compliance

Kratom Ads: What’s Allowed and What’s Not? | Why It Matters

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Did you know that there are many limitations put on what we can and cannot say about kratom? Even when new science points out exciting possibilities for kratom, we can often not share that news with our customers due to FDA regulations. 

What can we put on our kratom labels, and why does this matter so much in the industry?

Today, we’ll give you some deep insight into what is and what is not allowed when it comes to kratom advertisement and how we are working to improve that. The restrictions in place may be shocking, but they are the reality of what the industry must deal with.

The Truth About What We Can Say

Here at Phytoextractum, we do our best to keep our customers informed with the latest news in Kratom while ensuring our advertising and labeling first with all current guidelines. It’s not always an easy line to walk, but we do our best.

Our Product Information

When you visit our website and browse the kratom products that we have available, there is certain information that you will always find:

  • Product name
  • Product strain
  • Product strain origins
  • Product active ingredients
  • Testing information

You will notice that our product pages never mention any specific benefits that consumers might look for from kratom, nor do we give guidance about using kratom for any specific conditions.

Avoiding Unsubstantiated Claims

The biggest thing that we have to avoid when writing up any product labels, descriptions, or articles is that the FDA would consider unsubstantiated claims.

Under FDA guidance, there are two types of claims. Health claims are claims that must be pre-approved by the FDA and specifically address how a product or ingredient treats a specific condition or symptom. Structure/function claims are claims about nutrient effects that can be used more generally, but they still must have enough evidence to support these claims.

The FDA does not permit kratom vendors to use either health or structure/function claims as they do not currently recognize much of the ongoing research about kratom and its potential effects.

AKA’s Compliance Guidelines

In addition to paying attention to the latest news about kratom out of the FDA, we use the GMP compliance program rules from the American Kratom Association to guide what we do and do not say about kratom in our advertising and on our labels.

Essentially, this means that we do the following on our labels:

  • We do not say that kratom can treat any specific disease, nor do we include any specific research data, clinical studies, or health claims as the FDA could claim they are unsubstantiated.
  • We always include a disclaimer that our products are not intended to treat any specific disease or condition.
  • We ensure that our products affirm that we have not altered the content of the active ingredient in any way.
  • We make sure our products all have the appropriate batch and lot numbers.

By extension, we are also careful not to make any specific claims about what kratom can and cannot do in our marketing as well. We have seen how the FDA prevents vendors from sharing these types of experiences or ongoing research areas, so we reduce our risk by covering other areas instead.

FDA Pushback

The back-and-forth between advocates for the kratom industry and the FDA has been going on for years. While the FDA continues to try to push for the scheduling of kratom as a drug, the National Institute of Drug Abuse has concluded through their studies that it does not qualify for scheduling at this time.

Still, the FDA continues to ignore ongoing research and considers all claims about kratom to be unsubstantiated. Simultaneously, they affirm that kratom research suggests it may be just as dangerous as opioids, which is an unsubstantiated claim by their own terms.

Ultimately, the FDA’s conflict to settle on reasonable and measured regulation of the kratom industry will continue for years to come.

The Future Of Advertising And Labeling

The restrictions placed on kratom vendors is dangerous, and we’re not just saying that because it can be challenging to know what we can and cannot legally say!

Strict limitations are put in place without giving clarity to the kratom industry at large, leading to a lot of confusion for customers. High-quality vendors like us take these restrictions seriously while other companies ignore them and make bold, inaccurate claims.

As a consumer, how are you supposed to know what is and what is not okay? Without clarity or approved regulation from the FDA, consumers are left in a dangerous position.

Implementing The KCPA

One way that the American Kratom Association is addressing this problem is by working with specific states to implement the Kratom Consumer Protection Act. These acts function on the state level and ensure that kratom vendors working in that state must follow guidelines. These guidelines provide information on how labeling and information should be handled and regulated. 

Truth in Labeling Program

The AKA also recently started a program known as Truth in Labeling. Through this program, companies that are making bold or unsubstantiated claims can be reported to the group. AKA will then reach out to the vendor to help them get their labels under control.

If the vendor continues to risk the industry’s future by refusing to comply with FDA protocols, the vendor will be reported to the FDA. This process will begin the self-regulation that is present in other industries.

Keep Yourself Informed

While we will continue to ensure that we provide as much good information as possible while also creating our high-quality products, we urge curious consumers to stay up to date through other sources.

Kratom vendors like us are limited in what we are permitted to say because unsubstantiated claims could cause the FDA to target our business. Still, other organizations such as the American Kratom Association can share more research, statistics, and information.

To stay up to date with the latest kratom news, visit AKA’s website today.

Quality Tips: How To Choose The Right Kratom Vendor For You

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One of the most appealing parts of modern technology is the options that it gives us. When we want to buy a new picture frame, we can check out dozens of prices and styles online before we choose a seller, buy it, and have it shipped our way. Never have there been more choices so easily accessed.

With so many more options, it can become difficult to decide which is the best because it becomes overwhelming.

Buying kratom is no different from buying anything else when shopping online. There are dozens of websites that sell various strains online, and your local CBD or herbal store might carry some as well. How do you decide where to buy something like kratom when it can be impossible to see the differences?

Choosing the right vendor is very important when purchasing kratom, especially if you will be buying it online. We’ll cover how to choose a vendor and why you should be careful in today’s tip roundup.

Tip #1: Ask Your Friends

Do you have friends that use kratom regularly? If so, those friends can be a great resource when choosing a vendor for your next kratom purchase. Everyone has different standards, but it is likely that everyone with kratom experience will be able to give you a good picture of what to expect from the vendors that they have tried.

If you don’t have a lot of friends that personally use kratom, reach out to an online kratom community and see what they have to say about vendors. Everyone who has purchased kratom a few times will have at least some information about their experiences with those particular vendors, and this information can help you to make more educated choices.

Tip #2: Consider Reviews Carefully

Reviews on the internet are a complicated topic. While they can be a great way to get an idea of how much people like a product, there is always the risk that the reviews found online are secretly commissioned or sponsored by the vendor themselves.

For that reason, it’s always important to consider reviews with balance. Take the things that are mentioned seriously, but don’t fall for reviews that seem too-good-to-be-true; they probably are. Think logically as you read through each review, and you’ll be able to get valuable information from them.

Banner For Kratom Products
 

Tip #3: Shop For What You Enjoy

Another way that you can decide where to buy your kratom is to decide what strain, blend, or variety you want to purchase first. Even though there is considerable stock overlap between vendors, not all shops carry the same items. Kratom strains that are rarer or specially blended by a vendor will be harder to find, so you want to choose based on that.

If you’re not very particular about which specific products you want to buy, you can skip this tip and instead move to tip #4 to help you learn about vendor reliability while shopping.

Tip #4: Certifications, Reliability, and Policies

Let’s talk about what it means to be a reliable kratom vendor. Here at Phytoextractum, we think that it is incredibly important to keep an eye on our quality so that our customers don’t receive anything from us except the very best kratom.

Kratom safety has been a concern for the kratom community for a few years, and we fully support the efforts by groups like the American Kratom Association to ensure that safety is a reality in the community.

As such, we have spent time and money, ensuring that we follow their manufacturing guidelines and have all of the necessary certifications. When shopping around at various kratom vendors, these certifications can be a guide for you. After all, wouldn’t you feel more comfortable buying from a vendor that cares about that type of safety regulation?

Contaminated kratom has made it to the market in recent years, and we don’t want to see that happen ever again. We’ve implemented additional testing procedures, and we know that all reliable vendors would be proud to say that they have done the same.

Before you buy from a new vendor, check the following:

By checking into these items, you can quickly discover if the vendor takes safety as seriously as they should.

Tip #5: Seek a Partner

We always mention that we believe the process of using kratom is always changing. As new information, strains, and techniques come into the community, you are consistently going to need a way to become informed about these things.

For that reason, we think it’s really important to choose a regular vendor that also offers educational support. You don’t need to enroll in kratom school, but knowing that your favorite vendor has a blog with up-to-date and detailed information can help you to feel more secure when making choices in the future.

One of our favorite parts of our website is our blog! There, we take the time to write up detailed information full of tips, tricks, and research that you might not find otherwise. Any vendor that goes out of their way to ensure that you know what you’re dealing with is likely to be a good quality choice.

Keep Your Options Open!

If you haven’t already done so, we’d love it if you give our online store a try. We always source high-quality products, and we do our best to ensure that our customers are always able to have the most positive experience possible.

Of course, we don’t think that you should only consider us! There are a number of reliable kratom vendors out there. Trying out a few different vendors makes sense as long as you are sure that they are selling safe, reliable strains of kratom. Doing this, you’ll get a better idea of what best fits your wants and needs, and that’s essential!

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. 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.

Buy Kratom online at Phytoextractum

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.

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.