Congress Dear Colleague Letter Calls For FDA To Retract Kratom Advisory

7 years ago
211 Views
kratom leaf

Looks like there is yet another Dear Colleague letter of support for the continued availability of kratom. Kratom, a Southeast Asian plant related to coffee, has become a subject of great interest and some controversy as well over the past several years. For many, it is considered a lifesaver, but for years now the Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) have been passing responsibility back and forth for trying to quell the kratom craze.

Last year Congressmen Pocan and Samon circulated a Dear Colleague letter from the House while Senator Orrin Hatch signed one that was sent through the Senate. Most recently, the Pocan-LoBiondo letter to the DEA is being passed around to accrue signatures, urging the DEA not to act on the FDA’s faulty information. As we have mentioned previously, Freedom of Information Act (FOIA) documents show the statements made by the FDA in their advisory regarding kratom were pulled from nowhere and the former head of the National Institute of Drug Abuse (NIDA) has blasted the FDA for the “junk science” they employed in attempting to smear the plant, its users and those who market and sell it. One of the concerns addressed in the Pocan-LoBiondo letter is the potential for agency overreach.

Representatives Brat and Polis also gathered signatures this week, their letter is addressed to the FDA themselves, requesting that the Agency reconsider its health advisory on kratom. As in the case of the letter from Pocan and LoBiondo, et al. the Brat-Polis letter represents bipartisan support for kratom’s continued legality and availability. In the age of hyper-partisan politics, it’s an exceptional rarity that any issue can bridge the red/blue divide, kratom has been and continues to be such a rarity.

There were a few points in the Brat-Polis letter that should be clarified, however. They point out how thousands of Americans use kratom to fight opiate or opioid addiction. This is certainly so, however, the reasons for using kratom are as varied as its studied benefits. Many users, of all ages, find that kratom improves their quality of life. It may be that they are looking for a way to deal with chronic pain and are tired of the endless narcotic haze of doctor prescribed medicines. Multiple studies have suggested that kratom may be helpful for those with anxiety issues, PTSD, depression and more, so it’s important to note that, unlike methadone or suboxone, kratom is far more than an “opioid replacement.”

Another minor issue in the letter is that it is pointed out that if kratom were classified as schedule 1 (as the DEA previously attempted) it would be unavailable for research purposes. The letter refers to “heroin, methamphetamine, cocaine, and other illicit drugs” in the schedule 1 category. As insane as it may seem, Desoxyn is pharmaceutical grade methamphetamine. The FDA has approved it for use in children as young as 6 years old. Cocaine is a schedule 2 substance, also considered to have some valid medical uses. The fact that the FDA believes methamphetamine is suitable for 6-year-olds, that Oxycontin (or hillbilly heroin” as it is known in certain parts) is suitable for preteens while decrying the use of a plant that didn’t prove lethal in any amount to small mammals in laboratory tests would be laughable if the potential results weren’t so tragic.

Brat and Polis do an excellent job of rebutting the FDA however. The FDA’s claims of the drastic rise in calls to emergency call centers may seem like a big deal until you realize that the hundreds of calls are dwarfed by the hundreds of thousands of calls for energy drinks, acetaminophen, antihistamines and other legal products available over the counter.

From the letter:

According to your press release, the Agency’s two main concerns, which we consider insufficient for a warning or action, are the significant increase in calls to Poison Control Centers between 2010 to 2015, as well as thirty-six deaths the Agency believes to be associated with kratom.

Our letter considers and puts these concerns in perspective when compared to other commonly used substances like energy drinks, and presents sound scientific evidence that was submitted to the FDA, Drug Enforcement Agency (DEA), and Members of Congress in 2016 showing that kratom is safe and poses little to no health risk to Americans. This letter also discusses manufacturing practices and standards 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 plant.

As is pointed out in the letter, last year, when the DEA attempted their extra-judicial ban of kratom through emergency scheduling, in a matter of weeks, 8 U.S. senators and 51 U.S. Representatives signed on with their support when thousands of constituents (among them consumers, researchers, health professionals, law enforcement officials and others) shared their perspective during the open comment period. According to data from the Centers for Disease Control (CDC) and Poison Control Centers kratom poses far less of a risk than energy drinks.

This 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 that “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.”

As is pointed out, however, getting kratom vendors up to code with Current Good Manufacturing Practices (cGMP) guidelines will be vital to ensuring consumer safety, but the opinion of Brat-Polis, et. al is that the voice of scientific researchers and consumers should be heard. In the end, isn’t that the very definition of representative democracy?

 

You may also like