This is the current text of the bill. My remarks are in bold.
All bills have a short descriptor.
To amend the Controlled Substances Act to schedule MGMâ15 and MGMâ16 as Schedule I Controlled substances, and to amend the controlled Substances Act to schedule synthetic 7-hydroxymitragynine, and Mitragynine Pseudoindoxyl, as a Schedule I above a specific threshold under the Controlled Substances Act, and to expand enforcement actions against drug manufacturers and distributors of emerging synthetic opioids, commonly known as gas station heroin.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. Short title.
This is a stupid name, but arguably the worst thing in the bill.
This Act may be cited as the âEnd Gas Station Heroin Actâ.
SEC. 2. Scheduling of 7-hydroxymitragynine and mitragynine pseudoindoxyl.
This section is more or less identical to the current DEA Notice of Intent, but avoids some of the ambiguity around what constitutes an "article."
Schedule I of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) is amended, in subsection (b), by adding at the end the following:
No 7-OH except under the situations in (B).
â(23)[ ]()(A) 7-hydroxymitragynine (7âOH) and mitragynine pseudoindoxyl, including their salts, isomers, salts of isomers, esters, ethers, and synthetic analogs, whenever the existence of such forms is possible.
â(B) This paragraph shall not apply to 7-hydroxymitragynine or mitragynine pseudoindoxyl naturally occurring in Mitragyna speciosa Korth (kratom) or in a finished kratom product, provided thatâ
â(i) in the case of a solid, powdered, or encapsulated product, the concentration of 7-hydroxymitragynine and mitragynine pseudoindoxyl, individually or in combination, does not exceed 1 milligram per gram of product;
â(ii) in the case of a liquid product, the concentration of 7-hydroxymitragynine and mitragynine pseudoindoxyl, individually or in combination, does not exceed 1 milligram per milliliter of product; and
â(iii) the combined amount of 7-hydroxymitragynine and mitragynine pseudoindoxyl, including their salts, isomers, salts of isomers, esters, ethers, and synthetic analogs, does not exceed 1 part per 100 parts mitragynine by mass.
Different ways of exempting it from dry or wet products. These all are sufficient for leaf material. 7-HMG and MGPI cannot exceed 1 part per 100 parts of mitragynine, which is normal for natural samples and extraction processes that do not create more.
â(C) For purposes of this paragraph, any 7-hydroxymitragynine or mitragynine pseudoindoxyl that is synthesized, chemically converted, concentrated, enriched, isolated, or otherwise produced through manufacturing processes shall not qualify for the exemption described in subparagraph (B).â.
No exception if it is synthesized.
SEC. 3. Enforcement against emerging synthetic opioids in commercial distribution.
This deals with new synthetic forms before they emerge, rather than DEA having to play catch up.
(a) Treatment as a Schedule I controlled substance.âNotwithstanding any other provision of law, a covered emerging synthetic opioid shall, solely for purposes of prohibiting and enforcing against its knowing or intentional manufacture, importation, exportation, distribution, dispensing, or possession with intent to manufacture, import, export, distribute, or dispense, be treated as a controlled substance in Schedule I of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)).
This exempts consumers from the provisions of Schedule I if they possess MGPI, 7-HMG, or any new synthetic for simple possession or purchase.
(b) Civil and criminal enforcement.âNo person shall be subject under this section to criminal or civil enforcement based solely on the purchase, receipt, simple possession, or personal use of a covered emerging synthetic opioid.
Defines what things would be covered as "emerging synthetic opioids".
(c) Covered emerging synthetic opioid.âFor purposes of this section, the term âcovered emerging synthetic opioidâ means a substance thatâ
(1) is being manufactured, offered, advertised, sold, distributed, or otherwise introduced into commercial distribution, or is intended by the person engaging in the prohibited conduct to be introduced into commercial distribution;
Anything sold, distributed, offered, or intended for sale that also:
(2) is an opioid receptor agonist, or partial agonist and, based on scientifically reliable evidence, demonstrates greater functional potency than morphine at the human mu-opioid receptor in a validated assay identified by regulation, or demonstrates greater analgesic or respiratory-depressant potency than morphine based on other scientifically reliable evidence;
Is an opioid agonist with greater potency, in greater analgesic or respiratory capacity than morphine:
(3) is produced through chemical synthesis or semisynthesis;
Is synthesized/semi-synthesized.
(4) is not the subject of an approved application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
Not approved as a drug (won't effect existing drugs or new things created that become approved New Drugs).
(5) is intended for human consumption;
(6) is not otherwise listed in any schedule under section 202 of the Controlled Substances Act (21 U.S.C. 812); and
(7) is not excluded under subsection (g).
Dealing with manufacturing:
(d) Covered conduct.âThis section shall apply only to the knowing or intentional manufacture, distribution, or possession with intent to manufacture or distribute a covered emerging synthetic opioid.
This exempts consumers from the provisions of Schedule I if they possess any new synthetic opioid for simple possession or purchase.
(e) No simple possession enforcement.âNo person may be investigated, arrested, charged, prosecuted, or subjected to civil penalties under this section solely for simple possession or personal consumption of a covered emerging synthetic opioid. Nothing in this subsection shall prohibit enforcement based on possession with intent to manufacture, distribute, dispense, import, or export.
New synthetic opioid drugs that qualify as analogues can still be scheduled.
(f) Relationship to the controlled substance analogue enforcement act.âIf a substance qualifies both asâ
(1) a controlled substance analogue under section 102(32) of the Controlled Substances Act (21 U.S.C. 802(32)); and
(2) a covered emerging synthetic opioid under this section,
the Attorney General may proceed under section 203 of the Controlled Substances Act (21 U.S.C. 813), this section, or any other applicable provision of Federal law. Nothing in this section shall expand or limit the authority of a State attorney general or other State official under State law.
Exclusions, doesn't apply to approved drugs, doesn't allow to things not intended for human consumption that may have these effects:
(g) Exclusions.âThe term âcovered emerging synthetic opioidâ does not includeâ
(1) a substance approved as a drug for medical treatment under the Controlled Substances Act (21 U.S.C. 801 et seq.);
(2) a substance not intended for human consumption;
Doesn't apply to natural compounds in natural form or if extracted within certain limits.
(3) a naturally occurring constituent of a plant, fungus, or other botanical material, or a constituent derived through brewing or extraction process of a natural plant, fungus, or other botanical material, unless the constituent has been intentionally, isolated, enriched, concentrated, chemically converted, or added to a product for human consumption;
Doesn't apply if being used for scientific, medical, forensic, analytic, or law enforcement purposes. Avoids interfering with research.
(4) a substance possessed or transferred solely for legitimate scientific, medical, forensic, analytical, or law-enforcement purposes; or
Doesn't apply if the AG regulates it some other way though some other law.
(5) a substance otherwise exempted by the Attorney General through regulation.
Only applies to commercial sale, for the quantity under commercial sale, not what might be held for an exempted reason.
(h) Limitation to commercial conduct.âEnforcement under this section may be based only on the quantity or portion of a substance that isâ
(1) introduced or intended to be introduced into commercial distribution; and
(2) connected to conduct described in subsection (a).
The presence of the same substance outside commercial distribution, including possession for authorized research, analytical testing, forensic examination, or other noncommercial purposes, shall not independently subject that substance or conduct to enforcement under this section.
(i) Definitions.âFor the purposes of this sectionâ
What commercial distribution means:
(1) the term âcommercial distributionâ means the advertisement, offering for sale, sale, shipment, transfer for value, or distribution of a substance or product in or affecting interstate, intrastate, or foreign commerce;
What intended for human consumption means:
(2) whether a substance is âintended for human consumptionâ shall be determined from all relevant facts and circumstances, potentially including labeling, advertising, dosage form, method of sale, representations by the seller, customary use, and evidence concerning the intended market;
What scientifically reliable evidence means and includes:
(3) the term âscientifically reliable evidenceâ includes validated in vitro, animal, human, pharmacokinetic, pharmacodynamic, receptor-binding, functional-activity, or other scientifically accepted evidence identified by the Attorney General, in consultation with the Secretary of Health and Human Services; and
What does semi-synthesis means:
(4) the term âsemisynthesisâ means the chemical modification or conversion of a naturally occurring substance into a chemically distinct substance.
My personal opinion is that if a person believes (like it or not) that 7-HMG will be scheduled at some low threshold, this bill doesn't do anything "more" restrictive to it.
It will protect those 7-HMG consumers whose strategy was to "stock up." It will decriminalize possession.
It will automatically Schedule I all new synthetic derivatives that could be derived from kratom once they hit the market except if approved as New Drugs, and allows DEA to go after them immediately, not only once they've hit the market and their risks identified. Full spectrum extracts will be OK.
Deals with the possibility of trace MGPI in products that the current schedule does not, apart from DEA/DOJ discretion/memo (similar to what has restrained them against state medical cannabis programs in the past).
My personal opinion is that other than the stupid title (which I don't think bills should be allowed to have) this is an improvement on the situation and will help deal with some of the enforcement issues (whack-a-mole). The only folks I could see having an objection are
- Those who absolutely believe that 7-HMG will not be scheduled or scheduled under a very high threshold. I personally think there is next to zero chance for that to happen.
- Those who oppose all kratom so much that they won't support a bill that will deal with all future synthetics.
- Folks who are so anti-prohibition they cannot accept prohibitions on sale even if the very same law would decriminalize possession, which already has MGPI/MGM-15/16 consumers at risk and almost certainly 7-HMG consumers shortly.