Some advocates credit the supplement with getting them off opioids.

Bobby DiBernardo credits the herbal nutritional supplement kratom with taking him off heroin, oxycodone and alcohol six years back.

“It saved my life,” he said. “I could have died any day from a heroin overdose and kratom gave me a fresh lease. It helped eliminate the pain of withdrawal”

DiBernardo, 41, of Rochester, New York, nevertheless mixes a teaspoon of the herbal powder into a glass of water once or twice a day and drinks it although he says it tastes awful.

He is only one of the millions of Americans — possibly upwards of 15 million, according to estimates from the American Kratom Association (AKA) — to use kratom, a supplement made from the leaves of this Mitragyna speciosa tree native to Southeast Asia. Since at least the 19th century, the leaves are either chewed or brewed in tea by men and women in Thailand, Malaysia and Indonesia to relieve pain, ease fatigue and improve mood. Kratom is thought to act as a stimulant at lower doses and has opioid-like painkilling effects and sedative properties at higher doses.

But while the supplement has surged in popularity in the U.S., safety issues have prompted the Food and Drug Administration to warn users against kratom usage and also to crack down on companies making fraudulent health claims.

Kratom and Alcohol: Effects, Overdose Risk, and More

“We have issued a lot of warnings about the serious dangers associated with using kratom, including warnings about the contamination of kratom products with high rates of salmonella that put individuals using kratom products at risk, and led to numerous illnesses and recalls,” acting FDA Commissioner Dr. Ned Sharpless said at a June 2019 statement, when the agency issued warning letters into two firms selling kratom. “Despite our warnings, companies continue to sell this hazardous product and make bogus medical claims that are not backed by any reliable scientific proof.”

Six states — Alabama, Arkansas, Indiana, Rhode Island, Vermont and Wisconsin — and the District of Columbia have even taken the step of banning the nutritional supplement.

That’s a movement that kratom advocates, such as Lois Gilpin, 58, of Louisville, Kentucky, oppose.

Gilpin has been mixing kratom powder into her orange juice around two or three times a day for four years and says it relieves the chronic pain in her left leg and back so nicely that she could now escape bed and enjoy her family back again. “It is certainly not a fix-all,” Gilpin said. “But for it to function well enough that I’m able to pick up my granddaughter out of college and take them to the park is enormous.”

She was so impressed with kratom she started volunteering her time to coincide with the social media attempts of the AKA, a consumer advocacy group in Virginia which was founded in 2014.

Thus, is kratom all it’s cracked up to be? Or is more caution needed?

How is kratom used in the USA?

A 2016 online survey of more than 8,000 kratom users contacted primarily through the AKA discovered that many were using the product for relieving pain or treating mood disorders like depression and stress. Others employed kratom to fight withdrawal symptoms from prescription opioids or illicit drug use.

Most often, kratom was consumed as a powder mixed into a drink or in pill form, according to the survey, which was conducted by Oliver Grundmann, a clinical associate professor of medicinal chemistry at the University of Florida, also published in the journal Drug and Alcohol Dependence.

Is there solid evidence that kratom is valuable?

“To date, we don’t have clinical studies, rigorous studies as we do for drugs which the FDA requires before a drug is approved to go into the market,” Grundmann said.

That strict “gold standard” is not mandatory before dietary supplements could be marketed; rather, “what we’ve mostly are the beneficial uses that have been reported in a traditional setting in East Asia, and polls and user reports from the U.S. and Europe,” he said.

In his survey, the most commonly reported benefits of kratom were decreased pain, increased energy and better mood. The majority of respondents reported an advantage at doses up to five grams consumed to three times per day.

“I would state that we have comparatively good anecdotal emerging signs that kratom has advantages for the ordinary user as long as we think about how much kratom has been used and what products have been used,” Grundmann said.

But while there could be encouraging anecdotal reports of benefits, some experts are calling for further study.

Can Be kratom safe?

That depends on whom you ask — and opinions vary widely.

The FDA has issued a strong warning against kratom use. “FDA is concerned that kratom, which impacts the exact same opioid brain receptors as morphine, appears to have properties that expose users to the dangers of dependence, abuse and dependence,” the group states.

Kratom is an opioid. #FDA is still deeply worried that its widespread recreational use is leading to the opioid dependency catastrophe. Individuals are abusing kratom and, sometimes, are unaware that they’re using an opioid with addictive qualities

— Scott Gottlieb, M.D. (@SGottliebFDA) February 25, 2019

“There are no FDA-approved uses for kratom, and the bureau has received regarding reports about the safety of kratom,” the FDA says in a statement. “FDA is actively evaluating all available scientific advice on this issue and proceeds to warn users to not use any products labeled as containing the botanical chemical kratom or its carcinogenic chemicals, mitragynine and 7-hydroxymitragynine.”

In fact, at 2016, the Drug Enforcement Administration went as far as temporarily listing kratom as a Schedule 1 controlled substance — a classification which means it has no approved medical use and higher potential for abuse — just withdrawing the decision following a public outcry and a concentrated petition effort from advocates.

The FDA also has expressed concerns that kratom products could be contaminated with heavy metals or salmonella, which marketers are making misleading health claims.

In 2018, as an example, the supplement has been connected to a multistate outbreak of salmonella, prompting a mandatory recall from the FDA. (A specific source of this pollution was not identified, however, it might have occurred during the creation or manufacturing process.) And an April 2019 analysis of 30 different kratom products discovered traces of heavy metals, such as lead.

Over the summer, the FDA issued warning letters to two companies for selling”unapproved, misbranded kratom-containing medication products with unproven claims about their ability to cure or treat opioid dependency and withdrawal symptoms.”

It’s that illusion that it is a plant so it’s going to be OK.

Dr. Paul Earley, an addiction medicine specialist in Atlanta and president of the American Society of Addiction Medicine, stated that he treats patients dependent on kratom, including a recent patient who was in recovery from opioid abuse when he changed to kratom believing it was safe. That individual afterwards had to be hospitalized for kratom dependence.

“It is that illusion it is a plant, so it’s definitely going to be OK, it is milder than heroin — and yes that is true — but it’s not a safe compound,” Earley told NBC News.

“Kratom does create a physical dependence, and individuals who are vulnerable to addiction especially ought to stay away from it because it’s going to tickle that same portion of the mind that opioids do,” he added.

Two reports this year linked kratom use to different adverse effects, even death.

One research from the journal Clinical Toxicology found that between 2011 and 2017, more than 1,800 calls between kratom were put to U.S. poison control centers. The most frequent complaints were agitation/irritability and quick heartbeat, followed by nausea, drowsiness, vomiting, confusion and higher blood pressure. But there were also several reports of severe complications such as seizures, respiratory problems, coma and, in 11 cases, deaths. Nine of those deaths involved other drugs such as cocaine, fentanyl and alcohol, but 2 instances were imputed to kratom only.

Another report, from the Centers for Disease Control and Prevention, looked at more than 27,000 medication overdoses entered into a multistate connection between July 2016 and December 2017 and discovered that 91 Americans died from overdoses involving kratom. Most of the cases involved multidrug usage, including fentanyl, heroin and benzodiazepines. But in seven instances, kratom was that the only chemical revealed in post-mortem testing. The investigators, however, noted that “the presence of further substances cannot be ruled out.”

Critics say these types of reports are tough to draw business cause-and-effect conclusions from as other contributing factors might be in play.

The AKA maintains there have been no deaths directly resulting from kratom products that are unadulterated and have not been used in conjunction with other medications. “Kratom has been widely used for centuries in Southeast Asia where there are no deaths connected to the pure kratom consumption,” Mac Haddow, the AKA’s senior fellow on public policy, stated. “From the U.S., there are no deaths that are linked to pure kratom consumption.”

What is ahead for kratom?
While some health professionals support a kratom ban, others say regulation would be a better path.

Dr. Peter Grinspoon, a primary care physician and teacher at Harvard Medical School, said prohibiting kratom would leave many chronic pain sufferers without an alternative they could be relying on should they would like to avoid prescription opioids or cannot get them out of their doctor.

However, Grinspoon recommends his patients prevent kratom because of the lack of regulation.

“If you buy kratom you do not know what you’re getting,” he said. “Are you really getting a gram of kratom or are you getting a gram of whatever is in the capsules at the powder they’re calling kratom? There is no oversight of this growth, manufacturing, packaging, sales or distribution of kratom.”