New letter from Phytoextractum/Kraken this a.m.

[herbalhippie]

Just woke up to this in my inbox



A personal message from Phytoextractum.


As you probably know, Phytoextractum has been working with the Food & Drug Administration to conduct a recall of certain kratom products since the first week of March. Early last month, we were informed about a confirmed positive case of Salmonella associated with our products and, since then, we’ve cooperated fully with the FDA’s investigation of Salmonella in kratom products. At this point, we are confident that we have recalled all affected products and have eliminated any potential sources of contamination from our facility and supply chain.

Over the course of their inquiry, FDA identified three more cases of Salmonella associated with our products, bringing the total to four. Additionally, FDA officials performed numerous tests on products at our facility. Their testing detected Salmonella, in samples obtained from consumers and in unopened boxes from suppliers, where our testing had not. Further test results substantiated the FDA’s findings of Salmonella in products from several different suppliers.

Phytoextractum 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.

We’ve suspended our operations during this time in order to audit our facility and our standard operating procedures so we could identify and remedy the gaps that allowed contaminated product to make it to market. Though this process has been laborious for us and inconvenient for our customers, please know that we are taking the steps necessary to prevent a similar situation from happening again.

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
More rigorous screening process for suppliers and products
Sterilization of all products: we are considering dry heat sterilization, steam vacuum pasteurization, high pressure processing (HPP), electron beam (E- Beam), gamma ray, and industrial microwave processes
Milling process to allow for more accurate testing
More comprehensive testing protocol
The use of two or more labs in testing our product


While these efforts mean additional steps and more work for us, we’re more than willing to go the extra mile to ensure our customers’ 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.

At this time, all suppliers affected by positive Salmonella findings have been notified and now have the responsibility of reviewing their own products and processes in order to prevent a similar occurrence. We urge all kratom suppliers and vendors to evaluate your current processes and determine if you are doing all you need to ensure that no adulterated products reach consumers. If you are a vendor with questions or concerns about this, please contact us [email protected] in order to discuss.

Finally, 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 Phytoextractum 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.

With appreciation,
Phytoextractum

[labdog03]

So in reading this, it is safe to say there REALLY WAS contamination in product FROM Indo and that this was NOT cross contamination from end users or the FDA/DEA or CDC. I guess now we can put that conspiracy theory to rest. Good to know, and good on Phyto for stepping up and doing what needs to be done.

Hard to believe this has not happened before now?...Or maybe it has and people just didn't know what made them sick? In light of all this, I'm wondering if the FDA will ever let up in their quest to make Kratom illegal, or at least FORCE Vendors into cGMP practices? I don't see how they can NOT keep up the pressure on Vendors, since if this happens again, or more often, everyone will point the finger at the FDA and scream "why didn't you do something".

Thoughts?

[kratomandmath]

So in reading this, it is safe to say there REALLY WAS contamination in product FROM Indo and that this was NOT cross contamination from end users or the FDA/DEA or CDC. I guess now we can put that conspiracy theory to rest. Good to know, and good on Phyto for stepping up and doing what needs to be done.

Hard to believe this has not happened before now?...Or maybe it has and people just didn't know what made them sick? In light of all this, I'm wondering if the FDA will ever let up in their quest to make Kratom illegal, or at least FORCE Vendors into cGMP practices? I don't see how they can NOT keep up the pressure on Vendors, since if this happens again, or more often, everyone will point the finger at the FDA and scream "why didn't you do something".

Thoughts?

Thank you for saying this! I'm so tired of the conspiracy theories with this. People need to accept this is part of what happens when set regulations aren't enforced.

[lumberjack]

Good on them for fessing up to it. We need regulation, I would prefer it. Hope this company gets whatever they need to sorted out. I'm sure they will, most Kratom is safe.