Last month, the American Kratom Association (AKA) revealed that the United States Health and Human Services department (HHS) had rescinded a recommendation to ban kratom nationwide as early as 2018. However, despite mentioning the decision in a letter to the DEA, the HHS never broke the news publicly. And according to the AKA's Senior Fellow on Public Policy, Mac Haddow, the FDA is to blame for that lack of transparency.
"That letter is a very significant finding because it undermines all of the negative [kratom] messaging that the FDA has attempted to promote since 2012," said Haddow during an AKA Webinar (12:00). "[It's] something that should've been released at the time of its actual transmission to the DEA. And interestingly, it was the FDA who asked the DEA not to release [the letter] publicly."
Prior to the letter, Haddow and kratom researcher Dr. Jack Henningfield had met with the HHS to discuss why current science didn't support a kratom ban. Haddow said that the HHS staff was "very receptive" to their explanation of "deficiencies in the [FDA's] science."
After the meeting, Haddow later asked the HHS about the kratom ban's status. At that time, the HHS would've already sent the letter detailing the rescission to the DEA. But Haddow claims the HHS staff told him "there was nothing to report" because the FDA requested that the letter shouldn't be released publicly.
"The FDA used a section of the Controlled Substances Act ... that allows for an agency to sequester information based on administrative review," said Haddow. He noted that the process is supposed to be temporary, but the FDA dragged it out for two-and-a-half years. During that time, the FDA would've had to meet five scientific criterion before resubmitting a kratom scheduling recommendation. And in the end, building a credible case against kratom "... would require many, many years of study and evaluation," according to Haddow — perhaps more time than the FDA had.
"This was a sham by the FDA," said Haddow. "[The letter] is a powerful statement against the FDA's disinformation campaign that they have launched and promulgated over the last six years as they've moved forward with their attacks on kratom and the consumers who use it to maintain their health and wellbeing. All in pursuit of trying to force kratom into the new drug application process and to ban it from literally millions of people..."
Haddow later stated that the FDA's refusal to release the letter brings the agency's credibility into question: "You would think that if the American people were to trust the FDA that they would at least have the good sense to be transparent and provide information that should be publicly available, but they failed to do so." He also believes that the FDA's suppression of information has caused deaths: "As the Assistant Secretary for Health correctly pointed out, it's the responsibility [of] the FDA for the deaths that have occurred because they have kept this secret about the actual pharmacologic nature and the scientific profile and safety profile of kratom."
Haddow also remarked that the FDA Commissioner at the time, Scott Gottlieb, continued to tweet disparaging statements about kratom a day after the letter's transmission. "He acted as though the HHS letter didn't exist, and by the way, in his mind, it didn't, because he had asked for it to be kept secret," said Haddow. "That is unconscionable when it comes to any public official that is supposed to be maintaining the trust and the confidence of the American people."
Congressman Mark Pocan (Wisconsin) and Congressman Griffith (Virginia) are the only reason that the public ever saw the letter. The two discovered and released the letter under their obligations to oversee the HHS and FDA.
Haddow noted that the FDA's suppression of information will influence the AKA's advocacy efforts going forward: "That issue is going to have a tremendous impact on how we work with the states in order to pass the KCPA (Kratom Consumer Protection Act) because it is a fact that the FDA hasn't changed their stripes on this at all."