5 ways to make the kratom marketplace safer

The Tampa Bay Times found that hundreds of people in Florida have died while using kratom during the past decade. Most of the fatalities involved a lethal mixture of substances, but medical examiners attributed dozens of overdoses to kratom alone.

Companies have sold kratom with little information about how to safely use the herb or about potential risks. Products often lack dosing instructions or a list of ingredients. Some have no label at all — leaving consumers on their own to navigate the safety of the substance, which can produce opioidlike effects.

The products, the Times found, are made through a secretive supply chain, where importers and manufacturers have taken steps to evade regulators and avoid detection.

Federal and state officials have repeatedly recommended banning kratom, but in the absence of prohibition, have left the substance virtually unregulated, with potent options widely available. Lawmakers in Florida and across the country have been swayed by industry-backed lobbyists for the American Kratom Association, who’ve crafted legislation that primarily preserves the right to buy and sell kratom. The bills do little to create safety standards for businesses and those who take it.

After the Times published its first piece, Mac Haddow, the chief lobbyist for the kratom association, acknowledged in a news release that the organization could do more for consumer safety. The group said it would add a new labeling component to its good manufacturing certification program starting in January.

Scientists see therapeutic promise in kratom. University of Florida kratom researcher Oliver Grundmann told the Times in an email that “if kratom products are adequately labeled, have dosing and warning instructions on them, and are regulated as such, these products can benefit consumers and patients alike.”

He and other researchers surveyed and interviewed by the Times believe the substance shouldn’t be banned but say there are many steps regulators and lawmakers could take to make the industry safer.

Here are five big ones.

1. Limit the potency of kratom products

In Florida, there are no laws limiting the strength of kratom products. That’s left highly potent options widely available to purchase online or in smoke shops or gas stations across the state.

The products that worry kratom scientists the most are concentrated extracts. Such products — often found in liquid or pill form — are far stronger than dried kratom powders, researchers say.

“Of great concern from a public health perspective, commercial kratom extract products lack data regarding their safety, efficacy and abuse potential,” seven kratom researchers wrote in a letter published in the journal Addiction earlier this year.

Four researchers surveyed by the Times said lawmakers should limit the amount of mitragynine, kratom’s main chemical compound affecting strength, allowed in products. The compound is typically the most abundant alkaloid in kratom shots, capsules and powders.

“There is no meaning of any bill until they control the total dose available for human consumption,” University of Florida kratom researcher Abhisheak Sharma wrote in an email to the Times.

Despite researchers’ concerns, the American Kratom Association has defended the safety of such products. In an effort to change kratom legislation around the country, the association has promoted dozens of bills that do nothing to limit the mitragynine content in kratom products. Such bills have passed in some form in 11 states, including Florida.

The Times was able to purchase several products that experts worry are dangerous.

One liquid shot analyzed by the Times packed more than 367 milligrams of mitragynine into 1 ounce. That product is sold by MIT45, a retailer that the kratom association lists as a “Kratom Consumer Champion.” The consumer champion title is earned in part by donating to the association.

In December, Republican lawmakers in Florida’s House and Senate introduced new legislation backed by the association. Like the other association-promoted bills, it doesn’t limit the strength of products by capping mitragynine levels.

Most of the association-backed bills — including the Senate’s version of the new Florida legislation — do propose limits to the intensity of kratom products by restricting the amount of a different alkaloid, 7-hydroxymitragynine. This potent alkaloid is closer to a traditional opioid than its cousin, mitragynine.

But researchers consulted by the Times said the association’s bills still allow for too much 7-hydroxymitragynine to be present in kratom products. One proposed lowering the association’s limit by as much as 96%.

In response, the association’s chief lobbyist, Haddow, said his group bases its legislation on scientific studies, not the opinions of individual researchers.

Florida’s current law contains no such limits on 7-hydroxymitragynine. The Times was able to purchase a pack of supercharged pills online, containing high levels of the alkaloid, that Sharma compared to “legal morphine.”

2. Warn consumers about the potential danger of mixing kratom with other substances

Research indicates that mixing kratom with certain substances could be harmful.

Kratom can slow enzymes that break down various medications and illicit drugs as they make their way through the body. This could cause the substances to build up in the bloodstream and reach toxic levels. Medical examiners have attributed more than 30 overdoses in Florida to a lethal mixture that included kratom and at least one drug used to treat anxiety or depression. And experts say combining kratom with opioids like fentanyl could add to the dangers of the potent painkillers.

Legislation regulating kratom should require more robust warning labels on products, including language about potential drug interactions, six researchers told the Times. One suggested that kratom products should come with a label clarifying that kratom is intended only for healthy adults who have no preexisting health conditions and do not take medications.

The association has acknowledged the risk of consuming kratom with more dangerous substances. Most of its bills introduced across the country ban kratom laced with illegal drugs, including the new Senate legislation in Florida. But it’s already a crime in every state to sell products tainted by illicit drugs.

Just one of 34 association-backed bills analyzed by the Times required companies to warn of potentially harmful drug interactions.

3. Establish enforcement mechanisms for kratom regulations

Regulations are of little use without an explicit way to enforce them, experts said. One researcher who said he was “very supportive” of the association’s bills worried that they lacked meaningful enforcement mechanisms.

Earlier this year, when Florida lawmakers were negotiating the passage of a bill that banned selling kratom to those younger than 21, there was a debate about the cost of more stringent regulations. Legislators floated a product registration system for kratom — an association-backed idea that has taken effect in a few states.

The Florida Department of Agriculture and Consumer Services estimated that implementing, enforcing and monitoring such a product registry would require 19 full-time employees, including 13 inspectors to visit places that sell kratom and verify that products meet state requirements. The department estimated it would’ve cost about $2 million per year.

Rather than fighting for its regulations, the kratom association fought the cost estimate, arguing that fewer employees could perform the regulatory tasks.

C. Michael White, a pharmacologist at the University of Connecticut, suggested that kratom growers, manufacturers and retailers should have to register their products, and should be subject to inspections and audits of their manufacturing processes. He also said products should be tested for contaminants by independent labs to help ensure good manufacturing practices.

White called the lack of enforcement mechanisms in most kratom legislation “a major weakness.”

4. Require kratom manufacturers to follow good manufacturing rules

The FDA is in charge of making sure companies comply with federal rules for food and dietary supplement manufacturing. But in many cases, these rules are not being enforced when it comes to kratom, experts said.

The rules require companies to use clean, consistent and safe methods while making their products to limit the chance of contamination and to standardize quality. Companies that make or hold dietary supplements have to register with the agency.

“FDA needs to have oversight over kratom products in the same manner as other supplements,” wrote Grundmann, the University of Florida kratom researcher, in an email to the Times. “Kratom should be classified as a dietary/herbal supplement which comes with multiple legal requirements.”

Sharma, the other University of Florida kratom researcher, told the Times that the FDA should enforce drug manufacturing rules — not supplement rules — on companies that make highly concentrated kratom products.

Not a conventional food nor an approved drug, kratom doesn’t neatly fit into any regulatory category at the federal level — which has created holes in enforcement. Part of that has to do with industry-friendly laws for dietary supplements, which are largely built around the FDA responding to harmful products instead of proactively preventing their sale.

In 2018, in the wake of a salmonella outbreak linked to dozens of kratom products, the agency sent a warning letter to a Utah-based kratom supplement maker, Avalon Packaging. It warned that the company had fallen short of federal rules for making supplements. For example, the company had no written procedures in key quality control areas, the agency found.

In 2020, the FDA inspected Avalon again, and found half a dozen additional violations, a federal database shows.

But there’s little evidence the FDA is taking regular actions like these to police the kratom industry, experts said.

5. Crack down on kratom being marketed as a drug

Kratom companies aren’t allowed to make medical claims about their products because the herb is not an approved drug. But vendors routinely do so.

“Unsubstantiated medical claims are both detrimental to consumers and paint a picture of kratom that is not supported by science,” Grundmann, the University of Florida researcher, said in an email.

Times reporters did not have to look hard to find such products. A shop in St. Petersburg, Botava.life, was handing out flyers that touted kratom as being able to treat a range of ailments, from anxiety to opioid withdrawal. (When the Times asked about the claims, the store’s owner said the business would stop making them.) One product, KTAB by Phoria, purchased by the Times online, advertised “pain relief + mood enhancement” on its packaging.

Companies aren’t allowed to promote the medical benefits of a product until they’ve gone through the FDA’s extensive drug approval process.

The FDA has sent 16 letters to companies warning them against making these kinds of claims.

The kratom association says it has reported dozens of kratom companies to the FDA for making medical claims. When asked for these reports, the association declined to share them.

Haddow, the association lobbyist, recently told CBS News that the industry has about 8,000 players. When asked how many are legitimate, he responded: “I would say three dozen, maybe a few more than that.”