GMP

 

KTA Guidelines: Current Good Manufacturing Practices (cGMPs) Standards

KTA’s guidelines adhere closely to FDA regulatory dietary supplement cGMP standards and are applicable to companies that manufacture, package, label, hold/store, or distribute raw kratom ingredients or kratom products.

The entire set of FDA standards is found at 21 C.F.R. Part 111, which are meant to be tailored by each regulated entity to its own particular functions.  For example, if an entity only distributes kratom products (e.g., receives packaged and labeled product from another entity, warehouses that inventory while sales are in process and then ships to the customer without any processing or re-packaging), then only distribution and holding requirements likely will apply to its facility. Each company’s quality system should be appropriately scaled to cover the activities it actually performs.

Many of the responsibilities below may be outsourced to third parties or conducted with assistance from a third party, e.g., labs that conduct testing for pathogens, establishment of specifications for your product.  However, you ultimately are responsible for ensuring your own compliance, so we recommend conducting appropriate due diligence when selecting any contracting parties. KTA resources may be useful to members in this regard.

 

Kratom Trade Association Guide to Good Manufacturing Practices

Ensuring safe, high-quality Kratom products is one of the primary goals of the Kratom Trade Association (KTA). Our manufacturers and vendors adhere to a strict quality control regimen called “current good manufacturing practices,” or cGMP. This sets the pace for what consumers should expect from Kratom, and what all of us in the industry are committed to delivering – superior botanical products for people to manage their health and well-being.

 

 

Download KTA’s GMP guide today.

To sign up and learn more about kratom industry standards, contact us at membership@kratomtrade.org

 

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

 

Webinars

GMP: Protect the Process:  Presented by InstantGMP,Inc. and the Kratom Trade Association


Articles

Good Manufacturing Practices 101: The Lowdown on Prevention Low Quality Products

 

Other Resources

American Herbal Products Association

 

Have more questions?  Write us with your inquiries.