Statement to Members and Supporters – January 6, 2016
American Kratom Association (AKA) Statement on Regulations, Seizures and the Road Ahead
As a community of Kratom consumers, the AKA, www.americankratom.org, knows the many benefits this wonderful plant can provide. But loving this botanical, a miracle to so many of us, does not satisfy the many regulatory bodies that have jurisdiction over our beloved Kratom. As you know, in 2015 Kratom faced a flurry of regulatory challenges, and there is no indication that 2016 will be any different.
On January 6, 2016, The U.S. Food and Drug Administration (FDA) released a statement regarding another large seizure of products containing Kratom, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm480344.htm. These products made unlawful medicinal claims. While FDA has sent a few signals with small seizures and continues to increase the number of organizations affected by Import Detention Alert 54-15 by adding to the "red list", their recent action, and perhaps even moreso the public release of such action, sends a clear message that manufacturers are not going to be able to skirt around federal regulations any longer.
Manufacturers have known this was a very distinct possibility in selling any form of a product that is not currently considered an Old Dietary Ingredient (ODI) by the FDA. An ODI is any dietary supplement ingredient marketed and sold in the U.S. before 1994 (grandfathered in as an approved dietary ingredient by the FDA under the Dietary Supplement Health and Education Act, or DSHEA of 1994). Kratom is not an ODI, nor is it a New Dietary Ingredient (NDI) approved for consumption in the U.S. While there have been hopes of obtaining evidence that Kratom is an ODI, no evidence has surfaced to date—If anyone has tangible documentation of the sale of Kratom in the U.S. before 1994, access to that information is now more important than ever.
Unfortunately, as a consumer organization we cannot pursue any federal regulatory path, that’s something only individual manufacturers can do for individual products. Our advice for consumers is to encourage their manufacturer of choice to explore whatever options may be required to lawfully sell the products they love. And it’s important to note that this process may not be the same for every manufacturer or every product. The regulatory options are not non-existent, but we are not the FDA, nor are we FDA attorneys that can provide specific counsel.
This does not mean we’ve given up the fight! It’s incumbent upon industry organizations to band together now to determine a way to proceed, together, to ensure Kratom's future availability to all who need and count on it to live better lives. The American Kratom Association can and is willing to help in these efforts, along with organizations like the Botanical Legal Defense, but we cannot lead the charge when it comes to the federal regulatory pathway. We’re hopeful we’ll be able to work with industry partners to pursue the best options for manufacturers and consumers, but there is a long road ahead. To put it in perspective, it takes years, even decades and millions of dollars for incredibly well established organizations to get through regulatory hurdles with the FDA—and sadly some never do.
In 2015, we were successful at defeating attempted legislative bans at the state level in Louisiana and Florida; and we helped open the door to reversing the ban on Kratom in Wisconsin. We got our message out to a lot of important media outlets and we got to know all of you. We focused on growing our membership so that we can be more effective in state legislative discussions during the 2016 legislative session. We’re ramping up our efforts in Florida and Alabama, two states we know will be hot-button states in the first few months of the year. And we need your support now more than ever.
Andy Warhol once said, “It doesn’t matter how slowly you go, so long as you do not stop.” We know we’re facing big challenges in supporting and advocating for Kratom, but as long as we keep going, there is always possibility. As long as we stay in this, together, there is hope!