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Letter with Petition to Trump
#1
This is the letter that was sent with the petition yesterday.

March 23, 2018

Kellyanne Conway Counselor to the President 

The White House 1600 Pennsylvania Avenue,
 NW Washington, D.C. 20500

Robert W. Patterson Acting Administrator 

Drug Enforcement Administration 
Lincoln Place-West 700 Army Navy Drive 
Arlington, VA 22202

RE: PROPOSED SCHEDULING OF KRATOM

Ms. Conway and Mr. Patterson:

On behalf of the more than three million kratom users in America, I write today to address the significant deficiencies in the scheduling recommendation reportedly made by the FDA to schedule the alkaloids of kratom, mitragynine (MG) and 7-hydroxymitragynine (7-OH) as a Schedule I controlled substance, and ask that this recommendation be denied and sent back to the FDA to allow for a more rational regulatory plan for adulterated or contaminated kratom products that may present risks for the public.

Rationale:

§ Kratom is not an imminent health hazard. Based on research and studies by scientists, Kratom has been described as having a remarkable record of safety and low abuse risk. Despite the widespread use of Kratom in Southeast Asia, overdose, death, and serious adverse health events have rarely been associated with Kratom usage there.1

§ Kratom is not a classic opioid and does not have effects of classic opioids. The current body of credible research on the actual effects of kratom demonstrates that it is not dangerously addictive, nor is it similar to “narcotics like opioids” with respect to “addiction” and “death” as stated by the FDA in its November 14th Kratom Advisory. Equally important, four surveys indicate that kratom is presently serving as a lifeline [Satariya Trakulsrichai et al., Pharmacokinetics of mitragynine in man, DRUG DESIGN, DEV. AND THERAPY 2015:9; 24212429, 2422 (2015). Kellyanne Conway Robert Patterson March 22, 2018, Page 2 of 3] away from strong, often dangerous opioids for many of the several million Americans who use kratom (see attached, “Scientist Letter, dated February 8, 2018”). The alkaloids in Kratom can provide pain relief, but kratom’s alkaloids binding to the opioid receptor in the brain is only a partial opioid agonist. Partial opioid agonists affect the same opioid receptors in the brain but do so in a much different fashion than opiates such as Heroin or Morphine) or Opioids like Oxycodone or Methadone. Kratom use is not associated with high-risk negative side effects of opioids such as dangerous addiction or respiratory failure.

§ The FDA data used to claim deaths “attributed to kratom” does not meet any reasonable standard for scheduling of a controlled substance that “causes” deaths. The standard applied for past scheduling decisions, and the intent of the Controlled Substances Act, was to address risks to the public health where there is a substantial likelihood of an immediate threat of death or serious bodily harm or significant abuse of a substance will occur in the absence of scheduling. None of those criteria are met in the use of kratom. Unlike overdose deaths that are rightly attributed to classical opioids, which reliably cause respiratory depression and death at high doses, the fatalities that the FDA lists as having been associated with kratom include deaths with a wide variety of apparent causes in people suffering from various diseases and/or taking other substances that also likely contributed to their deaths (see attached, “The FDA Kratom Death Data: Exaggerated Claims, Discredited Research, and Distorted Data Fail to Meet the Evidentiary Standard for Placing Kratom as a Schedule I Controlled Substance, Jane Babin, March 2018”).

§ Kratom is not dangerously addictive. Publicly available research documents show that kratom has a long history of acceptably safe consumer use, and, when used as an alternative pain management therapy, kratom provides a far more favorable safety profile for consumers compared to more dangerously addictive and potentially deadly classical opioid medications. Current scientific research suggests that kratom provides some pain relief activity on the pain centers in the brain without the dangerous and potentially deadly respiratory suppression induced by classical opioid medications (see attached, “Scientist Letter, dated February 8, 2018”).

§ Scheduling kratom would contradict the Administration’s commitment to “Right to Try” policy. The “Right to Try” addresses an important tradeoff between benefits and risks. For some kratom users who have found relief from chronic pain, the only alternative if kratom is scheduled would be dangerously addictive or potentially deadly opioid use. Scheduling kratom violates the Administration’s defense of the Right to Try laws that contemplate the use of substances that are valuable if their expected benefits exceed the potential risks of use.
[Kellyanne Conway Robert Patterson March 22, 2018, Page 3 of 3]

§ Scheduling kratom would create greater safety risks for the public. Criminalizing kratom will force kratom users to an uncontrolled black market where substance adulteration and contamination are rampant. Indeed, the FDA’s own claims of death rely heavily on the claims that a dangerous street drug called “Krypton” – that the FDA incorrectly claims is kratom – that caused the deaths of 9 people in Sweden. Researchers investigating these deaths concluded that “Krypton” is actually a black market substance where powdered kratom leaves were adulterated with a toxic dose of O-desmethyltramadol, and cited the safety issues that are common in the black market where the user has little control over the contents of powders and plant materials because they may be spiked with one or more powerful synthetic drugs (see attached report, “Unintentional Fatal Intoxications with Mitragynine and O-Desmethyltramadol from the Herbal Blend Krypton”). A ban on kratom that would be imposed by CSA Scheduling would put them at risk of relapse to opioid use with the potential consequence of overdose death. Similar unintended consequences are to be expected in some who would be forced to use opioids to manage acute or chronic pain. (see attached, “Scientist Letter, dated February 8, 2018”).

The American Kratom Association supports the role the FDA should play in the regulatory framework to restrict contaminated and adulterated kratom products; kratom products that make impermissible health claims; and kratom products that do not meet minimum good manufacturing standards. We also agree that any kratom products where the plant material is chemically altered to increase its effects should be subject to regulatory requirements of the Dietary Supplement Health and Education Act of 1994 (DSHEA) prior to its being marketed to consumers.

We ask your careful consideration of the conclusions of the nine prominent and highly respected scientists in the attached letter, and the more than 41,400 kratom consumers who signed the attached Petition to President Donald J. Trump to “Stop the Criminalization of Americans Who Safely Use Kratom.”

Respectfully submitted,

David Herman Chairman American Kratom Association


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