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Publisher's rating: Blissful Remedies is the latest brand of kratom products recalled
Users of kratom supplements may be at risk for Salmonella infections from of a product that has no nutritional or medical benefit
After a multi-month investigation, the US Food and Drug Administration came to this conclusion, as FDA Commissioner Scott Gottlieb, announced Monday. The Gottlieb announcement follows many recalls of products containing kratom since February due to salmonellosis.
Kratom is made from a tropical tree native to Southeast Asia and some have psychoactive or psychodysleptic effects. It is sometimes eaten like a tea. Kratom is not legally marketed in the United States as a drug or dietary supplement. Kratom is an opioid, according to the FDA.
"The FDA has now completed its investigation for several months after identifying extremely high levels of salmonella contamination in collected and tested kratom products," Gottlieb said in a statement.
"This has led to several recalls, including the first mandatory recall order from the agency to a provider.In addition to the known addictive properties and serious damage associated with the use of kratom, the Evidence from this survey indicates another significant risk with the use of kratom: Salmonella. "
Recently, the FDA sent warning letters to three merchants and distributors of kratom products – Front Range Kratom's Aurora, CO, Kratom Spot of Irvine, CA, and Revibe Inc. of Kansas City, MO, – for the illegal sale of unapproved pharmaceutical products containing kratom with unproven allegations about their ability to help in the treatment of opioids dependence and withdrawal. The companies also claim treatment for pain, as well as other medical issues like lowering blood pressure, treating cancer and reducing neuronal damage caused by stroke.
In his statement, Gottlieb describes the scientific analysis used by the FDA. About kratom
In February, the PulseNet of the US Centers for Disease Control identified an outbreak of Salmonella diseases that initially involved 24 people, Gottlieb said in Monday's announcement. The diseases were linked to each other by the molecular fingerprint of Salmonella I 4 bacteria, [5] 12: b: – using a laboratory technique called pulsed field electrophoresis
"Interviews conducted by departments and coordination with the CDC revealed that a high proportion of sick people reported recent kratom consumption, either in the form of capsules, powders or herbal remedies, "according to the statement of Gottlieb. "In some cases, affected patients still had the kratom they consumed before becoming ill for testing. In other cases, patients provided information on the source and brand of kratom that they had purchased either on the Internet or from a commercial establishment. The investigators then took samples of the designated products for further testing.
Investigators took samples of kratom that they sent to public public health laboratories or FDA laboratories. If Salmonella was found, the FDA worked with merchants to voluntarily recall the kratom product to prevent other people from getting sick. "In most of these cases, traders were cooperative and a series of voluntary reminders ensued," Gottlieb reported.
In one case, the marketer was uncooperative and refused to recall his product. The FDA has issued a mandatory reminder to protect public health, according to the commissioner of the agency.
"It was the first time that the FDA needed a mandatory recall order to protect Americans from contaminated food products." In 2011, in the Act on the Modernization of Food Safety food, "he said.
"As other samples of kratom were tested, other diseases caused by serotypes other than I4, [5] 12: b: – were identified.These test results were provided at the CDC, which compared molecular fingerprint data from kratom samples to the PulseNet CDC database of salmonella fingerprint data from salmonella strains collected from sick people in the United States In several cases, matches were found between salmonella strains in the kratom samples and the strains found in samples taken from sick people.The interviews of these people, which in some cases had been sick months earlier , found that they had also consumed kratom, which showed that the problem of kratom being contaminated with salmonella was more widespread than it was initially
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At the end of May, a total of 199 cases of salmonellosis in 41 states were related to kratom consumption; 38% of these illnesses led to hospitalizations. According to the Centers for Disease Control and Prevention, no deaths have been reported. In addition to Salmonella I 4, [5] 12: b: -, diseases were associated with Salmonella Heidelberg, Salmonella Javiana, Salmonella Okatie, Salmonella Thompson and Salmonella Weltevreden.
A total of 81 kratom samples were collected. tested during the outbreak investigation. Of these, 42 to 52% were infected with Salmonella. This means that users of these products had essentially one in two chance of being exposed to this pathogen, reported Gottlieb.
"Although these samples were not collected at random, they were tested because they were eaten or mentioned by sick people, the contamination rate of more than 50 percent is incredibly high It represents a level rarely seen in epidemic inquiries of this nature. "According to a statement by Gottlieb,
" Throughout the year, the FDA has announced additional kratom reminders because of the Salmonella contamination of products from different companies. and marks, showing that it is a persistent problem.
The FDA found that the flowing kratom in the United States originates from Southeast Asia, particularly the rural areas of Indonesia and Thailand. is cultivated, harvested and treated under problematic conditions that easily create a situation of widespread contamination by foodborne pathogens.A bit of kratom is then processed once in the United States.It is used in capsules, Powder and Herbal Remedies Based on the FDA's findings, these procedures do not appear to eliminate microbial contamination.
According to FDA investigators, Kratom has been associated with serious consequences for the In spite of these risks, Gottlieb said that kratom has gained popularity in recent years because of allegations that are not based on its alleged benefits. mble that the Salmonella problem with kratom detected earlier this year probably occurs for some time. We concluded our investigation into the epidemic, concluding that anyone who consumes kratom is likely to be exposed to salmonella significantly, "reported Gottlieb.
" As we have already The kratom and the FDA strongly discourage the public from consuming kratom. The subsequent findings of this survey only reinforce this public health recommendation. Kratom is an inherently addictive product that can cause harm, which is reason enough not to consume it. Now, in addition to these risks, we can conclude that there may be a high proportion of products containing kratom and kratom contaminated with salmonella.
"This is another firm reminder of why people should avoid kratom." (To subscribe for free to Food Safety News, click here .)
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