We are petitioning today in regards to the FDA’s public health advisory related to their mounting concerns regarding the alleged risks associated with the use of kratom, a traditional tealeaf in the same family as the coffee plant. The agency’s two main concerns that this advisory focuses on are poison control center calls, increasing 10-fold from 2010 to 2015, and 36 deaths “associated” with kratom. This letter considers these concerns, puts them in perspective to other commonly used substances like energy drinks, and presents sound scientific evidence that was submitted to the DEA, FDA, as well as members of Congress and the U.S. Senate in 2016 showing that kratom tea is safe and poses little to no health risk to Americans nationwide. We will also cover mutually beneficial manufacturing practices and standards that have been adopted by the kratom industry that would alleviate any compliance issues, and ensure continued safe use for the millions of Americans that enjoy this celebrated traditional tea.

As recent as the Fall of 2016 the DEA brought up the same concerns that the FDA has now, but sought a much more aggressive approach by attempting to emergency schedule kratom tea through the Controlled Substances Act. This was the first time a natural tea was targeted in this fashion, and Senator Orin Hatch along with 8 other U.S. Senators and 51 U.S. Representatives advised the DEA to consider consumers, researchers, health professionals, law enforcement officials, and other stakeholders to allow a more fulsome decision. This opened a six-week public comment period that resulted in an overwhelming 23,023 Americans (99.1%) submitting comments during the DEA’s 6-week comment period favoring to keep kratom legal. Only 113 people (0.49%) were for banning kratom. If it were as “deadly” as the FDA says it is, wouldn’t at least 1% comment to ban it?

The FDA claims Poison Control Center calls increased 10 fold from 2010 to 2015 but neglected to report the actual call numbers or put them in perspective. The agency is citing a July 2016 study by the CDC that states the calls were at 26 in 2010 then 263 in 2015. Out of 323.1 million Americans only 263 calls were made to poison control centers while in 2014 energy drinks received 5,156 calls with more than 40% of those calls involving children younger than 6, with some suffering cardiac and neurological symptoms. Scientific research, expert testimony, and Poison Control data have shown that kratom tea is far less dangerous than these common substances that pose serious health risks to Americans and our nation’s youth.

The agency uses the term “associated” when describing the 36 deaths because kratom was not the sole cause of death when in fact no deaths have ever been attributed to kratom alone. This numbers pales in comparison to 34 deaths attributed to energy drinks in 2014 alone. In all kratom cases individuals died while taking prescription drugs and other substances, some even of natural causes, but happened to have been taking kratom at the same time. This issue was of great concern to the state of Florida and was addressed by the Florida Department of Law Enforcement Commissioner Rick Swearingen with the Office of Statewide Intelligence in 2015. Their investigation concluded, “A review of available law enforcement and laboratory sources in Florida demonstrates that Kratom does not currently constitute a significant risk to the safety and welfare of Florida residents. According to the Florida Department of Health (DOH), no pervasive health issues have been attributed to the ingestion of Kratom products in Florida.” This subject has also forced independent studies by revered scientists like Jack Henningfield PhD of Pinney & Associates, one the world’s leading experts on addiction and safety. He states, “This is a remarkable record of safety and low abuse risk for any substance used by millions of Americans, as described by other witnesses in this hearing, and it is especially remarkable for a substance with some opiate-like pharmacological activity.”

The beneficial potential, safety, and efficacy of kratom tea has been discussed, studied, even clinically researched and found to be as safe as coffee, its close relative, with several NIH funded studies conducted, some of which are still ongoing within the last few years. In recent years the kratom industry has labeled all products for adults 18 years of age and up, adopted FDA labeling standards, analytically tests kratom leaf with state of the art technology, as well as recommending reasonable and safe dosage, while manufacturing in American made GMP facilities. Given the 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. Please urge the FDA to reconsider their stance and take a closer look at the facts and science that is still fresh from last year. We sincerely appreciate Commissioner Gottlieb’s concern but we need not repeat that past so quickly.