Product Compliance and Safety

This document outlines guidelines and best practices for any businesses that are involved in the bulk Kratom industry, from manufacturers to retailers.

As you should know, Mitragyna Speciosa has unjustly come under attack in both the media and at the state level of government recently. This is primarily due to a lack of accurate information on the benefits of this amazing herb. There is also a misperception that it is a ‘legal high’ similar to spice and bath salts; with no traditional medicinal value.

In our efforts to keep the plant legal, there are some things that you can do to help as a manufacturer, distributor or retailer of this product.

It is very important for those of us involved in the industry to ensure we are following all state and federal guidelines in both our manufacturing and in marketing the product responsibly, as is the case in any industry.

If you are selling your product as a dietary supplement and not for research then you are required to obtain the following documentation unless you are buying a product that is packaged with a tamper proof seal and already labeled with a brand.

A certificate of analysis

This is something that proves that what you are buying and marketing is the product labeled on your packaging. That is, it has not been adulterated or mixed with other botanicals. This is also referred to as a botanical identification. If your supplier does not provide you with this you should ask for it, or contact one of the following labs to get your material tested. Note if you are repacking this material in any way it is always good to re-test the product.

Please note the BLD is not endorsing these places and in no way benefits from listing them:

https://chromadex.com

http://www.alkemist.com/

Microbe panel

(Note this can be included in the certificate of analysis.) This will show that there is no contamination of the material that poses health risks in consumption or contact with the skin.

https://chromadex.com

If you would like more information on what the acceptable levels of Microbes are please take a look at the following website:

http://www.ahpa.org/default.aspx?tabid=223

Packaging and Labeling

Once you have tested your product and verified it is safe now you can pack it. If you are selling as a dietary supplement or for use in bath or beauty products then you must be using a facility that is following GMP practices or following these practices yourself.

Please visit here: http://www.fda.gov/food/guidanceregulation/cgmp/default.htm

And here: http://www.fda.gov/food/guidanceregulation/cgmp/default.htm

Finally you must then ensure your branded product is labeled with compliant labels. BEA has a labeling document that we can provide you with upon request. Note this document is a guideline and often the FDA changes their process so we recommend your final label being reviewed by your FDA consultant or legal counsel.

Please visit this link for more information about FDA labeling guidelines.

If you have further questions please feel free to email BEA at travis@botanical-education.org.