All Kratom Vendors Should Sell Kratom As A Food, Since Kratom Can Be Sold Without Any FDA Pre-Market Approval When It Is Classified As A Food
At the 2020 Kratom Leadership Summit in Tampa, Michael Werner from the Holland & Knight law firm presented an excellent legal loophole which can be used to protect the Kratom industry. Specifically, Werner discussed how if Kratom is sold as a food, then it can be sold without any pre-market approval from the Food and Drug Administration (FDA). This is critically important, since the FDA has made attempts to ban Kratom on the grounds that Kratom is a drug, and drugs cannot be sold without pre-market approval from the FDA.
Indeed, this topic was discussed on The Kratom Herald three months ago, although Werner makes it much clearer what exactly this loophole means, and the precise way which Kratom vendors can apply this loophole to protect the industry from FDA over-regulation.
First off, a substance is classified as a food if it is consumed for taste, aroma, or nutritive value. Fortunately, the primary way the FDA classifies food versus drugs is what the manufacturer says about the product. Therefore, Kratom vendors simply need to label Kratom as a food, and avoid making any claims that Kratom is for curing, mitigating, treating, or preventing any disease, and automatically Kratom becomes a food.
On a side note, it is critically important that Kratom vendors avoid making any health claims, since if a Kratom vendor makes health claims, then Kratom automatically becomes an unapproved drug, and the vendor could be charged with illegal drug trafficking, For example, in a case from May 2019 a Kratom vendor was sent to prison for two years and had to forfeit $1 million simply because he was making health claims when selling Kratom.
Back to the topic, if a vendor properly labels Kratom as a food, then it no longer requires pre-market approval from the FDA, meaning Kratom can legally be sold for human consumption without consulting the FDA.
That being said, the FDA still does have the authority to regulate food. For example, if a food is adulterated then the FDA can take action, although as long as Kratom is 100% pure then it is not considered adulterated, and the FDA can’t take any action.
Also, food manufacturers need to follow Good Manufacturing Practices (GMP) guidelines, which are an extensive set of rules for ensuring that the place where the food is manufactured is extremely cleanly. Therefore, all Kratom vendors need to follow GMP guidelines in order to sell Kratom as a food. Additionally, food labels have very specific requirements, and Kratom vendors need to follow these labeling guidelines to sell Kratom as a food.
Notably, Werner strongly advises against labeling Kratom as “not for human consumption”, since the FDA will easily be able to prove that it is for human consumption. The good thing about classifying Kratom as a food is that it can be sold for human consumption and still be legal.
Thus, selling Kratom as a food, via not making any health claims, following GMP guidelines, and using proper labeling is clearly the best way for vendors to sell Kratom, since classifying Kratom as a food allows vendors to legally sell Kratom for human consumption while simultaneously not needing FDA approval.