Kratom groups are divided over California bill to regulate botanical

Josh Long, Associate editorial director, SupplySide Supplement Journal

August 15, 2024

7 Min Read

Two groups representing brands in the kratom market have clashed over a bill to regulate the botanical in the nation’s largest state economy, California.

The quarrel reflects differences over the best approach for regulating and policing the fast-growing market for kratom, derived from leaves found on trees in Southeast Asia and said to be used by tens of millions of Americans for myriad reasons including to wean off powerful opioids like heroin and fentanyl.

If replicated across the country including in the 13 states operating today under a Kratom Consumer Protection Act (KCPA), the proposed regulatory scheme in California would put manufacturers out of business, according to Mac Haddow, senior fellow on public policy with the American Kratom Association.

“Not even the federal government does this,” Haddow said in an interview, commenting on AB 2365 in California. “How could you do it in 20, 30 or 40 states?”

California Assembly Bill 2365 already passed in the state assembly and has been on hold since June after being placed on “suspense file” pending a review by the senate appropriations committee. A staff member in the California State Legislature did not immediately respond Thursday to a request for comment.

But at 4:32 PT Thursday, the Los Angeles Times reported that AB 2365 was "quietly shelved" as part of a culling of hundreds of bills on the suspense file.

Related:Kratom groups, researchers sound alarm over 7-hydroxymitragynine products

The bill authorizes the California Department of Public Health to establish an annual fee for processors, prescribes specific amounts of alkaloids present in kratom products, creates labeling and packaging requirements, and prohibits the sale of kratom leaf and associated products to those under the age of 21.

Several law enforcement agencies have expressed support for AB 2365, including the California Narcotic Officers’ Association (CNOA).

“Kratom use or sale has been banned or restricted in several states and countries, but kratom products in California remain currently legal and accessible online and in stores without any restrictions,” Ernie Collaso, president of the CNOA, wrote in an Aug. 11 letter to Anna Caballero, chair of the state senate appropriations committee in Sacramento. “AB [2365] takes an important first step in regulating this mind-altering substance by establishing maximum levels of the psychoactive substances, ensuring proper quality control and other consumer safety guidelines as well as a prohibition on the sale and marketing of kratom products to children.”

The rigor within AB 2365

Matthew Lowe is executive director of the Global Kratom Coalition, founded by JW Ross, a major player in the kratom space who owns Botanic Tonics. Lowe supports AB 2365 and doesn’t believe it is burdensome.

Related:FDA doubles down on kratom in dietary supplement products

“Do we think it’s rigorous? Yeah,” he said in an interview before the LA Times reported the bill was shelved. “It’s rigorous compared to the KCPAs. Do we think it’s onerous? No, we don’t think so.”

He argued a model of self-regulation in the kratom market is not working. Exhibit A: Lowe pointed to the proliferation of products containing concentrated amounts of 7-hydroxymitragynine (7-OH), which kratom researchers said can only be detected in negligible amounts in dried kratom leaves and binds to opioid receptors in the human body.

In an interview Wednesday, he pointed to a new product — ice cream cones — containing 70 milligrams of 7-OH. The website contains a warning that a person must be at least 21 years old to purchase the cones, though Lowe expressed concerns about the health consequences if such products get into the hands of kids.

“We need to get ahead of this because otherwise we [have] a problem,” he said.

California’s bill would limit the amount of 7-OH in a product to 1 percent of the amount of total kratom alkaloids.

A July 29 letter to Caballero from a lobbyist firm representing the American Kratom Association opposed the 1 percent limit of 7-OH and proposed 2% by dry weight.

Lowe responded that the above proposal would mark a 100-fold increase over the amount of 7-OH found in dried leaves.

“Kratom doesn’t have 7-OH at those levels,” he said. “In fact, in almost all unadulterated kratom products that are sold in the U.S. at the moment,” the amount of 7-OH is virtually undetectable.

Meanwhile, a firm representing 7-OH interests — or the Holistic Alternative Recovery Trust (HART) — urged the senate health committee in a June 20 letter to oppose AB 2365, "unless it is amended to reflect the evolving science behind the plant and its products." Rand Martin of MVM Strategy Group, a government relations consulting and advisory firm, expressed concerns that the proposed 1 percent limit of 7-OH “will sideline this emergent health and wellness alternative to opioids.”

“HART supports limiting 7-OH in California kratom products but urges the Legislature to be cautious about imposing limits that are so low that the product loses its therapeutic and anti-opioid benefits, making kratom products useless to California consumers,” Martin wrote to Caballero. “Research has already begun to show that the presence of 7-OH is crucial for pain relief effects.”

Representatives of Aaron Read & Associates LLC used essentially the same language in a letter written on behalf of the American Kratom Association.

The proposed limit of 2% by dry weight reflected a misunderstanding with the lobbyist who had been recently hired by AKA, Haddow told Natural Products Insider. AKA believes 7-OH should contain no more “than 2% of the overall fraction of the total alkaloids in the plant material used to produce the product,” he said in an email.

“If a kratom product has a level of 7-OH that exceeds 2 percent of the overall fraction of the total alkaloids/metabolites in the kratom product it shows the product contains an isolated, purified, or semi-synthetically generated form of 7-OH,” the AKA stated in an Aug. 12 consumer alert. “The AKA does not believe such products should be classified or marketed as kratom products.”

Compliance costs for kratom brands

Haddow remains opposed to AB 2365. He cited, for example, projected costs to register with the California Department of Public Health (CDPH). To oversee the kratom regulatory program, CDPH has estimated ongoing annual costs between $3.6 million and nearly $4.1 million, excluding one-time costs in 2024-2025 of $242,000 to $267,000 for staffing resources to monitor compliance, carry out investigations and analyze and compile data.

In addition, CDPH estimated IT-related costs of $1.6 million over 17 months.

An economist retained by AKA estimated that on the low end, firms would have to pay over $111,000 in the first year to register with the health department, or about $121,000 on the high end. The analysis was based on processor registration data in Utah, where the state reportedly has more than 500 registered retail outlets and 49 registered processors. Registration fees in subsequent years in California would range from over $73,000 to a high of about $83,000, according to the fiscal impact analysis.

Very few firms could afford to pay those registration fees, Haddow maintained.

“The result: Fewer choices for consumers of kratom products; significantly higher prices; the stifling of innovation; and putting many small and mid-sized kratom businesses in California out of business,” according to AKA’s consumer alert.

Haddow also told Natural Products Insider that exorbitant registration fees in California would drive kratom firms to the black market.

GKC’s Lowe countered that he anticipated changes to the projected costs, including the removal of $1.6 million in costs associated with IT requirements. He added the current bill contemplates a structure of tiered registration fees based on annual sales.

CDPH’s figure of estimated costs won’t be the “final number,” Lowe said. He nonetheless acknowledged it will be more expensive to operate the program in California — the nation’s largest economy with a population of over 39 million — compared to other states including Utah, which is among the 13 states with some version of the Kratom Consumer Protection Act.

“We would like to see this type of structure implemented in many more states” because it will preserve access to kratom while keeping consumers educated, informed and safe, Lowe said.

About the Author

Josh Long

Associate editorial director, SupplySide Supplement Journal , Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at SupplySide Supplement Journal (formerly known as 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.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

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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