FDA orders recall of salmonella-tainted herbal supplement


On April 2, 2018, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella.

Refusal of the company to work with FDA prompted order While companies typically comply with government requests and voluntarily recall tainted products, Triangle Pharmanaturals refused to cooperate with the FDA.

The Food and Drug Administration calls it a unsafe opioid, but kratom advocates call their pill of choice a life-saving supplement. All salmonella bacteria can cause the foodborne illness salmonellosis, although the strains found related to this recall are not now linked to the outbreak.

Mitragyna speciosa, known as kratom, is a plant that grows in Thailand, Malaysia, Indonesia and Papua New Guinea. Research suggests the drug taps into some of the same brain receptors as opioids, spurring the FDA to classify it as one in February.

FDA has advised consumers to discard all kratom products they may have in their possession.

At least 87 people in 35 states have been sickened by a salmonella outbreak linked to Kratom. Most people infected with salmonella develop diarrhea, fever and abdominal cramps 12 to 72 hours after infection.

Four people in Oklahoma have gotten salmonella after taking kratom, an herbal supplement some people take as an opioid substitute. Supporters, such as the American Kratom Association, continue to fight to keep the substance legal and available. That has led to a growing concern among several regulatory agencies including the FDA and the CDC.

So, for the first time ever, the agency issued a formal order that Triangle recall its kratom today.

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The FDA said the Salmonella strains found in Triangle's kratom products don't match the outbreak trains, but it added that all Salmonella can cause foodborne illness.

In the United States, kratom is sold as a dietary supplement in the form of pills, powders, capsules and tea.

Triangle did not immediately respond to a request for comment.

The 2011 FDA Food Safety Modernization Act gave the FDA powers to force recalls for the first time, but the agency has been reluctant to move too aggressively, preferring to persuade companies to recall troublesome products voluntarily. It was then that the FDA issued its mandatory recall.

"Our first approach is to encourage voluntary compliance, but when we have a company like this one, which refuses to cooperate, is violating the law and is endangering consumers, we will pursue all avenues of enforcement under our authority", FDA Commissioner Scott Gottlieb wrote in the release.

Kratom is banned in Australia, Malaysia, Myanmar, Thailand, and several USA states (Alabama, Arkansas, Indiana, Tennessee, and Wisconsin). The agency also has received concerning reports about the safety of kratom, including deaths associated with its use.

Kratom is made from the eponymous plant, a native species to Southeast Asia where it has historically been used as a stimulant - not unlike chewing tobacco - in low doses, or to treat pain by inducing eurphoria a higher doses. The agency says that kratom has no approved medical use and chemically resembles an opioid, the class of addictive drugs behind the current nationwide epidemic of drug abuse.