Kratom, an herbal substance that can have opioid-like effects, is widely available and unregulated in Ohio, but an industry-backed bill that’s halfway through the General Assembly could set standards for the substance.
The Kratom Consumer Protection Act aims to guarantee the purity of the greenish-brown powder sold in stores throughout Southwest Ohio and prevent regulators from treating it as a drug.
Economists estimate kratom is a $1.3 billion industry in the U.S. and growing, according to Mac Haddow, senior fellow on public policy for the American Kratom Association. Up to 10 million Americans use kratom for some purpose, said state Rep. Scott Lipps, R-Franklin, co-sponsor of the bill to regulate the substance. One researcher estimates 300,000 Ohioans use it.
Research remains thin on kratom, but health authorities have urged against its use and linked it to multiple deaths over the past few years, as well as seizures, liver damage, withdrawal symptoms and respiratory depression. Several states and cities have banned it.
Proponents say it’s safe and helpful when taken properly.
What all sides seem to agree on is that contaminants in what buyers thought was pure kratom are a major concern — and that’s what the act, introduced as House Bill 236, aims to address.
“They have some bad actors in that industry who are adulterating the product,” said Lipps, also chair of the House Health Committee..
The full House passed the bill 82-9 on Feb. 9, sending it to the Senate.
In a committee hearing, Lipps said it’s unusual for him to seek additional regulations. But two factions requested rules for kratom: manufacturers and users. The Ohio Board of Pharmacy is looking to legislators for direction before considering its own restrictions, he said.
Former state Rep. Gary Scherer, now a Pickaway County commissioner, introduced the Kratom Consumer Protection Act in a previous legislative session. But Lipps said it was delayed for six months so House Health Committee members could tour a kratom processing facility in Columbus and meet with customers.
The bill is backed by the American Kratom Association, the industry’s main lobbying organization. Arizona, Georgia, Nevada and Utah have already adopted similar legislation.
What is kratom, and who uses it?
Kratom is made from the dried leaves of a southeast Asian bush, mitragyna speciosa. Kratom is not cultivated in the U.S. but is processed here, said bill co-sponsor state Rep. Mark Fraizer, R-Newark.
In small doses kratom has a stimulant effect, like caffeine. In larger amounts, however, it has an opioid-like effect.
A 2018 report from the Ohio Substance Abuse Monitoring Network found about 70% of users in the Akron-Canton area injected kratom, and 30% would take it orally, such as in tea.
Jack Henningfield, an adjunct professor of behavioral biology at the Johns Hopkins School of Medicine and vice president of a research firm working on behalf of the kratom association, told legislators about 300,000 Ohioans use kratom. That’s about one Ohio resident in 40.
The average age of kratom users is 30 to 55, Henningfield said.
People use kratom for a variety of conditions, he said, but perhaps a third of them use it to get off opioids. Another third use it to reduce anxiety, according to Haddow.
What would the bill do?
The Kratom Consumer Protection Act would guard against “unscrupulous vendors” who add things to kratom, David Carlucci, senior adviser on external affairs for the American Kratom Association, told legislators.
The bill would formally declare that kratom is not a drug, and prohibit the State Board of Pharmacy from listing it as a controlled substance.
Instead, it would require the Ohio Department of Agriculture to:
- Set standards for kratom processing.
- Monitor and regulate processing.
- Create a mandatory license for processors.
- Establish criminal penalties for violators.
- Inspect any place kratom is processed, distributed or sold.
What do sellers and users say?
Rabi Ahmed lays out bags of powdered kratom on the counter of Smokers Plus Vapes in Dayton: $7 for a 25-gram bag, $10 for 50 grams, $18 for 100 grams, or 75 single-dose capsules for $19.
Kratom, though a fraction of the store’s merchandise, now accounts for 40-48% of Smokers Plus Vapes’ business, he said.
Ahmed is a partner in the family business on Wilmington Avenue, where kratom is sold alongside tobacco, CBD and hemp products, snacks and drinks.
Smokers Plus Vapes has sold kratom for seven of the store’s nine years in business. While it’s been available in major cities for a decade, Ahmed said, Smokers Plus Vapes may well have been among the first to sell kratom in Dayton.
“We use it back in India,” and have for decades, he said.
Ahmed said his customers use kratom for extra energy and pain relief, replacing coffee or opioids. But he believes its greatest benefit is for blood circulation.
“We never find anything wrong with this product,” he said. “My mom uses it, my dad uses it.”
Ahmed cautions that a single dose should be 3 to 6 grams maximum, with no more than 6 grams in a three-hour period.
Taking more than that risks vomiting, he said. Ahmed recalled one customer who planned to fly but knew he couldn’t ingest kratom during the flight. So he took four doses before boarding the plane — and got sick.
“Lost his flight and everything,” Ahmed said.
Ahmed recommends people research kratom before trying it. He hopes any legislation or regulation includes an educational component, telling people how to use it properly.
Smokers Plus Vapes imports its own kratom directly from a known source, Ahmed said. It’s packaged in the United States, but arrives already processed, he said.
“We do not buy from third parties,” Ahmed said.
This week Ahmed sold a bag of kratom to a regular customer named John, who didn’t want to give his full name. He said he buys it once or twice a week and uses it for chronic back pain. He said he’s never had problems from kratom, which he has taken for about a year.
John said he takes kratom to wean himself from opioids, and that it’s helped.
“I was eating pain pills like Skittles prior to using kratom,” he said.
The Ohio Board of Pharmacy analyzed kratom on eight criteria, including its potential for abuse and the state of scientific knowledge of the substance. The board found kratom users can build up tolerance and experience withdrawal symptoms. It cited the FDA’s conclusion that “we feel confident in calling compounds found in kratom opioids.”
A 2014 study found that more than half of regular users developed severe dependence, both physical and psychological, the board of pharmacy report said. In Ohio, it cited three cases of withdrawal symptoms and one case of liver damage suspected to stem from overuse of kratom.
In 2017, the FDA identified at least 44 deaths related to kratom. All but one of those involved kratom that had been adulterated, or was taken with other potent substances. Deaths also were reported from kratom packaged as dietary supplements or dietary ingredients and laced with other compounds.
“According to FDA, mixing kratom with other opioids is a serious concern because the activity of kratom at opioid receptors has similar risks to combining FDA-approved opioids,” the board of pharmacy report said. “Additionally, the agency found that there may be serious side effects associated with kratom, including seizures, liver damage, withdrawal symptoms and respiratory depression.”
The National Institute on Drug Abuse, in April 2019, cited earlier research that between 2011 and 2017, 11 deaths were associated with kratom, including two involving kratom alone. The rest involved other drugs, such as antihistamines, alcohol, caffeine, tranquilizers, fentanyl and cocaine.
In Ohio, between 2016 and 2018, the Ohio Department of Health found 15 unintentional drug overdose deaths in which kratom was mentioned on the death certificate.
In 2018, the FDA ordered a recall of kratom products from one Las Vegas firm, after 199 people were infected with salmonella in 41 states. About 75 were hospitalized, but no deaths were reported.
In November 2018 the FDA tested 26 kratom products and found unsafe levels of heavy metals, including lead and nickel. The agency repeated those results with 30 products in April 2019.
Based on the data it examined, the board of pharmacy concluded kratom has a high potential for abuse, has no accepted medical use, lacks safety for use under medical supervision and poses a public health risk.
Bans and regulation
Kratom has been banned by Alabama, Arkansas, Indiana, Vermont, Rhode Island, Wisconsin, the District of Columbia and several major cities.
In 2016 the U.S. Drug Enforcement Administration considered listing kratom as a Schedule 1 substance, the same as heroin or LSD. That means a drug has a high potential for abuse, has no accepted medical use in the state, and lacks safety standards for use under medical supervision. But the agency backed down after getting thousands of public comments in favor of kratom.
The FDA issued an advisory in 2017 urging consumers not to use kratom or any compounds in the plant. In September 2018, then-FDA Commissioner Scott Gottlieb said in a warning letter that the agency continues to find marketers selling kratom with unsubstantiated claims.
In 2019 the Ohio Board of Pharmacy also considered dubbing kratom a Schedule 1 drug. One of the board’s primary concerns was adulteration of kratom with other substances, including heavy metals, said Cameron McNamee, the board’s director of policy and communications.
But like the DEA, it got thousands of public comments favoring kratom. The American Kratom Association opposed the drug designation.
“After several rounds of public testimony in strong support of keeping Kratom legal, the board decided to place the rule banning the substance on hold to allow for the General Assembly to determine whether regulation was the preferred route,” McNamee said.
The Ohio Board of Pharmacy can’t regulate kratom testing and labeling via administrative rule, he said. That authority lies with legislators.
House Bill 236 would put regulation of kratom under the Ohio Department of Agriculture, not the Board of Pharmacy, McNamee said. The board doesn’t have an official position on the bill.