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This news follows closely on FDA's announcement last week of the voluntary recall and destruction of kratom products by a Missouri distributor and the CDC's February 20 announcement and ongoing surveillance of a multi-state Salmonella outbreak possibly linked to kratom products. The traditional Asian herbal medicine, kratom, has been the focus of increased regulatory attention over the last several months due to its use by an estimated 3 to 5 million North Americans as an unapproved drug for chronic pain, anxiety, depression as well in recovery from physical dependence on opioids and alcohol. The agency released consumer warnings last November and earlier this month that kratom has been linked with dozens of fatalities, cases that I and others have criticized for lacking causation or were otherwise fraught with confounding variables. The agency also claimed unpublished computational chemistry findings that many kratom components behave similarly to strong opioids, a finding I noted that was already established in the scientific literature but that lacked complete characterization and context that distinguish kratom components from strong opioids. But the agency appears to have been successful in equating 'kratom' and 'opioid' in the public vernacular. Related - FDA Weaponizes 'Opioid Label Against Kratom Consumers However, I can't criticize FDA for acting against the makers of this particular product. (The makers of Mitrasafe or their attorneys have not yet responded to my requests for comment.) Anthony Roberts , an independent journalist on the dietary supplement beat, has chronicled this organization's troubled attempts to garner new dietary ingredient classification for their product. The new dietary ingredient notification (NDIN) process is required of products intended for sale as dietary supplements that were not already sold as such in the U.S. as of October 15, 1994, the cutoff date established by the Dietary Supplement Health and Education Act of 1994. Without getting into the voluminous details, a recent survey of 101 NDIN submissions over the last fiscal year showed that the FDA Office of Dietary Supplement Programs has issued objections more than 70% of the time, primarily because the sponsor was missing details on the composition and safety of the specific product, or simply because the product did not qualify as a dietary supplement. In the case of the Mitrasafe NDIN, much of what we know comes from documents obtained by Roberts via a Freedom of Information Act request to the FDA. He reported that the sponsor made an extract of kratom leaves that was highly purified to contain 99%+ mitragynine, the tree's major bioactive chemical, but then only used historical data on the whole herbal product to support its safety.

For the original version including any supplementary images or video, visit https://www.forbes.com/sites/davidkroll/2018/02/27/fda-warns-against-launch-of-kratom-extract-mitrasafe-cites-misleading-regulatory-and-drug-claims/

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