Returning home from Indonesia, we tried bringing with us a sizeable amount of Kratom. We of course declared it, but it was confiscated by the US Border and Protection Agency on behalf of the FDA according to reasons established in Import Alert 54-15.
That was not the first time a shipment of Kratom sent to us had been stopped by Customs, but it was certainly the instance that caused us to be investigated by the FDA and what got us placed on their “Red List”.
At the time, our position as a company was that we were only selling Kratom to be used as an ingredient in soaps and cosmetics. As we understood it, that was the only way the FDA might consider admitting Kratom into the U.S.. Unfortunately, in their investigation, the FDA dug up some comments that we had made on the www.ILoveKratom.com forum that suggested that Kratom is used for consumption. Yes, that was our mistake, and it cost us our business.
We have already spent many thousands of dollars on legal fees in attempt to maintain a method of importing Kratom, but we got to the point where we realized that it would cost many tens of thousands of dollars more to complete our case, and even if we won, we wouldn’t be any further ahead than any other new business selling Kratom. At this point, we recognize that it is simply not worth it for us to continue. A better use of that amount of money would be to pool it with other vendors and try to change the laws, however at this point, we need to focus on other avenues of earning money.
We would however like to share this with other Kratom vendors out there: until the FDA changes it’s policy under USC 22 or retracts Import alert 54-15, the FDA is going to consider Kratom powder as a product that is meant for consumption, no matter how well you try to market it and label it for another purpose. Unless you can provide evidence that all your customers are using the powder directly for making soaps, or cosmetics, or whatever, the perception is that you are selling it for consumption, and the FDA will confiscate your shipments. So don’t bother trying to market it as something other than for consumption. It is a waste of time. We tried because we thought that might be the only route for us to be able to import Kratom into the country. We were very careful and distinct about marketing our product as a bulk botanical ingredient for the purpose of making soaps and cosmetics only. We had all of our paperwork in order, we had a broker, packaging that met FDA requirements for cosmetics, but in the end, none of that mattered, the FDA still withheld our shipment until they had a chance to investigate. So our advice to you is that if you want to sell Kratom, know that you are taking a risk, but you might as well stand up for what you believe in and market it for consumption with truthful labeling and keep trying to change the public perception of Kratom. Sell it for what it is, a great product!
It is also worth noting that we also considered a number of other avenues in which one might be able to get Kratom to be approved somehow by the FDA. I spent a significant amount of time researching New Dietary Ingredient (NDI) Notifications. There have been a few more than 200 that have been submitted since DSHEA was passed in 1994 and after studying them, it has been observed that in the early years, while the FDA was still figuring out how to review and respond to the notifications, many of the New Dietary Ingredient Notifications were not denied, but in more recent years, only a very few have not been denied. Nearly everything is being rejected, including shiitake mushroom powder. And by reviewing the FDA responses to each, it seems that in order for an NDI Notification to not be denied, the bare minimum requirement is that the research must at least include one clinical trial of a NDI at the suggested levels of consumption with no adverse reactions in order for it to be considered “reasonably safe”. This of course is a very expensive requirement to achieve, and certainly not an option for us… I did however draft an argument, that if supplemented with such a clinical trial, might possibly be the quickest avenue to allow Kratom to be “not denied” as an NDI, assuming that there is not some crazy death streak that would cause the FDA to change their mind at some later time and then declare it unsafe.
The other obvious option might be to submit a Generally Regarded As Safe (GRAS) Notification, by which it is the duty of the FDA to prove that a product is not safe. This might be a better approach than the NDI if multiple clinical studies were done to address various dosages, however, that might be an even more expensive route, and in either case, the FDA will be acting as both Prosecutor and Judge, and neither Notification is likely to change the status of Kratom unless clinical trials have been completed and can provide enough evidence to them that it is as safe as we all know it is…