GMP

Kratom Products Labels: What They Mean And Why They Matter

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Have you ever taken the time to read the product label on the last batch of kratom that you bought? Do you know what type of information you should see on that type of label? Or are you completely unsure about what it says on the package other than the company and product name?

If you’ve ever taken the time to look at a kratom label, the chances are pretty high that you haven’t found much information there. Due to a lack of regulation in the industry, there isn’t a lot of incentive for companies to include a lot of information.

Here at Phytoextractum, we find that to be incredibly frustrating. What is a consumer supposed to do if they can’t get any information from the label? Are people expected to know everything about a product before they buy it?

Let’s take a look at the complicated world of kratom product labels and what we hope to see happen in the future.

Creating a Brand

The first reason that we’re used to seeing labels on products is to let you know who made it. Brands are eager to put their names and logos on everything that they put into the world because they know that indirect marketing like this can bring them more business in the long run.

Consumers who have used their products before are more likely to recognize their name and logo if they saw it on the packaging, and that recognition can lead them to buy again. That’s why companies put so much time and money into choosing the right imagery, colors, and words for their logos.

Branding is incredibly important in all industries, and the kratom industry is no exception.

Generalized Label Expectations

At this time, not all states require specific information to be included on kratom labels. We believe that this doesn’t mean that general label expectations should not be followed. In fact, we think that the lack of regulation makes it even more important.

Usage

The first thing that needs to be included is some type of instructions about how to use the product. Any relevant information and suggestions from the manufacturer to the consumer can be included here so that the customer sees it.

Warnings

Other things that you can (and should) see on a label are warnings. If there are any cautions, warnings, or other precautionary information that would benefit the consumer to know, it is a company’s obligation to warn the customer about these things.

Many products have warnings that are regulated and must be put on every product, such as cigarettes. For unregulated products such as kratom, however, no such requirements exist.

Stats

Another important thing to include on the label is any specific information about what is in the product. Ingredients, nutritional information, serving size, and more are all examples of stats that you might find on a product label.

As kratom is not under FDA regulation, product labels should not include any type of nutritional information unless otherwise advised by a regulatory agency.

The Complicated Kratom Label Situation

If you know anything about kratom’s legal status, you know that the status is always at risk. While some states have legalized kratom and made moves to protect consumers from unregulated dangers, not every state is as open to the idea of legal kratom.

Because of this, there are no official regulations that kratom vendors need to follow when they sell their products. There are some things that vendors are not allowed to say per FDA rules, but that doesn’t mean they have to say other things instead.

Vendors can put whatever they want on the labels, and we don’t believe that is enough. Though official classification of kratom at levels is still underway, it is possible to label kratom properly.

AKA’s GMP Label Program

For own labeling purposes, we follow the labeling protocol that is outlined within the American Kratom Association’s GMP Standards Program. The AKA is working tirelessly to help protect kratom consumers in America, and we believe that this is a program fully worth supporting.

With the standards laid out through AKA’s research, we (and other kratom vendors) can be sure to protect our consumers to the best of our abilities.

AKA’s Label Requirements

To be part of the GMP program with AKA, you have to follow their guidelines. Many of the guidelines have to do with labels, as you can see in the program guidelines:

  • • The labels, labeling, or advertising of any kratom product should not bear any disease claims (i.e., claims regarding the treatment, cure, prevention, or mitigation of disease) or unauthorized health claims.
  • • The labels, labeling, or advertising of any kratom product should not bear any structure/function claims.
  • • The labels, labeling, or advertising of any kratom product should not reference any research or clinical data.
  • • Each finished product label must include a batch or lot number.
  • • Each finished product should be labeled to disclose the mitragynine and 7-OH alkaloid content of the product.
  • • Each finished product label must advise consumers to consult with a physician for dosing information relative to alkaloid values.
  • • No kratom products may be sold to individuals under the age of 18.
  • • The label should bear a statement that pregnant women should not use kratom products during pregnancy.
  • • All labels, labeling, or advertising should include the following statement: “This product is not intended to diagnose, treat, cure, or prevent any disease or condition.”

As you can see, those labeling requirements can be quite complicated, but that’s not a problem because AKA resources to help clarify things for vendors and consumers alike. The requirements don’t exist just to be complicated. They exist to ensure that vendors and consumers both are protected from the risks and dangers of the industry.

When you’re buying kratom online or in stores, take the time to look at the label on each product. Does the label give you good information? Do you feel like you have a good idea of the product by the time you read through it? If you answered yes to those questions, you should feel confident that you’re making a good choice.

How The Kratom Consumer Protection Act Affects You

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As kratom vendors, we feel that it is our responsibility to help ensure that you, our customers, get the best product possible. We’ve seen a lot of vendors that lie, exaggerate, and act dishonestly about the products that they offer. And that’s the last thing that we want to do.

There is a lack of regulation and control in the world of kratom. Regulation is an important step to ensuring consumer safety. While many kratom vendors are compliant with Good Manufacturing Practices and always have their products tested before selling them, there are some companies that would rather make a quick buck than guarantee the safety of their customers. 

Here at Phytoextractum, we do our best to put time, energy, and money into compliance and into supporting organizations and projects that we believe will make kratom safer and more widely accepted. 

Recently, we’ve been thrilled to see a few states adopt the Kratom Consumer Protection Act (KCPA), and we hope to see these bills spread across the entire country.

What is the Kratom Consumer Protection Act, and why do we think that it is a wonderful thing for vendors and consumers alike? Let’s explore this issue together.

Why Protection Is Needed

At this time, there are not many official regulations about kratom, kratom packaging, kratom sales, kratom processing, or any other aspect of the industry.

Usually, the rules about a product like kratom would depend on what category it is, such as a dietary ingredient or a supplement. Unfortunately, there is not even an official ruling about how kratom will be managed, so vendors are in the position of to marketing and selling kratom without clear guidelines to follow.

Unfortunately for the consumer and the industry at large, that has at times allowed not-so-good kratom to slip through and cause a lot of misunderstanding about the plant itself. Kratom can be a safe product when harvested, processed, and used properly, but not every vendor is in a position to do that on their own.

Most problems seen in the media about kratom today were caused by contaminated kratom that could have been kept off the market if vendors were given better guidance about testing requirements. Without changes, it’s possible that contaminated and adulterated kratom will continue to cause problems for both consumers and vendors alike.

For that reason, we believe that explicit consumer protections are absolutely necessary.

Introducing The Kratom Consumer Protection Act

It’s time to meet the Kratom Consumer Protection Act.

This act is a set of guidelines that ensure consumers can safely and legally buy kratom in the form of consistent, reliable, and unadulterated products. The guidelines offer protections to kratom users while also giving guidance to vendors about the right ways to test, label, and market their products.

There is no reason that kratom vendors should be permitted to sell dangerous and contaminated products on the market, and these laws help to prevent that from happening.

Generally speaking, the guidelines of the act have included the following terms:

  • • Officially defines kratom
  • • Gives vendors and processors guidelines about how to label kratom with specific terminology and disclaimers
  • • Prevents the sale of adulterated or contaminated kratom products
  • • Establishes a penalty system for kratom vendors who break the rules
  • • Requires vendors to register themselves with state regulators
  • • Requires that each state set up testing standards and other procedures for kratom vendors and processors

When companies follow protocols such as these, kratom consumers can feel more safe and confident in their purchases. Additionally, the fear of kratom that has been caused by contaminated products will begin to disappear as the market is overtaken by safe and controlled products.

Who Created These Guidelines?

The Kratom Consumer Protection Act was conceptualized and put into motion by the AKA. AKA, the American Kratom Association, is an organization which advocates on behalf of kratom consumers and vendors. Their goal is to promote safe and legal kratom use. 

AKA is involved in many areas of Kratom advocacy. One of their most well-known initiatives is their compliance program, which tracks the testing progress of Kratom vendors. The program requires vendors to follow Good Manufacturing Practices, including lab testing policies to ensure their customers’ safety.

Here at Phytoextractum, we are fully in support of AKA’s work on the compliance program and the Kratom Consumer Protection Act! We are AKAA GMP Qualified, and we hope to help pass the KCPA here in Oregon.

States With Consumer Protection Laws About Kratom

Since the AKA first introduced the Kratom Consumer Protection Act at the beginning of this legislative session, it has been adopted in a number of states.

At this point, it’s important to understand that every state will need to pass this type of law individually because there is no federal law about kratom. Similar to cannabis, these laws will need to be passed on the state level until the federal government offers more guidance on regulating kratom.

Because of this, every state’s Kratom Consumer Protection Act may be slightly different. AKA has proposed the guidelines to many states in their original form, but state officials may alter them to fit the specific wants and need of their states and constituents.

At this time, these states have passed Kratom Consumer Protection Acts:

In Oregon, the bill has made it through the Senate Judiciary Committee and will be presented to the Joint Ways & Means Committee in the coming weeks for another vote before it reaches the chamber floor.

In addition to several states have passing the Kratom Consumer Protection Act so far, the federal government recently approved funding for more studies about kratom and its effects. We can only hope that the findings of these studies will help to pave the way for more open acceptance of kratom use for its many benefits.

The Future of Kratom Depends On The KCPA

Kratom is at a critical juncture in the United States. Due to some issues with misinformation and contaminated products, the FDA has been looking at kratom vendors and users with a critical eye. As huge proponents of the right to choose kratom, however, we know that that perception needs to change. 

In order to protect consumers and help change the mainstream opinion about kratom, laws like the Kratom Consumer Protection Act must be put into place. These regulations will help ensure that consumers are properly educated and protected while also keeping the industry alive for reputable vendors who care about compliance and their customers’ safety. 

In the end, these laws will be a win-win for everyone involved.

Cheap Kratom: The Scary Risks of Saving Money

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Saving money when you find a great deal is always fun. Whether you have a coupon code or you simply found the same item for a cheaper price, the savings always feel like a big win.

When it comes to Kratom, however, saving with cheap Kratom may actually be more risk than you realize!

Many consumers find themselves comparing different Kratom websites without being sure of what they should look for when they’re choosing Kratom. For many, the lowest price that they can find becomes the Kratom that they invest in. But is this the smartest options?

Honestly speaking? No; it’s not.

While we do our best to make our Kratom available at a price point that works for our customers, we don’t agree with Kratom vendors cutting corners to sell for a lower price or turn a bigger profit. Doing that is downright dangerous, and we believe that you have the right to know why!

The Dangers of Cheap Kratom

Why is that taking cheap Kratom can be dangerous?

Cheap Kratom is usually untested or mixed Kratom which means that you may not know what is going into your body at all. Even though these Kratom products are never advertised as anything but pure, the vendors are not being completely honest with you when they market their products.

Untested Kratom can contain many different substances, all of which have their own unique effects on the body:

  • Dried powder products: mixed into Kratom to add bulk weight
  • Added chemicals: use to fake the chemical composition of the Kratom
  • Pathogens: unsanitary processing can spread disease

These are just a few of the many ways that Kratom can become infected or contaminated with something that you certainly wouldn’t put into your body knowingly! And since these companies lie or disclose the truth about their products, you would never know the difference without additional research.

How Kratom Vendors Cut Corners

Now that you know how low quality Kratom can be dangerous, you might be wondering where along the supply chain these contaminations occur. Where exactly do Kratom sellers and suppliers cut corners in a way that leads to these risks?

Today, we’ll go into a little bit of detail about the different ways that we suspect companies are saving money by skipping essential safety routines.

While we cannot say exactly who does what, our experiences have shown us that these safety precautions are some of the most expensive to implement -and that is a good indicator that they are things that might get skipped!

Lab Testing

Lab testing is one of the most important steps of selling Kratom, and many suppliers fake their lab tests or lie about it altogether. Testing, when done properly, will reveal the exact composition of the Kratom and warn the company about any potential contamination. Regular testing can help ensure that contaminated products never reach the customer.

But Kratom vendors that want to sell at incredibly low prices do not always follow through on testing due to the costs, and that can be very dangerous to you.

Here at Phytoextractum, we know that lab testing is one of the most important things that Kratom companies must keep doing.

Always make sure that a site gives you information about their testing produces before you buy anything from them. If that information is not clearly available, send an email to find out how their testing works and to let them know that you care about seeing the testing results before buying.

Quality Checks & Staffing

Some vendors do not do enough random quality checks or have the proper quality assurance staffing availability to be able to sort, package, and sell their products without increasing the risks that are passed on to customers like you.

If a company is not willing to talk about their QA practices or how they ensure that every order is checked for quality and packed safely, you should keep looking for a different vendor.

Doing The Bare Minimum

The biggest way that Kratom vendors save money is simply by doing the bare minimum.

Because there aren’t many official regulations in place about how vendors must source, store, test, or sell Kratom products, there is no reason for vendors to do more than that if their main priority is their profit margin.

Until regulation and rules become required, however, there are ways that the Kratom industry is working to self regulate.

AKA’s GMP Standards

AKA, also known as the American Kratom Association, is leading the pack to ensure that Kratom consumers aren’t left in the dark about what goes into their products and whether or not it is safe. After all, customers have a right to know exactly what they are taking and how it moved through the supply chain.

AKA has a program called GMP Standards. These standards represent the manufacturing practices that specialists at AKA have determined should be followed to ensure that a truly uncontaminated product is sold every single time.

Joining this program is voluntary and costs the company a bit of money. We happily signed up and are now proud to be one of the certified Kratom sellers through AKA!

Companies that care more about making more money and less about fixing their cheap Kratom problem, however, will not have joined this program. Keep this program in mind as a factor to consider when you choose which company to buy from next time.

You Deserve Safety

Here at Phytoextractum, we understand the power of Kratom, and we also understand the power that we have when it comes to your Kratom experience. We want every single experience to be perfect, and for that reason, we’ve put the time and resources necessary into creating a safe and secure supply chain.

The next time you’re trying to buy the cheapest Kratom that you can possibly find, remember that not all Kratom companies are created equal, and not all companies will treat you equally, either. Do you want to be treated like nothing more than a way to make some extra money? We didn’t think so.

Leave the cheap Kratom in the past, and find the company that cares about you!

Lab Testing: Why Buying Lab Tested Kratom Is Important

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Researching Kratom strains, powders, and vendors will often bring you to these words: lab tested Kratom. Often, sites (ours included!) will talk about why buying Kratom from a vendor that does lab testing for quality on their Kratom is important.

But what exactly does that mean, and why does it matter so much?

We think it’s important for Kratom consumers to be able to make informed decisions about the products that they buy and the vendors that they buy from. To be able to do this, you’ll need to know a bit more about what lab testing Kratom involves, how companies do it, and why it matters so much. Let’s get into it!

What Is Kratom Lab Testing?

Like with all botanicals, it is possible to run Kratom through a series of tests at an accredited testing laboratory to ensure that the powder is what the supplier says that it is.

In the case of Kratom lab testing, the testing is usually done to ensure all of the following:

  • • Identity, i.e. that the plant material is actually Kratom
  • • No pathogens or other contaminants present
  • • Sample does not contain high levels of heavy metals
  • • Kratom isn’t mixed with an undisclosed substance
  • • Amount of common alkaloids, mitragynine, and 7-hydroxymitragynine
  • • Alkaloids are real

For most commercially available Kratom, the amount of mitragynine present is not typically more than 2%. There is usually even less 7-hydroxymitragynine in any given substance unless it has been processed further into a tincture or extract.

As far as pathogens, it is possible that Kratom that is not processed safely by the supplier could contain the following:

  • • Coliforms
  • • Salmonella
  • • Mold or yeast

Finally, the following heavy metals should be tested for in Kratom supplies:

  • • Arsenic
  • • Lead
  • • Mercury
  • • Cadmium
  • • Nickel

When a Kratom seller tests their supply in a lab, they are typically testing for pathogens, metals, and alkaloid content to ensure that their customers will only be sold high-quality Kratom that is not dangerous to use.

Why Is Kratom Lab Testing Important?

The biggest reason that Kratom lab testing is important is to ensure both the safety and the quality of the product that is being sold to Kratom consumers.

Contaminated Kratom can cause illnesses such as a Staph or Salmonella infection, and both of these conditions can be dangerous if not treated properly. If a Kratom user gets sick from their Kratom, they might not even know that either of these infections is a risk to them!

For that reason, it’s very important that vendors do their due diligence and have their supplies regularly tested for quality and safety purposes. Without testing, they could be accidentally giving their customers an adulterated or contaminated product.

Testing is always important when consumables are being sold, and that truth is no different when it comes to Kratom.

Advocating For Safety Testing

Another reason that it is very important to test Kratom for safety is to help dispel many of the misunderstandings and misconceptions about Kratom consumption that are commonly spread.

Kratom consumption is currently a grey zone in terms of its legality. While it has not been banned in most places, it is also not regulated in most places. Instead, Kratom waits somewhere in the middle. And all it takes is one bad batch of Kratom for it to be ruled illegal and dangerous.

As a Kratom vendor, it is part of our responsibility to the community to help prove that Kratom can be safe when used and vetted properly. Like anything that you eat, it can be dangerous if the supplier was not honest about its source. For that reason, it is incredibly important to test Kratom.

Having solid testing proof about the composition and safety of Kratom – in the form of Certificates of Analysis from accredited labs – will help to advocate for its regulation as a safe and beneficial supplement. Any vendor that sells a product without testing is putting both their customers and the entire Kratom community at risk due to bad products.

How To Know If Lab Testing Was Done

Now we’ve come to another difficult part of understanding what goes into lab testing Kratom: how do you know that the testing was completed?

First, you’ll need to check the website of the vendor in question. Because there are not yet any widespread systems of proving whether a vendor tests their product or not, you will need to a little bit of research on your own.

Some vendors have worked with the AKA – American Kratom Association – to show that they regularly test their product and have other Good Manufacturing Practices in place, and this may be noted on their website by a seal that they are GMP Qualified.

If you do not see evidence of lab testing on a company’s website or marketing materials, ask for Certificates of Analysis. Any reputable vendor should be willing to provide you with this document that guarantees lab testing and quality assurance.

Without the legitimate proof demonstrated by Certificates of Analysis, it will be up to you to do the investigative legwork and decide whether or not you believe vendor claims that they tested a product.

Our Testing Policy

Here at Phytoextractum, we are very proud of our commitment to only selling high quality products that pass lab testing and meet all of our other rigorous standards.

In fact, we were one of the first companies to be recognized by AKA as a GMP Qualified Kratom Vendor!

This means that we have proven to AKA, through an independent third-party audit, that we follow all of the standards for both processing and manufacturing Kratom to ensure our customers’ safety. You can read our final audit report which confirmed our status as GMP qualified here.

We hope that today’s article has helped you to get a more complete understanding of what it is that we mean when we say that we are dedicated to lab testing our products to ensure that you are getting the highest quality Kratom that we can possibly offer to you at this time.

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.

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 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!