Federal regulators and state lawmakers examine kratom safety as the supplement faces addiction concerns, wrongful death lawsuits, and increasing regulatory action across multiple states.

Popular Supplement Kratom Faces Growing Scrutiny Over Safety and Addiction Concerns

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Author: Joy
Date: October 28, 2025

The dietary supplement kratom is facing intensified regulatory scrutiny as concerns mount over addiction potential, adverse health effects, and marketing practices. Derived from leaves of a tree native to Southeast Asia, kratom has experienced explosive growth in the U.S. market in recent years, appearing in drinks, pills, powders, and brewed tea products marketed as energy boosters, relaxants, and pain relievers.

According to CBS News reporting, kratom is currently banned in six states and Washington, D.C., while at least 18 states have implemented some form of regulatory framework. The supplement's accessibility through convenience stores and online retailers, largely without standardized oversight, has raised questions about consumer safety and product consistency.

Federal and State Regulatory Responses

The Food and Drug Administration has issued warnings advising consumers not to use kratom, citing risks including substance use disorder, seizures, and death—particularly when kratom is combined with other substances such as alcohol. In August 2025, Health and Human Services Secretary Robert F. Kennedy Jr. announced plans for a crackdown targeting one kratom compound, though specific details of the regulatory action were not disclosed.

Matthew Rossheim, who researches intoxicating substances, stated that a common misperception exists that plant-based products are inherently safe or non-addictive. He expressed concerns that kratom products are too accessible and frequently lack proper warnings on their labels.

The regulatory patchwork creates challenges for both consumers and businesses operating in the kratom space. States with regulations have implemented varying approaches, including age restrictions, labeling requirements, and registration systems for kratom vendors. This inconsistent framework complicates compliance efforts for manufacturers and retailers operating across multiple jurisdictions.

Legal Actions and Industry Response

Dozens of wrongful death lawsuits related to kratom have been filed across the country. In 2023, a class action lawsuit was filed against Botanic Tonics, manufacturer of the kratom beverage Feel Free Classic, alleging the product was misleadingly advertised as a safe alcohol alternative while being highly addictive and marketed to people struggling with sobriety.

Botanic Tonics has since settled that lawsuit. In a statement to CBS News, the company stated they "deeply regret any confusion or harm past marketing may have caused" and indicated they now provide comprehensive information about their products, including intake limits and clear safety warnings.

Consumer testimonials have highlighted addiction concerns. Jasmine Adeoye, 29, told CBS News she became dependent on Feel Free Classic after hearing about it on a podcast while quitting alcohol. She described being advertised an alcohol alternative that seemed totally safe, leading her to believe something was wrong with her when she became addicted. Adeoye now uses social media to warn others, stating that many people are struggling in silence and that the substance is ruining lives.

Industry Advocacy for Standards

The American Kratom Association told CBS News it advocates for regulations aimed at keeping dangerous kratom products off the market. The organization supports labeling requirements and bans on kratom sales to minors, positioning itself as favoring regulatory frameworks rather than prohibition.

This advocacy approach reflects broader tensions within the supplement industry between maintaining market access and implementing safety standards. The kratom sector faces similar challenges to those encountered by other emerging botanical supplement categories, where rapid market growth has outpaced regulatory development.

Compliance Challenges in Unregulated Markets

The kratom situation illustrates fundamental challenges facing businesses in minimally regulated supplement markets. Without federal scheduling or comprehensive regulatory frameworks, manufacturers operate with limited guidance on testing standards, potency limits, labeling requirements, or quality control protocols.

For supplement companies seeking to operate responsibly in this environment, implementing voluntary quality management standards becomes essential. This includes comprehensive testing protocols, standardized manufacturing processes, detailed record-keeping systems, and transparent labeling practices that go beyond minimum legal requirements.

The absence of standardized Certificate of Analysis protocols for kratom products creates additional complexity. Unlike cannabis, where state-regulated testing laboratories provide COAs documenting cannabinoid profiles and contaminant screening, kratom products often lack consistent third-party verification. Companies that voluntarily implement rigorous testing and documentation protocols position themselves more favorably as regulatory frameworks develop.

Market Access and Banking Challenges

Beyond health and safety concerns, kratom businesses face significant operational challenges. Banking institutions and payment processors frequently classify kratom as high-risk, creating obstacles similar to those faced by cannabis companies. Merchant account providers may refuse service or impose restrictive terms, while major credit card networks have limited kratom transaction processing.

These financial service restrictions compound compliance challenges. Without stable banking relationships, businesses struggle to implement the financial controls and audit trails that regulators typically expect. Companies that can demonstrate comprehensive quality management systems, transparent supply chains, and rigorous compliance documentation may find it easier to establish and maintain merchant processing relationships.

Looking Forward

As federal and state regulators continue examining kratom safety and marketing practices, the supplement industry faces an uncertain regulatory future. Businesses operating in this space must balance market opportunities against evolving compliance requirements and liability risks.

The kratom regulatory situation demonstrates how quickly botanical supplement markets can shift from minimal oversight to intensive scrutiny. Companies that proactively implement comprehensive quality management systems, transparent testing protocols, and conservative marketing practices position themselves more favorably regardless of how regulations develop.


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