PROPOSED FEDERAL LEGISLATION SEEKS TO LEAN ON SCIENCE FOR KRATOM REGULATION

The start of 2023 has seen a flurry of activity at the local level from voices on both sides of the kratom question—about how to properly regulate and protect consumers of the herb.

At the heart of those policy questions is the anti-kratom stance of federal agencies, to the point that the feelings of the Food and Drug Administration are even trickling their way into the legal system. The only problem with that is advocates feel the FDA is working off of flawed logic, and has used its discretion to enact a “bias” against the herbal supplement.

Now it’s up to Congress to help settle the dispute.

Kratom advocates and the FDA have been caught up in a seemingly endless back-and-forth in recent years, with the FDA most recently providing the basis for attempts to ban kratom and legal action against kratom distributors. With legislation pending in both houses of Congress, advocates are hoping the first steps can be taken to give kratom a fair shake from federal agencies, and center the debate on facts over fear mongering and protectionist points of view.

Late last year, a pair of bills were introduced in both the Senate and the House of Representatives by a bipartisan coalition of lawmakers. Among the bill’s text is direct language challenging the FDA’s treatment of kratom, specifically banning the agency from increasing scrutiny on the substance under current law.

According to Mac Haddow, a senior fellow with the American Kratom Agency (AKA), the fight with the FDA centers around a decades-old dispute of how kratom fits into American law. Per legal changes in the 1990s, Haddow said kratom lacked the marketing materials to be grandfathered in as a safe dietary ingredient. Because of that, Haddow said the substance has faced increased scrutiny as a new dietary ingredient, despite kratom’s use in the United States since it was brought back by soldiers who had served in Vietnam.

If the proposed federal legislation were to pass, that would change.

“They would have to base every decision related to kratom on scientific evidence and data, not their bias against kratom and other herbal supplements,” Haddow said.

The legislation would also require transparency on all research being funded by the federal government, and make it publicly available to consumers and lawmakers. To go with that, a task force would be created that would include public meetings and public input on kratom.

Beyond those implications for federal lawmakers and consumers, the trickle down effect of a science-based approach at the federal level would help alleviate the stress of what Haddow calls the FDA’s “war on kratom.”

One of the most visible impacts of the FDA’s treatment of kratom can be seen in a rash of lawsuits that have been filed in relation to overdose deaths. In the past year, three deaths in different states have led to litigation, with each lawsuit leaning heavily on the FDA’s treatment on kratom as a basis for damages. All three lawsuits reference kratom’s status as a “new dietary ingredient” and use the FDA’s rules around dietary ingredients to claim kratom is an illegal substance. Kratom is currently legal in each of the three states where the lawsuits were filed, and remains federally legal after the Drug Enforcement Agency withdrew an attempt to schedule kratom in 2016.

In the case of a man who collapsed at the dinner table and later died, a lawsuit brought by his estate includes the FDA’s Import Alert and an FDA warning as footnote documents in the filing. Both of those regulatory functions would be affected by the proposed federal legislation.

Under the current law, though, these lawsuits use the FDA’s logic and policies to claim the kratom was illegally distributed. In different lawsuits filed in Florida and Texas, separate legal counsel included nearly identical paragraphs, calling the kratom industry in America a “profitable black-market industry” which has used “ill-gotten gains” to fund the AKA and other advocacy groups.

The basis of the claim of kratom as an “black-market industry” centers on the FDA’s requirements for new dietary ingredients in all three lawsuits.

From the AKAs perspective, Haddow said that the science “does not justify” the findings of death from the ingredients in kratom alone. Pre-existing health issues, reactions between kratom and other substances, and even the use of other drugs and medications are more often to blame, Haddow said. That lapse in reality vs. framing represents the larger issue of the FDA’s denial of available scientific information.

Haddow said that he does not doubt the intentions of family members seeking answers, rather, it’s unfortunate that they are being steered toward a conclusion that flies in the face of available research and circumstantial evidence.

“We empathize with them, we sympathize with them… but we think that they should know the truth, as should every individual in this whole chain of custody of these kind of reports, including medical examiners,” he said, “and not be misled by the FDA’s pernicious campaign to circulate disinformation.”

“We’re willing to go head-to-head with them on the science.”