A letter from the Department of Health and Human Services (HHS) went 3 years before being made public. Once again, history goes to show that kratom advocates are fighters.
On Thursday, January 28th, 2021, the American Kratom Association (AKA) announced that they were in possession of a letter from the HHS written in August 2018. The AKA obtained the letter with the help of two Congressmen, Rep. Mark Pocan (D-WI) and Rep. Morgan Griffith (R-VA), who oversee of the HHS and FDA.
The breakthrough: two and a half years ago, the FDA received a letter from the HHS that said kratom did not meet the criteria for being scheduled under the Controlled Substance Act (CSA).
Kratom advocates owe a huge debt of gratitude to the AKA and the member of Congress who made this public. If it’s not obvious, this is huge news.
Why Does The HHS Kratom Letter Matter?
The letter vindicates what kratom advocates have been saying for years. The FDA’s focus should be on contamination and drug interaction research – not scheduling a plant that has helped millions of Americans become normal members of society.
Impacts of the Hidden Letter
Importantly, the Assistant Secretary of Health to the HHS, Brett Giroir M.D., wrote the letter. It contains rational thinking, an understanding of science, and respect for 11+ million American kratom users.
This “pending classification” line was the most valuable tool in the FDA’s arsenal. And they used it to strong-arm and deceive states and municipalities across the country into scheduling kratom.
When regulators aren’t transparent, people don’t know who to trust. In turn, the AKA has been forced to spend countless hours and millions of dollars educating well-meaning public officials who were misled by the FDA. As Mac Haddow writes:
“A perverse outcome of the FDA’s failure to make a timely and appropriate disclosure of the recession of its scheduling recommendation for kratom is obvious. Failing to disclose the recession allowed the FDA to achieve an almost de facto ban on kratom.” (Pg. 2)
Let’s also not forget who this has had the greatest impact on: kratom consumers. As Dr. Giroir warns in the HHS letter “…there is a significant risk of immediate adverse public health consequences for potentially millions of users if kratom or it’s components are included in Schedule I.” (Pg. 3)
The HHS understood that banning kratom would push millions of Americans to look for relief elsewhere. And you don’t need to be a public policy expert to understand where that leads.
Protecting Public Health: Unanswered Questions
The story is still unfolding, so we’re trying to exercise restraint in how we interpret this. Until we have more answers, however, it seems like an abuse of power. The HHS letter explained why the FDA shouldn’t perpetuate the idea that the government was pending a scheduling of kratom. Nevertheless, the FDA continued to promote their agenda.
At Top Tree Herbs, we are excited about the opportunities this letter brings to the new administration. First, the new head of the FDA, whoever that may be, must denounce how the FDA’s has treated kratom consumers.
Second, the FDA must regulate the kratom market fairly. The kratom community is ready and willing to work with the FDA on this initiative. We could build a regulatory framework that is consistent with the current guidelines for similar products, such as coffee.
A New Path Forward for Kratom
Ultimately, we wholeheartedly welcome unilateral product safety standards that everyone in the industry must adhere to. Our tea goes through many layers of testing to ensure it meets our standards for cleanliness and quality.
However, vendors aren’t yet legally held to this standard. That creates serious issues for consumers. They may not be able to access necessary information on the contamination of the products from microorganisms or heavy metals. They may not have any instructions as to the serving size or proper method for consuming the product.
The FDA’s stance is causing excessive and unnecessary public harm. If their position matched the recommendation of HHS, they’d find a number of allies in the kratom community. We all want access to safe, compliant products. We just have to work together to make it possible.