labeling

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. As kratom is only categorized as a supplement or herb, we cannot give this type of guidance.

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 supplement 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.

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.

PHYTOEXTRACTUM

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