Label Guidelines

Kratom Trade Association Basic Product Label Guidelines

The Kratom Trade Association (KTA) is dedicated to the safe and responsible use of kratom botanical products in the U.S. KTA is committed to regulatory compliance and to developing and promoting use of best practices and quality standards for the industry. The following labeling guidelines re ect this commitment, in conformance with the U.S. Food and Drug Administration (FDA) labeling requirements. KTA is adopting FDA dietary supplement labeling “guidelines” for kratom as well as cGMP requirements.

Note: Supplement A contains state and local government special legal requirements for labeling in those jurisdictions that are in addition to the guidelines below. Please check the supplement for locations where you sell product and incorporate as needed.

 

 

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 ClaimsTo 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).

Download KTA’s Labeling guide today