Ethylene Oxide/Sterigenics Updates

Kratom Supplements Which Contain Opioids are Recalled by the FDA after Salmonella Outbreak

It sometimes seems these days as if taking an herbal supplement is akin to gambling…you never know what you are going to get.

Just last week, the FDA issued its first mandatory recall of kratom products after Triangle Pharmaceuticals refused to comply with a March 30th agency request for a voluntary recall. That earlier action came after 87 people in 35 states became sick with salmonella after ingesting kratom supplements. Of those 87 people, 27 were sick enough to require hospitalization. Multiple companies that market kratom products conducted recalls, but Triangle Pharmaceuticals, despite having samples of their kratom products test positive for salmonella, refused to cooperate, forcing the FDA to issue the mandatory recall.

The recalled products include supplements such as 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.

This is not the first time that kratom has come under fire from the FDA. In fact, the FDA was urging consumers not to take kratom even before the recent salmonella outbreak. In February, the FDA announced a voluntary destruction and recall of a “large volume of kratom-containing dietary supplements” based on the scientific evidence of risk associated with kratom’s use. The drug has been linked to seizures, respiratory depression, and even death. According to the FDA, it is also addictive. At the time, the FDA also encouraged all companies that sell kratom-containing products in the USA to take their products off the market.

Most people have never heard of kratom. So what is it? Kratom–also known as Mitragyna Speciosa–is a tropical tree native to Thailand, Malaysia, Myanmar, Indonesia, and Papua New Guinea. Its leaves contain two potent chemicals, mitragynine and 7-hydroxymitragynine. Mitragynine has mild opioid effects and 7-hydroxymitragynine is 13 times more potent than morphine. This puts kratom in the opioid family and makes it highly addictive.

Despite this fact, kratom is widely available on the internet in unregulated supplements. Health food and herbal supplement websites tout kratom’s benefits, claiming that it can increase energy, help with concentration, boost your mood, fight stress and naturally relieve pain, conveniently ignoring the fact that it can have potentially dangerous side-effects and be addicting. Considering the current opioid epidemic in the country, this is unbelievable.

Proponents of kratom believe it can be used to help treat opioid addiction, however, there is no reliable evidence to support kratom’s effectiveness for that use. Furthermore, addicts already have access to two drugs that CAN reduce dependency on opioids–suboxone and methadone-that have been rigorously studied. The only reason to use an untested product like kratom for this purpose would be the ability to treat a dependency anonymously without involving the health care system, a dubious choice at best.

The government has long been aware of the dangers involved with this product. The DEA tried to ban kratom in 2014 but backed down after facing public opposition from politicians and users. Likewise, the FDA issued a public health warning about kratom last November, urging consumers not to use kratom or any compounds from the plant, citing the dangers of its use.

Finally, this February, the FDA officially declared that kratom is an opioid and issued a recall and voluntary destruction of kratom-containing supplements. The agency came to their decision after reviewing peer-reviewed research and assessing the growing number of calls (over 660 calls to US poison control centers from 2010-2015) reporting adverse event– including 44 deaths– associated with kratom use. In light of this admission by the FDA, it is unclear why the supplements are not considered an illegal drug, especially in light of the opioid problem facing the nation.

In addition to the recall, the FDA is recommending that consumers dispose of any kratom containing products and report any adverse effects to the agency’s online Safety Reporting Portal.

If you or a family member has been injured or become addicted because of a dietary supplement containing kratom, please call us at The Collins Law Firm at (630) 527-1595, for a free evaluation of your case.

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