Important Lessons from the FDA’s Kratom Salmonella Probe

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Important Lessons from the FDA’s Kratom Salmonella Probe

Back in February, many kratom manufacturers recalled products due to Salmonella contamination. The outbreak occurred across 41 states with 199 individuals hospitalized per the Centers for Disease Control (CDC). While the outbreak is on the smaller side, the Food and Drug Administration (FDA) started the probe to better understand why products became contaminated in the first place and aimed to learn more about the controversial herbal supplement from Southeast Asia.

Mitragyna speciose, best known as kratom, is derived from the leaves of a tree from Thailand or Indonesia and is used by millions of Americans as an alternative to opiates for a number of conditions, including depression and chronic pain.

Salmonella is a bacterial infection caused by exposure to contaminated water or food sources and outbreaks are common, often originating from food products, like raw bean sprouts; poultry; and melons.

Akin to the rise in popularity of Cannabis, Hemp, and CBD; kratom’s catapult to popularity comes as more and more Americans are eschewing prescription drugs for more natural products.

What Caused the Outbreak?

No one really knows, and that worries FDA officials.

Although the probe delved into the February outbreak, FDA officials believe that Salmonella contamination with kratom is ongoing and dates back to January 2017. 81 Kratom samples were tested and over 50% of them tested positive for strains of Salmonella bacteria.

FDA Commission Dr. Scott Gottlieb commented that a 50% chance of being exposed to Salmonella is a concerning amount of risk for the loosely regulated product. Furthermore, kratom is often marketed as a treatment for conditions, which is impermissible for a non-drug. Unsubstantiated claims are one of the biggest violations for the FDA and often results in agency action. And since kratom’s audience is only growing, regulators are prioritizing their understanding the plant itself and its effects.

It is believed that the environment in which kratom is grown, harvested, and produced from creates a perfect storm for spreading pathogens. Depending on the producer, kratom may be further processed stateside into capsules and powders. Ultimately, Gottlieb concludes, producers are not adequately finding or eliminating problematic microbes. Kratom is also widely available, with no current restrictions on its sales.

How to Reduce Risks

The purpose of FDA regulations, known as Good Manufacturing Practices (GMPs), exist to ensure that products sold to consumers are safe and effective and made in a quality and consistent way. The emphasis on quality controls provides benefits for fledging brands and those looking to establish trust in their brands.

Unfortunately, there’s no overnight remedy for producers, however, with time and other resources, it’s possible to significantly reduce risks and better prepare for a recall. Standard Operating Procedures (SOPs) provide a framework for qualifying vendors and testing their materials prior to use in manufacturing.

InstantGMP, Inc. offers various sets of SOPs and the widely used software, InstantGMP™ MES. InstantGMP™ MES has assisted numerous kratom producers in managing the Salmonella outbreak, complying with FDA regulations, and implementing the processes to prevent further issues. Check out InstantGMP™ MES and see the software in action to learn more about its benefits.