Hurdles, Talking kratom and the FDA.
Kratom’s legal limbo has made navigating the Kratom community a little tricky. In 2017, the FDA lifted the federal ban on Kratom. This decision solidified Kratom’s legality on a federal level. However, during this process, certain limitations were placed on what retailers and manufacturers could and could not say about Kratom and its effects.
At Club 13, our primary goal has always been to educate our customers about our favorite plant, and it’s wide array of strains and uses. In addition to bringing you the highest quality Kratom products possible, we also want to shed light on the limitations we face when speaking to you.
The Basic Restrictions
As mentioned above, talking about Kratom and how it works can be tricky. Vendors can’t make specific claims about the effects of Kratom. For example, we cannot say that Kratom treats any disease or serves any other medical purpose.
When a retailer or manufacturer claims the effects of their consumable products, that retailer has entered FDA territory. The FDA categorizes product claims in two ways: health claims and structure-function claims.
Claim One: Health Claims
The first type of claim is a health claim. Health claims are the only type of claims that are regulated by the FDA. When you make a health claim, it must be pre-approved before it’s included on any packaging or in any marketing campaigns.
A health claim is a claim which states that a specific substance (food, dietary ingredient, etc.) can affect a particular disease or health condition. If a statement contains both of these components (a substance and a disease), it can be legally considered a health claim.
Claim Two: Structure-Function Claims
The other type of claim is the structure-function claim.
This is a claim that:
Claims that a specific nutrient or ingredient changes the normal function of the body;
Does not mention any specific disease;
Does not present itself as a cure; and
Focuses on improving the body’s overall health
The FDA narrowly limits structure-function claims. No pre-approval is required, and a vendor can make any structure-function claim that is supported by evidence. Still, these claims must be reported to the FDA within 30 days of marketing them.
All products that use structure-function claims for advertising must also include a disclaimer, which says the FDA did not regulate the statements. This is legally required; any products without the disclaimer can be pulled by the FDA at any time.
In the case of Kratom, neither health claims nor structure/function claims are accepted by the FDA. So, even though we can’t say everything we wish we could say, we can still tell you to go out there and do the research for yourself. And we can proudly say that Club 13 is the nation’s most trusted brand of pure, organic, and wonderful Kratom!
So what else CAN we say about Kratom? We’ve said a lot already! Read more here!