According to the news report, "The agency asked Triangle on Friday to voluntarily recall the kratom items. When the company did not comply with the request, the FDA the next day ordered the firm to cease distribution. The company could have requested a hearing, the agency said, but it did not respond within the required time frame. The agency then issued the mandatory recall order."
Once the weapon is pulled out of the holster for the first time, it become a lot easier the second time around.
Washington Post
https://www.washingtonpost.com/news/to-your-health/wp/2018/04/03/in-a-first-fda-orders-recall-of-a-contaminated-food-kratom-with-salmonella/?utm_term=.214cd8fb6fe4
In a first, FDA orders recall of a ‘contaminated food’ — kratom with salmonella
by Laurie McGinley by Laurie McGinley Email the author
To Your HealthApril 3, 2018
The Food and Drug Administration on Tuesday ordered a mandatory recall of a Las Vegas company's powdered kratom products because salmonella was found in the herbal supplement.
The recall involves powdered kratom products that were manufactured, packed and processed by Triangle Pharmanaturals. The FDA said the company did not cooperate with the agency's request for a voluntary recall.
The mandatory recall was the agency’s first-ever recall of a contaminated food item. In general, dietary supplements are considered foods under federal law. In the case of kratom, a botanical from Southeast Asia, FDA officials determine whether the products are a food or an unapproved drug depending on the way they are labeled.
The FDA doesn't have the authority to order mandatory recalls for drugs and seeks voluntary recalls if it sees a safety problem. But it got mandatory-recall authority for tainted food under the Food Safety and Modernization Act that went into effect in 2011.
“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,” FDA Commissioner Scott Gottlieb said in a statement.
The recall is the latest development in a high-decibel controversy surrounding kratom. The herb, which is rapidly rising in popularity, is hailed by advocates as a readily available pain remedy that is safer than traditional opioids, an effective addiction withdrawal aid and a pleasurable recreational tonic. But it has been assailed by the FDA as a dangerous and unregulated drug that can result in opioid-like abuse and death. The Drug Enforcement Administration is weighing whether to place kratom, which comes from a leafy tree, in the same category of illegal drugs as heroin.
In his statement Tuesday, Gottlieb said that while the agency has serious concerns about any kratom-containing product, the mandatory recall of the Triangle products is based on salmonella contamination. The bacteria can cause fever, diarrhea and severe abdominal cramps.
The agency said that two samples of kratom products manufactured by Triangle and sold through the retailer Torched Illusions in Tigard, Ore., were collected by state authorities and tested positive for salmonella. So did four additional samples of various types of kratom products collected by the FDA, the agency said.
The recall involves powdered kratom products that were manufactured, packed and processed by Triangle Pharmanaturals. The FDA said the company did not cooperate with the agency's request for a voluntary recall.
The mandatory recall was the agency’s first-ever recall of a contaminated food item. In general, dietary supplements are considered foods under federal law. In the case of kratom, a botanical from Southeast Asia, FDA officials determine whether the products are a food or an unapproved drug depending on the way they are labeled.
The FDA doesn't have the authority to order mandatory recalls for drugs and seeks voluntary recalls if it sees a safety problem. But it got mandatory-recall authority for tainted food under the Food Safety and Modernization Act that went into effect in 2011.
“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,” FDA Commissioner Scott Gottlieb said in a statement.
The recall is the latest development in a high-decibel controversy surrounding kratom. The herb, which is rapidly rising in popularity, is hailed by advocates as a readily available pain remedy that is safer than traditional opioids, an effective addiction withdrawal aid and a pleasurable recreational tonic. But it has been assailed by the FDA as a dangerous and unregulated drug that can result in opioid-like abuse and death. The Drug Enforcement Administration is weighing whether to place kratom, which comes from a leafy tree, in the same category of illegal drugs as heroin.
In his statement Tuesday, Gottlieb said that while the agency has serious concerns about any kratom-containing product, the mandatory recall of the Triangle products is based on salmonella contamination. The bacteria can cause fever, diarrhea and severe abdominal cramps.
The agency said that two samples of kratom products manufactured by Triangle and sold through the retailer Torched Illusions in Tigard, Ore., were collected by state authorities and tested positive for salmonella. So did four additional samples of various types of kratom products collected by the FDA, the agency said.
The FDA also said that its investigators were denied access to the company's records that it sought as part of a probe into a multistate salmonella outbreak linked to kratom. The FDA said the strains found in Triangle's products are not linked to the outbreak.
The agency asked Triangle on Friday to voluntarily recall the kratom items. When the company did not comply with the request, the FDA the next day ordered the firm to cease distribution. The company could have requested a hearing, the agency said, but it did not respond within the required time frame. The agency then issued the mandatory recall order
More - https://www.washingtonpost.com/news/to-your-health/wp/2018/04/03/in-a-first-fda-orders-recall-of-a-contaminated-food-kratom-with-salmonella/?utm_term=.214cd8fb6fe4
https://www.fda.gov/Safety/Recalls/ucm603536.htm
FDA Orders Mandatory Recall for Kratom Products Due to Risk of Salmonella
For Immediate Release
April 3, 2018
Contact Consumers 888-INFO-FDA
Media FDA Office of Media Affairs fdaoma@fda.hhs.gov 301-796-4540
Announcement
View Product Photos
Triangle Pharmanaturals refused to cooperate with FDA despite repeated attempts to encourage voluntary recall.
Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.
View Product Photos
Triangle Pharmanaturals refused to cooperate with FDA despite repeated attempts to encourage voluntary recall.
Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.
The FDA is advising consumers to discard the products that are part of the mandatory recall, which include, but are not limited to: 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. The FDA understands that Triangle Pharmanaturals may manufacture, process, pack and/or hold additional brands of food products containing powdered kratom, including powder and encapsulated powder forms.
“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. “We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately. But the action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen. 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.”
Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand,
“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. “We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately. But the action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen. 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.”
Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand,
Malaysia, Indonesia and Papua New Guinea. Importantly, the FDA advises consumers to avoid kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, in any form and from any manufacturer. The agency also has received concerning reports about the safety of kratom, including deaths associated with its use. There is strong evidence that kratom affects the same opioid brain receptors as morphine and appears to have properties that expose people who consume kratom to the risks of addiction, abuse and dependence. The agency also remains concerned about the use of kratom as an alternative to FDA-approved pain medications or to treat opioid withdrawal symptoms, as neither kratom nor its compounds have been proven safe and effective for any use and should not be used to treat any medical conditions.
In this instance, two samples of kratom products manufactured by Triangle Pharmanaturals of Las Vegas, Nevada, sold through the retail location Torched Illusions in Tigard, Oregon and collected by the Oregon Public Health Division, tested positive for salmonella, as did four additional samples of various types of kratom product associated with the firm collected by the FDA. Adding to the concerns, in the course of investigating a multi-state outbreak of salmonella infections linked to kratom products in conjunction with local officials, FDA investigators were denied access to the company’s records relating to potentially affected products and Triangle employees refused attempts to discuss the agency’s findings.
Under the FDA Food Safety Modernization Act, the FDA has the authority to order the recall of certain food products when the FDA determines that there is a reasonable probability that the article of food is adulterated or in violation of certain allergen labeling requirements and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.
On March 30, the FDA issued Triangle Pharmanaturals a Notification of Opportunity to Initiate a Voluntary Recall, a formal request that advised the company that the agency could order the firm to cease distribution and notify applicable parties within 24 hours if the company did not conduct a voluntary recall. However, Triangle Pharmanaturals did not comply with the request. 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. The company did not respond within the timeframe specified, therefore waiving its opportunity for an informal hearing, and the agency ultimately issued the mandatory recall order in the interest of public safety. 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.
Numerous brands of kratom-containing products have been linked to a multi-state outbreak of salmonellosis from multiple strains of salmonella. The FDA continues to advise consumers to avoid kratom and kratom-containing products and discard any in their possession. All salmonella bacteria can cause the foodborne illness salmonellosis, although the strains found in Triangle Pharmanaturals’ products are not currently linked to the outbreak. The FDA is working with the U.S. Centers for Disease Control and Prevention to continue to investigate the ongoing outbreak. Most people infected with salmonella develop diarrhea, fever and abdominal cramps 12 to 72 hours after infection. The illness usually lasts 4 to 7 days, and most people recover without treatment. However, in the current salmonellosis outbreak associated with kratom products, unusually high rates of individuals have been hospitalized for their illness.
If consumers have one or more of these products in their homes, they should discard them immediately. As a precaution, kratom no longer stored in its original packaging should be discarded and the containers used to store it should be thoroughly washed and sanitized. In order to prevent cross-contamination, consumers should wash their hands, work surfaces and utensils thoroughly after contact with these products, and not prepare any food in the area at the same time.
For more information:
•FDA and Kratom
•FDA Investigates Multistate Outbreak of Salmonella Infections Linked to Products Reported to Contain Kratom
In this instance, two samples of kratom products manufactured by Triangle Pharmanaturals of Las Vegas, Nevada, sold through the retail location Torched Illusions in Tigard, Oregon and collected by the Oregon Public Health Division, tested positive for salmonella, as did four additional samples of various types of kratom product associated with the firm collected by the FDA. Adding to the concerns, in the course of investigating a multi-state outbreak of salmonella infections linked to kratom products in conjunction with local officials, FDA investigators were denied access to the company’s records relating to potentially affected products and Triangle employees refused attempts to discuss the agency’s findings.
Under the FDA Food Safety Modernization Act, the FDA has the authority to order the recall of certain food products when the FDA determines that there is a reasonable probability that the article of food is adulterated or in violation of certain allergen labeling requirements and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.
On March 30, the FDA issued Triangle Pharmanaturals a Notification of Opportunity to Initiate a Voluntary Recall, a formal request that advised the company that the agency could order the firm to cease distribution and notify applicable parties within 24 hours if the company did not conduct a voluntary recall. However, Triangle Pharmanaturals did not comply with the request. 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. The company did not respond within the timeframe specified, therefore waiving its opportunity for an informal hearing, and the agency ultimately issued the mandatory recall order in the interest of public safety. 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.
Numerous brands of kratom-containing products have been linked to a multi-state outbreak of salmonellosis from multiple strains of salmonella. The FDA continues to advise consumers to avoid kratom and kratom-containing products and discard any in their possession. All salmonella bacteria can cause the foodborne illness salmonellosis, although the strains found in Triangle Pharmanaturals’ products are not currently linked to the outbreak. The FDA is working with the U.S. Centers for Disease Control and Prevention to continue to investigate the ongoing outbreak. Most people infected with salmonella develop diarrhea, fever and abdominal cramps 12 to 72 hours after infection. The illness usually lasts 4 to 7 days, and most people recover without treatment. However, in the current salmonellosis outbreak associated with kratom products, unusually high rates of individuals have been hospitalized for their illness.
If consumers have one or more of these products in their homes, they should discard them immediately. As a precaution, kratom no longer stored in its original packaging should be discarded and the containers used to store it should be thoroughly washed and sanitized. In order to prevent cross-contamination, consumers should wash their hands, work surfaces and utensils thoroughly after contact with these products, and not prepare any food in the area at the same time.
For more information:
•FDA and Kratom
•FDA Investigates Multistate Outbreak of Salmonella Infections Linked to Products Reported to Contain Kratom
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