On August 16, 2018, Brett Giroir, Assistant Secretary of Health for the Department of Health and Human Services (HHS) sent a letter to then Acting Administrator of the Drug Enforcement Administration (DEA), Uttam Dhillon, rescinding a previous HHS recommendation that kratom should be federally outlawed.
Pursuant to the Controlled Substances Act…, I am rescinding our prior recommendation dated October 17, 2017, that the substances mitragynine and 7-hydroxymitrangynine be permanently controlled in Schedule I of the CSA…
..the level of scientific data and analysis presented by the FDA and available in the literature do not meet the criteria for the inclusion of kratom or its chemical components in Schedule I of the CSA at this time…
Furthermore, there is a significant risk of immediate adverse public health consequences for potentially millions of users if kratom or its components are included in Schedule ILetter from HHS to DEA stamped Aug 16 2018
This letter was discovered by Congressman Mark Pocan of Wisconsin after he made an inquiry to HHS. Pocan made the letter public via an announcement on an American Kratom Association live-streaming press conference on January 28, 2021, about a month after he made the inquiry, and nearly two and a half years after the letter was sent to the DEA.
On August 17, 2018, one day after the HHS letter, the acting Food and Drug Administration (FDA) Commissioner Scott Gottlieb took to twitter to rant about kratom from an account that has since been deleted, then archived on FDA.gov.
Scott Gottlieb, M.D. ✔ @SGottliebFDA In July, #FDA warned that a high proportion of kratom and kratom-containing products may be contaminated with salmonella. This week, 2 more companies recalled their kratom products which were found to have salmonella and other bacteria, like c. diff. go.usa.gov/xUe34
Scott Gottlieb, M.D. ✔ @SGottliebFDA There are no proven medical uses for kratom and #FDA strongly discourages the public from consuming it. Kratom is an opioid and it’s an inherently addictive product that can cause harm, which is reason enough not to consume it, but also may make users sick go.usa.gov/xUe3T
Scott Gottlieb, M.D. ✔ @SGottliebFDA If you or a loved one are addicted to the opioid kratom, treatment options are available. #FDA approved medications combined w/counseling & behavioral therapies can help regain control of your life, transition to one of sobriety. Please consult your doctor go.usa.gov/xUe3N
Writing for Inverse, journalist Peter Hess reported on these tweets at the time:
While his first tweet was relatively uncontroversial, the next two in the thread raised some hackles among kratom advocates.
Kratom’s classification as an “opioid” and as an addictive substance are central to the debate over whether kratom should remain legal. In its February announcement, the FDA stated that kratom is an opioid, referencing a computer model of how the active molecules in kratom bind to opioid receptors in the human body. It also claimed kratom was involved in 44 deaths since 2009, citing case reports in which people had died after consuming kratom.
Both of these points have been subjects of great scrutiny. Some experts say the computer assessment doesn’t provide the strong evidence the FDA claims it does, and many have noted that almost all of the deaths cited by the FDA involved other substances that can be deadly on their own.https://www.inverse.com/article/48192-fda-kratom-scott-gottlieb-kratom
Also suspect is the timing of multiple negative media reports, just in the month of August 2018 about “kratom overdoses” and other unsubstantiated horrors. Gottlieb retweeted a Philadelphia Inquirer report by Mari Schaefer published on the same day as the HHS letter. Schaefer has been notoriously anti-kratom ever since the son of an Inquirer staffer died in a car accident in June 2018. The Chester County, PA coroner ruled death by kratom intoxication, then refused to release the toxicology report even when ordered by PA’s Office of Open Records via a request by journalist Nick Wing, who was covering the story for Huffington Post.
Scott Gottlieb, M.D. ✔ @SGottliebFDA Deaths and adverse events from the opioid Kratom are on the rise – Aug 16, The Philadelphia Inquirer. Consumers should take measure of these risks. Safe, effective treatments are available for those suffering from addiction www2.philly.com/philly/health/… Retweeted by @SGottliebFDA
Less than two weeks after the HHS letter and Gottlieb’s tweets were published, an August 28, 2018 FDA press release promoted “the agency’s ongoing work to forcefully address the opioid crisis”… A crisis, they claimed, kratom use contributes to.
we’ve taken steps to address what we believe may be abuse of substances that contribute to the opioid crisis, like gabapentinoids and loperamide or kratom.FDA press announcement 8/29/2018
Though the August 28 press release claims the FDA’s opioid crisis response was “part of a comprehensive approach that the Secretary of Health and Human Services has outlined”, it contradicts the HHS Assistant Health Secretary’s August 16 letter, which listed among the risks of banning kratom: “Kratom users switching to highly lethal opioids.”
As acting FDA commissioner, an agency within HHS, and given the timing of these Tweets, the probability Gottlieb knew about the HHS decision to withdraw a kratom ban recommendation seems high. Yet Gottlieb made no mention publicly of the decision, crucial for millions of Americans who consume kratom. Nor did Giroir, who made the decision. Nor did Dhillon, who received that decision. Nor did anyone else at HHS, DEA, or FDA.
We don’t know why.