‘EMBARRASSINGLY POOR EVIDENCE AND DATA’: LOOKING AT THE LEGACY OF THE LETTER THAT SQUASHED KRATOM BAN

Six years ago, the kratom industry found itself backed into a corner by the federal government. 

For the second time in a matter of years, a federal agency had kratom in its crosshairs in the form of an attempt to make the plant a Schedule I substance. This time, it was the Food and Drug Administration (FDA) that drafted a letter to the Drug Enforcement Agency (DEA) to add kratom to the list of substances that were banned for all purposes. 

That was a path the DEA had already traveled–in 2016 the agency pursued the process of scheduling kratom before public backlash squashed that attempt. This time, it didn’t even make it that far. 

On August 16, 2018, a letter penned by Assistant Secretary for Health Brett Giroir reversed that recommendation and set the groundwork to embrace a data-driven approach to kratom policy. Behind the scenes, the letter killed the federal government’s desire to criminalize kratom as science figured out the facts. 

Six years later, that letter has shaped a path toward kratom’s normalization in the United States. 

Giroir’s letter changed the tone around kratom and created the space for scientists and policymakers to give the herbal supplement a fresh look. Since the Department of Health and Human Services (HHS) changed its course on kratom it has had ripples across the political spectrum: instead of banning kratom, 13 states passed laws creating a framework for kratom sales and regulation; rather than pursue another ban of kratom, the FDA has begun looking into kratom and is in the early stages of a human impact study; and most importantly, lawmakers at all levels of government are listening to the science and data–an idea that was at the heart of Giroir’s letter in 2018. 

“This decision is based on many factors, in part on new data, and in part on the relative lack of evidence, combined with an unknown and potentially substantial risk to public health if these chemicals were scheduled at this time,” Giroir said. 

“Further research, which I am proposing be undertaken, should provide additional data to better inform any subsequent scheduling decision.”

A Baseless Ban Attempt

At the time of the letter, kratom was a new frontier at seemingly every level of government. When the DEA first attempted to ban kratom in 2016, the FDA petitioned individual legislatures to take action at the state level, alongside what those officials said was the imminent decision to move kratom into Schedule I at the federal level. That federal follow-up never came, but the FDA did encourage six states to ban kratom with the same evidence that was available to Giroir. 

When it came time to review that information, Giroir would later classify the FDA’s case as “embarrassingly poor evidence & data” in a tweet to the man who led the FDA’s charge to take action against kratom. Rather than trying to pursue a personal perspective on kratom, Giroir considered the data, including a new animal study that indicated a potential positive for kratom. 

Giroir’s conclusion painted the picture of where kratom was headed in terms of public policy. 

“I have reviewed the Acting Assistant Secretary's earlier recommendation as well as previous and new scientific data,” he said. “In light of this review, combined with concerns for unintended public health consequences, I now conclude that…scheduling these chemicals at this time in light of the underdeveloped state of the science would be premature.”

Ripple Effects of the Letter

Following Giroir’s lead, advocates for kratom began approaching state governments with a new idea: Regulating the market for kratom. 

Just months later in January of 2019, a bill was introduced in the Utah state Senate that would eventually become the first Kratom Consumer Protection Act (KCPA). The bill required specific label requirements, set a framework for kratom producers to abide by and established kratom as a food product without an accepted medical use. In essence, it was the exact safeguards that were called for in Giroir’s letter, and it became law in Utah within months of the guidance from HHS. 

Other states would add more restrictions: age requirements for purchase, bans on synthetic alkaloids being added to kratom products and wording that discouraged kratom producers from artificially increasing the potency of their products. As of this year, 13 states have passed versions of the KCPA and a modified bill has been introduced at the federal level in two different sessions of Congress. 

Kratom has also gained momentum in the states where the plant was banned before Giroir’s letter. Wisconsin banned kratom in 2013, a move that state Rep. Robin Vos said was done “inadvertently” when the state tried to ban synthetic marijuana. There has been a movement to overturn that law in recent sessions, with Vos telling the Milwaukee Journal Sentinel that he thinks the past legislature made a mistake. 

"I believe they're wrong," Vos said. "Forty-five states already have no restrictions on kratom."

Despite the progress, kratom is still illegal in Wisconsin. Similarly, Rhode Island passed a law this session to overturn a 2017 kratom ban and regulate kratom sales in the state. On the final day to act on the bill, Rhode Island Gov. Dan McKee vetoed the bill. The bill passed thanks to positions similar to that presented in Giroir’s letter and was then vetoed for the same reasons that Giroir said “lacked evidence.”  

But there is proof of progress. In McKee’s veto of the bill, he referenced an announced human abuse potential study on kratom by the FDA and said he’s willing to “review and discuss these issues” with the sponsors of the bill to try and work out a compromise in future sessions.