Issue Brief: STOP THE IMPORTATION AND TRAFFICKING OF SYNTHETIC ANALOGUES ACT OF 2017 (SITSA Act)

Senator Chuck Grassley (R-IA) and Senator Diane Feinstein (D-CA) filed S. 1327, the SISTA Act, that attempts to respond to the threat posed by “analogues” of already-controlled substances that pose a danger through the street drug and opioid epidemic.  A companion bill, H.R. 2581, has also been filed by Representative John Katko (R-NY).

 

It is clear that the Department of Justice (DOJ) and the Drug Enforcement Administration (DEA) are seeking additional powers to address how controlled substance analogues are to be regulated to address the problem with synthetic street drugs that are killing users.  But this expansion of powers being granted to DOJ and DEA poses a significant threat to kratom, and potentially other botanical and herbal supplements, if these agencies decide to use the new powers that would be granted by this legislation.

 

Current Landscape:  The August 31, 2016 Federal Register Notice by the DEA attempted to use the emergency scheduling authority to interdict dangerous and often lethal street drugs to ban consumer access to kratom and kratom products.  On October 13, 2016, the DEA was forced to withdraw its proposed scheduling order in the face of an outcry from kratom supporters, including a bi-partisan group of U.S. House and Senate members.

 

That has made kratom an issue of substantial and embarrassing controversy within the DEA. There were more than 80 previous Emergency Scheduling Notices that were filed and successfully implemented by the DEA before the unprecedented withdrawal of their “Emergency Scheduling Notice” for kratom in October 2016.  Based on reports with various staffers on the Hill, the DEA’s “scorecard” on the kratom withdrawal was both an embarrassment and, in their view, remains as “unfinished business.”

 

Issues of Concern with SITSA:  In order to properly understand the effect of the proposed legislative change to the Control Substances Act, it is important to look at the proposed expansion of powers given to the Attorney General under the proposed “Schedule A” designation.

 

What constitutes a “controlled substance analogue” is the critical question in the context of this proposed legislation.  The term “analogue” is actually a very vague term that has a variety of meanings that are all dependent upon the context in which the word is used.

 

 In pharmacology, the term “analogue” refers to one of two specific concepts:

 

  1. Functional analogue:  A chemical compound with similar properties to another;

  2. Structural analogue: A chemical compound with a slightly altered chemical structure compared to another.

 

Whether or not a compound is an “analogue” is independent of whether it is natural or not. In that context, prosecutors can argue that natural mitragynine is a morphine analogue because it produces similar effects. 

 

There have been numerous studies on kratom and its alkaloids that can and likely will be used by government attorneys to argue that kratom poses a threat to public safety, and those alkaloids are, in their view, analogues of controlled substances. The issue will not be whether the conclusions of such studies are accurate or not, it will only be that the government has a credible basis to add kratom to the new “Schedule A.”

 

As an example, in a study presented by Dr. Irna Elina Ridzwan at a 2015 workshop for the International Islamic University Malaysia’s Repository System, reported as follows:

 

“Similar to morphine, mitragynine mainly acts at mu-opioid receptor which is the main target to treat opioid dependency.”

 

In a report published in the Journal of American Chemical Society on May 18, 2016, Dr. Andrew Kruegel of Columbia University and several colleagues drew the following conclusion:

 

“These results show that mitragynine and the oxidized analogue 7-hydroxymitragynine, are partial agonists of the human mu-opioid receptor and competitive antagonists at the kappa- and delta-opioid receptors.”

 

Another research report, “From Kratom to mitragynine and its derivatives: Physiological and behavioural effects related to use, abuse, and addiction,” done by a group of researchers published in the Neuroscience & Biobehavioral Reviews (Volume 37, Issue 2, February 2013), concluded as follows:

 

“Mitragynine and its derivatives actions in the central nervous system involve μ-opioid receptors, neuronal Ca2+ channels and descending monoaminergic projections. Altogether, available data currently suggest both, a therapeutic as well as an abuse potential.”

 

A report published in The Journal of the American Osteopathic Association, December 2012, “Pharmacology of Kratom: An Emerging Botanical Agent With Stimulant, Analgesic and Opioid-Like Effects,” concluded as follows:

 

“Recent studies have shown that kratom contains a variety of active compounds that produce major pharmacologic effects at opioid and other receptors. Kratom and kratom-derived drugs may potentially be used for the management of pain, 

opioid withdrawal symptoms, and other clinical problems.”

 

Finally, the conclusions of the European Monitoring Centre for Drugs and Drug Addiction provide a damning assessment of kratom’s opioid-like effects:

 

“In general, the effects of kratom in humans are dose-dependent: small doses produce ‘cocaine-like’ stimulation while larger dosages cause ‘morphine-like’ sedative-narcotic effects.”

 

These are just a few examples of studies that draw a close correlation between the alkaloids in kratom and their opioid counterparts that are scheduled as controlled substances. These studies, and many like them, will provide ample argumentation for government regulators to argue that kratom should be construed as an analogue of opioids on the Controlled Substances Schedule I.  It is a well-established precedent in the courts that judges will yield to the scientists when it comes to complex pharmacologic effects of substances.

 

Some states have banned kratom on the basis that it is an analogue for controlled substances, and their underlying reasoning has not been questioned to date.

 

The proposed SITSA legislation in Section 2, Establishment of Schedule A, outlines the criteria for the inclusion of any substance that (1) has a chemical structure that is substantially similar to the chemical structure of a controlled substance in schedule I, II, III, IV, or V; and (2) an actual or predicted stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than that of a controlled substance already scheduled.

 

The Act goes on to create even more potential havoc for kratom:

 

“For the purpose of this paragraph, the predicted stimulant, depressant, or hallucinogenic effect on the central nervous system may be based on (i) the chemical structure, structure activity relationships, binding receptor assays, or other relevant scientific information about the substance; (ii)(I) the current or relative potential for abuse of the substance; and (II) the clandestine importation manufacture, or distribution, or diversion from legitimate channels, of the substance; or (iii) the capacity of the substance to cause a state of dependence, including physical or physiological dependence that is similar to or greater than that of a controlled substance” that is already scheduled.

 

In DEA’s justification for the August 31, 2016 “Temporary Placement of Mytragynine and 7-Hydroxymitragynine Into Schedule I”, it is clear in its intent to define kratom as an opioid that should be controlled, including the following stated evidence:

 

  • Kratom is abused for its ability to produce opioid-like effects. 

  • Attempted importations of kratom are routinely mis-declared and falsely labeled. 

  • Considerations of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution.

  • Available information indicates that these opioid substances, constituents of the plant kratom, have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 

  • Kratom, which contains the main active alkaloids, mytragynine and 7-hydroxymitragynine, has a long history of use in Southeast Asia as an opium substitute.

  • In recent years, the presence of the psychoactive plant kratom has increased dramatically in the recreational market in the United States due to its opioid-like effects. 

  • In the United States, kratom is misused to self-treat chronic pain and opioid withdrawal symptoms, with users reporting its effects to be comparable to prescription opioids. 

  • Kratom is abused for its ability to produce opioid-like effects.

  • Users have also reported dose-dependent psychoactive effects to include euphoria, simultaneous stimulation and relaxation, analgesia, vivid dreams, and sedation (at higher doses).

  • The FDA stated that kratom products “pose a risk to the public health and have the potential for abuse”, and the seizure of certain kratom products was necessary “to safeguard the public from a dangerous product”.

  • These substances produce opioid-like effects, making their abuse a serious public health concern.

  • Reports of hepatotoxicity, psychosis, seizure, weight loss, insomnia, tachycardia, vomiting, poor concentration, hallucinations, and death associated with kratom use have been documented.

 

In that Notice, the DEA outlined a very specific case against kratom because it is, in their judgment, associated directly with substances that are already scheduled. The only protection the kratom community has been able to utilize to this point under the current law is the fact that there are very specific statutory limits on the procedural and evidentiary requirements set forth by the DEA in its Federal Register Notice, and under those requirements the DEA failed to meet their evidentiary burden for emergency scheduling.

 

The SITSA Act grants broad new powers to the Attorney General that will be predicated upon a much lower standard of evidence to schedule kratom and potentially other botanicals in the newly created Schedule A. Based on the publicly declared position of the DEA, it would not be unreasonable to expect that kratom would be added to Schedule A if this legislation were passed. Given that there is no judicial review permitted for such scheduling in the proposed law, consumers would be denied access to kratom and would be stripped of their freedoms to make their own personal health and well-being decisions.

 

The merit of most public policy decisions by the Congress is evaluated on the “risk-matrix” of what could happen if legislation were to pass. Based on the available evidence, the proposed legislation needs to be amended, at a minimum, to provide an exemption for natural botanical products (including kratom), or kratom advocates will have to work to defeat the bill completely.

 

Ultimately, if the AKA defers on any attempt to amend this legislation, it requires a “trust” in the DEA and the FDA to act responsibly with respect to kratom. That approach puts every kratom user, and the products provided by the kratom industry, at substantial risk.

 

 

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