Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb, who served on the boards of multiple Big Pharma companies before he started the FDA war against Kratom and once again is on the boards of multiple Big Pharma companies now that he has left the FDA, published a letter in November 2017 about the ‘deadly risks associated with Kratom’, and this letter is chock full of double-talk, including that the FDA hasn’t reviewed Kratom yet and therefore Kratom should be avoided.
In the letter, it specifically says “To date, no marketer has sought to properly develop a drug that includes kratom. We believe using the FDA’s proven drug review process would provide for a much-needed discussion among all stakeholders. Until then, I want to be clear on one fact: there are currently no FDA-approved therapeutic uses of kratom. Moreover, the FDA has evidence to show that there are significant safety issues associated with its use. Before it can be legally marketed for therapeutic uses in the U.S., kratom’s risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with.“
In other words, the FDA refuses to do a proper scientific review process for Kratom until someone pays the FDA $1.2 million to review Kratom, which is the fee established for supplements under the Prescription Drug User Fee Act (PDUFA).
First off, the FDA starts the letter by saying they have an obligation to keep the public safe, and it seems like nonsense that the FDA wouldn’t cough up the $1.2 million themselves and thoroughly review Kratom if there was a risk to public health, especially considering that the FDA budget is over 5,000 million dollars per year.
Further, the FDA has spent an untold amount of effort and money over the years to attack Kratom, and the FDA’s misinformation campaign against Kratom continues to this day.
It makes no sense that the FDA would attack Kratom and try to get it banned without first doing their own scientific review process that they do for any other drug or supplement.
In all likelihood, the FDA is bluffing in this statement from November 2017. If the FDA did a proper unbiased scientific review on Kratom, then they would find that it is safe, since Kratom has not caused one scientifically proven death in history and Kratom does not cause any respiratory suppression and has relatively little addiction potential due to activating G proteins while failing to activate beta-arrestin. Also, the FDA would find that Kratom is the ideal pharmacotherapeutic intervention for managing opioid dependence and ending the opioid pandemic, like other scientific studies have already confirmed, aside from a litany of other scientifically proven Kratom benefits including being an effective antidepressant.
The reality is that the FDA does not want to put Kratom through a proper review process, and if they did the chances are incredibly high that they would bias their results against Kratom. This is because the FDA is intimately tied to Big Pharma.
Indeed, a recent article on Kratom Cafe discussed how the FDA receives over $1 billion a year from Big Pharma, essentially making Big Pharma and the FDA business partners. This explains why the FDA has been trying to get Kratom banned, since Big Pharma considers Kratom competition in both the prescription opioid and psych med sectors, and therefore Big Pharma wants to get Kratom banned to enhance their profits, and the FDA is doing Big Pharma’s bidding.
This relationship between Big Pharma and the FDA explains why the former FDA Commissioner would use legal mumbo jumbo like Kratom hasn’t been properly reviewed yet and therefore Kratom should be avoided, while failing to mention that this review process costs $1.2 million, and the FDA could theoretically do the review if they weren’t all about money and really cared about public safety. Basically, the FDA has no good excuse to ban Kratom, so they resort to legal tricks like this in order to try and get Kratom banned.
Indeed, near the end of the letter, Scott Gottlieb says this “To those who believe in the proposed medicinal uses of kratom, I encourage you to conduct the research that will help us better understand kratom’s risk and benefit profile, so that well studied and potentially beneficial products can be considered. In the meantime, based on the weight of the evidence, the FDA will continue to take action on these products in order to protect public health.“
In other words, the Former FDA Commissioner is saying that the FDA wants researchers to scientifically review Kratom, but in the meantime the FDA will act as fast as possible to ban Kratom before such science can be completed, and won’t contribute to the scientific research process for Kratom at all despite their immense resources. This is the definition of double-talk.