A bill introduced in the U.S. Congress is intended to promote Americans’ access to kratom (Mitragyna speciosa) and support research of the botanical, which many consumers have hailed as a godsend that saves them from addiction and reliance on harmful pain medication.

But a law firm that has sued kratom brands argued the bill does nothing to protect consumers and instead shields companies that make and sell a substance blamed for human deaths in a growing number of civil lawsuits from Florida to Washington state.

The Federal Kratom Consumer Protection Act (KCPA) was introduced in October, amid a fairly steady pace of enforcement actions against kratom products that the Food and Drug Administration considers to be “adulterated” or unlawful.

"The FDA regularly exercises its authority to protect consumers from firms selling unapproved or adulterated kratom products and making false or misleading claims about unproven ‘benefits’ of kratom,” an FDA spokesperson said. “The FDA has partnered with U.S. Customs and Border Protection and with the Department of Justice to take numerous actions to limit the sale of unlawful kratom products in the U.S., such as refusing shipments of unlawful kratom products and seizing adulterated kratom dietary supplements. When kratom is offered for import and the article is determined to be an FDA-regulated product that appears to be in violation of FDA laws or regulations, it will be refused admission.”

Federal Kratom Consumer Protection Act

In early October, Sen. Mike Lee (R-Utah) introduced the latest version of the Federal Kratom Consumer Protection Act (KCPA). Lee backed a similar bill in December 2022 that did not pass through Congress.

The American Kratom Association supports the bill, seemingly in response to what the group described as attempts by FDA to enact a “de facto ban” on all kratom products. AKA also said it wants to hold accountable “bad actors who make misleading, therapeutic claims and sell adulterated products.”

A critic of the federal KCPA contends the bill protects kratom brands, not consumers.

“The word ‘consumer’ is only used in the title and nowhere else in the rest of the document,” noted an Oct. 30 blog on the mctlaw website. “Sections of the bill even have self-serving names like ‘The Protection of Kratom from Current Regulations’ and ‘Protection from Future Administrative Actions.’ All the protection is pointed in the wrong direction—toward industry and away from consumers.”

In wrongful death cases involving kratom, attorneys for mctlaw won an $11 million default judgment in Florida on behalf of a 39-year-old mother of four and a separate $2.5 million jury verdict in Washington state on behalf of a 39-year-old man.

The bill introduced in Congress suggests pure kratom is safe, ignoring federal “safety regulations which say kratom itself will be adulterated until [the supplement] industry can establish it is safe for human consumption with the 75-day premarket notification that [manufacturers] have verified safety,” said Talis Abolins, of counsel to mctlaw, in an interview.

Abolins, who has written to U.S. lawmakers opposing the legislation, concluded the bill only “makes sense if you’re trying to perpetuate the free-for-all of profiteering from a dangerous product.”

Quick kratom refresher

Kratom is a tropical tree native to Southeast Asia. For centuries, people in that region have chewed on kratom leaves for its energetic effects, much like the coca leaf before it’s processed into cocaine.

However, kratom sold in the U.S. often contains concentrated extracts rather than the whole leaf, raising alarm for federal regulators and increasingly garnering the attention of private litigators.

Kratom contains two chemical substances—mitragynine and 7-OH-mitragynine—that “bind to the same receptors in the brain (mu opioid receptors) as opioid drugs such as codeine,” according to a webpage on kratom published by FDA.

“Some [manufacturers] take these dried leaves and make concentrated extracts that result in much more plant material being present in a product,” explained Christopher R. McCurdy, a medicinal chemist, behavioral pharmacologist and pharmacist, and professor at the University of Florida’s College of Pharmacy.

Speaking to Natural Products Insider this past summer, he likened the effects of that process to those of drinking light beer compared to a shot of 151-proof alcohol. “There are drastic differences in the products used in the West versus the traditional methods,” McCurdy maintained.

Kratom: Life giver or life taker?

Despite the risks that can accompany the consumption of packaged kratom, rather than whole-leaf form, supporters remain vocal in their insistence that kratom has saved their lives.

“Kratom has been in my life for the last 10 years,” wrote Lisha Adcock on the Federal Kratom Consumer Protection Act’s comments page. “It’s helped my husband work as a plumber while needing double knee replacement and has helped save my life from an addiction to pain pills. This plant has been nothing but a God send [sic] to me and my family. Please pass SB3039.”

Another kratom user, Leisa Bailey, shared a similar experience, describing herself as “a victim of the opioid epidemic” who was prescribed eight 30-milligram oxycodone pills daily for a decade. Since the year she’s been taking kratom, she shared, her anxiety and pain has been “drastically reduced” and her “mental state has improved significantly.”

“It’s saved my life as a zombie to an active person with a granddaughter who needs me alert & not loopy from pain pills,” Bailey wrote.

A contributor calling herself Drea Discussions also touted the benefits of kratom.

“Kratom saves lives,” she wrote. “Fentanyl kills. If kratom is banned, the death toll is going to rise.”

She said she knows many people who have stopped using fentanyl thanks to their use of kratom, including family and friends.

“I use kratom to avoid pain pills and without it, I would have to use them,” she added.

But on the same comments page, two members of the public warned about the fatal consequences of kratom use.

Citing the coroner, Janice Coppola said her son died from a kratom overdose in 2021.

“My son was a doctor of pharmacy but was fooled by the misinformation available,” Coppola wrote, adding kratom “is NOT safe.”

Rhoda Hall recounted a similar experience, writing that her son died on Oct. 28, 2022, due to kratom. She said he was admitted to the hospital on Aug. 11, 2022, diagnosed with psychosis, and that he informed doctors he had been only taking kratom capsules that he ordered online.

“He was told to stop taking kratom capsules, but he ordered more in September 2022 and died a month later,” Hall wrote. “His autopsy and toxicology results show the immediate cause of death was from mitragynine use. People who are trying to stop taking kratom are reporting that their side effects are worse than opioids.”

Amid such reports, the number of wrongful death lawsuits related to kratom continues to grow.

One of the latest was filed in Nevada this fall, and Abolins—the Seattle-based litigator—said his firm is planning to file a lawsuit in Washington state on behalf of a 40-year-old man he described as “very healthy and [with] nothing else in his system but kratom.”

He said the complaint will be filed in the same county where his firm won a $2.5 million jury verdict on behalf of Patrick Coyne in July. He died from the “Toxic Effects of Mitragynine (Kratom),” according to the lawsuit filed in Cowlitz County Superior Court, citing the county coroner.

‘Guardrails for kratom regulation’

According to a Feb. 1 statement from a representative of AKA, the number of estimated kratom users in the U.S. has grown from 3 to 5 million in 2016 to 12 to 15 million today, contributing $1.5 billion to the economy.

“For many consumers, kratom shows promise as they search for a natural supplement to help with pain management, addiction recovery or other conditions,” Sen. Lee told Natural Products Insider in an email through a spokesperson. “States have appropriately taken the lead in evaluating and regulating kratom. However, federal agencies have taken a heavy-handed approach to kratom regulation, such as the recommendation to classify kratom under Schedule I of the Controlled Substances Act (CSA) and the issuance of import alerts allowing for detention of kratom products without physical examination. These actions have been taken with limited data on the risks of kratom consumption.”

The U.S. senator added, “Congress should establish guardrails for kratom regulation, protecting continued access for consumers and encouraging additional research. The bipartisan Federal Kratom Consumer Protection Act supplies these important guardrails as states, researchers, businesses, consumers and regulators continue to evaluate kratom and its potential benefits.”

The office of Sen. Cory Booker (D-N.J.), who co-sponsored the KCPA, did not respond to requests for comment.

In the U.S. House of Representatives, Rep. Mark Pocan (D-Wisc.) introduced the companion bill to Lee’s legislation. Neither his office nor the office of Rep. Jack Bergman (R-Mich), who co-sponsored the bill, responded substantively to requests for comment.

Mac Haddow, senior fellow on public policy at the AKA, told Natural Products Insider in October he did not expect the latest version of the kratom act to gain consideration until 2024. In the meantime, “Congressman Pocan has personally assured me he is as committed as ever to the KCPA, particularly with the actions by the FDA that continue to promote their efforts to create a de facto ban on kratom in the U.S.,” Haddow said in an email.

Indeed, last year, Pocan told the publication Marijuana Moment that kratom “can be a harm-reduction tool for those struggling with opioid dependency across the country—it doesn’t belong in our broken drug scheduling system.”

“This legislation will prevent the criminalization of kratom consumers and distributors while promising scientific research is conducted,” Pocan added.

Public hearing, ‘Kratom Research Task Force’

The federal bill includes several components related to the study of kratom. First, KCPA calls for the U.S. Secretary of the Department of Health and Human Services (HHS)—by acting through the commissioner of FDA—to hold a public hearing no later than 90 days after the act passes.

The hearing would allow for discourse “on the current scientific data and information about safety and use of products containing kratom or kratom-derived products marketed as a food, dietary ingredient or dietary supplement.”

The hearing calls for “input from leading scientific researchers on kratom and kratom-derived products” and consideration of the following: The number of U.S. consumers of kratom and related products; degree and scope of addiction or dependence linked to kratom and its chemical compounds (mitragynine and 7-hydroxmitragynine); and “the causality of deaths in which kratom or kratom-derived products are associated.”

The latter consideration (“causality of deaths”) includes “instances in which a kratom-containing product or kratom-derived product was consumed together with legal or illegal drugs; or the kratom-containing product or kratom-derived product consumed was contaminated with a different non-drug adulterant know to endanger health.”

In 2019, the Centers for Disease Control and Prevention (CDC) reported that nearly 100 deaths in the U.S. involved kratom. But the report suggested determining the exact causes of the deaths is complicated because nearly all the decedents tested positive for other substances, including heroin, fentanyl—the powerful synthetic opioid—and cocaine.

On the other hand, Abolins highlighted cases in which people died and had nothing toxic in their system except for kratom. The notion that pure kratom is safe and addicts are to blame is a “false narrative,” he said, adding, “It’s the kratom itself that is adulterated under federal law.”

The bill would direct HHS to examine in a hearing whether users would suffer any “adverse health impacts” should kratom no longer be available. On the flip side, the bill specifies the hearing would further evaluate kratom’s “potential health and wellness benefits.”

FDA would open a docket for public comments in advance of the hearing.

The bill would further require HHS to assemble a Kratom Research Task Force. This entity would coordinate any kratom research that the federal government conducted or supported.

The first report from the task force would be due to Congress, the HHS secretary and FDA commissioner within 90 days following the bill’s enactment. After that, the group must submit quarterly reports with updates on research and analysis of the results. The bill further specifies the task force would be disbanded two years after the group submits its initial report.

Bill’s effect on adulteration provisions, notification requirement

The KCPA’s most controversial provisions likely pertain to “protection of kratom from current regulations.”

First, the bill would prevent HHS—and, therefore, FDA—from putting requirements on kratom that are more restrictive than the requirements for food, and dietary supplements and dietary ingredients under the Federal Food, Drug and Cosmetic Act (FDCA).

Second, the KCPA would bar FDA from treating kratom as “an adulterated dietary supplement for containing a new dietary ingredient [NDI] as described in subparagraph (B) of section 402(f)(1) … or
pursuant to subparagraph (C) of such section 402(f)(1).” These adulteration provisions in the law relate to:

FDA’s current position is that kratom is not lawfully marketed in the U.S. as a drug product, dietary supplement or as a food additive in conventional food.

“The FDA understands that there is public interest to use kratom. However, to date, there are no FDA-approved uses for kratom and the agency continues to receive concerning reports describing safety concerns with kratom, including death,” an FDA spokesperson told Natural Products Insider. “In fact, the FDA has warned consumers not to use kratom because of the risk of serious adverse events, including liver toxicity, seizures and substance use disorder.”

The KCPA, however, would further exempt kratom from a premarket notification requirement for NDIs. This requirement was incorporated in the Dietary Supplement Health and Education Act of 1994 (DSHEA) to establish the safety of novel dietary ingredients in supplements.

Since 2015, FDA has objected to all seven ingredient notifications for kratom for one or more reasons. In its responses to the notifications (see NDIs 881, 944, 992, 1063, 1126, 1220 and 1264), FDA has cited safety concerns and other considerations, including incomplete submissions that in the agency’s opinion do not meet regulatory requirements.

“The FDA has not received an NDI notification that demonstrates the ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe, and our response letters to the respective notifications have been clear on this point,” the FDA spokesperson said.

Import alert authorities

An FDA import alert (54-15) on kratom has been in effect for years, which the agency says allows it to detain without physical inspection supplements and bulk dietary ingredients that contain kratom. Relying on section 402(f)(1)(B) of the FDCA, FDA has concluded kratom-containing supplements are adulterated, or in layman’s terms unlawful, “because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.”

Kratom products that FDA determines are FDA-regulated drugs also may be subject to Import Alert 66-41, “Detention Without Physical Examination Of Unapproved New Drugs Promoted In The U.S.”

“As indicated in the import alert, the products listed are new drugs without an effective new drug application,” the FDA spokesperson explained. “With certain exceptions not applicable here, imported unapproved new drugs are subject to refusal of admission into the U.S.”

Lee’s bill would prevent FDA from issuing, implementing or enforcing an import alert for kratom—absent a determination by the HHS secretary that the kratom or kratom-derived product is adulterated based on a “history” or “evidence” of adulteration under section 402(f)(1)(A) of the FDCA.

That section of the law pertains to “a dietary supplement” or product containing “a dietary ingredient that presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use.”

The bill does not preempt any state laws around kratom.

Strong reactions to KCPA

Rend Al-Mondhiry is an attorney who advises clients on FDA regulations and an expert on DSHEA, which amended the FDCA nearly 30 years ago and generally requires premarket notifications for NDIs.

She said she “would be shocked if this bill gained traction in Congress.”

“It limits FDA’s ability to determine kratom is adulterated or issue an import alert, and I’m not aware of any dietary ingredient being subject to the type of specific exclusions this bill would create just for kratom,” Al-Mondhiry said in an email. “Given the potential safety issues with this ingredient, it doesn’t make sense to remove these guardrails.”

On the other hand, kratom supporters view the bill as a win.

“The AKA supports the regulatory scheme outlined in the proposed federal KCPA, and the efforts we have made in the 11 states that passed the state KCPAs to date,” Haddow said. “While there are some in the kratom advocacy community who want no regulations, the behavior of bad actors who routinely make illegal therapeutic claims that mislead consumers in violation of existing statutes and those who intentionally adulterate their products to provide an effect natural kratom does not provide should be subject both to regulations and prosecution. In short, any kratom advocate who says there should be no regulation on kratom is simply wrong.”

One of the law firms spearheading a growing number of wrongful death lawsuits against kratom brands—mctlaw—disagrees with the AKA, and with the overall positioning of the Federal Kratom Consumer Protection Act.

“Sadly, this bill does nothing to help people who’ve faced real problems because of kratom, including addiction, seizures, psychosis, organ failure, and the death of loved ones from kratom,” the firm proclaimed in its Oct. 30 blog.

Kratom businesses have “given up on trying to comply with the premarket safety” notification requirement” in DSHEA, and in the face of the FDA import alert, they have resorted to sneaking kratom “into the country as plant food or incense,” concluded Abolins, the mctlaw attorney.

The “only thing left for them to do,” he maintained, “is lobby Congress.”