Kratom Claims Guide

There are many ways we describe Kratom — natural, effective, life-changing — but there are certain words businesses should not use when talking about Kratom. While several studies have documented Kratom’s potential, there are phrases we should stay away from until Kratom receives the definitive scientific study it deserves.

 

*Kratom has not been approved for any usage by humans by the Food & Drug Administration (FDA) nor has the FDA approved any of the statements used in this Claims Guide. The Federal Food, Drug, and Cosmetic Act requires that manufacturers and distributors marketing dietary supplements containing “new dietary ingredients” (NDIs) notify the FDA about these ingredients and the basis on which the product is reasonably expected to be safe under the conditions of use recommended or suggested in the labeling.

 

For product labeling see below:

 

Q: What claims may I make about the product on labels?
A: CAUTION: At this time, due to the increased scrutiny on kratom products, we do not recommend making any claims about the product, as doing so may draw additional attention.
General Well-Being and Structure/Function Claims

To the extent you wish to make claims, you may make “general well-being” claims and/or “structure/function” claims.

  • Structure/function claims generally describe the role of a dietary ingredient intended to affect the normal structure or function of the human body (e.g., “calcium builds strong bones”) or characterize the role a dietary ingredient takes in maintaining such structure or function (e.g., “fiber maintains bowel regularity”).  
  • General well-being claims describe general well-being from consumption of a dietary ingredient.

NOTE: In order to make a “general well-being” or “structure/function” claim, you are required to do the following:

  • Have substantiation that the claim is truthful and not misleading;
  • Include the following disclaimer on the product label: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease;” and
  • Notify the FDA no later than 30 days after the first marketing of the product that you are making the relevant claim(s).

Please see KTA Label Guidelines (email info@kratomtrade.org)