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The Food and Drug Administration on April 3 recalled all products containing kratom manufactured by Triangle Pharmanaturals LLC, after a number of supplements tested positive for salmonella.
The FDA advises consumers to get rid of products including Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red.
Evidence of the contamination was found after two samples were collected from a retail store in Oregon by the Oregon Public Health Division and tested positive for salmonella.
The recall was ordered after Triangle Pharmanaturals did not comply with a March 30 formal request from the FDA to voluntarily recall their products.
“This action is based on the imminent health risk posed by the contamination of this product with salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions,” said FDA Commissioner Scott Gottlieb, M.D., said in a statement. “The action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen.”
At press time, Triangle Pharmanaturals did not respond to a request for comment.
This is the most recent in a list recalls of kratom products as part of an ongoing investigation of a salmonella outbreak by the FDA; however Triangle Pharmanaturals’ noncompliance is unique to the agency, according to an FDA representative.
“This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products,” Michael Felberbaum, an FDA press officer, said in an interview. “This is the third time the FDA has invoked its mandatory recall authority, but the first time the agency ordered a mandatory recall because a company has opted not to voluntarily recall after the FDA’s notification of an opportunity to initiate a voluntary recall.”
Earlier in March, the CDC reported 87 people in 35 states infected with either Salmonella Javiana, Salmonela Okatie, or Salmonella Thompson, which have been associated with the outbreak.
While salmonella was identified in Triangle Pharmanaturals’ products, the strains identified are not currently linked to the outbreak.
Kratom, a plant that commonly grows in South East Asian countries like Thailand, Malaysia, Indonesia, and Papua New Guinea, has recently been used to produce food supplements and marketed as an alternative to addictive pain medication like opioids, as well as used to help treat opioid withdrawal symptoms.
Use of the food supplement has fired debate among physicians, patients, and public officials as all sides continue to determine its efficacy and how, or whether, it should be given a drug classification.
The Food and Drug Administration on April 3 recalled all products containing kratom manufactured by Triangle Pharmanaturals LLC, after a number of supplements tested positive for salmonella.
The FDA advises consumers to get rid of products including Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red.
Evidence of the contamination was found after two samples were collected from a retail store in Oregon by the Oregon Public Health Division and tested positive for salmonella.
The recall was ordered after Triangle Pharmanaturals did not comply with a March 30 formal request from the FDA to voluntarily recall their products.
“This action is based on the imminent health risk posed by the contamination of this product with salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions,” said FDA Commissioner Scott Gottlieb, M.D., said in a statement. “The action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen.”
At press time, Triangle Pharmanaturals did not respond to a request for comment.
This is the most recent in a list recalls of kratom products as part of an ongoing investigation of a salmonella outbreak by the FDA; however Triangle Pharmanaturals’ noncompliance is unique to the agency, according to an FDA representative.
“This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products,” Michael Felberbaum, an FDA press officer, said in an interview. “This is the third time the FDA has invoked its mandatory recall authority, but the first time the agency ordered a mandatory recall because a company has opted not to voluntarily recall after the FDA’s notification of an opportunity to initiate a voluntary recall.”
Earlier in March, the CDC reported 87 people in 35 states infected with either Salmonella Javiana, Salmonela Okatie, or Salmonella Thompson, which have been associated with the outbreak.
While salmonella was identified in Triangle Pharmanaturals’ products, the strains identified are not currently linked to the outbreak.
Kratom, a plant that commonly grows in South East Asian countries like Thailand, Malaysia, Indonesia, and Papua New Guinea, has recently been used to produce food supplements and marketed as an alternative to addictive pain medication like opioids, as well as used to help treat opioid withdrawal symptoms.
Use of the food supplement has fired debate among physicians, patients, and public officials as all sides continue to determine its efficacy and how, or whether, it should be given a drug classification.
The Food and Drug Administration on April 3 recalled all products containing kratom manufactured by Triangle Pharmanaturals LLC, after a number of supplements tested positive for salmonella.
The FDA advises consumers to get rid of products including Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red.
Evidence of the contamination was found after two samples were collected from a retail store in Oregon by the Oregon Public Health Division and tested positive for salmonella.
The recall was ordered after Triangle Pharmanaturals did not comply with a March 30 formal request from the FDA to voluntarily recall their products.
“This action is based on the imminent health risk posed by the contamination of this product with salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions,” said FDA Commissioner Scott Gottlieb, M.D., said in a statement. “The action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen.”
At press time, Triangle Pharmanaturals did not respond to a request for comment.
This is the most recent in a list recalls of kratom products as part of an ongoing investigation of a salmonella outbreak by the FDA; however Triangle Pharmanaturals’ noncompliance is unique to the agency, according to an FDA representative.
“This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products,” Michael Felberbaum, an FDA press officer, said in an interview. “This is the third time the FDA has invoked its mandatory recall authority, but the first time the agency ordered a mandatory recall because a company has opted not to voluntarily recall after the FDA’s notification of an opportunity to initiate a voluntary recall.”
Earlier in March, the CDC reported 87 people in 35 states infected with either Salmonella Javiana, Salmonela Okatie, or Salmonella Thompson, which have been associated with the outbreak.
While salmonella was identified in Triangle Pharmanaturals’ products, the strains identified are not currently linked to the outbreak.
Kratom, a plant that commonly grows in South East Asian countries like Thailand, Malaysia, Indonesia, and Papua New Guinea, has recently been used to produce food supplements and marketed as an alternative to addictive pain medication like opioids, as well as used to help treat opioid withdrawal symptoms.
Use of the food supplement has fired debate among physicians, patients, and public officials as all sides continue to determine its efficacy and how, or whether, it should be given a drug classification.