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June 18, 2020
Four lawmakers from Arizona, Georgia, Utah and Nevada who sponsored kratom legislation in their states have requested a meeting with the top official of FDA—an agency that has long raised concerns about the safety of the botanical from Southeast Asia.
Positions held by FDA related to kratom and another botanical ingredient—CBD—were adopted long before Dr. Stephen Hahn was appointed commissioner, the lawmakers wrote to Hahn in a June 8 letter.
“The realities of the marketplace where kratom is and will continue to be used by the American public requires us to act reasonably and responsibly,” wrote Arizona Rep. Tony Rivero (R-Peoria), Georgia Rep. Vernon Jones (D-Lithonia), Nevada Assemblyman Jim Wheeler (R-Douglas) and Utah Sen. Curtis Bramble (R-Provo).
The lawmakers suggested they wanted to review with FDA officials the “current science” on kratom and “a realistic view” of the market in support of a “responsible regulatory scheme” rather than FDA’s current stance. None of them immediately responded to requests for an interview.
An FDA spokesman, Nathan Arnold, declined to comment on the letter to Hahn.
Asked about the agency’s current position on kratom, Arnold pointed to an FDA webpage that continues to warn consumers not to use the botanical, also known as Mitragyna speciosa, or “its psychoactive compounds, mitragynine and 7-hydroxymitragynine.”
“FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse and dependence,” the agency explains on the page. “There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom.”
An import alert for kratom products that was issued in 2019 remains current. The alert identifies several firms and their products subject to detention without physical examination—with the targets of the “red list” based in Canada, Indonesia, Malaysia, Philippines and the United States. Another import alert also applies to kratom.
Based on "publicly available information" regarding the botanical, "there does not appear to be a history of use or other evidence of safety establishing that kratom will reasonably be expected to be safe as a dietary ingredient," FDA stated in one of the import alerts. "In fact, the scientific literature disclosed serious concerns regarding the toxicity of kratom in multiple organ systems."
In 2016, in the wake of pressure from Congress and the American public, the Drug Enforcement Administration (DEA) withdrew its notice of intent to temporarily place the main constituents of kratom into schedule I under the Controlled Substances Act.
In the letter to Hahn, the lawmakers stated his comments on CBD reflect their conclusions about kratom. Although FDA has maintained CBD cannot be lawfully sold in dietary supplements or conventional food, Hahn has acknowledged consumers perceive value in CBD and his agency wants to provide them information “to help them make the right decisions.”
During a February 2020 conference in Washington, D.C., the commissioner described as a “fool’s game” any attempt to keep CBD products from the American people. “We’re not going to be able to say, ‘You can’t use these products,’” he said. “Even if you did, it’s a fool’s game to even try to approach that.”
If Hahn reviewed the kratom marketplace, “you would agree the same principle applies to kratom consumers,” lawmakers wrote to him. “There are between 10 and 15 million kratom consumers in the United States today, and demand is growing rapidly every year.”
Due to its “low rate for adverse events,” according to the letter, consumers prefer the botanical over “conventional medicines” and “to help them abstain from the use of other more harmful substances." Kratom advocates have warned that banning the substance could exacerbate, rather than mitigate, the opioid epidemic by depriving consumers of a safe alternative to addictive and dangerous drugs.
Bramble, Jones, Rivero and Wheeler were principal sponsors of versions of the Kratom Consumer Protection Act (KCPA) incorporated into law in Arizona (May 2019), Georgia (April 2019), Utah (March 2019) and Nevada (June 2019), according to their letter. They stated their motivations for sponsoring the legislation was to give consumers information so they could “make informed decisions,” and they wanted to ensure products are accurately labeled and properly manufactured.
“We believe we started that process with our state legislation, and we hope you will lead the FDA into the same position,” the lawmakers wrote to Hahn.
Several states that proposed bans on kratom have withdrawn legislation, or the bills have died or been replaced with other alternatives, including the KCPA, they said.
The provisions of the KCPA in Arizona, Georgia, Utah and Nevada are not identical, though they all bar the sale of kratom products to minors and have certain disclosure requirements. In Utah, home to many dietary supplement companies, the law requires registration with the state’s Department of Agriculture and Food, and it’s among the states that create a private right of action for violating the statute. In Nevada, Assembly Bill 303 establishes a civil penalty of $1,000 for violating certain provisions.
In Arizona, violations of the law—including selling a kratom product containing any synthetic alkaloid—are a Class 2 misdemeanor. Such restrictions don’t apply in Georgia, where synthetic material containing mitragynine or 7-mitragynine meets the definition of a kratom product.
Had the coronavirus not disrupted legislative sessions, Bramble, Jones, Rivero and Wheeler advised Hahn they believed more than a dozen proposals for kratom legislation in other states would have become law. Among other actions, they cited the passage of KCPA versions in the Missouri House of Representatives, Oklahoma House of Representatives, Oregon House of Representatives and New Hampshire Senate.
“In summary,” the lawmakers wrote to Hahn, “to paraphrase the view we share with you about the realities of consumer’s impact on the marketplace: ‘We’re not going to be able to say you can’t use kratom products. It’s a fool’s game to try to even approach that.’”
Daniel Fabricant, Ph.D., a former FDA official who leads the Natural Products Association (NPA), worked as director of the then-Division of Dietary Supplement Programs when FDA first issued an import bulletin on kratom in 2013 and an import alert in 2014. In an email, he suggested the letter to Hahn reflects the confusion created from FDA inaction on CBD now “carrying over to other areas, especially ‘new’ botanicals, which the state legislators make the case for here—the ‘similarity’ between kratom and CBD.”
On the one hand, he added in a follow-up interview, FDA says CBD is illegal in supplements. But on the other hand, “They go, ‘Well, it’d be silly for us to try to take it away.’” Consequently, the kratom advocates think “that seems to apply to us,” Fabricant said.
C.M. (“Mac”) Haddow, senior fellow on public policy with the American Kratom Association, argued FDA is abdicating its responsibilities to protect consumers.
The agency’s chief responsibility is to “protect the safety of the American people, and today the FDA is the primary obstacle in doing that mission of protecting the safety because they refuse to regulate adulterated kratom products," he said in an interview. “Every time you hear of an adverse event or of a death that is associated with kratom, a large number of those are directly because of adulterated products. And that’s attributable to the failure of the FDA to regulate these products correctly."
Consequently, kratom advocates have "turned to the states for help to protect American consumers, making sure we have safe, unadulterated products available for them," Haddow added.
Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition
Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.
Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.
Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.
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