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WASHINGTON, April 25, 2018 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration (FDA) may have inadvertently contributed to the current small number of kratom-associated salmonella cases (fewer than 150 out of 1 million from all sources annually) when it preemptively imposed import restrictions on the herb and also focused on banning kratom rather than regulating its manufacture consistent with good manufacturing practices used with other supplements, according to statements made today during a news conference of leading kratom scientists.
By imposing an effective ban on importing kratom (including seizures at ports), the FDA forced manufacturers to shift from high-quality sources of the herb to lesser suppliers, thus increasing the potential for issues such as salmonella, which had never previously been an issue with kratom in the U.S. Further, the risk of adulteration and other issues increased when the FDA opted to push for a ban of kratom, rather than enforcing the mandatory 2007 current good manufacturing practice (CGMP) rule for dietary supplements, which also would have reduced salmonella risks.
Cautioning against the demonization of kratom, the scientists underscored the fact that the history of use by three million or more Americans and recent published scientific surveys indicate the herb is not a significant public health problem (including death and addiction) and is consumed in much the same way as many other botanical dietary supplements widely and legally available across the United States. Further, in some cases kratom is a lifeline away from often deadly opioids.
The statements of the experts below:
Paula N. Brown, Ph.D., director of applied research, BC Institute of Technology, Canada Research chair, Phytoanalytics and adjunct professor of biology, University of British Columbia.
"The salmonella outbreak is not a reflection on kratom per se and underscores the need for FDA enforcement, not scheduling. The FDA's designation of kratom alkaloids as opioids is consequential for both regulation and quality of marketed products. While traditional use is not a standard of evidence recognized in the US, where market access is based on presence prior to 1994, ultimately the focus needs to be ensuring the public has access to products that are safe and of high quality. The FDA issued import alert that permits automatic detention of kratom materials without physical examination, has resulted in several kratom product being seized at ports and has forced many existing consumers to obtain products through internet distributors and dubious sources. The recent salmonella contamination of kratom products highlights the inconsistent enforcement of the mandatory 2007 current good manufacturing practice (CGMP) rule for dietary supplements by the FDA. The import alert and failure to enforce CGMP regulations has forced kratom products into an illicit market where adulterated and substandard products may flourish while driving legitimate products out of the marketplace."
Michael McGuffin – leading expert on dietary supplement regulations and executive director, American Herbal Products Association.
"Trade associations serve a unique role in the interface between regulatory agencies and the relevant regulated trade, both by providing guidance and encouraging best practices for industry and by communicating with regulators on behalf of the trade. When it comes to the particular case of kratom, AHPA views this as just one of the many herbs or other botanicals that are allowed under U.S. law to be marketed as a dietary supplement. But AHPA also notes that the Food and Drug Administration has identified kratom as a 'new dietary ingredient' (or NDI) and so AHPA has recommended that companies that want to market kratom comply with FDA's new dietary ingredient requirements by submitting an NDI notification in conformity with FDA's rules. At the same time, we encourage FDA to treat any such kratom NDI notification exactly as it would a notification for any other new herb. AHPA has also circulated suggestions that kratom marketers understand and meet all of the other regulations required for any herbal product sold as a dietary supplement, such as registering as a food facility, meeting the extensive good manufacturing practice rules, refraining from making any drug claims, and submitting to FDA all serious adverse event reports received in association with their kratom products."
Oliver Grundmann, Ph.D., clinical associate professor, College of Pharmacy, University of Florida.
"The science doesn't support kratom nor its alkaloids as being labelled a dangerous opioid. Instead, further research is necessary to support its unique pharmacology which may lead to safer drugs for the treatment of pain. Surveys and observational studies indicate the majority of kratom use is for alleviation of mild to moderate acute or chronic pain, to reduce anxiety or elevate mood. A smaller number of users indicate they consume kratom as a substitute for using opioids or to mitigate withdrawal symptoms from illicit or prescription drug dependence. Kratom use in the US is on the rise, independent of its intended use and it is in the best interest of public health if consumers have access to products that adhere to established FDA CGMP rather than driving this market into the grey area of internet sales or unregulated international distributors."
Jack Henningfield, Ph.D. vice president of research, Health Policy and Abuse Liability, at PinneyAssociates, and adjunct professor of Behavioral Biology, Johns Hopkins University School of Medicine.
"With the opioid crisis claiming the lives of more than 100 people daily it is clear much more needs to be done to expand access to existing opioid use disorder treatment and research into new approaches for prevention and treatment. While the White House Opioid Report did not explicitly discuss complementary and alternative therapies, kratom, which is marketed as a dietary supplement in the US, has been used for nearly a century for anxiety, improving mood, minor pain and treating opioid addictions in South East Asia (SEA) and at least two decades in the US. This is supported by thousands of comments to FDA dockets, four Internet surveys and is consistent with the neuropharmacology of the main kratom alkaloid, mitragynine. The results of the surveys and recent research suggests kratom and its alkaloids may be among the promising next generation of safer treatments for pain and addiction, but also anxiety and minor depression. Unfortunately, research and the use of kratom by many people to sustain abstinence from opioids is threatened by FDA's recommendation to the Drug Enforcement Administration (DEA) to ban lawful sales and possession of kratom by placing it in the Controlled Substances Act as a Schedule I drug. Recent statements and actions by FDA actually make the case for responsible regulation/marketing – not a ban. The importance of access to product for millions of American consumers cannot be understated nor can the dangers of an illicit market."
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By imposing an effective ban on importing kratom (including seizures at ports), the FDA forced manufacturers to shift from high-quality sources of the herb to lesser suppliers, thus increasing the potential for issues such as salmonella, which had never previously been an issue with kratom in the U.S. Further, the risk of adulteration and other issues increased when the FDA opted to push for a ban of kratom, rather than enforcing the mandatory 2007 current good manufacturing practice (CGMP) rule for dietary supplements, which also would have reduced salmonella risks.
Cautioning against the demonization of kratom, the scientists underscored the fact that the history of use by three million or more Americans and recent published scientific surveys indicate the herb is not a significant public health problem (including death and addiction) and is consumed in much the same way as many other botanical dietary supplements widely and legally available across the United States. Further, in some cases kratom is a lifeline away from often deadly opioids.
The statements of the experts below:
Paula N. Brown, Ph.D., director of applied research, BC Institute of Technology, Canada Research chair, Phytoanalytics and adjunct professor of biology, University of British Columbia.
"The salmonella outbreak is not a reflection on kratom per se and underscores the need for FDA enforcement, not scheduling. The FDA's designation of kratom alkaloids as opioids is consequential for both regulation and quality of marketed products. While traditional use is not a standard of evidence recognized in the US, where market access is based on presence prior to 1994, ultimately the focus needs to be ensuring the public has access to products that are safe and of high quality. The FDA issued import alert that permits automatic detention of kratom materials without physical examination, has resulted in several kratom product being seized at ports and has forced many existing consumers to obtain products through internet distributors and dubious sources. The recent salmonella contamination of kratom products highlights the inconsistent enforcement of the mandatory 2007 current good manufacturing practice (CGMP) rule for dietary supplements by the FDA. The import alert and failure to enforce CGMP regulations has forced kratom products into an illicit market where adulterated and substandard products may flourish while driving legitimate products out of the marketplace."
Michael McGuffin – leading expert on dietary supplement regulations and executive director, American Herbal Products Association.
"Trade associations serve a unique role in the interface between regulatory agencies and the relevant regulated trade, both by providing guidance and encouraging best practices for industry and by communicating with regulators on behalf of the trade. When it comes to the particular case of kratom, AHPA views this as just one of the many herbs or other botanicals that are allowed under U.S. law to be marketed as a dietary supplement. But AHPA also notes that the Food and Drug Administration has identified kratom as a 'new dietary ingredient' (or NDI) and so AHPA has recommended that companies that want to market kratom comply with FDA's new dietary ingredient requirements by submitting an NDI notification in conformity with FDA's rules. At the same time, we encourage FDA to treat any such kratom NDI notification exactly as it would a notification for any other new herb. AHPA has also circulated suggestions that kratom marketers understand and meet all of the other regulations required for any herbal product sold as a dietary supplement, such as registering as a food facility, meeting the extensive good manufacturing practice rules, refraining from making any drug claims, and submitting to FDA all serious adverse event reports received in association with their kratom products."
Oliver Grundmann, Ph.D., clinical associate professor, College of Pharmacy, University of Florida.
"The science doesn't support kratom nor its alkaloids as being labelled a dangerous opioid. Instead, further research is necessary to support its unique pharmacology which may lead to safer drugs for the treatment of pain. Surveys and observational studies indicate the majority of kratom use is for alleviation of mild to moderate acute or chronic pain, to reduce anxiety or elevate mood. A smaller number of users indicate they consume kratom as a substitute for using opioids or to mitigate withdrawal symptoms from illicit or prescription drug dependence. Kratom use in the US is on the rise, independent of its intended use and it is in the best interest of public health if consumers have access to products that adhere to established FDA CGMP rather than driving this market into the grey area of internet sales or unregulated international distributors."
Jack Henningfield, Ph.D. vice president of research, Health Policy and Abuse Liability, at PinneyAssociates, and adjunct professor of Behavioral Biology, Johns Hopkins University School of Medicine.
"With the opioid crisis claiming the lives of more than 100 people daily it is clear much more needs to be done to expand access to existing opioid use disorder treatment and research into new approaches for prevention and treatment. While the White House Opioid Report did not explicitly discuss complementary and alternative therapies, kratom, which is marketed as a dietary supplement in the US, has been used for nearly a century for anxiety, improving mood, minor pain and treating opioid addictions in South East Asia (SEA) and at least two decades in the US. This is supported by thousands of comments to FDA dockets, four Internet surveys and is consistent with the neuropharmacology of the main kratom alkaloid, mitragynine. The results of the surveys and recent research suggests kratom and its alkaloids may be among the promising next generation of safer treatments for pain and addiction, but also anxiety and minor depression. Unfortunately, research and the use of kratom by many people to sustain abstinence from opioids is threatened by FDA's recommendation to the Drug Enforcement Administration (DEA) to ban lawful sales and possession of kratom by placing it in the Controlled Substances Act as a Schedule I drug. Recent statements and actions by FDA actually make the case for responsible regulation/marketing – not a ban. The importance of access to product for millions of American consumers cannot be understated nor can the dangers of an illicit market."
View original content:http://www.prnewswire.com/news-releases/leading-scientists-say-salmonella-outbreak-tied-to-kratom-may-be-side-effect-of-fda-crackdown--underscores-need-for-regulation--not-a-ban-300636501.html
SOURCE Paula N. Brown, Ph.D., director of applied research, BC Institute of Technology, Canada Research chair, Phytoanalytics; Jack Henningfield, Ph.D., vice president of research, Health Policy and Abuse Liability, at PinneyAssociates
