Federal Lawmakers Are Preparing To Reintroduce Legislation To Regulate Kratom Amid Pushback To FDA-Proposed Ban

Federal Lawmakers Are Preparing To Reintroduce Legislation To Regulate Kratom Amid Pushback To FDA-Proposed Ban

As federal lawmakers prepare to reintroduce a bill to regulate kratom, a former Trump administration drug czar stressed the need to beat back “misinformation” from the Food and Drug Administration (FDA), which has attempted to ban the substance in the U.S. and abroad.

Members of the American Kratom Association (AKA) said during a webinar Tuesday that they expect federal legislation to regulate the drug “will be filed shortly” in Congress and could be taken up later this session.

The text of the forthcoming bill “will be word-for-word the same” as congressional legislation introduced last session, said Mac Haddow, a senior fellow at AKA. The title, however, will be updated to the Kratom Consumer Protection Act, a nod to model legislation that AKA has been lobbying for at the state and federal levels.

Sponsors will include, on the Senate side, Sens. Mike Lee (R-UT) and Cory Booker (D-NJ), who also sponsored last session’s bill, the Federal Clarity for Kratom Consumers Act. In the House, lead sponsors will be Reps. Mark Pocan (D-WI) and Jack Bergman (R-MI). Pocan sponsored last year’s bill in the House, while Bergman is a new addition.

The forthcoming legislation’s bipartisan sponsorship in each chamber—specifically pairing a “very liberal” elected official with a “very conservative” one—is designed to highlight “that this is not a partisan issue,” Haddow said. “This is about good policy.”

If the bill becomes law, it would require FDA to take further steps to evaluate the health and safety of kratom and would also prohibit the agency from regulating kratom products in a way that’s more restrictive than regulations for food or dietary supplements.

Neither chamber took action on the proposal last session, but AKA expects more traction—and more sponsors—on this year’s bill.

Haddow spoke alongside former Trump drug czar Jim Carroll and John Shinholser, co-founder of the recovery organization The McShin Foundation, during an AKA-hosted webinar on Tuesday. Much of the discussion centered on FDA’s attempts to outlaw kratom federally, which advocates so far have managed to prevent.

Carroll, who separately spoke to Haddow earlier this month about his efforts as drug czar to push back on FDA’s past anti-kratom recommendations, said the agency is uniquely responsible for perpetuating overblown fears about kratom.

“I was at the epicenter when this issue came up in 2018,” he said, “FDA came and, really unilaterally, tried to ban kratom.”

During a presentation to his office, he said, the agency presented “an incomplete picture of the facts that were out there,” suggesting that kratom had no redeeming value and carried serious risk of injury or death.

After conferring with a colleague, Brett Giroir, then the assistant secretary of health at the Department of Health and Human Services (HHS), Carroll said he and others were able to scuttle the proposed ban. “All of the facts were presented, and the FDA ban was quickly shot down,” Carroll recalled, “because in fact, they’re missing a lot of the story.”

Among the myths FDA perpetuated, he said, was the idea that kratom had been linked to a significant number of deaths, when in fact those deaths were later attributed to hazardous contaminants in kratom products. AKA’s model legislation would help avoid that by requiring lab testing for pesticides, heavy metals and other adulterants, advocates say.

“They’ve told so many people the same nonsense,” Haddow said of FDA, “and it’s been rejected, including at HHS, by the DEA, by the U.S. Congress [and] by the National Institute on Drug Abuse. The lone wolf is the FDA, and they continue to propagate their disinformation about this.”

In addition to federal legislation, AKA is also working to better hold FDA accountable for its apparent failure to provide accurate information about kratom.

“We’re doing a couple things,” Haddow said. First, AKA “along with some other colleagues and friends in the dietary supplement industry” are planning to launch a website that will allow people to report FDA disinformation on kratom.

“We want to report them to Congress, and we want to report them to the Federal Trade Commission about the disinformation they’re circulating,” he explained, “because it’s obvious that their embarrassingly poor evidence and data needs to be called out.”

AKA is also pushing members of Congress who oversee FDA to send letters to the agency “to hold them accountable for their current actions,” Haddow said.

At the state level, the organization has already successfully reversed some kratom bans, for example in Vermont. Other states, however, still have bans in place—including Arkansas, where the daughter one of the webinar’s attendees was recently arrested for possessing 11 grams of kratom after moving from Texas, where the plant is legal. (“You need to get a good attorney for your daughter immediately,” Haddow said.)

Ideally, AKA would like to see kratom producers licensed, products tested and retailers required to check IDs and sell only to consumers 21 and older, according to the group’s statement of principles. The organization says unlicensed, unregulated producers perpetuate stigma against kratom by selling to minors, failing to accurately label products and, in the worst cases, introducing potentially dangerous additives.

So far 11 states have passed some version of the Kratom Consumer Protection Act, although state lawmakers have sometimes departed from AKA’s core principles. The latest version of the bill in Florida’s legislature, for example, does not include any product testing requirements.

Carroll said it’s time for FDA to step in and, rather than try to ban kratom, go after bad industry actors. He noted that several years ago, when FDA began considering how to regulate e-cigarettes, “the industry was not regulating itself, so the government took that action.”

“The same should be true here,” he said. “Kratom should not be sold and marketed in a way that’s intended for children. It shouldn’t be cartoon characters on there, it shouldn’t be candy-flavored and it shouldn’t be sold to minors.”

Kratom is used by people for various purposes, including relaxation and anxiety relief. It’s also a popular tool for helping reduce symptoms of opioid withdrawal, which has earned it attention amid the nation’s ongoing epidemic of opioid overdose deaths. Shinholser said he’s witnessed firsthand how powerful kratom can be in easing opioid withdrawal, comparing it to alternatives such as suboxone or methadone.

Earlier this summer, the American Medical Association updated its position on kratom, adopting a resolution that said people “who are using kratom only for personal use should not face criminal consequences.” It further said that kratom “should be regulated by the [Food and Drug Administration], and its safety and efficacy should be determined through clinical trials before it can be marketed or prescribed as a treatment for any condition.”

While advocates want consumers to be able to continue to purchase kratom over the counter from retailers, AKA said at the time that the resolution was a step in the right direction, departing from a more aggressive, criminalization stance.

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Photo courtesy of Wikimedia/ThorPorre.

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