March 23, 2020
The FDA intent to ban kratom hasn't dimissed even as world health crisis increases. The AKA is working hard to remain vigilent and monitoring legislatures even as closures continue.
FDA officials are telling Congressional members and staffers they remain resolute on pushing their proposed scheduling of kratom’s two primary alkaloids, mitragynine and 7-hydroxymitragynine as Schedule I substances – effectively banning kratom and stopping new research in its tracks.
It seems almost unthinkable that this position would be taken given the new science that has emerged since the FDA submitted their scheduling recommendation in October 2017, and the worsening opioid crisis where kratom offers a far safer option for management of acute and chronic pain.
The FDA is strongly opposed to states passing the Kratom Consumer Protection Act because they claim kratom is an unapproved drug – not a dietary supplement or food. Now, in a dramatic expansion of their anti-kratom campaign, we are seeing some state regulatory agencies are buying the FDA propaganda that kratom has not been approved for use as a tea or food and therefore should be banned. The fact is, there is no premarket approval for food products and the FDA can only react when legitimate safety issues arise.
The FDA does have the authority to approve certain ingredients before “they are used in foods.” Kratom used to brew a tea is not an “additive” nor can it properly be treated as an “additive” unless the FDA wants to claim putting kratom into water for the tea meets that definition. The FDA is now promoting the theory that putting kratom powder into a capsule makes kratom a “food additive.”
This is not the first time the FDA has tried this nonsense. FDA has previously claimed that adding any ingredient to a capsule made that ingredient into a “food additive” simply because it was added to a capsule or tablet. That allowed the FDA to ramp up their enforcement on any food that was provided in capsule or tablet form.
The courts issued a scathing rebuke of the FDA’s position the first time they tried this regulatory plot stating that “the only justification for this Alice-in-Wonderland approach is to allow the FDA to make an end-run around the statutory scheme.[1]” Yet, the FDA is trying to do the very same thing today in reportedly advising state regulatory agencies they should ban sales of kratom as unapproved food ingredients only because they are sold in capsule or pill forms.
The AKA has been forced to open negotiations with the Ohio Department of Agriculture all based on the false information being disseminated by the FDA that kratom is an unapproved food ingredient, particularly when sold in capsule or pill form.
In fact, the capsule or pill forms do not interact with or change the character of kratom, but merely act as a container comparable to a bottle containing liquids for teaspoon consumption. The FDA’s newest recreation of this theory to apply to kratom defies logic and common sense.
- The FDA has been unsuccessful in their application to the DEA to have kratom scheduled.
- NIDA is actively studying the potential value of kratom as a non-addictive alternative to deadly opioids to manage acute and chronic pain.
- The FY2020 Budget Bill approved by the Congress recognized the reports by kratom consumers who are successfully using kratom as an alternative to opioids.
- States are approving the Kratom Consumer Protection Act to stop kratom product adulteration – a job the FDA should be doing.
In the midst of the COVID-19 Pandemic, the FDA’s cynical push to advance their anti-kratom agenda is unconscionable. We have to fight back hard to educate the Congress and state regulatory agencies about the deeply flawed FDA disinformation campaign against kratom.
[1] U.S. v. Two Plastic Drums, 984 F.2d 814 (7th Cir. 1993)
