Attorneys for The American Kratom Association made a move to block a move by the U.S. Drug Enforcement Agency (DEA), which is seeking to list two of kratom's primary alkaloids as Schedule I substances under the Controlled Substances Act.
In a letter from the law firm of Hogan Lovells US LLP addressed to DEA Acting Administrator Chuck Rosenberg, the attorneys asked the agency “to immediately suspend the process of scheduling mitragynine and 7-hydroxymitragynine, constituents of the kratom plant, pursuant to the emergency scheduling provisions of the Controlled Substances Act (CSA).”
Background on The DEA's Move to Ban Kratom
On August 31, 2016, the DEA filed a notice of intent concerning its plans to include kratom alkaloids, called mitragynine and 7-hydroxymitragynine, as Schedule 1 controlled substances. This is the most restrictive classification reserved for substances with a high risk of abuse with no recognized medicinal value. Substances in the Schedule 1 category include heroin, cocaine and LSD.
The temporary change in classification was eligible to go into effect on September 30, 2016, but much to the relief of kratom enthusiasts and proponents, the DEA indicated that the Schedule 1 classification has not yet gone into effect. An agency spokesman indicated that the DEA is still in the process of moving forward with the new scheduling, but there has been some indication that the agency may allow for public input prior to finalizing this matter.
If the scheduling change does go into effect, it would remain valid for up to two years. At any time during this period, the DEA could move to make the Schedule I status permanent.
An Overview of the Letter to the DEA From The American Kratom Association's Attorney
Hogan Lovells' 35-page letter, dated September 26, 2016, is quite clear in its intention. The law firm wrote, “The Drug Enforcement Administration's (DEA) proposed use of the emergency scheduling authority in this instance is completely unprecedented. Because it allows for a departure from formal, public regulatory processes prior to taking effect, the entry of an emergency scheduling order is intended only for the most extreme instances of harmful illicit drug use, where no other options are available to prevent 'an imminent hazard to public safety.'
“Far from being 'an imminent hazard,' kratom herbal products are used routinely, safely and responsibly by several million consumers in the United States. Never before has [the] DEA invoked its emergency scheduling authority to take action against a natural product with a long history of safe use in the community.”
Notably, the emergency scheduling provision that's available to the U.S. Attorney General and the DEA is designed to allow for the prompt criminalization of new, “rapidly emerging” synthetic, “designer drugs” that quickly and suddenly arise on the market. These substances are typically highly addictive, extremely dangerous in terms of their ability to cause illness or even death.
Kratom, the attorneys argue, does not bear these qualities and therefore, does not deserve to be the subject to emergency scheduling measures.
The attorneys point out that kratom – which has literally been used throughout Southeast Asia for thousands of years and has been in use amongst millions of Americans for at least a decade – does not fit the category of “rapidly emerging.” Nor is kratom a so-called designer drug that was “concocted to avoid existing DEA controls.”
Attorneys Argue that Kratom Lacks Danger and Potential for Abuse
Notably – and somewhat problematically – the concept of “abuse” is not clearly defined in the Controlled Substances Act. Even so, the American Kratom Association's legal team has made a compelling argument against the claims that kratom is a dangerous and addictive substance.
In fact, Hogan Lovells cited the work of one of the planet's premier experts on drug abuse and addiction, Jack Henningfield, PhD. Henningfield classified kratom as having “a remarkable record of safety and low abuse risk,” with “little evidence of dependence or serious adverse events and no documented kratom-caused overdose deaths.”
The legal brief even cited the pharmacologic properties of kratom, which make it “a poor choice as an agent of abuse. Research shows that it would require a 'heroic effort' to consume enough kratom to achieve the types of effects typically associated with abuse.”
The letter indicated that “kratom does not demonstrate a high potential for abuse similar to fentanyl or oxycodone – but, rather, shares characteristics of unscheduled naturally-derived substances such as caffeine.” They also cited research performed at Columbia University, where it was discovered that “the primary constituents of kratom, mitragynine and 7-hydroxymitragynine, have significantly different pharmacology profiles from traditionally abused opioids.”
The lawyers pointed to the pharmacological properties of kratom's alkaloid constituents, which have been called “opiate-like” in their effects. But this similarity, they argue, does not equate to a similarly high risk of abuse: “...Kratom does not exhibit the binding profile associated with the reinforcing qualities that lead to opiate addiction and abuse. Mitragynine binds to several non-opioid receptors and demonstrates both agonist and antagonist effects at the opioid receptors, limiting the 'high' that can be achieved with kratom and, with it, the potential for abuse.”
As for the other targeted alkaloid, 7-hydroxymitragynine, the attorneys pointed to research involving mass spectrometry, which revealed that “only trace quantities” of this alkaloid were present in kratom leaves and as such, “is unlikely to generally account for the psychoactive properties of this plant.”
They also cited research that revealed that the more than two dozen additional alkaloids contained within kratom “showed no measurable agonist activity at any of the human opioid receptors, even at high concentrations.”
Additionally, kratom also differs from traditional opioids “in terms of its very low bioavailability, as only 3% is bioavailable when taken orally.” Compare this to the bioavailability of morphine 20% to 25%), fentanyl (50% to 70%) and codeine (90%). This relatively low degree of bioavailability “limits the extent to which a user could experience a 'high,'” while simultaneously reducing the risk of overdose and the reinforcement that may lead to dependency and addition.
What's more, there is no evidence to link kratom to social harms, such as auto accidents, violent acts, unemployment, criminal behaviors or other acts that are linked to highly addictive and harmful illicit drugs. In reality, users report the precise opposite: “Indeed, many kratom users assert that kratom has enabled them to once again be active, contributing members of their communities.”
“There is little evidence that individuals are taking kratom in amounts sufficient to create a hazard to their health or to the safety of others. If that were the case, we would expect to see many cases of serious adverse events and overdose deaths,” the attorneys wrote.
In reality, millions of people in Thailand alone use kratom and worldwide, there have been fewer than 100 “serious adverse events” reported in connection to kratom. And in these cases, it's believed that the adverse health effects “were likely caused by the co-administration of other substances.”
The AKA's attorneys also highlighted the fact that making kratom's alkaloids Schedule 1 substances would cause irreparable harm to numerous businesses and millions of Americans who use kratom on a routine basis.
A Closer Look at Alleged Kratom Deaths
In the DEA's announcement in the Federal Register when it announced its plans to make kratom's alkaloid Schedule 1 substances, the agency cited 660 calls to the U.S. Poison Control Center (with the Centers for Disease Control or CDC) in the timeframe from January 2010 through December 2015, along with a number of kratom-related fatalities.
In response to this claim, the American Kratom Association's attorneys examined the approximately 30 alleged reports of kratom-related fatalities. They reported that “a close examination of these reports shows that there are no instances in which kratom itself was determined to be responsible for the cause of death....Because kratom does not appear to induce respiratory depression (the dominant reason why abuse or misuse of traditional opioids leads to death)... there is good reason to question whether these reports indeed represent a valid or meaningful signal with respect to kratom.
“Close review of the totality of the evidence points clearly in the other direction, namely, that kratom is well tolerated and relatively mild in its effects.” They also point to compelling evidence of kratom's prominent use as a self-care staple, which is allowing Americans to live productive lives without relying upon prescription medications and/or illicit drugs.”
In their announcement, the DEA had also referenced autopsy and medical examiners' reports, although the DEA's spokesman Melvin Patterson acknowledged that just one death was “directly attributable to kratom alone.” But even this is no longer accurate.
The kratom death in question involves a 36-year-old man who was living in Denver, Colorado when he reportedly ingested kratom and experienced a fatal seizure. While the full and complete medical examiner's autopsy report, toxicology reports and medical history are not publicly available, it was noted that “the medical examiner's report later revised its toxicology findings to state that it was 'indeterminate' whether 7-hydroxymitragynine was present in the man's bloodstream.” The medical examiner also noted that the decedent had a history of cardiopulmonary arrest – a factor that may have contributed to the death.
And while the AKA's legal team called the death “regrettable and concerning,” they noted that far more evidence is needed to qualify the substance for emergency scheduling.” This is especially true in light of the fact that other legal, and widely available substances, such as ginseng, have been linked to fatality, yet ginseng and many others remain available and without regulation.
Examining the Flaws in the DEA's Reliance Upon Poison Control Center Call Data
The lawyers also made a very apt point concerning the DEA's reliance upon the Poison Control Center data, as the data did not “demonstrate imminent harm or a substantial likelihood of an immediate threat of abuse.”
In fact, some have argued that many of the Poison Control Center calls could be attributed to physicians' lack of knowledge concerning kratom and its effects. In cases where a patient has ingested an unfamiliar substance, it is standard protocol to contact the Poison Control Center to learn more about that substance and its effects.
So, for instance, if a patient arrived at a hospital for treatment of a broken arm and the medical team determined that emergency surgery was necessary, they would typically ask the patient if they had recently ingested any substances or supplements. If the physician or anesthetist was not familiar with kratom and its effects (particularly relative to anesthesia or other medications that would be administered), then it would be standard practice to contact the Poison Control Center to learn more about kratom – even though the patient is not seeking treatment for a kratom-related issue.
According to the legal brief, many of the calls to the CDC involved patients who had ingested many different substances, making it impossible to determine what, if any, adverse effects were caused by kratom.
If you eliminate these cases from the equation, the 660 calls are reduced to just 428 calls over six years – a very low figure when you examine that figure relative to the millions of Americans who use kratom on a regular basis.
Relatively, these 428 kratom-related calls are insignificant. Over the same six-year timeframe, the CDC has received 23,203 calls concerning caffeine and a total of 66,300 calls concerning essential oils.
When you compare kratom's 428 single-substance calls to the Poison Control Center to other natural supplements that are generally considered “safe,” the reality of this situation comes into even greater focus:
· Echinacea has been involved in 1,149 single-substance reports and 1,464 reports overall;
· Valerian has been involved in 778 single-substance reports and 1,499 reports overall;
· St. John's Wort has been involved in 717 single-substance reports and 1,173 reports overall;
· Yohimbe has been involved in 985 single-substance reports and 1,246 reports overall; and
· Ginseng has been involved in 412 single-substance reports and 638 cases overall.
What's more, substances such as Valerian and St. John's Wort have been found to have “reinforcing effects” that can lead to dependence. And ginseng was even implicated in a death in 2011!
The legal brief also faults the DEA for failing to consider multiple sources, which is typically the case. The attorneys argued that “When evaluating whether a substance has a history or current pattern of abuse, DEA ordinarily relies on a number of national surveys and data sources. These sources include the National Survey on Drug Use and Health, Monitoring the Future, the Drug Abuse Warning Network, and Treatment Episode Data Sets, among others. These databases report the age of users, the frequency of use, involvement with the criminal justice system, use in combination with illicit substances, use leading to emergency department visits, and use patterns consistent with addiction... These databases could have provided the information that DEA’s notice is sorely lacking: statistics that differentiate between legitimate use and abuse and that indicate the presence or absence of risk factors that affect the public health.”
AKA's Lawyers Call Emergency Scheduling “Unlawful”
In their letter to the DEA's Acting Administrator, the American Kratom Association's lawyers made a case for the unlawful nature of the emergency scheduling of kratom, which they called “an important law enforcement tool.”
They noted that historically, the DEA has used its emergency scheduling authority for three types of cases:
- synthetic fentanyl analogs;
· synthetic analogs to MDMA (also known as ecstasy); and
· “powerful synthetic cannabinoids and cathinones, substances directly associated with disturbingly bizarre adverse events and deaths.”
They added, “In contrast, DEA has never exercised its emergency scheduling authority to control a natural botanical substance. It has never exercised its emergency scheduling authority to control a widely used consumer product with a long history of safe marketing and it has never exercised its emergency scheduling authority to control a substance in the absence of evidence of a high potential for abuse or an immediate threat of death or serious bodily harm. Indeed, doing so in the case of kratom would be patently inconsistent with both the plain language and legislative history of the CSA.”
It's also argued that the emergency scheduling of kratom would be a violation of the Administrative Procedure Act (APA) on a substantive and procedural level and it could be considered a violation of the due process clause.
On the latter point, they noted that “if the scheduling order takes effect without an opportunity for interested parties to provide comments and participate in a meaningful hearing, the scheduling order will violate procedural due process requirements...Here, [the] DEA is criminalizing a substance that has been used by millions of Americans for many years, yet providing only a retrospective opportunity to object....Such 'post-enforcement procedures' do not satisfy the minimum procedural safeguards guaranteed by the due process clause.”
It was also argued that the DEA failed to follow the “important considerations, oversight and public involvement required by executive orders 12866 and 13563.”
Executive Order 13563 requires federal agencies to carefully consider their actions and the impact of those actions on the public, in addition to considering options that “reduce regulatory burden and maintain flexibility and choice for the public, and to involve the public in their considerations.
Executive Order 12866 requires any “significant regulatory actions” to be submitted to the White House's Office of Information and Regulatory Affairs and the Office of Management and Budget (OMB).
Significant regulatory actions are regarded as decisions that – amongst other things – “have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities...” The legal brief's authors argue that a kratom ban could fall under this umbrella.
As a result, the “DEA is duty-bound to withdraw the notice” to add kratom's alkaloids to the list of Schedule I substances.
In a final point, Hogan Lovells' attorneys argue that the DEA's emergency scheduling notice fails to meet the standards put forth in the Data Quality Act (DQA) due to the incomplete and inaccurate nature of some of the information put forth in the proposed temporary scheduling order. They also criticize the lack of proper analysis, which includes failure to place information “in the context of the broader population safely consuming kratom and without reference to the very similar data for similar botanical substances or other consumer products.”
A copy of the full letter can be viewed at https://drive.google.com/open?id=0BwMPT92bOJKdZWM2bzlLeU5DdDg.