Kratom Industry Calls for FDA Regulation Amid Legal and Health Debates

In the ever-evolving landscape of herbal supplements, kratom, a tropical tree native to Southeast Asia, has emerged as a subject of intense debate and legal scrutiny. Despite its growing popularity in the United States, kratom remains unapproved for medical use by the U.S. Food and Drug Administration (FDA). This lack of regulatory clarity has led to a complex situation where import alerts, warning letters, and even seizures by U.S. Marshals are not uncommon (Food Safety News).

Kratom contains two primary psychoactive ingredients, mitragynine and 7-hydroxy mitragynine, which produce stimulant effects at low doses and sedative effects at high doses. The leaves of the kratom tree can be crushed, smoked, brewed with tea, or placed into gel capsules. While it has a long history of use in Southeast Asia, where it is known by various names such as thang, kakuam, thom, ketum, and biak, its abuse in the U.S. has increased markedly in recent years.

The legal status of kratom in the U.S. is complex. It is not controlled under the Controlled Substances Act, but some states have regulations or prohibitions against its possession and use. The Drug Enforcement Agency (DEA) has listed kratom as a Drug and Chemical of Concern, reflecting the ongoing concerns about its safety and potential for abuse.

Amidst this backdrop, the American Kratom Association (AKA), a consumer-based, nonprofit organization, has issued a Consumer Advisory in response to recent wrongful death jury awards in Florida and elsewhere. The AKA’s advisory focuses on urging the FDA to publish product manufacturing standards for kratom products sold to consumers. They recommend that until such standards are implemented, consumers should avoid kratom products that have not been certified by an independent third-party lab to be free of dangerous contaminants or contain adulterants, are offered for sale with illegal therapeutic claims, do not contain the name of the product distributor, or are delivered in unprofessional packaging (American Kratom Association).

Mac Haddow, the AKA’s Senior Fellow on Public Policy, has criticized the FDA’s failure to regulate the kratom marketplace, attributing recent product liability awards to this lack of regulation. Haddow argues that the safety and addiction profile of pure, unadulterated kratom is well-documented by science, and there is no known level of kratom use that would cause fatality unless it is irresponsibly consumed, adulterated with a toxic drug, or used concurrently with a deadly drug substance. The AKA supports congressional action to compel the FDA to develop and implement a set of standards for the manufacturing and marketing of kratom products to protect consumers in the United States.

The call for regulation by the kratom industry is a significant development, reflecting a desire for legitimacy and safety in a market that operates in a legal grey area. The FDA’s stance on kratom has been cautious, with the agency not approving the herb for sale in the U.S. due to concerns about its safety and potential for abuse. The FDA has issued several warnings about the risks associated with kratom, including addiction, abuse, and serious health consequences (FDA – Kratom).

The debate over kratom’s legal status and its health implications is far from settled. While proponents argue for its benefits and call for regulated, safe access, health authorities and regulatory bodies remain concerned about its potential for harm. As the kratom industry pushes for FDA regulation, it remains to be seen how this will shape the future of kratom in the United States, both in terms of its legal status and its role in public health.

In conclusion, the kratom industry’s call for FDA regulation is a pivotal moment in the ongoing discourse surrounding this controversial herb. It highlights the need for a balanced approach that ensures consumer safety while respecting the rights of individuals to access herbal supplements. As the situation evolves, it will be crucial for regulatory bodies, industry stakeholders, and consumers to engage in an informed and constructive dialogue to navigate the complexities of kratom regulation.