The mandatory order comes after the company did not cooperate with a voluntary recall request. The agency issued another notice to Triangle the following day, ordering the company to stop distributing its kratom products.
Other firms have complied with FDA requests to recall their kratom products, the agency said.
State and federal officials detected salmonella in a half-dozen samples of Triangle's products.
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"We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately", Gottlieb said. Most people get sick within a few hours to a few days after consuming products contaminated with this pathogenic bacteria.
"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 said.
Kratom is a plant native to Malaysia. Importantly, the FDA advises consumers to avoid kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, in any form and from any manufacturer. Across the U.S., several reports of deaths and addiction led the Drug Enforcement Administration to place kratom on its list of "drugs and chemicals of concern". It is consumed for its stimulant effects and as an opioid substitute.
Products containing kratom have recently been linked to a multi-state outbreak of salmonellosis from several strains of salmonella, prompting voluntary recalls by various companies.
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According to the news release, the FDA was unable to obtain company records or information from Triangle Pharmanaturals employees while investigating the outbreak. Since non-prescription supplements typically fall under the food (rather than the drug) category, the FDA made a decision to flex that muscle in the instance of Triangle Pharmanaturals. On March 31, the FDA then ordered the company to cease distribution of the products and the company was provided with an opportunity to request an informal hearing. After not responding within a specified timeframe, the FDA issued the first-ever mandatory recall "in the interest of public safety".
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. It gave Triangle Pharmanaturals 24 hours to comply. This investigation is ongoing. The test results revealed the kratom was contaminated with salmonella, a bacteria that causes fever, diarrhea, and abdominal cramps.
Kratom is sometimes used as an alternative to opioids, has been the culprit in almost 90 cases of salmonella in recent months. If these products are in homes, the FDA asks people to throw them out immediately and to thoroughly wash their hands and any containers that came in contact with the product.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
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Melissa Millewich, an emergency room physician who has overseen many of these cases, told the Chicago Tribune . However, the effects of those chemicals on a person are, according to IDPH, quite risky .