Kratom Sterilization and Testing
As many of you know, Soul Speciosa issued a product recall and halted all sales on March 9, 2018, after a confirmed case of Salmonella was linked to a product from our inventory. As a company that exercises GMP (Good Manufacturing Practices) and is working its way toward GMP certification, we were surprised to learn that these products somehow escaped our extensive testing, which did (and does) include a panel for Salmonella.
Upon learning of the contaminant and after reviewing over 50 sets of prior results indicating otherwise, we made the decision to run sample sets through two new labs. When we did so, we found Salmonella contamination in an additional supply line, prompting us to immediately and voluntarily issue an expanded recall and then a second expanded recall in the interest of public safety.
On that note, we know you have questions about our suppliers. We want to be as transparent as we can without compromising the FDA’s ongoing investigation and without exposing ourselves to unnecessary legal problems. We can share that, though not all kratom was affected, certain products from all of our tested suppliers did come up positive for Salmonella.
Soul Speciosa has always employed rigorous receiving, testing, and quarantine procedures to ensure the safety and purity of our products. We believed these protocols were sufficient to identify any potential contamination, but it is clear now that they were not. We take responsibility for this oversight and are committed to refining our processes and resolving the underlying issues.
Here are a just a few of the improvements we’re implementing:
- Environmental controls to test for pathogens in the facility
- Revamped sanitation controls policies and procedures
- Rigorous screening process for suppliers and products
- Sterilization of all products: we are currently evaluating dry heat sterilization, steam vacuum pasteurization, high pressure processing (HPP), electron beam (E- Beam), and gamma ray processes.
- Milling and blending process to allow for more accurate testing
- More comprehensive testing protocols
- The use of two or more labs in testing our product
Currently we are working with regulatory authorities and experts in pathogen and food safety to ensure that our planned method of sterilization and testing is adequate to safely supply raw Kratom products to our customers. We’ve moved our testing to new labs (with a secondary lab acting as a failsafe), and we’re sharing our educational resources with suppliers, as well as other vendors. We are taking all measures necessary not only to guarantee the safety of our customers, but also to protect our industry as a whole.
At this time, and while we refine our sterilization process, Soul Speciosa is only offering extract and liquid Kratom Tea products for sale. Rest assured that all of our products are tested for identification, heavy metals content ([AOAC 2013.06] Arsenic, Cadmium, Lead, Mercury) and for microbial safety (Aerobic Plate Count [AOAC 990.12], Yeast and Mold [AOAC 997.02], Coliforms and E Coli [AOAC 991.4], and Salmonella [AOAC-RI 050701]), and that only products which pass these tests will be available to order.
The health and safety of kratom consumers is important to us. It’s why we aim to be compliant with Good Manufacturing Practices, why we conducted a voluntary product recall, and why we’re auditing our facility and supply chain. Having gone through this process with FDA, we can say with a great deal of certainty that most companies simply aren’t doing enough to keep consumers safe.
At the same time that we hope all kratom companies will take seriously their responsibility to prevent unsafe products from entering the market, we urge consumers to conduct due diligence when choosing a kratom vendor. Don’t be afraid to ask important questions about their manufacturing practices and testing, or to request Certificates of Analysis from accredited laboratories. Reputable vendors will have no problem answering these queries and should be able to provide you with information about their products and processes.
The Soul Speciosa team extends our deepest gratitude for your understanding and support during this time. We remain steadfast in our commitment to providing safe and effective products for our customers and look forward to the opportunity to serve you again in the near future.Soul Speciosa