kratom

Response to FDA Statement on Heavy Metals

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April 5, 2019

Dear Valued Phytoextractum Customers,

We know many of you have seen the FDA’s most recent statement on kratom, regarding what they’re calling high levels of heavy metals found in kratom products. At Phyto, we hold the health and safety of our customers as our highest priority, and we take our responsibility to provide pure, safe products seriously. Because of this commitment to our customers, we are constantly working to stay current with Good Manufacturing Practices, and we recently underwent a third-party audit to validate our GMP compliance.

We’d like to address a few things in the FDA’s statement:

First, it’s troubling that we have never been contacted by the FDA about high levels of metals in our products. We are registered as a dry food facility with the FDA, which led us to believe that it was incumbent upon them to alert us to any concerns regarding the safety of our products.

Phytoextractum has no information regarding the samples the FDA used in their tests, including when or how the FDA acquired our products or when they tested the samples they obtained.

We can only assume that they were part of samples taken and tested as part of an FDA investigation of an unrelated food safety issue in March of 2018. FDA representatives were at our facility for several days, inspecting, taking samples, and meeting with our company. They never mentioned an issue with metals at that time.

If these samples are from that investigation, their product lots were pulled from the market over 12 months ago as part of the extensive recall we did in cooperation with the FDA. Further, it would indicate that the FDA was rehashing old information, not in an attempt to protect the public, but as a way to target and further stigmatize kratom. 

Additionally, the numbers the FDA is publicizing are misleading. While their recommendations for the presence of heavy metals use the ‘micrograms per kilogram’ format, their recently publicized metal levels are represented in the ‘nanograms per gram’ format.

The FDA is not changing the numbers, i.e. the analytical data, but they are changing how the numbers are presented and therefore interpreted in order to draw more attention to this issue than it actually warrants. If this were an actual threat to public health, we expect the FDA would have moved more quickly to alert vendors and consumers about specific affected products.

While Phyto has always prioritized customer safety, in the year since our product recall we have fine-tuned our policies and procedures to achieve compliance with Good Manufacturing Practices as defined by the FDA and to become an American Kratom Association GMP Qualified vendor. This includes comprehensive lab testing for identity, purity, and contaminants such as high levels of heavy metals for all products.

After learning of the FDA’s statement on heavy metals in kratom products, we consulted our testing laboratory. They reviewed our test results and provided the following information: “all metals analyzed in here are at less than limits concentrations assuming that daily [serving] is 10 g. For example, Lead result is 0.450 mg/Kg with the limit of 0.5 mg/Kg. So, it is a PASS result based on USP limits [see chart below].“

We never introduce products to the market that do not pass rigorous quality assurance tests and meet our own high standards. Our company keeps Certificates of Analysis on file for all products, we and are happy to share those with our customers at their request.

Please feel free to contact our customer support team with any questions you may have about our products or practices.

Georgia State Senate Unanimously Approves Kratom Bill

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Another legislatively victory for the kratom community! The Georgia State Senate has unanimously passed the Kratom Consumer Protection Act, following its approval in the Georgia House by an overwhelming 164-1 vote. The bill now goes to the Governor’s office, to be signed into law.

The Kratom Consumer Protection Act will keep consumers safe from adulterated or mislabeled kratom products. It will also ensure the future of kratom by demanding that responsible, compliant vendors step up to lead the industry. We applaud the work of the American Kratom Association, organizing and educating in Georgia. Of course, this progress would not be possible without the political will and engagement of kratom consumers like you.

Phytoextractum is a proud supporter of the American Kratom Association, and we hope our customers will be too! Their important work is funded by donations and volunteer work from vendors and consumers. Please support the AKA however you are able!

Georgia Update from the AKA:

Georgia State Senate Unanimously Approves Kratom Bill

Utah Passes Kratom Consumer Protection Act

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We’ve just learned from the American Kratom Association that the Kratom Consumer Protection Act has been passed and signed into law in Utah! This important legislation will protect kratom consumers from adulterated, contaminated, and mislabeled products and will encourage a responsible and compliant kratom industry.

We are grateful to the AKA for their leadership on this issue and their diligence in educating Utah’s lawmakers about kratom, to the legislators who championed our cause, and to all the vendors and consumers who supported this effort on the ground in various ways.

Because of the Kratom Consumer Protection Act, consumers are safer – and so is kratom. Phytoextractum is proud to support the AKA’s important work and to be an AKA GMP Qualified Kratom Vendor. We encourage all kratom consumers to learn more about the AKA’s efforts and to support them however you can!

From the American Kratom Association:

Phytoextractum is an AKA GMP Qualified Kratom Vendor

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Phytoextractum is proud to be an American Kratom Association Good Manufacturing Practices Qualified Kratom Vendor. This accreditation demonstrates our commitment to compliance, cGMP (current Good Manufacturing Practices), and our customers. Here are a just a few of the recent improvements we’ve implemented:

• Environmental controls to test for pathogens in the facility
• Revamped sanitation controls policies and procedures
• More rigorous screening process for suppliers and products
• 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

We have always employed extremely stringent receiving, testing, and quarantine procedures to ensure the safety and purity of our products. Within the last few months, we’ve enhanced these processes so we can be sure that we identify any potential contamination or adulteration. 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. Our company is taking all measures necessary not only to guarantee the safety of our customers, but also to protect our industry as a whole.  

Phytoextractum only offers Kratom Tea products for sale that 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 only products which pass these tests will be available to order.

We hope all kratom companies will take seriously their responsibility to prevent unsafe products from entering the market, and 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.

American Kratom Association Phytoextractum

The health and safety of kratom consumers is important to us. It’s why we aim to be compliant with Good Manufacturing Practices and why we’ve recently undergone a third party audit of our facility and processes. The Phytoextractum team is steadfast in our commitment to providing safe and effective products for our customers and we appreciate the opportunity to serve you!

Potential Scheduling & Kratom Ban in Indonesia

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The American Kratom Association recently learned that the Indonesian government, through the Minister of Health, has made a proposal that would categorize kratom as a Schedule I drug. If enacted, this policy would ban kratom exports to the United States, essentially cutting off an important supply chain for American kratom companies and consumers.

The AKA, along with the Botanical Education Alliance and support from vendors like us, has assembled a delegation of lawmakers, policy experts, and scientists to go to Indonesia and meet with high-ranking government officials there. They will make the case, from a policy, science, and economic perspective, that Indonesia should not embark upon this course of action.

Members of the delegation include former Congressman Matt Salmon (a key supporter in 2016 with extensive foreign relations experience in Southeast Asia), Utah State Senator Bramble (sponsor of Utah’s Kratom Consumer Protection Act and chair of the National Conference of State Legislators Foundation International Committee), and kratom researcher Dr. Jack Henningfield. They will be meeting with Indonesia’s Ministry of Health and the Indonesian equivalent of the DEA, as well as with Indonesian kratom growers.

This is a critical moment for the US kratom industry and for kratom consumers everywhere. Please consider a donation to the American Kratom Association to support their delegation’s trip to Indonesia. Your donations are greatly appreciated!

Donate to the AKA today!