If you’ve been a user of Kratom for some time, you’re probably familiar with the ways that Kratom companies have to be careful about what they say and do. Like many alternative brands, there are a number of restrictions that they must follow when it comes to talking about Kratom consumption and effects.
What are these regulations, and why do they affect Kratom vendors even though there aren’t any true rules in the FDA about Kratom? How do these rules work?
While we happily follow the guidance that we have been given about what is OK and helpful to say to our customers, that doesn’t mean that we think this is the best choice. In fact, we believe that some changes to this system would improve the general opinion of Kratom.
FDA Regulations: Health & Structure/Function Claims
Let’s begin by talking about the various regulations that are in place. These regulations affect any company that creates a product in the affected categories. The two many types of regulation that we need to think about today are health and structure/function claims.
Health Claims
The only claims that the FDA requires pre-approval for are health claims.
A health claim must include two specific components:
- 1. A substance (food or food component)
- 2. A disease or health-related condition
Any claim that contains both of these items can be called a health claim. If a claim does not contain both of these things, then it does not fall into the category of what needs to be regulated.
Let’s talk about an example.
A package says that eating more fruit and vegetables promotes better digestion. This would not be considered to be a health claim because there is no specific health-related condition. It also does not talk about a specific food and instead talks about a category of food. Instead, it would be considered to be dietary guidance.
Structure/Function Claims
Another type of claims that we should discuss are what we call structure/function claims. These claims talk about how a specific nutrient or ingredient affects the normal function of the body. Rather than claiming that the substance cures a disease, this type of claim instead talks about how the general well-being of the body can be improved.
For example, saying that “calcium builds strong bones” is a structure/function claim.
When adding a structure/function claim to a product in the US, the FDA does not need to regulate what it says. As long as you have substantial evidence that the claim is true, you are permitted to write about it. Then, you must notify the FDA within 30 days of marketing the product.
The final important aspect of this type of claim is that packaging must clearly indicate that the FDA did not evaluate the claims made. This disclaimer is required, or the FDA could order the product to be pulled from the shelves.
Why Kratom Vendors Can’t Use These
The problem with Kratom is that it is not FDA approved. Most vendors would say that it falls into the alternative health category, but that classification depends largely on how it is imported, sold, and marketed.
Regardless of how Kratom is categorized, Kratom vendors are not legally able to use health claims or structure/function claims.
Let’s break down why that is.
First, health claims are not valid for Kratom.
There is not yet enough evidence supported by the FDA to prove that Kratom can treat any diseases, so there are no valid health claims that can be considered FDA approved and added to Kratom marketing.
There are unreliable Kratom vendors out there who regularly break these rules. They market their product with claims that they can cure cancer or opioid addiction disorders, but these types of health claims are not legal unless regulated by the FDA.
And at this time, the FDA does not support any claims about Kratom, so we can’t say much. This issue is the same in many industries where products and substances aren’t fully vetted by the FDA. So, they cannot make particular claims.
Second, structure/function claims are also not valid for Kratom.
There is not enough substantiated evidence in the eyes of the FDA to make any type of structure base claim. While mitragynine (the main active component in many types of Kratom) has effects on the body, it does not affect the base function level of your body.
For that reason, there is a lot that we as Kratom vendors cannot say about Kratom. We cannot legally make claims about much of what Kratom can and cannot do, and it will likely be some time before Kratom studies are further substantiated.
How You Can Change The Perception of Kratom
You’ve probably realized that there isn’t a lot that we as Kratom vendors are allowed to say about one of the products that we are most proud of working on!
It is frustrating for us to not be able to share what we think this product is capable of, but we understand the need to follow appropriately outlined regulations.
This is one of the many reasons that we support the American Kratom Association’s efforts to get more clarification and guidance about what Kratom vendors can do from the FDA. Because of the lack of regulation, AKA made their own Good Manufacturing Program to help vendors keep their products legal and safe to use.
As a consumer, there are a few things that you can do to help change the tide of how people tend to think about Kratom:
- • Support companies that are part of the AKA accreditation program
- • Share your positive stories and testimonials
- • Put pressure on the FDA and other official organizations to be more transparent
- • Support scientific research about Kratom and its effects
You have the power to make changes to the way that the Kratom industry changes in the next few years; don’t waste that power!
