The FDA-Kratom Spat and Scott Gottlieb — Kratom’s Fiercest Critic

    FDA and kratom don’t go together.

    But have you ever wondered why? Is kratom really that bad? If you’ve used it, you know it isn’t.

    Today, I’ll explain to you why the FDA hates kratom. Perhaps the biggest reason behind the FDA-kratom spat was Scott Gottlieb — FDA’s former commissioner and kratom’s fiercest critic.

    Who is Scott Gottlieb? How did the story begin? And what are the current dynamics of the FDA-kratom relationship?

    To find out, let’s dive into a world of politics, personal agendas, and the Big Pharma!

    Scott Gottlieb: A Profile

    Gottlieb hails from a small town in New Jersey, USA, called East Brunswick.

    He attended medical school at the Icahn School of Medicine at Mount Sinai, and a lot of his subsequent endeavors might help us understand his fierce opposition to kratom as the FDA commissioner.

    Gottlieb has a long history with the FDA. He started working for the agency in 2002, initially as a senior advisor to the then-commissioner, and later as the director of the FDA’s Medical Policy Development wing.

    In 2003, Gottlieb left the FDA, only to rejoin it back in 2007, when he helped devise a strategic plan to counter bioterrorism in the USA.

    Here’s where the real story starts.

    From 2007 to 2017, Gottlieb worked with an insane amount of private companies. He served on the Board of Directors of firms like Bravo Health and American Pathology Partners.

    Additionally, Gottlieb worked as a director for Tolero Pharma and the second-largest pharmaceutical company in Japan, Daiichi Sankyo Inc. He also served as a member of GSK’s product investment board and interestingly, on the Board of Directors of Kure, Corp — a company that sells vaping pens!

    In 2017, Gottlieb got nominated as the FDA commissioner. But the real point to note here is that he had to recuse himself from making decisions regarding 20 companies because he had worked with them in the past. 20 companies!

    Gottlieb was very concerned about the opioid epidemic that had America in its grips right from the beginning.

    In a speech during his confirmation hearing, he likened the opioid crisis to those of Ebola and Zika. To curb the opioid epidemic, it seemed Gottlieb would encourage research into alternative forms of medicine — like kratom — to treat opioid withdrawal, and that relationship between the FDA and kratom would actually improve. But no-one could’ve predicted what happened next.

    Personal Agenda and Vested Interests: Kratom’s Persecution During Gottlieb’s Era

    To the surprise (and disappointment) of the kratom community, Gottlieb did the exact opposite of what people were expecting of him — Gottlieb declared kratom to be a potential cause of the opioid crisis.

    He argued that because kratom’s active substance activates the same receptors as opioids do, kratom could easily cause addiction, and therefore, worsen the already widespread opioid addiction in the US.

    What followed was essentially a crackdown.

    Under Gottlieb, the FDA issued multiple warnings to kratom companies and barred them from making any claims about the medical benefits of kratom.

    Kratom companies were now in trouble because they couldn’t provide information and education to potential users. But it was the users who suffered the most — information about kratom, its types, and its benefits became harder to access, and this led to immense difficulty when it came to buying kratom.

    The agency’s justification for this censorship was that it had to prevent the spread of misinformation. But one wonders if that was indeed the real motive behind the move.

    Because while the FDA supposedly prevented the spread of misinformation, it did nothing to promote and encourage research about kratom and its medical benefits. In fact, the FDA has now ignored the American Kratom Association’s (AKA) meeting request for more than 700 days.

    The AKA wants to present the science on kratom to the FDA, but the agency won’t listen.

    Going one step further, Gottlieb’s FDA explicitly warned customers not to use kratom for any purpose whatsoever and upheld the import alerts on kratom (which made importing kratom into the USA almost impossible).

    The tightening noose of censorship around kratom damaged companies significantly and made existing customers doubtful of their choices.

    But was kratom alone in its suffering? No. Gottlieb treated all traditional and homeopathic medicines, and natural supplements (like kratom) equally. He persecuted them all.

    So now that alternative medicine was out of the game, pharmaceutical companies had no-one to compete with. Gottlieb had essentially taken out any competition these companies faced.

    Why? Maybe because he had worked with so many of them.

    Gottlieb’s Resignation and a Glimmer of Hope

    On 5th March 2019, a glimmer of hope suffused through the kratom world when Gottlieb announced his retirement.

    Director of the National Cancer Institute, Norman Sharpless, was sworn in as the acting commissioner, and kratom users hoped that he would stay.

    Sharpless was part of the group that spoke against the intended scheduling of kratom by the DEA in front of a House Committee in 2018. Schedule 1 drugs have no accepted medical use and have a high potential for addiction. Examples include heroin and marijuana.

    Clearly, it was unfair to place kratom with heroin and marijuana. Kratom users were hurt — and Sharpless had spoken against it.

    The glimmer of hope, however, would not last very long.

    Current Dynamics of the FDA-Kratom Relationship

    So, before Sharpless’s sentiments about kratom could become apparent, he was replaced. After all, he was an acting commissioner.

    In December 2019, Stephen Hahn was chosen as the successor to Gottlieb.

    Unfortunately, the FDA’s relationship with kratom hasn’t changed very much under Hahn — it remains as strained as it was during Gottlieb’s era.

    The FDA’s website still warns people not to use kratom for any purpose whatsoever.

    Hope, however, still dangles on a string.

    Because during a conference in 2020, Hahn admitted that although CBD (another product persecuted like kratom) is illegal in the FDA’s eye, people find value in it, and it would be foolish to take it away from them.

    This tells us that Hahn is different from Gottlieb — he cares about what people think.

    Whether or not he’ll realize the love thousands of people harbor for kratom remains to be seen.

    But if he does, we can expect the FDA-kratom relationship to improve in the future.

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