The BEA would like to start off by saying: we know that there is a lot of confusion around Kratom and what companies are required to do in terms of compliance.
We are going to keep this updated to Testing Best Practices for Food Ingredients and Dietary supplements, which means this article applies to anyone marketing a product with the intention for consumption or contact with human skin (especially your face).
To quote from the European Journal of Nutrition:
Disclaimer – Minor grammatical and spelling errors have been changed from original
Gone are the days that companies can just simply rely on their raw material suppliers’ certificate of analysis (CoA). Companies have to assume the responsibility for the accuracy of the CoA through testing to verify the accuracy of the data and qualify the data against the company’s own internal specification for all raw material. GMPs require that food ingredient and dietary supplement companies qualify their suppliers if they are going to rely on the data on the CoA.
Unfortunately, dietary ingredients and their CoAs can pass through many hands, especially if brokers of raw materials are used, before making their way to a company’s facility for processing. As a result, this provides plenty of opportunity for contamination and/or fraud to occur. Depending on the nuances of a company’s supply chain, it may not be enough to just compare a CoA against expected specifications. CoAs may not always be a reliable testament to the quality of the ingredient, and proper testing to verify the source may help eliminate this type of adulteration.
If YES proceed to next question
If NO? You need to be doing this to ensure safety of your product.
Due to the recent FDA notice regarding the Kratom and Salmonella contamination, we encourage all manufacturers to take precautions by cleaning all work surfaces and ensuring proper Lot Sampling (one box per 1000 kilos is not enough!) It has been recommended one per 100 kilos and using a probe to ensure you can get from the bottom of the box.
If in the case you are a kratom vendor receiving a FDA notice in regards to a concern about your product, the BEA encourages cooperating with the FDA to resolve the situation promptly. These are matters of federal law and are non-negotiable.
While the BEA, is not able to answer any company specific GMP questions that you as a vendor may have there are resources that can actively do that.
For instance, please visit the AHPA website for various SOP templates (for members) to use as examples. They also have helpful resources, webinars and seminars for all things GMP/FDA related as a dietary supplement company on regular basis. It is well worth the membership.
If you are brand new, we suggest watching YouTube videos on GMP such as this webinar or doing a few googles to learn more. YouTube has a few videos such as the one above that can really explain GMP in a digestible manner.
Until next time, this concludes GMP Best Practices Series 1. The BEA will continue this on-going educational series to help kratom vendors with their journey to becoming GMP ready.