compliance

What We Say: How and Why Kratom Advertising Is Restricted

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Kratom is classified as a food in many parts of the United States. This classification puts limitations on what we as kratom vendors can and cannot say about our products. The FDA limits what is permitted, and we must follow those guidelines if we want to be able to continue to market and sell our products legally.

How exactly do these restrictions come into play, and why aren’t we fighting against them?

Let’s talk about kratom, kratom labeling, and how advocacy organizations are working to improve the misinformation surrounding kratom.

What Can And Cannot Be Said

Ultimately, the FDA has made it clear that they are willing and able to send cease-and-desist letters to any kratom vendor that is publishing what they deem to be unsubstantiated claims.

Even in the articles that we publish, we have to be careful about our language and how we talk about kratom.

In the past, companies selling kratom have made huge claims about what kratom can do, and the FDA pushed back against these. But it wasn’t only bold claims that the FDA warned about; simple, seemingly common knowledge statements have also attracted their attention. 

Risky Statements

What type of statements do we have to be careful about when using on our site? There are many, and it is also difficult for us to follow these limitations. We want to be as open, clear, and helpful as possible for our customers, but FDA rules make this difficult at times.

These are just a few examples of statements that have got kratom vendors into trouble with the FDA in the past:

  • Claiming that people use kratom as an alternative to some medications.
  • Claiming that people prefer kratom over their other medication options.
  • Claiming that people use kratom to help them stop using other things.
  • Claiming that kratom has specific benefits.

We know that these examples are vague, and that is intentional as not to catch ourselves in this trap. As you can see from the breadth of those examples, however, it becomes difficult for honest vendors like ourselves to share any information or evidence with our customers without risking trouble.

What Are Unsubstantiated Claims?

Let’s talk a little more specifically about what the FDA considers “unsubstantiated claims,” which is the most common reason they send out warning letters. We’ve given a few vague examples above, but let’s look at direct news from the FDA to see how they frame their approach.

Specifically, a press report from the FDA states the following:

  • Vendors are selling kratom “with deceptive medical claims for which there’s no reliable scientific proof to support their use.”
  • Vendors “ take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction.”

If the FDA is truly against products that are not backed by science and willing to support kratom research, that would be an understandable position. However, the statement goes on to say that Kratom is an “opioid analog that may actually contribute to the opioid epidemic,” which may be an unsubstantiated claim by the FDA’s own rules.

Additionally, the FDA report states that the FDA is willing to look into how kratom may or may not relieve pain or opioid addiction symptoms if people believe that kratom’s active ingredients show that potential. However, the AKA states that FDA has refused to support that type of research for years.

Simultaneously, the National Institute on Drug Abuse has refused to support scheduling kratom as a drug because NIDA’s own research has not borne out that claim according to NIDA’s standards.

As you can see, it is a very confusing field for kratom vendors like ourselves to navigate. Our goal is always to provide safe, high-quality products to our customers. We want to support those products with information, but it isn’t always an easy thing to do.

The Standards We Follow

How do we handle the labeling and advertising of our products when faced with limitations and concerns about what we can and cannot say?

As members of the American Kratom Association’s GMP Compliance Program, we ensure that our labeling fits these things’ standards. AKA is up-to-date with the FDA’s latest requirements, and they are also at the forefront of helping to implement Kratom Consumer Protection Acts in states across the country.

In short, they know what they’re talking about when it comes to labeling, advertising, and more.

As of June 2020, the compliance program has laid out the following guidelines for vendors and marketing:

  • Labels may not include:
    • Any disease-related or unauthorized health claims
    • Any reference to a “high”
    • Any reference to clinical or research data
  • Labels must:
    • Be fully compliant with FDA claim rules
    • Include a batch or lot number
    • Affirm that mitragynine and 7-OH alkaloids haven’t been altered from their original allocation
    • Advise consumers to talk to a physician about dosing
    • Include a statement that pregnant women should not use kratom
    • Include this exact statement:  “This product is not intended to diagnose, treat, cure, or prevent any disease or condition.”

These same rules apply to the descriptions, websites, and advertisements used when marketing kratom products.

New: The Truth in Labeling Program

Recently, the American Kratom Association has started a reporting program known as the Truth in Labeling Program.

Due to the rise in vendors directly going against the guidelines expected by the FDA, the American Kratom Association and other advocates have seen a need for a program to keep track of and improve improper labeling practices.

Through this program, the AKA hopes to educate vendors that are putting the industry at risk through dishonest practices. If the vendors refuse to change their ways, the industry will start to self-regulate by reporting offenders to the FDA. To read more about how or why the Truth in Labeling Program is meant to work, you can check out AKA’s statement.

How The Future of Kratom Relies On The GMP Program

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The kratom industry in America has always been a bit shaky, especially from the outside looking in. Due to strict rules, importation problems, and changing laws, the status of kratom is not always clear or consistent. This can lead to some fear and discomfort among both kratom vendors and kratom consumers.

Due to this uncertainty, the GMP program was established by the American Kratom Association in an attempt to organize and plan for the future of the kratom industry. Varying laws and disorganization were putting the industry’s future at risk. The GMP program has, in many ways, smoothed out many of those risks.

In this article, we’ll take a deep dive into understanding the GMP program and what it is all about. How can a single program change the future of the industry forever? Find out today!

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All About The GMP Program

If you aren’t familiar with the GMP program run by the American Kratom Association, don’t worry! We’ll cover it (and why it matters for consumers like you) today.

The GMP Program, also known as the Good Manufacturing Practices Program, is a standards program that was set up to help kratom vendors establish a high level of manufacturing. The program sets up certain industry standards that help to ensure every batch of kratom sold is safe and reliable for consumers.

What Guidelines Are Established?

The specific guidelines established by the GMP program are very detailed. If you want to read the full guidelines, you can check them out on the AKA website here.

Generally, these guidelines set up provisions to ensure the following:

  1. Kratom is being tested regularly
  2. Kratom is being tested in batches that are tracked with proper documentation.
  3. The facilities are being managed in safe, secure ways.
  4. The workers are in safe conditions and are also being encouraged to follow safety procedures properly.
  5. The labeling on kratom is not misleading for consumers.
  6. The business is being properly audited by a 3rd party every year.
  7. There are systems in place to track the complete kratom supply chain being used.

Each of these areas, as well as all of the others covered in the complete guidelines, are important to ensure that the kratom sold to customers is being monitored for safety. Before these guidelines existed, there were discrepancies within the community about what level of testing was necessary.

With industry standards like the GMP rules in place, it makes it easier to share and apply all new research about what is best for kratom processing as well.

How Are Vendors Added?

If a vendor wants to join the GMP program, they have to make sure that they are compliant with all of the guidelines. That, however, is just one step of the complete process. Joining the GMP isn’t necessarily simple, but it is a worthwhile time investment for vendors.

Here is what vendors have to do to join the program:

  1. Enroll on AKA’s website.
  2. Complete the initial 3rd party audit within 90 days.
  3. If the 90-day audit window is missed, AKA will work with the vendor to find out if this was a reasonable mistake or if their practices are out of the GMP requirements. The AKA will update their participant list accordingly.
  4. Every year, the vendor must complete another 3rd party audit.

As long as a vendor remains in line with the guidelines laid out by the AKA’s program, they will be able to stay in the program for many years to come.

Why Does GMP Matter?

Has it become clear to you why the GMP is so important yet?

If not, that’s okay!

It can be confusing to pay attention to the behind-the-scenes workings of an industry when you are just a consumer in that area. Let’s focus on why the GMP program should matter to you.

There are a few major reasons why having this program in place is so important for kratom consumers:

  • Gives you an easy way to check if your preferred vendors take safety seriously
  • Ensures that only safe and tested kratom is being sold
  • Helps track any contaminated batches and who bought them if that should happen
  • Builds up the community into a respected, safe place

Kratom’s status in the United States can be scary and confusing when the laws are different depending on where you live. A program like GMP helps to ensure that regardless of limited state laws and actions, the industry as a whole is being held to a level of high-quality.

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Left Coast Kratom and GMP

Left Coast Kratom is a proud member of the GMP program. In addition to passing the initial screenings after we made sure that our business was in line with the guidelines, we continue to update our processes to follow the best practices as they are updated by the GMP program.

As time goes on, we believe that having such high standards in the industry is going to make it a better place for consumers and vendors alike.

Support The GMP Program

The best way that you, as a consumer, can support the GMP program is to make sure that you are only buying from vendors that are actively working towards accreditation or are, even better, already participants.

The complete list of qualified vendors is updated on AKA’s website regularly.

Buying from vendors on this list rather than those that do not take these protections seriously helps to ensure the future of safe kratom in America. When low-quality products make it to the market, they put the entire industry at risk.

Shopping Locally

Kratom lovers that love to shop for kratom locally can still follow this rule by checking out the list of vendors before they hit up their local shop. In the shop, you should be able to find more than one brand option for kratom. And if your local shop doesn’t carry any qualified vendors, you can strike up a conversation and find out why not!

In some cases, they may not be able to source from those vendors, or they may not be aware of the program’s importance. Either way, getting involved with kratom advocation at the local level is a great thing to do.

What Is The AKA? How The American Kratom Association Is Changing Everything

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The world is full of companies and organizations that are working hard to change things for the better. Some of these organizations have bigger impacts on our lives than others, and many have work that goes unknown to a huge majority of the population.

Even as a kratom consumer, you might not be familiar with AKA. What is the AKA? AKA, which stands for American Kratom Association, is an organization that is working to ensure the legality and safety of kratom products for kratom users in America.

While that sentence gives you a brief idea of what AKA is doing in the world of kratom, there is a lot more to learn about if you want to get a full grasp on how they might have an effect on your own life and experiences. Let’s deep dive into the details of this fascinating organization and why we are supporting their efforts in the interesting world of kratom!

AKA Basics

First, let’s cover the most important basics of AKA so that you can find out what the American Kratom Association was founded on as well as what their goals are today.

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What Is The AKA?

The American Kratom Association, often abbreviated as AKA, is a nonprofit organization dedicated to improving the standards, processes, safety, and legal status of kratom in America. 

In order to protect consumers of kratom, AKA is taking a leading position to ensure that the industry is better regulated to ensure safety for customers from both dangerous products and unfair laws.

The Mission

According to its website, AKA’s mission is divided into five main categories. Here’s what AKA themselves have to say about their goals:

  1. 1. Support Consumers. We believe many political and private entities don’t make the needs of the consumer and constituents a priority. Our goal is to change that.
  2. 2. Educate. Kratom has many beneficial purposes and is an all-natural alternative. Our goal is to educate all Americans—from potential consumers to regulators and everyone in between.
  3. 3. Amplify. We represent thousands of Americans that each have a story to tell. We believe the current environment in the United States often does not listen to individual voices and together we will make our voice heard.
  4. 4. Global Awareness. We hope to demonstrate responsible use and practical knowledge other countries may study when considering Kratom legislation.
  5. 5. Protect Natural Resources. Kratom is a precious natural resource. We support and advocate for sustainable harvesting techniques and reforestation efforts.

All of the work that AKA has been doing proves just how committed they are to these goals. Through changes in laws spearheaded by their efforts and changes to the way that kratom sellers are doing business in this country, their effect in the larger American kratom community is apparent. It’s hard to imagine what the kratom industry would look like without their efforts.

We Love The GMP Compliance Program!

One of our favorite things that AKA has worked on in recent years is the GMP compliance program. GMP, which stands for Good Manufacturing Practices, is an acronym used in many different industries. Most industries have a standard level of safety and performance that is expected from manufacturers, but the kratom industry was missing this.

AKA set out to change that.

Through their efforts, the GMP Compliance Program was established, and we are very happy to be members of the program here at Left Coast Kratom.

What Does The GMP Compliance Program Do?

The GMP Program run by AKA sets up a series of standards that must be followed when processing, making, or selling Kratom. The rules require specific types of packaging, testing, labeling, marketing, and educational efforts be made by the vendor. If they do not pass their yearly audit by a third-party, they can no longer be part of the program.

Vendors that commit to following the best practices laid out by the GMP program are more likely to sell quality products to their customers, and this improves the safety for their customers.

Additionally, there are some great secondary effects of ensuring product safety beyond just ensuring that customers are safe. As you might know, many states are considering banning kratom because of outdated and inaccurate data; dangerous kratom supplies can further motivate these types of laws.

By helping to ensure that additional safety checks are in place, it is less likely that any kratom-related incidents will occur in America.

What Is LCK Doing?

To join the GMP compliance program, we took the practices suggested by AKA and improved the way that we were working with our kratom products. While we have always had the safety of our customers in mind, the research done by AKA for the program is incredibly thorough. This meant that we were able to further refine our safety practices to ensure the best for our customers.

Moving forward, we are always sure to follow the examples and guidelines laid out by AKA for the GMP program. The program is hugely important to how we do business, and we hope that our customers are able to feel just how much we care.

Why You Should Love AKA, Too

We’re not the only ones who should love AKA for all the amazing work that they have done in the Kratom industry. You should, too!

As a consumer and member of the kratom community, AKA has already had a huge impact on your life even if you haven’t realized it before. Most vendors in America are following AKA’s lead in safety practices. And if it wasn’t for AKA’s efforts, kratom might already be completely banned in America!

The American Kratom Association is working tirelessly to protect consumers like you, and we think that’s pretty cool. If you want to continue to support their efforts, there are a few things that you can do:

  • • Donate to their work and research directly
  • • Only purchase kratom via GMP-compliant vendors to ensure quality and safety
  • • Join AKA’s local advocacy efforts
  • • Support kratom regulation laws and protections at the local level

AKA is doing everything it can to ensure that you can continue to enjoy kratom safely and legally. Here at LCK, we’re doing our best to follow that same mentality. What will you do to help the community thrive?

Good Manufacturing Practices Matter: Why We Take GMP Seriously

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In every industry, there is an expected standard for safety, manufacturing, and consumer knowledge. For food products, for example, manufacturers must meet health codes and label all products properly before the consumer ever sees them.

In the kratom industry, however, such standards are still being established. Without strict regulation or rules due to the precarious legal status of kratom in some states, some vendors and producers are not being monitored in any way. This leaves consumers at risk, and that’s not okay.

The American Kratom Association has stepped up to the plate to create the GMP Compliance Program, also known as Good Manufacturing Practices. These industry standards are meant to protect kratom consumers, and we can’t wait to see them take effect on a larger scale.

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Introducing The American Kratom Association

Before we get into the specifics of how good manufacturing practices make a difference, let’s introduce some information that you should know about the American Kratom Association. Also known as AKA, this association has committed itself to ensure that kratom consumers and vendors are legally protected.

This means that the nonprofit organization wears a lot of different hats while working, but the main goals that they have set out to accomplish are as follows:

  • • Support customers
  • • Educate politicians, vendors, and consumers
  • • Amplify the voices of kratom lovers everywhere
  • • Raise global awareness of safe and practical kratom information
  • • Protect natural kratom resources

The work that we have seen American Kratom Association do is absolutely amazing. They make a real difference in the way that people can use and access Kratom. For example, they’ve spent a lot of time in the last three years helping to pass legal regulations and protections for kratom consumption in various states.

Our Involvement With AKA

We find that the work the American Kratom Association is doing is essential. Inspired by their mission and messages, we’ve taken a lot of time to ensure that we are doing our part to educate our consumers.

These blog posts, for example, are just one way that we are trying to make information about kratom, how it is used, and what is going on behind-the-scenes in the industry more accessible to anyone who is curious. We hope that consumers like you find these pieces to be useful for your own educational purposes.

Another way that we are keeping up with AKA’s practices is by joining their GMP program. GMP, which stands for Good Manufacturing Practices, are generally standard practices used in specific industries to ensure that all products that make it to consumers are safe and legal. 

These standards did not officially exist in the kratom industry, so AKA has set out to change that. Since AKA created its GMP program, many vendors have taken the time to improve their practices and follow the new industry standard. Some states have even adopted a variation of the GMP rules as official legal regulatory guidelines for kratom in that state.

GMP: Good Manufacturing Practices

What exactly are the Good Manufacturing Practices that the American Kratom Association asks of any vendors who want to be recognized as GMP-compliant? By understanding what these measures are, you’ll gain a better idea of the industry.

The GMP Program

Kratom products are sold as food products, so the only legal requirements placed on them by the federal government are the basic rules set by the FDA. The American Kratom Associate researched what needed to be done for manufacturing, labeling, and verification requirements that go above and beyond what the FDA has in place.

Specifically, the vendors that want to be GMP-compliant must pay attention to the following:

  • • Annual 3rd party audit to ensure all procedures are being followed
  • • Proper personnel training
  • • Clean, sanitary, and functioning equipment
  • • Random sampling for pathogens or contamination
  • • Proper procedures for all aspects of receiving and monitoring supplies
  • • Proper recordkeeping
  • • Manufacturing records according to the AKA’s outline
  • • Keeping thorough batch records
  • • Appropriate quality control standards
  • • Establish and follow a reporting system for any discovered problems
  • • Proper labeling and advertising

The complete guidelines laid out by AKA are thorough, and the yearly audit completed by a third-party carefully ensures that the vendor is following them. If a vendor misses their audit period, they will have to improve their standards and reapply in the future for AKA to consider their reinitiation into the program.

What We’re Doing

We’ve posted before about our efforts to follow these standards. While we are officially recognized by AKA as a GMP-qualified vendor, we are still constantly striving to improve our manufacturing practices.

A few things that we are always doing include:

  • • Finding new ways to test for potential pathogens
  • • Revamping our sanitation controls and procedures
  • • Screening our supplier and products
  • • Testing more accurately
  • • Testing more comprehensively

Everything that AKA suggests that we do, we do our best to implement as quickly and effectively as possible. AKA has done a lot of work to figure out what needs to be done to maintain the safety of kratom, and we appreciate that. The very least that we can do is make sure that we follow their great example!

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Why You Should Care About Quality Control

You might be wondering why we think you care about quality control, and the answer is pretty simple. You should care!

When you use kratom, the product can have some very real effects on your life and body. If you were to be sold contaminated kratom or something that isn’t what it says it is, wouldn’t you be upset? By supporting companies that have good manufacturing practices in place or only buying from those that are AKA GMP compliant, you are protecting yourself.

That’s not the only reason to care about GMP-compliance, either. There have been a few instances of contaminated kratom causing problems for users in the past, and we want to avoid repeating those situations at all costs.

Vendor-focused programs like the GMP programs help to ensure that consumers are protected at the legal level as well. If there are no contamination incidents, such incidents cannot be used to change the laws about kratom. And that is key to protecting the future of the kratom industry!

AKA, LCK, and Compliance: What We Think You Should Know

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If you were to open up a newspaper right now or watch the local news, the chances are pretty high that you would see a story about a company causing problems with untested or fake products. We see it everywhere, and it can make consumers very wary of buying from anyone.

It’s scary, really, to think that you could be buying things without even truly knowing what is in them. 

In the kratom industry, this problem is just as prevalent, and that is why we find the work that the American Kratom Association is doing so important. Today, we’re going to discuss AKA, their compliance programs, and what our role in the future of kratom’s safety is.

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All About The American Kratom Association

Have you heard about the American Kratom Association? If not, it’s time that you learned more about this group, their mission, and how they have already made a difference in your life!

What is AKA?

AKA, also known as the American Kratom Association, is a kratom advocacy nonprofit organization that works to standardize kratom manufacturing procedures, protect consumers, and improve the regulatory laws that affect the industry as a whole.

AKA’s Mission

The mission of the American Kratom Association is pretty simple. Here’s what they want to do:

“Make natural kratom safe and to keep it available for millions of Americans who use it for health and wellness; manufacturers, wholesalers, and retailers whose livelihoods depend on a safe and robust market; and for scientific and research communities that are actively exploring its potential.”

There are a few specific ways that AKA works to do these things. They work with politicians, vendors, consumers, suppliers, shop owners, and more. Realistically, they have become involved at nearly every stage of kratom production and sales to ensure that consumers may continue to safely and confidently use kratom.

AKA Victories

If you’ve ever used kratom before, there is a good chance that work done by the American Kratom Association has already had a positive effect on your life. The organization has been working at every turn for years to ensure that kratom lovers like you can continue to use kratom safely and legally.

While they have had a lot of different victories, these are a few key accomplishments by AKA that have found to be the most inspiring:

These are just a few of the many things that the American Kratom Association has done to help protect the availability and quality of Kratom. In the future, there will be more and more updates to check out from their hard work! 

AKA Science

Another cool thing that AKA puts a lot of money and time into is researching the science of kratom. One of the biggest complaints or points made about kratom when it is being discussed in the political arena is the lack of solid scientific proof for or against its effects.

The existing science doesn’t say it is truly dangerous, but it doesn’t say it is fully safe, either. AKA wants kratom users to be able to know for sure what the risks, potential benefits, and chemicals involved in kratom, and that is why they have put a lot of effort into deep-diving into the science of kratom.

GMP Compliance Program

One of the victories we mentioned above is AKA’s Good Manufacturing Practices program, also known as the GMP compliance program. This program helps to certify that kratom vendors are following complete and thorough safety procedures with all of their products.

To remain in the program, vendors initially accepted must complete a yearly audit with a third-party tester. This auditor ensures that all of the proper procedures are being followed so that consumers are only sold safe and well-tested kratom.

We’re proud to be part of AKA’s GMP compliance program.

We Have A Big Role To Play

Here at Left Coat Kratom, we know that we have a big role to play in the future of kratom. Every day, we connect with customers when we sell our kratom and other products. Every week, people visit our website to learn more about how kratom is manufactured and everything else there is to know about it.

As a reputable vendor, it’s up to us to help support the good name that AKA is helping to build for kratom. We want our consumers to be able to safely and legally use kratom, and we want to ensure that our products are the best that they can possibly be.

With these thoughts in mind, we’ve made it a big part of our mission to ensure we are following AKA’s GMP compliance standards and staying up-to-date with all of their news about kratom. When we can, we even help support their cases in various states to protect kratom’s legal status.

We have a big role to play – and we’re ready to help!

What You Can Do To Help

We’re not the only ones who can make a difference in the future of kratom, however. You, too, can be a key player in how kratom will be used, viewed, and accepted in years to come. While it can be overwhelming to think about becoming an active advocate, your involvement doesn’t have to be that extreme.

In fact, there are a lot of simple things that you can do to make a difference:

  • • Donate to AKA – funding them funds the future of kratom.
  • • Purchase from GMP-qualified vendors – supporting them supports quality.
  • • Get involved locally – visit local shops that sell kratom and see what they need help advocating for.
  • • Support kratom laws – regulatory laws protect consumers like you; show your support for them to make a change.

As you can see, it’s pretty easy to get involved in supporting the kratom industry. It’s in your best interest to seek safe kratom that comes from a vendor that focuses on quality control. We hope that you’ll consider that as you do your future kratom shopping.