Bring Awareness: Face The Facts!
Last year I tried to bring attention to the natural substance known as Kratom and the DEAs attempt to ban. Kratom has been scientifically proven to be safe! Within this past year TWO 8 Factor Analyses totaling 383 pages of factual scientific data highlighting the positive safety profile, non-addictive potential, and overall low abuse profile of kratom!
Pharmaceuticals are the leaders in this widespread opioid epidemic. I am one of the many effected by pharmaceutics forced drugs leading to chemical dependency. Several years of being prescribed narcotics to include hydrocodone, xanax, then to subutex. The clinics did not want to dose down so I started detoxing with Kratom. Within 60 days I was drug free! -
Andrea D. Jackson
Write Your Legislatures!
(Sample Letter)
We write today in regards to the November 14 FDA public health advisory on kratom, a traditional tealeaf and dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(ff)(1)], that is supported by millions of Americans nationwide. This advisory comes to us one year after the DEA attempted to emergency schedule kratom and its natural constituents in September 2016. This unprecedented action prompted 51 members of the House of Representatives and 11 U.S. Senators to request that the DEA delay the order, gather additional information and science, and allow time for a public comment period. The 6-week comment period garnered over 23,000 comments: 99.1% of Americans requested kratom remain legal and 0.49% were for scheduling the herb, while the DEA deferred to the FDA for the additional facts and science that elected officials and Americans requested.
University professors and scientists, world-renowned addiction experts, and the nation’s leading toxicologists came together to produce not one, but two 8 Factor Analyses totaling 383 pages of factual scientific data highlighting the positive safety profile, non-addictive potential, and overall low abuse profile of kratom. The recent FDA advisory statement claims that kratom “has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases, death.” This statement is contrary to the overwhelming science that has been presented before us by countless researchers and scientists alike. The FDA’s own Adverse Event Reporting System (FAERS) database, looked after by the FDA, shows that between 2011-2017 there has not been one single death attributed to kratom alone in the U.S. while TOXNET, Toxicology Data Network, documents no deaths attributable solely to kratom, as reported in Dr. Sawyer’s sworn affidavit signed November 30, 2016. The most recent information collected by the U.S. National Poison Data System, and published in the journal Clinical Toxicology , shows “no deaths whatsoever from dietary supplements across the board or any other dietary ingredient.” Scientific study has proven that mitragynine, a natural constituent of the kratom leaf, will not cause respiratory depression, which is how most opiate overdose deaths occur.
The FDA advisory is also concerned with kratom products being marketed to diagnose, treat, cure, or prevent disease. We applaud the FDA for sending notices to companies that are making therapeutic and drug claims about kratom products. In recent years the majority of responsible manufacturers have properly labeled their products and have followed cGMP guidelines for manufacturing. Some states even restrict sales to minors and most companies’ labels reflect this.
Given these facts, there is more than enough research and evidence in support of kratom being a safe herb that millions of Americans use to support their health and overall well-being. We understand the FDA’s desire to uphold public health and safety, and we share the common goal of seeing unsafe products removed from the market. However, we politely ask that the FDA refrain from recommending that kratom be scheduled and withdraw its current advisory alert. The peer reviewed science and research that was requested by our elected officials and the DEA is still fresh from last year, while marketers are seeking proper development through the FDA's guidance process. Please urge the FDA to reconsider their present course and to pursue a more favorable path for the stakeholders involved and the American public.
