BEA Letter to the FDA

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Preserving Plant Legality Through Education

We write today in regards to the November 14th FDA public health advisory on kratom, a traditional tea leaf 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 Congress and 11 U.S. Senators to request that the DEA delay the order, gather additional information and science as well as allow time for a public comment period. The 6 week comment period garnered over 23,000
comments with 99.1% Americans requesting kratom remain legal and 0.49% for scheduling the herb while the DEA differed to the FDA for the additional facts and science that elected officials and Americans requested.

University professors and scientists, world-renowned addiction experts, along with 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 30th 2016. The most recent information collected by the U.S. National Poison Data System, and published in the journal Clinical Toxicology1, shows “no deaths whatsoever from dietary supplements across the board or any other dietary ingredient.” Scientific study2 has proven that mitragynine, a natural constituent of the 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 company’s 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 the FDA to refrain from recommending that kratom be scheduled. The current peer reviewed science and research that was requested by elected officials, and DEA is still fresh from last year while marketers are seeking proper development through the FDAs guidance process. Please reconsider your present course to pursue a more favorable path for the stakeholders involved and the American public.

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