By Pat Anson, Editor

The Centers for Disease Control and Prevention says a dozen more people have been sickened by a Salmonella outbreak linked to the herbal supplement kratom – raising to 40 the number of suspected cases. The number of states where the illnesses have been reported rose from 20 to 27.

For the first time, investigators have also found Salmonella bacteria linked to the outbreak in kratom powder samples in North Dakota and Utah.

“The outbreak strain of Salmonella was identified in both samples. The ill person in North Dakota purchased S.K. Herbalist brand kratom powder from the website soapkorner.com. The ill person in Utah purchased kratom powder from the website kratoma.com,” the CDC said in a statement.

“Despite the information collected to date about where ill people purchased kratom, a single common brand or supplier of kratom has not been linked to the outbreak. At this time, CDC recommends that people not consume kratom in any form because it could be contaminated with Salmonella and could make people sick.”

State and local health officials have interviewed 24 people sickened by Salmonella, asking them about food and other substances they were exposed to before they became ill.

Seventeen of the 24 reported consuming kratom in pills, powder, or tea. Three said they purchased kratom from retail locations and 10 said they bought kratom online.

Illnesses from the Salmonella outbreak began last October, with the most recent case reported on February 13. Fourteen people have been hospitalized. No deaths have been reported.

Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Salmonella causes an estimated one million food-borne illnesses a year in the United States, with 19,000 hospitalizations and 380 deaths.

It generally takes about two to four weeks before a person infected with Salmonella is reported, so its possible there could be more than 40 cases in the current outbreak. 

Kratom comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries for its medicinal properties. In recent years, millions of Americans have started using kratom to treat chronic pain, depression, anxiety and addiction, conceivably costing the pharmaceutical industry billions of dollars in lost revenue.

FDA Warns Utah Company

In a move apparently unrelated to the Salmonella outbreak, the Food and Drug Administration warned a Utah company this week not to launch a new dietary supplement that is based on mitragynine -- one of the alkaloids found in kratom.

The FDA said Industrial Chemicals was using “inaccurate and misleading statements” on its website to promote Mitrasafe. Among other things, the company said that Mitrasafe was “fully compliant with all FDA laws and rules.”  

“Today, we notified a company making claims for a compound in kratom that its product is an unapproved new drug and an adulterated dietary supplement,” FDA commissioner Scott Gottlieb, MD, said in a statement.

“The company is claiming that its product is a ‘natural substitute for opium,’ that it has ‘morphine-like effects,’ and that it can help relieve pain along with a litany of other ailments. Just as troubling, this company promotes kratom as effective in ‘curing addiction’ and treating ‘withdrawal symptoms.’ These unlawful practices not only mislead consumers, but can also prevent people suffering from addiction from seeking effective treatments.”

Industrial Chemicals planned to start selling Mitrasafe on February 28. A spokesman for the company said the launch date has been postponed while it appeals the FDA decision.

“We did not make any drug claims. On the contrary. We did not claim that Mitrasafe itself could do these things or have opium like qualities at all. We never even came close,” said attorney John VanOphem. “The FDA wants to be taken seriously on this stuff? I’m sorry, they haven’t followed their own guidance. This is alarming to me. To have us become the whipping boy poster child on this is just outrageous."

VanOphem told PNN the company has spent years trying to work with the FDA to get Mitrasafe approved.

“The FDA has done nothing to prove that they’re actually interested in addressing the substance of this. They’re just not credible and it’s a shame,” said VanOphem. “All they intend to do is ban kratom, period. There’s no other option for them. They’ve never acknowledged any other option.”  

Unlike pharmaceutical drugs, dietary supplements like kratom are -- for the most part -- loosely regulated by the FDA. But in recent months the agency has launched an unprecedented public campaign to discourage people from using kratom.

In November, the FDA released a public health advisory warning about kratom's potential health risks, especially when used to treat opioid addiction. Last month the agency released a computer analysis that alleged kratom contains over two dozen opioid-like substances that share structural similarities to painkillers such as morphine.

“Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use. And claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous,”  Gottlieb said in a statement.

In 2016, the Drug Enforcement Administration attempted to ban kratom by scheduling it as an illegal controlled substance, but a public outcry and lobbying campaign forced the DEA to suspend its scheduling decision. Many kratom supporters fear that another attempt to ban kratom is imminent.

“We’re in for a fight,” said David Herman, president of the American Kratom Association, a pro-kratom consumer group. “There’s no question they want to ban it.”