly 200 people across 41 states. The FDA used this outbreak to issue additional warnings about kratom and to support its argument for increased regulation. Kratom advocates acknowledged the seriousness of the contamination issue but argued that it was a manufacturing quality control problem—one that underscored the need for regulated production standards (such as GMP compliance) rather than prohibition.

2019–2020: Scientific Pushback and AKA Response

The 2019–2020 period saw growing scientific pushback against the FDA’s position on kratom:

• Researchers at the University of Florida, Columbia University, Memorial Sloan Kettering, and other institutions published peer-reviewed studies exploring kratom alkaloids’ pharmacology, with findings that complicated the FDA’s characterization of kratom as simply a dangerous opioid.
• The Johns Hopkins University survey (published in 2020 in Drug and Alcohol Dependence) of over 2,700 kratom users found that the majority reported using kratom for self-management purposes, with a relatively low rate of self-reported adverse effects.
• The National Institute on Drug Abuse (NIDA) funded multiple research grants to study kratom alkaloids, acknowledging that more data was needed.
• The AKA established its GMP Standards Program, creating industry-wide manufacturing and testing standards to address the quality control concerns that the 2018 salmonella outbreak had highlighted.

During this period, the DEA did not act on the FDA’s 2018 scheduling recommendation. The lack of DEA action was widely interpreted as an indication that the scientific evidence supporting Schedule I classification was insufficient.

2021–2022: State-Level Progress and the KCPA Movement

With federal scheduling stalled, the regulatory landscape shifted significantly toward the state level. The Kratom Consumer Protection Act (KCPA) movement gained substantial momentum:

• Multiple states passed KCPA legislation, establishing regulatory frameworks that legalized kratom while imposing quality standards, age restrictions, and labeling requirements.
• States with KCPA laws demonstrated a third path between prohibition and an unregulated market—one focused on consumer safety through responsible regulation.
• Meanwhile, Thailand decriminalized kratom in 2021, removing it from its narcotics list after nearly 80 years of prohibition under the Kratom Act of 1943.

2023–2024: Continued FDA Enforcement Actions

The FDA continued its enforcement approach during 2023–2024, primarily through:

• Warning letters to companies marketing kratom products with explicit health claims (claims that kratom treats, cures, or prevents specific diseases).
• Import seizures under the ongoing Import Alert 66-41.
• Mandatory recalls of specific kratom products found to be contaminated or adulterated.
• Increased scrutiny of synthetic 7-OH products and concentrated kratom extracts, which the FDA argued represented a different risk profile than whole-leaf kratom.

Notably, even during this period of enforcement, the FDA did not move to ban kratom outright. The agency’s approach was characterized by targeted enforcement against specific products and marketing claims rather than a blanket prohibition.

2025–2026: The Current Regulatory Landscape

The most recent chapter in kratom’s regulatory story includes several significant developments:

• The introduction of a federal Kratom Consumer Protection Act in Congress, which would establish national manufacturing standards, labeling requirements, and age restrictions for kratom products.
• A bipartisan Senate letter from Senators Ricketts and Blumenthal urging the FDA to schedule all kratom under the Controlled Substances Act, reinvigorating the scheduling debate.
• Continued expansion of state-level KCPA legislation, with additional states considering or passing consumer protection frameworks.
• Ongoing FDA review of kratom’s regulatory status, with the agency continuing to maintain its position that kratom products are “unapproved drugs” when marketed with health claims.

The regulatory future of kratom remains uncertain but actively contested. Consumer advocacy, scientific research, and legislative action at both the state and federal levels continue to shape the landscape.

What Consumers Should Know

Understanding the FDA’s regulatory history with kratom empowers you as a consumer. Here are key takeaways:

• Kratom is currently legal at the federal level in the United States. It is not a scheduled controlled substance under federal law, though some states and municipalities have enacted their own restrictions. Check our legality guide for current information.
• The FDA has not approved kratom for any medical use. Vendors making specific health claims about kratom are violating FDA regulations, and such claims should be viewed with skepticism.
• Quality and safety standards matter. The salmonella outbreak and other contamination incidents demonstrate why purchasing from vendors who follow GMP standards and provide third-party lab testing is essential.
• Your voice matters. The 2016 DEA scheduling reversal demonstrated that informed, organized consumer advocacy can influence regulatory outcomes. Staying informed and engaged is the most powerful tool available.

At Hudson Valley Botanicals, we believe that informed consumers are empowered consumers. We are committed to transparency, quality, and keeping our community up to date on every regulatory development that affects your access to kratom. Browse our products or contact us with any questions.