The FDA (U.S. Food and Drug Administration) has recently issued warnings about kratom products, particularly targeting concentrated derivatives like 7-OH (7-hydroxymitragynine) due to safety concerns.
This post explores the FDA’s position on kratom and its derivatives, examines the health implications of these warnings, and guides anyone unsure about the dangers associated with kratom and 7-OH (7-hydroxymitragynine).
What Is the FDA’s Current Stance on Kratom?
Kratom, a Southeast Asian tropical tree (Mitragyna speciosa), has been used in herbal medicine for centuries. Low doses of kratom trigger stimulant effects, while higher doses can provoke opioid-like effects. Kratom and its derivatives like 7-OH have gained popularity in the United States in recent years among those seeking alternatives for pain management, anxiety relief, and support during opioid withdrawal. Up to 15 million U.S. adults are reported to use kratom products.
The FDA has not approved any prescription or OTC drug products containing kratom or its two main chemical components, mitragynine and 7-OH. The agency has concluded from available information that kratom is a dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury. The FDA continues to evaluate safety data while warning against any medical use of kratom products.
7-OH (7-Hydroxymitragynine): Concentrated Kratom
Recent FDA enforcement actions have focused intensively on 7-OH, a concentrated alkaloid derived from kratom leaves that has earned the troubling nickname “gas station heroin” due to its opioid-like properties and widespread availability in convenience stores.
The FDA is specifically targeting 7-OH due to its potency. Traditional kratom leaf products contain naturally occurring 7-OH in trace amounts, typically less than 2% of total alkaloid content. Concentrated products contain much higher levels, sometimes exceeding 30 times the natural concentration found in raw plant material.
7-OH is increasingly recognized as having a strong potential for abuse because it acts on the same brain receptors as prescription painkiller and illegal opioid like heroin. Research indicates that 7-OH demonstrates full opioid agonist activity, meaning it activates these receptors completely and may produce effects even stronger than morphine. Kratom, by contrast, activates these receptors only partially, leading to less intense effects.
Manufacturing and Market Dynamics
The concentration process involves extracting and isolating 7-OH from kratom leaves through sophisticated chemical procedures that create products bearing little resemblance to traditional botanical preparations. These manufacturing techniques produce standardized alkaloid concentrations that eliminate the natural variability and balanced alkaloid profiles characteristic of whole leaf kratom.
The FDA’s concern goes beyond the pharmacological potency of 7-OH, focusing on market accessibility and targeting strategies. Individuals can easily purchase products with concentrated levels of 7-OH online and in gas stations, corner stores, and vape shops, which may require a prescription, age verification, or medical supervision.
The agency has expressed alarm about products explicitly marketed to appeal to children and teens, including fruit-flavored gummies, ice cream cone-shaped products, and drink shots that contain up to 98% 7-OH.
Regulatory Classification Challenges
The regulatory complexity surrounding 7-OH (7-hydroxymitragynine) arises from its dual nature as both a naturally occurring plant compound and a concentrated, pharmaceutical-grade substance. While 7-OH is present in trace amounts in natural kratom, concentrated products are transformed from botanical preparations into unapproved drugs with abuse potential.
Market confusion has occurred, with some manufacturers marketing concentrated 7-OH products as natural kratom supplements while others position them as enhanced wellness products. The FDA’s position clarifies that potency is key in determining consumer safety and legal compliance, with concentrated 7-OH products failing to meet safety standards for food additives, dietary supplements, or approved pharmaceuticals.
Accessibility patterns mirror historical concerns about synthetic drugs and NPS (new psychoactive substances) that exploited regulatory gaps to reach consumers before a comprehensive safety evaluation occurs. 7-OH, like other opioid-potent substances, has become readily available through retail channels traditionally associated with convenience products rather than controlled substances.
Health Risks and Safety Concerns
Kratom use can be damaging to many organ systems. SUDORS (State Unintentional Drug Overdose Reporting System) data indicated that kratom was implicated in more than 2,000 overdoses from 2020 to 2022.
While many kratom-related fatalities involve multiple substances, almost half of the reported overdoses have documented kratom as the sole detected compound. These findings challenge assumptions about kratom’s safety profile.
In June 2025, the FDA sent Hydroxie, LLC a warning letter flagging reports that linked 7-OH to respiratory depression, seizures, liver toxicity, and fatalities. These severe adverse events occurred across various product formulations, including tablets, beverages, and drink mixes.
The concentration-dependent nature of kratom’s effects raises challenges for consumer safety. Traditional kratom leaf contains balanced alkaloid profiles that may provide natural checks against excessive consumption. Concentrated products eliminate these natural safeguards while dramatically increasing potency.
Respiratory and Cardiovascular Effects
Kratom’s interaction with opioid receptors raises concerns about respiratory depression, especially when the substance is combined with other depressants of the CNS (central nervous system). This risk becomes more pronounced with concentrated 7-OH products that demonstrate full opioid agonist activity.
Cardiovascular effects include potential impacts on heart rate and blood pressure regulation. Limited clinical data makes it difficult to predict individual susceptibility to these effects, particularly among those with pre-existing cardiovascular conditions.
Hepatotoxicity
Reports of liver injury associated with kratom use have prompted FDA investigation and surveillance. The mechanism underlying potential hepatotoxicity is incompletely understood, but case reports document elevated liver enzymes and acute liver injury requiring medical intervention.
The variability in kratom product composition complicates risk assessment. Adulteration with other compounds, inconsistent alkaloid concentrations, and contamination with heavy metals or pathogens may contribute to hepatotoxic potential.
Addiction and Withdrawal Potential
7-OH (7-hydroxy) kratom products bind so strongly to opioid receptors that these concentrated substances have substantial addiction potential. People report experiencing withdrawal symptoms upon discontinuation that include anxiety, depression, muscle aches, and sleep disturbances. The duration and presentation of withdrawal symptoms appear related to usage patterns, product potency, and individual factors.
Healthcare providers increasingly encounter individuals seeking treatment for kratom dependence. The development of tolerance to kratom requires progressively higher doses to achieve the desired effects. This pattern of escalation increases exposures to potentially harmful compounds while increasing the risk of overdose. Standard opioid withdrawal protocols may provide limited effectiveness given kratom’s unique alkaloid profile and mixed receptor activity.
Regulatory Enforcement and Market Impact
In late July 2025, the FDA recommended a scheduling action to classify certain kratom products under the CSA (Controlled Substances Act). The scheduling recommendation targets concentrated 7-OH products rather than natural kratom. Under the CSA, substances are placed into one of five schedules based upon their medical use, potential for abuse, and safety or dependence liability.
State-level responses to kratom vary widely, with some jurisdictions implementing sweeping bans, while others pursue more nuanced regulation. Twenty-four states regulate kratom in some form. Seven U.S. states have banned kratom outright.
Colorado enacted comprehensive legislation in May 2025, prohibiting kratom products resembling candy, increasing labeling requirements, limiting 7-OH concentrations, and banning the manufacturing of synthetic kratom. This approach preserves access to natural kratom while addressing safety concerns around products targeting younger demographics.
Mississippi implemented similar measures in July 2025, raising the minimum purchase age to 21 while banning synthetic extracts and high-concentration 7-OH products.
New York lawmakers passed two bills regulating kratom. The first bill requires warning labels and prohibits “all-natural” marketing claims for kratom products, while the second establishes a 21-year minimum purchase age. These requirements address consumer confusion about product composition, particularly given the prevalence of enhanced products deceptively marketed under generic kratom branding.
Louisiana has adopted the most restrictive approach, implementing a complete kratom ban effective August 1, 2025. This prohibition encompasses all kratom products, regardless of concentration.
Rhode Island, by contrast, became the first U.S. state to reverse its kratom prohibition, citing unsustainability in the face of continued consumer demand and emerging safety data.
This regulatory fragmentation has accelerated pressure for federal standardization and more explicit guidance on acceptable product categories.
Warning Letters and Enforcement Actions
On July 15, 2025, the FDA issued seven warning letters to companies linked to the marketing of concentrated 7-OH products. These enforcement actions target companies marketing products as dietary supplements while containing concentrated alkaloid extracts.
The companies face potential seizures, injunctions, and criminal prosecution if they fail to address FDA concerns within the specified timeframe. This enforcement strategy shows escalating federal commitment to regulating these concentrated kratom products.
What This Means for People Using Kratom
Individuals currently using kratom products face ever-changing regulations that may impact the quality and availability of products. The FDA’s sharp focus on concentrated 7-OH products means that traditional kratom leaf preparations may remain available in some U.S. states, although regulatory frameworks are evolving, and legal uncertainty persists.
Regular medical monitoring is essential for anyone choosing to continue using kratom despite FDA warnings. Healthcare providers can assess for adverse effects, monitor liver function, and provide guidance on risk reduction strategies. The most effective approach is to avoid any use of kratom or kratom products like 7-OH.
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