By Kim DeMott on March 1, 2018
Over the last several months, the Food and Drug Administration’s (FDA) Commissioner Scott Gottlieb M.D. has issued several aggressive and misleading statements in a continued attempt to target the natural botanical commonly known as kratom. Kratom, scientific name Mitragyna Speciosa, is a traditional tealeaf that belongs to the Mitragyna species and is a member of the Rubiaceae family which is the same as coffee. It has been used since at least the 19th century in its indigenous place of origin in Southeast Asia for various beneficial qualities. This tropical tree is used in its raw plant form and the dried leaves are used to make a tea.
The FDA’s attack on the natural supplement began back in November of last year when Commissioner Gottlieb issued a public health advisory in regards to the agency’s increasing concerns about the alleged dangers and risks affiliated with the use of kratom. In this advisory, the two main concerns that are addressed appear to be a 10-fold increase in Poison Control Center Calls from 2010 to 2015 and 36 deaths the agency claims to be “associated” with kratom. Then, just last month, Commissioner Gottlieb released another statement in which he states that they determined kratom compounds are opioids and work like other opioid agonists such as morphine. This determination was made using a computational model developed by the agency and Gottlieb claims that this scientific analysis provides conclusive evidence in that kratom is expected to have similar addictive effects, risk of abuse and can even cause death. Just last week both the FDA and Center for Disease Control and Prevention (CDC) issued statements claiming that there was a multistate outbreak of salmonella infections in 28 people across 20 different states in which 11 people have been hospitalized. This resulted in the FDA issuing a voluntary recall and destruction of kratom containing products while the CDC has urged people to avoid and not consume any and all forms of kratom because it could be “contaminated.”
Looking at these statements, it is easy to see how the FDA could easily sway the public into thinking that kratom is just another dangerous opioid. However, we can’t let that distract Americans from the reality and truth about what this agency is continuing to try to do and that is to demonize kratom. What the FDA is not addressing is just how misleading their statements truly are and how much they neglect to actually put all of this into a realistic perspective. If you take a look at both the FDA and CDC reports, advisories and statistical information that they themselves provide on their websites, you can see just how much they are continuing to try and mislead the public in an effort to pressure the DEA into taking action while turning elected officials and the rest of country against it.
According to the CDC website, salmonella is responsible for an estimated 1.2 million illnesses, 19,000 hospitalizations and 450 deaths each year 1. This means that if there were 28 people sickened, then kratom-containing products make up less than 0.00003 percent of the total number of salmonella food related cases each year in the United States. Another troubling observation about the CDC report is it states that they only interviewed 11 of the 28 people and out of those 11 only 8 had reported consuming kratom. 8 people is no where near the 28 they claimed to have been sickened by kratom-containing products from October 13, 2017 to January 30, 2018. The CDC report also states that kratom was determined as the cause based off of epidemiologic data but they haven’t been able to identify a common supplier or brand 2. It is disturbing that the CDC and FDA are calling for consumers to avoid and destroy all kratom products when there are so many other things like eggs, meat, cheese, poultry and peanut butter that have millions of pounds recalled each year and greatly contribute to the 1.2 million salmonella illnesses a year, yet Americans are not encouraged to completely stop consuming any of those products. In fact, The United States Department of Agriculture (USDA) had 122 recalls and a total of 58,140,787 pounds recalled in 2016 and just last year there were 131 recalls with a total of 20,880,574 pounds being recalled 3. Did they urge everyone to stop consuming all of these USDA products which make up way more of the total salmonella illnesses each year? No. More recently, the CDC announced another multistate outbreak of salmonella linked to chicken salad that has sickened 65 people across 5 states and caused 28 hospitalizations 4. Did they direct people to not consume any and all forms of chicken salad? No. So then why are they asking, encouraging millions of Americans to stop consuming a natural supplement?
The FDA’s claims about a 10-fold increase in calls to Poison Control Centers from 2010 to 2015 are based on a study done by the CDC in July 2016 which fails to mention the number of calls for human exposures they received to put this increase in perspective 5. For example, in 2016 there were 2,159,032 human exposure calls logged in the Poison Control Database. According to the CDC study, there was an increase from 26 calls in 2010 to 263 calls in 2015. So out of the 2,168,371 calls made to Poison Control Centers in 2015 for human exposures, 263 were due to kratom. During this same 5-year time frame there were a total 13,575,496 human exposure calls logged on the Poison Control Database 6. In 2016 there were 13,439 poison control calls for laundry pods, over 20,000 calls associated with hand sanitizers, 17,000 from toothpaste exposure, 16,000 for deoderants and 13,000 for mouth wash 7. An additional CDC study found that there was a dramatic increase in poison control center calls from e cigarettes which went from one call per month in September 2010 to 215 per month in February 2014, an increase of 214 calls per month 8. Other commonly used products like energy drinks had 5,156 reported cases of exposure from October 2010 to September 2013 in which 40% of those calls involved children under 6 9. If the Poison Control Data has shown anything, it is that kratom is far less dangerous than more common substances like energy drinks and e cigarettes and is safer then laundry pods, hand sanitizer, toothpaste, deodorant and mouth wash.
The FDA is also using significantly flawed information when they continue to claim that kratom was responsible for first 36, now 44 deaths which the reports released by the FDA themselves reveal. The fatalities that they list show a wide range of apparent causes from people suffering from various diseases and conditions and/or having other harmful substances in their system all of which also likely contributed to their deaths. Another fatality was determined to be a suicide. 9 of the deaths the agency lists were in Sweden and those were the result of an adulterated product that included the prescription opioid tramadol. Another case that was also listed has been completely redacted and appears elsewhere in an agency database as a death by homicide from a gunshot wound to the chest 10. There is zero evidence supporting that kratom was the sole cause of death in any of the cases listed by the FDA.
Researchers have said that this new computational model that the FDA used seems “inconclusive and does not relate the real life relationship between kratom as a plant and humans.” Scientist have also challenged the FDA’s claims by pointing out that although kratom affects certain opioid receptors in the brain, it is different from classical synthetic opioids like oxycodone, morphine and heroine. Kratom is not poppy based and there is a difference in its biological effects, chemistry and origin. It works on the brain much like chocolate, exercise, coffee and breast milk do. Publicly available research also shows that kratom has a long history of safe consumer use and, that it has been used in other countries such as Malaysia and Thailand for hundreds of years without significant problems such as overdose deaths or widespread addiction. Dr. Andrew Kruegel, PHD, pharmacologist and researcher at Columbia University has said that kratom compounds activate a separate opioid pathway not associated with respiratory depression which is the primary cause of opioid deaths. Numerous researchers have stated that kratom is different for a lot of reasons but mainly it will not depress the respiratory system, which is what is always found in pharmaceutical opiate painkiller induced deaths 11.
The FDAs willingness to accept a computer model over the actual science, including the findings of leading scientist in this field of study and ignoring the backlash from not only scientist but both Houses of Congress clearly shows that not only are they blowing it out of proportion but they are also greatly misleading the public and the media about it. The article How the FDA Manipulates the Media is another perfect example of just how the agency continues to not only mislead the public but the media as well.
Everywhere you look and read there seems to be some news story about kratom. In a nation facing more than 90 opioid related deaths a day and President Trump declaring the opioid epidemic a public health emergency, its easy to see how the FDA could easily create public hysteria about kratom. But let’s face it, its clear that these concerns are being blown out of proportion and aren’t being portrayed from a realistic perspective. The agency is only continuing to use exaggerated, fabricated, misinformation to spread outrageous propaganda to demonize a plant that is being responsibly utilized by 3 to 5 million people across the country to support their overall health and well-being. Not to mention the money, time and resources they are wasting fighting a plant that is helping a millions of Americans.
1. Salmonella https://www.cdc.gov/salmonella/
2. Multistate Outbreak of Salmonella I 4,,12:b:- Infections Linked to Kratom https://www.cdc.gov/salmonella/kratom-02-18/index.html
3. Summary of Recall Cases in Calendar Year 2016 https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-summaries/recall-summaries-2016
Summary of Recall Cases in Calendar Year 2017 https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-healthalerts/recall-summaries/recall-summaries-2017
4. Multistate Outbreak of Salmonella Typhimurium Linked to Chicken Salad https://www.cdc.gov/salmonella/typhimurium-02-18/index.html
5. Notes from the Field: Kratom (Mitragyna speciosa) Exposures Reported to Poison Centers — United States, 2010–2015 https://www.cdc.gov/mmwr/volumes/65/wr/mm6529a4.htm
6. US Poison Control Annual Reports 2016 http://www.aapcc.org/annual-reports/
7. There were over 12,000 poison control calls for people eating laundry pods last year https://www.washingtonpost.com/news/wonk/wp/2018/01/16/there-were-over-10000-poison-control-calls-for-people-eating-laundry-pods-last-year/?utm_term=.c2d4f3ad0a04
8. New CDC study finds dramatic increase in e-cigarette-related calls to poison centers https://www.cdc.gov/media/releases/2014/p0403-e-cigarette-poison.html
9. Documents Link More Deaths to Energy Drinks https://cspinet.org/news/documents-link-more-deaths-energy-drinks-20140625
10. FDA and Kratom. CFSAN Adverse Event Reporting System: Kratom Deaths. December 1, 2017)
FDA Adverse Event Reporting System: Kratom Deaths (February 6, 2018) https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm584952.htm
11. FDA Science Falls Short in the Case of Kratom