American Kratom Association: HHS Rescinds Scheduling Recommendation For Kratom But FDA Failed To Notify The Public For 2 ½ Years

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American Kratom Association: HHS Rescinds Scheduling Recommendation For Kratom But FDA Failed To Notify The Public For 2 ½ Years

American Kratom Association: HHS Rescinds Scheduling Recommendation For Kratom But FDA Failed To Notify The Public For 2 ½ Years

PR Newswire

WASHINGTON, Jan. 28, 2021

HHS cites significant risk of immediate adverse public health consequences to potentially millions of users if kratom or its components are included in Schedule I

WASHINGTON, Jan. 28, 2021 /PRNewswire/ -- Congressman Mark Pocan (WI) and Congressman Morgan Griffith, in exercising their oversight responsibilities over the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), discovered that on August 16, 2018 HHS had rescinded the request for the kratom to be classified as a Schedule I substance under the Controlled Substances Act (CSA).

In the HHS letter to the Drug Enforcement Administration (DEA) HHS recommended that "mitragynine and 7-hydroxymitragynine not be controlled at this time, either temporarily or permanently, until scientific research can sufficiently support such an action." The FDA had made a recommendation for scheduling of kratom on August 31, 2016 that was subsequently withdrawn by the DEA on October 13, 2016 for insufficiency of evidence to support the scheduling under the CSA, and FDA submitted its second recommendation on October 17, 2017 that has been withdrawn by HHS because the scientific research did not justify the scheduling.

HHS concluded that "there is a significant risk of immediate adverse public health consequences to potentially millions of users if kratom or its components are included in Schedule I." The HHS letter outlined 5 specific criteria for "further analysis and public input regarding kratom" before any scheduling should be undertaken. Since the issuance of the recission letter, additional compelling research has further undermined the FDA's claims on the safety and abuse potential for kratom.

"Despite this formal action by HHS, the FDA has failed to make this action public and continued to allow the public; policy makers at the federal, state, and local levels; and the media to believe its recommendation for schedule kratom was actively being considered by DEA despite the fact the science did not support that action," stated Mac Haddow, Senior Fellow on Public Policy for the American Kratom Assocation (AKA). "The FDA abandoned its mandate to protect the public health and instead stood silent for more than 2 ½ years while the opioid overdose crisis deepened, particulary in the midst of the spike in overdose deaths related on the ongoing COVID-19 pandemic, all while HHS had concluded kratom could have helped those using highly lethal opioids."

To view the referenced letter and other supporting documents, click on the following link: https://americankratom.org/pr-documents

ABOUT AKA
The American Kratom Association (AKA), a consumer-based non-profit organization, focuses on setting the record straight about kratom and gives a voice to those who are suffering by protecting their rights to possess and consume safe and natural kratom. AKA represents millions of Americans, each of whom has a unique story to tell about the virtues of kratom and its positive effects on their lives. www.americankratom.org

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SOURCE American Kratom Association