FDA disregards the will of Congress and disrespects American public in comment process for World Health Organization
The AKA will host a webinar briefing Wednesday, August 25 at 8PM to discuss next steps required to stop an international kratom ban. Participants may register at https://us02web.zoom.us/webinar/register/WN_0rAOUtllSj-8MirEh8e8uA
Press should include their name and media outlet for the zoom call.
Following is background related to the FDA’s inappropriate handling of comments and potential consequences of FDA’s misguided actions:
- The FDA received notice of the proposed WHO Expert Committee pre-review of kratom on June 10, 2021 but delayed the required Federal Register Notice soliciting public comments for 42 days until July 23.
- When FDA finally announced a comment period, they only provided a 17-day window (11 business days) for scientists and the public to prepare and submit comments. Not only is that an unreasonable length of time but also a violation of requirements dictated by the Controlled Substances Act and procedural safeguards of the Administrative Procedures Act. It is also a stark departure from the typical 30 to 60-day comment period that FDA permits on such matters.
- In order to guarantee a fair process and reasonable comment window, AKA filed a lawsuit to extend the comment period and won.
- To comply with the lawsuit, FDA reopened the comment portal, but their website was no longer setup to receive comments directly, instead pointing people to a different website which created confusion and established a barrier to public input.
- At the recommendation of an FDA representative, the AKA attempted to hand deliver comments on August 9, but no staff were present to receive them. When the AKA Executive Director called the FDA, a representative said to redeliver the next day (past the deadline) or to submit electronically.
- The AKA submitted nearly 40,000 comments electronically, per FDA’s instructions, yet so far, receipt of comments has not been acknowledged by FDA or recorded publicly.