AKA Formally Demands FDA Rescind Inaccurate Advisory Regarding Kratom

The American Kratom Association is taking the FDA to task for their blatantly false claims regarding the herb that has been safely used as a folk medicine for hundreds of years. Several statements the FDA made were lacking any basis in reality. For instance, they claim it is responsible for multiple deaths when not one death has been causally linked directly to use of kratom. Neither is it an opiate or opioid. Claims that it has "opiate-like effects" ignore the fact that coffee, dairy and cheese products, even aerobic exercise, can also cause opiate receptor binding.

AKA feels the FDA's misinformation is potentially dangerous. Kratom is the only thing keeping thousands of chronic pain patients and former opiate users away from the opiates and opioids responsible for over 30,000 deaths last year. The FDA released an "advisory warning" using information that the AKA asserts is based on “discredited, incomplete, and mischaracterized scientific claims.” As a result, they are formally asking that the incorrect statements be rescinded. AKA is currently initiating a formal dispute resolution (FDR) petition with the U.S. Department of Health and Human Services (HHS) to challenge the FDA claims.

From a portion of the AKA statement:

<blockquote>“For years, the FDA has published scientifically inaccurate information on the health effects of consuming kratom, directly influencing regulatory actions by the DEA, states, and various local government entities. AKA believes the FDA health advisory on kratom will lead to more state and local bans, all based on discredited, incomplete, and mischaracterized scientific claims …”</blockquote>

President and Board Chair of the AKA, Dave Herman expressed his (and the kratom community's) fears that making kratom unavailable would only increase the number of people hooked on dangerous opioid drugs: “We care very much about the health and well-being

of the kratom community and that is why we welcome a full-scale review and the eventual rescinding of the FDA’s latest attack on kratom. We know from surveys that kratom consumers are concerned about being forced to seek relief by using illegal opioids in the event that kratom is banned. It would be an outrageous and unacceptable public health outcome if the effect of the FDA assault on kratom backfires and leads to more opioid addiction and death. The very real possibility of this kind of unintended consequence happening in the wake of FDA-inspired restrictions on kratom should give any responsible legislator or regulator real pause.”

The current opiate crisis results in thousands of deaths, mostly due to respiratory depression. Unlike prescription opiates, kratom has never been known to result in lethal respiratory depression or toxicity. Kratom is safe by comparison even to coffee, it's botanical cousin in the Rubiacea family. A research study released in May reported 50 recent deaths due to use of caffeine. The deaths previously attributed to kratom involve the use of other drugs which weren't taken into account. The previously announced figure of "15 kratom deaths" has been previously debunked numerous times. 9 of the deaths were due to the opioid research chemical O-desmethyltramadol and others involved contraindicated drug combinations and/or presence of other substances such as benzodiazepines and morphine.

A meta-review aggregating data from decades of use of kratom in its native South East Asia as well as numerous other recent independent studies and surveys show that

In fact, a review of decades of data from South East Asia where kratom use is common, and of all data from the US, including four recent independent surveys involving thousands of kratom consumers, indicates that “kratom is more likely a path away from opioids than a path to opioids,” this according to drug abuse authority and Johns Hopkins University professor, Jack Henningfield, Ph.D. Dr. Henningfield was the author of the 8-factor analysis of kratom that was delivered to the DEA and FDA November 29 of last year.

Dr. Henningfield's analysis concluded that restriction of kratom is not only unwarranted from a public health perspective but is actually more likely to create more issues. He also noted that kratom consumption has not become a public health or medical problem (unlike, for instance, abuse of processed sugar, culpable in millions of death). Dr. Henningfield also discovered that kratom is primarily preferred as a natural "home remedy" over opiate and other substances for its lack of intoxicating effects and other negative sides. The effects of the primary constituents of kratom were found to be generally mild and contribute to increased work productivity, quality of life and social relationships, especially as compared with prescription opiates for pain management.

Though kratom is psychoactive, it is most definitely safer than other legal psychoactives. Nicotine, alcohol and caffeine are responsible for multiple deaths. Even apparently benign over-the-counter substances like Tylenol or antihistamines are known to cause hundreds of deaths per year. Water and salt have a much higher potential for toxicity than kratom. At present, there has not been one single verifiable death due to kratom overdose. In addition to the favorable safety profile, kratom has been shown to have a whole host of positive medicinal and overall health benefits. Kratom is an immunostimulant and has been theorized as a possible treatment for PTSD, fibromyalgia, neuropathy, anxiety and other conditions.

In addition to health benefits, it is actually much safer for long-term use than several over-the-counter drugs such as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs pose serious GI and cardiovascular risks. The FDA statement also contradicts current scientific literature on the subject.

AKA notes:

<blockquote>“The published research of prominent scientists at Columbia University, Johns Hopkins University, the University of Mississippi School of Pharmacy, University of Florida College of Pharmacy, and Rutgers Robert Woods Johnson Medical School stand in stark contrast to the poorly articulated FDA staff recommendations on the hazards of kratom use.”</blockquote>

It's a year now since the historic back down of the DEA in their attempted scheduling and they seem to be passing the ball over to the FDA. For those who have been a part of the kratom community for some time, this should be familiar. For years now, the FDA and DEA have been relying on factually inaccurate information and trading off responsibility for attempting to restrict the use of this plant panacea. It may be possible that at this point, it's not just "business as usual" (i.e. protecting corporate interests of some of the pharmaceutical billionaires, such as recently indicted Fentanyl manufacturer). I'm afraid that the embarrassment of losing the last battle has made this personal.