- The Washington Times
Wednesday, March 14, 2018

A multi-state outbreak of salmonella has intensified focus on an herbal supplement that has drawn the support of thousands of users and the ire of federal authorities.

At least 27 states have reported salmonella cases involving kratom, an herbal powder that is popular as a stimulant and a sedative, usually consumed raw or in tea.

Since Feb. 20, federal agencies and state health departments have been investigating the salmonella outbreak, in which at least 17 of 40 infected people acknowledging kratom use within the past week before their illness. At least two samples of kratom collected from ill people tested positive for salmonella — one in North Dakota and one in Utah.

In California, kratom products from PDX Aromatics, a wholesaler based in Portland, Oregon, tested positive for the strain of salmonella most prevalent in the outbreak.

Over the weekend, PDX Aromatics issued a recall for 10,000 units of three products that contain kratom, which is made from the leaves of the tree Mitragyna speciosa, native to Southeast Asia.

Kratom users say it is an all-natural remedy providing energy and pain relief, and can help manage opioid withdrawal.

The National Center for Complementary and Integrative Health notes that some people have used it as an opium substitute.

Federal authorities, however, have expressed concern that the unregulated botanical supplement has a high potential for addiction, abuse and dependency. At least two of its compounds — mitragynine and 7-hydroxymitragynine — are known to activate opioid receptors in the brain.

The Food and Drug Administration has had kratom on an import alert since 2012, when authorities noted that companies marketing the substance as a dietary supplement were making misleading statements about its safety and efficacy, as reports about poisonings and deaths increased.

“Kratom is not a safe, benign plant,” FDA Commissioner Dr. Scott Gottlieb said Feb. 26.

In 2016, the Centers for Disease Control and Prevention reported that calls about kratom to poison control centers had increased from 20 in 2010 to 263 in 2015.

The FDA says it is aware of 44 deaths in which kratom was found in dead persons’ bodies.

“At a time when we face an opioid epidemic of devastating proportions, manufacturers should not be allowed to mislead consumers into believing kratom products are a ‘safe’ alternative to prescription opioids or that kratom is effective therapy for opioid use disorder,” Dr. Gottlieb said.

In 2014, the FDA confiscated about 25,000 pounds of raw kratom worth about $5 million in California. In 2016, the agency seized 90,000 bottles worth $400,000 and, in another instance that year, 100 cases worth $150,000.

But authorities say their limited resources and staffing — and subversive efforts by importers — have allowed the product to continue to be readily available in the U.S., either online or in specialty shops.

There are no accurate numbers on kratom users in the U.S., although media reports have put that number between 3 million and 5 million.

Kratom is illegal in Wisconsin, Arkansas, Tennessee, Alabama, Indiana, Vermont and Rhode Island, according to advocacy groups.

It also is banned in Denver; San Diego County, California; Jerseyville, Illinois; Union County, Mississippi; and Sarasota County, Florida.

Minnesota, Kansas, Illinois, Mississippi, West Virginia, New Jersey and New York have pending legislation on the substance.

Consumers can spend anywhere between $5 and $30 for an ounce of kratom powder, with sellers recommending ingesting about half a teaspoon per use. A small dose can increase energy while larger doses can lull the user into a state of relaxation.

The National Institute on Drug Abuse lists a number of adverse effects associated with kratom, including nausea, itching, sweating, constipation, increased urination, loss of appetite, among others. The agency describes it as “like other opioid drugs” with the potential for addiction and dependence and symptoms of withdrawal — including muscle aches, insomnia, irritability, aggression, to name a few.

The debate around kratom reached a fever pitch in 2016, when the Drug Enforcement Administration sought to emergency classify mitragynine and 7-hydroxymitragynine as Schedule I drugs — in effect banning kratom and putting it in the same category as heroine, ecstasy, LSD and marijuana, which are defined as having no potential for medical use.

Yet a public outcry halted the agency’s immediate efforts. This included at least 23,000 calls and postings to the agency about kratom, a petition with over 142,000 signatures, demonstrations and support from members of Congress.

“I think that the feedback response, the amount of it was probably unprecedented,” said DEA spokesman Melvin Patterson. “I can’t think of another substance that that many people responded to.”

“We usually emergency schedule when people are dying really quickly,” Mr. Patterson said.

“There were people calling saying, ‘This is a terrible drug,’ but more people saying they were self-treating [with it].”

One of the key differences of kratom compared to other opioids is that it doesn’t promote respiratory depression, said Dr. Oliver Grundmann, a clinical associate professor at the College of Pharmacy at the University of Florida. Drug overdoses from opioids, heroin and fentanyl continue to reach all time highs in the U.S., with the drugs stopping a person from breathing and in the lucky cases, the are revived with narcan or naloxone.

In 2016, Dr. Grundmann approached the advocacy group the American Kratom Association to distribute a survey to its members to get a better idea of why people use the supplement. Within two weeks he had received 10,000 responses.

“Which indicate to me that there was a significant rate of participation and interest by kratom users,” he said.

The majority of respondents said they use the herb to treat either acute or chronic pain, or for a mental or emotional condition such as anxiety or depression. A few respondents said they use the herb to mitigate withdrawal symptoms from an opioid addiction, “and that’s the primary concern that the FDA and other regulatory agencies have with kratom,” Dr. Grundmann said.

Recently, the DEA has received an eight-factor scientific review compiled by the FDA on the safety concerns and if there’s reason to believe it could have a medical benefit, which they are taking into consideration with public comments before deciding on how to regulate the substance.

Dr. Grundmann said that while he and other researchers agree with the FDA that safety of consumers and patients is of the highest importance, he’s concerned that declaring kratom a schedule I drug will seriously limit opportunities for research.

“If we keep research up and going on these substances and potentially bring new kratom-light substance or mitragynine-light substance to the market in some years, then we might have a better substitute for pain treatment than what’s available.”

CORRECTION: An earlier version of this article said that kratom is illegal in Washington D.C. This is not the case. A spokesman for the Metropolitan Police Department said the substance is not banned federally or in D.C.

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