The Food and Drug Administration took the unusual step Tuesday of ordering a mandatory recall for a kratom supplier that the agency said has failed to take responsibility for possible salmonella contamination in its products, in an outbreak that has sickened dozens of people.
The FDA said kratom products distributed by Triangle Pharmanaturals LLC of Las Vegas, Nevada, tested positive for salmonella.
“The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall,” the FDA said in a statement.
Kratom is either ingested dry as a powder or mixed with water as a tea, and proponents of it say it acts as an relaxing cup of coffee. Smaller doses of the plant can act as a stimulant while larger doses have a sedative effect.
Federal agencies identify the drug, which is derived from the leaves of the Mitragyna speciosa tree, which is native to Southeast Asia, as an opioid with a potential for addiction and negative health effects.
However, passionate advocates of the herb say it is a natural pain-reliever and has even helped in treating withdrawal symptoms associated with opioid withdrawal.
Kratom is not federally illegal although some states have laws against the sale of the product. The FDA has kratom on an import alert and directs its agents to seize the product at customs and border control.
Since the end of February, the Centers for Disease Control and Prevention was investigating a salmonella outbreak that was soon found to be linked to kratom substances. As of March 14, at least 87 people in 35 states contracted salmonella with 27 hospitalizations.
In March, the CDC and FDA linked some of the salmonella cases to kratom products from PDX Aromatics of Portland, Oregon. The company issued a voluntary recall, that in coordination with the FDA, provided information on potentially contaminated products and instructed customers to either destroy or return the products.
Two other distributors, Tamarack Inc. and Nutrizone LLC of Houston Texas, had earlier issued voluntary recalls for their products, which also tested positive for salmonella.