Wednesday, 25 April 2018

Did FDA Set Stage For Salmonella Outbreak?

Preemptive Steps Taken by FDA Seen As Disrupting Kratom Supplies and Forcing Reliance on “Substandard” Product; Salmonella Issue Shows Need for Properly Regulated Marketplace, Not DEA Scheduling that Would Ban Product; No Persuasive Case on Addiction or Death Made on Scientific Grounds Against Herb.

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.

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, states:

“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.?"

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