Article 039: Ending the Revolving Door of Synthetic Opioids Being Sold in Plain Sight at a Shop Near You

A Scientific and Legislative Proposal to Prevent the Next Generation of Dangerous Opioids From Reaching American Communities

An Open Letter and Scientific Legislative Policy Proposal

By Sam P. Stewart
Scientist and Independent Scientific Researcher
October 29, 2026

Addressed To

The United States Congress, including the United States Senate and House of Representatives; the U.S. Food and Drug Administration (FDA); the Drug Enforcement Administration (DEA); the Department of Health and Human Services (HHS); the Centers for Disease Control and Prevention (CDC); the National Institutes of Health (NIH); state and local public-health authorities; hospitals and healthcare institutions; medical professionals; scientific researchers; patient advocates; and all other individuals and organizations concerned with preventing opioid-related harm.

Purpose and Public Invitation

This open letter and legislative proposal is respectfully submitted for the consideration of lawmakers, regulatory agencies, healthcare professionals, researchers, and the American public.

Its purpose is to encourage serious scientific evaluation and congressional consideration of a preventive federal regulatory framework addressing newly developed, nonmedical opioid substances before they can be widely distributed to consumers.

This proposal is not intended to interfere with legitimate medical treatment, criminalize individuals suffering from addiction, or impose unnecessary restrictions on ordinary Americans. It seeks practical, scientifically defensible safeguards that protect public health while preserving access to approved medications, ordinary foods, legitimate research, and qualifying traditional products.

I welcome constructive criticism, independent scientific review, and recommendations from professionals and institutions with relevant expertise. No individual has every answer, and meaningful progress requires cooperation among lawmakers, scientists, healthcare workers, regulators, and the communities affected by this crisis.

The intention is not simply to identify a problem, but to encourage the people and institutions with the authority and expertise to help solve it.

Abstract

The United States has endured decades of opioid-related deaths, addiction, family disruption, and enormous demands on emergency medical services. First responders, healthcare professionals, researchers, law enforcement personnel, families, and ordinary citizens have worked tirelessly to address a crisis that continues to evolve.

Yet a fundamental weakness remains. When one dangerous opioid is prohibited, another compound with a different chemical structure can emerge. Regulators must repeatedly identify, investigate, and restrict substances that may already be circulating in American communities.

This paper proposes a preventive solution: a federal pharmacological standard that evaluates newly introduced, nonmedical opioid substances according to their biological activity rather than relying primarily on individual chemical names.

Congress should direct the Food and Drug Administration (FDA), in coordination with the Drug Enforcement Administration (DEA), to develop and evaluate a scientifically validated system using morphine as a reference standard. Two preliminary thresholds deserve consideration: substances demonstrating at least one-fifth or one-eighth of morphine's measured potency.

Approved medications, ordinary foods, authorized scientific research, and qualifying traditional products would be protected through explicit exemptions. Manufacturers and distributors introducing novel opioid-active substances into commercial markets would face appropriate testing, disclosure, and compliance requirements.

The objective is not to criminalize addiction or interfere with legitimate medical care. It is to prevent dangerous, inadequately studied opioid products from reaching consumers through ordinary retail channels, including smoke shops, gas stations, convenience stores, and online marketplaces. Concentrated opioid-active products have been marketed and sold in these settings, sometimes alongside everyday merchandise, making them accessible to adults and potentially exposing adolescents and children through inadequate age controls, misleading labeling, or accidental ingestion. Although people of all ages face risks, children and adolescents warrant particular protection because of their developmental vulnerability and the potentially life-threatening consequences of opioid exposure. Federal regulation should address these risks before newly developed substances become widely available in American communities.

Central thesis: The United States can reduce its vulnerability to emerging synthetic opioids by establishing a prospective, scientifically validated regulatory framework based on opioid-receptor activity, pharmacological potency, and demonstrated public-health risk.

1. Introduction: A National Emergency Demanding a New Approach

For decades, Americans have watched the opioid crisis evolve from the widespread misuse of prescription pain medications into an increasingly complex market involving heroin, illicitly manufactured fentanyl, synthetic opioid analogues, nitazenes, and concentrated opioid-active consumer products.

Each new generation of substances creates challenges for regulators, healthcare workers, law enforcement agencies, and families.

The underlying problem is straightforward.

The human body possesses a finite collection of opioid receptor systems, yet chemists can develop numerous structurally different compounds capable of interacting with those systems.

A molecule does not need to resemble morphine or fentanyl chemically to produce powerful opioid effects.

This creates a serious legislative challenge. A regulatory framework that depends heavily on naming individual compounds or proving chemical similarity can struggle to keep pace with a rapidly changing market.

I believe Congress should address this problem at its source.

Rather than waiting for each new opioid to be manufactured, distributed, discovered, investigated, and individually prohibited, federal law should establish clear scientific criteria that can apply to qualifying substances regardless of when they are developed.

The goal is simple: prevent dangerous new opioid products from becoming ordinary consumer merchandise.

Our children should not be exposed to inadequately studied synthetic opioids because a manufacturer has discovered a new chemical structure or marketed a product under a different name.

2. Historical Background: How We Reached This Point

The modern opioid epidemic did not begin with fentanyl, and it did not develop overnight.

Its history illustrates how commercial incentives, misleading information, addiction, and the emergence of new substances can interact over decades.

1995–1996: OxyContin and the Expansion of Prescription Opioids

In 1995, the FDA approved OxyContin, an extended-release oxycodone medication manufactured by Purdue Pharma. The product entered the market in 1996.

OxyContin was promoted as a treatment for pain, but subsequent investigations documented misleading representations concerning addiction and abuse risks.

The marketing and distribution of prescription opioids contributed to a broader period of increased opioid prescribing and opioid-related harm.

Not every patient prescribed opioids developed addiction. Nevertheless, the scale of prescribing, misleading promotional practices, diversion, and inadequate recognition of addiction risks contributed to a major public-health crisis.

2001: Internal Emails and Attitudes Toward Addiction

Court documents and congressional investigations later exposed disturbing correspondence involving members of the Sackler family, which owned Purdue Pharma.

In 2001, an acquaintance wrote to Richard Sackler expressing indifference toward deaths involving opioid misuse.

The Connecticut attorney general's amended complaint documents the acquaintance writing:

"Abusers die, well that is the choice they made"

Richard Sackler subsequently responded:

"Abusers aren't victims; they are the victimizers."

These statements appear in paragraph 39 of the Connecticut attorney general's May 6, 2019 amended complaint.

They reveal a troubling attitude toward people experiencing addiction.

The significance extends beyond the words themselves. Such correspondence illustrates why pharmaceutical marketing, commercial accountability, and public-health responsibilities must be examined together.

People suffering from substance use disorders should not be dismissed as disposable consumers.

2007: Purdue Pharma's Criminal Resolution

In 2007, Purdue Pharma and three company executives entered guilty pleas involving misleading representations concerning OxyContin.

The resolution included more than $600 million in penalties and related payments.

This case became a significant example of how corporate misconduct can contribute to public-health harm.

2013–2017: The Expansion of Illicit Synthetic Opioids

Beginning around 2013, illicitly manufactured fentanyl and related compounds became increasingly prominent in American drug markets.

Examples included acetylfentanyl, butyrylfentanyl, furanylfentanyl, and other fentanyl-related substances.

These compounds demonstrated that manufacturers and suppliers could introduce multiple chemically related opioids, sometimes faster than public-health authorities could identify their prevalence and risks.

Fentanyl itself remains an important approved medical medication. The major crisis involves illicit manufacture, distribution, contamination, and nonmedical use.

2016: U-47700

U-47700, a synthetic opioid originally developed for pharmaceutical research, appeared in illicit drug markets and became associated with overdoses and fatalities.

The DEA temporarily placed U-47700 in Schedule I in November 2016.

Unlike fentanyl analogues, U-47700 belongs to a different chemical family.

This distinction matters.

It demonstrates that opioid activity cannot be predicted solely by looking for compounds structurally similar to fentanyl.

2019–2025: Nitazenes Enter the Market

Nitazenes are synthetic opioids originating from pharmaceutical research conducted during the 1950s and 1960s.

They were not developed into approved medicines.

Beginning in 2019, nitazenes became increasingly visible in illicit drug markets.

Examples include:

• Isotonitazene

• Metonitazene

• Protonitazene

• Etonitazene

• Etonitazepyne

Some nitazenes have demonstrated exceptionally high potency in laboratory or animal studies.

Importantly, not all nitazenes have identical potency or pharmacological properties.

Federal drug-threat assessments have documented the appearance of new synthetic opioid compounds and the continuing challenges of identifying and controlling them.

This is precisely the recurring problem the proposed legislation seeks to address.

A market that can replace one prohibited molecule with another presents a challenge for laws that depend heavily on identifying individual substances.

2025–2026: Concentrated Kratom-Derived Opioid Products

More recently, federal regulators have focused on enhanced products containing 7-hydroxymitragynine (7-OH), mitragynine pseudoindoxyl (MGPI), and related synthetic derivatives.

These substances are associated with kratom alkaloid chemistry, but concentrated or chemically modified products are not necessarily equivalent to traditional botanical preparations.

On August 26, 2026, the DEA temporarily placed MGPI and the synthetic derivatives MGM-15 and MGM-16 in Schedule I.

On October 9, 2026, the Department of Health and Human Services announced updated recommendations for distinguishing certain concentrated or enhanced products from preparations more consistent with botanical kratom.

The recommendations proposed concentration and ratio thresholds for 7-OH and MGPI.

On October 14, the DEA published revised notices of intent reflecting those recommendations.

Importantly, the October threshold recommendations did not extend to MGM-15 or MGM-16. According to the DEA's October 14 Federal Register notice, the existing temporary Schedule I controls on those two substances remained in effect without a corresponding concentration threshold.

This distinction matters because it demonstrates how federal agencies can use different regulatory approaches depending on the scientific evidence concerning a particular substance.

The HHS recommendations concern concentrations and alkaloid ratios, not a universal morphine-equivalent potency standard.

The present paper proposes exploring that broader standard.

September–October 2026: A Genentech Scientist Dies After Exposure to MGM-15

A particularly troubling example emerged in San Francisco.

According to reporting published by the San Francisco Chronicle on October 28, 2026, Robert Schuldt, a 37-year-old scientist employed by biotechnology company Genentech, was identified as San Francisco's first known fatal overdose victim involving MGM-15.

Schuldt died at his San Francisco home on September 22, 2026.

The city's medical examiner ruled his death accidental, attributing it to the toxic effects of kratom alkaloids. Forensic testing confirmed MGM-15 in his body and in packaging associated with a product marketed as cat's claw botanical extract.

The Los Angeles Times reported that the product was associated with packaging for four 100-milligram tablets labeled as Uncaria tomentosa extract.

According to public-health officials, the packaging did not disclose MGM-15 or identify the relevant kratom-derived compounds. The product was marketed under the Script Botanicals x Maui Labs name.

MGM-15 is a chemically modified opioid derived from compounds associated with kratom. Public-health officials have described it as extremely potent, with an estimated potency as high as 50 times that of morphine, although such comparisons depend on the underlying testing methods and should not be treated as universal human dose equivalencies.

The fact that Schuldt worked as a scientist in the biotechnology industry makes this case particularly unsettling. Scientific education and professional experience cannot necessarily protect consumers from dangers that manufacturers fail to disclose. If a product's contents are inaccurately represented, even an informed consumer may have no reasonable way to recognize the risk.

Federal authorities had already temporarily placed MGM-15 in Schedule I in August 2026. Nevertheless, products containing this substance continued to appear in retail markets.

This case demonstrates why ingredient transparency, scientifically validated testing, and preventive commercial safeguards deserve serious consideration.

It does not establish that the specific potency thresholds proposed in this paper would have prevented Schuldt's death. It does, however, provide a documented example of the risks associated with inadequately disclosed, highly potent opioid-active consumer products.

3. The Human Cost of the Opioid Epidemic

The opioid crisis has affected families, workplaces, schools, hospitals, emergency departments, and entire communities.

It has left children without parents, parents without children, and families struggling with addiction, disability, grief, and financial instability.

First responders routinely confront the consequences of overdose emergencies.

Healthcare professionals treat respiratory depression, withdrawal, addiction-related complications, and long-term consequences of substance use disorders.

The economic costs include healthcare expenditures, lost productivity, emergency response, criminal justice expenses, and social services.

According to provisional CDC data released in May 2026, the United States recorded the following estimated overdose deaths in 2025:

Category	Estimated deaths
All drug overdoses	69,973
Opioid-involved overdoses	44,564
Synthetic-opioid-involved overdoses	38,084

These categories overlap and should not be added together.

The estimates represent substantial reductions from 2024, an encouraging development that deserves recognition.

Nevertheless, tens of thousands of opioid-related deaths in a single year remain a major public-health concern.

The emergence of new synthetic opioids creates additional risks even as overall overdose deaths decline.

Preventing exposure to dangerous new compounds should therefore remain a national priority.

4. Why New Opioids Continue to Appear

The body contains several opioid receptor systems, including mu, delta, and kappa receptors.

Mu-opioid receptors are especially important in the pain-relieving, euphoric, dependence-producing, and respiratory-depressant effects of many opioids.

However, these receptors do not respond exclusively to one chemical structure.

Morphine, fentanyl, U-47700, nitazenes, and certain kratom-derived compounds have different molecular structures and pharmacological properties.

Yet they can produce opioid effects through overlapping biological mechanisms.

This means that manufacturers can develop structurally different substances that interact with familiar biological targets.

Some opioid research is legitimate and medically valuable. Scientists continue to investigate compounds that might offer improved pain treatment or reduced adverse effects.

The concern addressed by this proposal is the introduction of inadequately evaluated, nonmedical opioid products into consumer and illicit markets.

In some cases, new compounds emerge after earlier substances are controlled.

This can create a recurring sequence:

1. A new opioid substance appears.

2. Products containing the substance enter commercial or illicit markets.

3. Public-health agencies begin detecting adverse effects or overdoses.

4. Scientists investigate its identity and pharmacological activity.

5. Regulators pursue restrictions or scheduling.

6. Suppliers may introduce alternative compounds.

The exact sequence differs between substances, and existing federal law already provides tools for emergency scheduling and controlling certain analogues.

Nevertheless, the repeated appearance of new opioid compounds demonstrates why Congress should consider a more prospective approach.

5. Opioid Tolerance, Dependence, and Escalation to Stronger Substances

One of the most troubling aspects of opioid addiction is the development of tolerance.

With repeated opioid exposure, the nervous system adapts, and a dose that previously produced substantial effects may become less effective.

Tolerance involves changes in receptor signaling, cellular responses, and broader neural systems.

This is not merely a theoretical concern.

Physicians who treat opioid use disorder regularly encounter patients who describe increasing their doses or seeking stronger substances.

People living with addiction also frequently describe this experience themselves.

What once seemed sufficient may eventually provide little relief, sometimes leaving individuals seeking stronger opioids simply to avoid withdrawal.

Some individuals begin with comparatively weaker opioid products and eventually progress to more potent substances.

Others increase their consumption of the same drug.

This progression is not universal, but it is a recognized pattern in opioid dependence.

The consequences can be devastating.

Increasing doses and switching to unfamiliar, highly potent opioids can substantially increase overdose risk, particularly when a person cannot reliably determine a product's strength or contents.

Tolerance to different opioid effects also develops unevenly. A person may develop tolerance to some effects without receiving equivalent protection against respiratory depression.

The risk becomes especially severe when a person resumes opioid use after a period of abstinence, because previously developed tolerance may have diminished.

This is one reason the continual introduction of new opioid compounds deserves greater legislative attention.

Manufacturers and distributors should not be able to exploit changes in chemical structure to introduce increasingly powerful, poorly studied substances into ordinary commercial markets.

The goal of this proposal is not to punish people suffering from addiction.

It is to reduce opportunities for dangerous exposure and escalation while preserving access to legitimate medical treatment and evidence-based addiction care.

6. A New Federal Standard: Morphine as the Pharmacological Reference

Morphine is one of the most extensively studied opioid medications in medical history.

Its pharmacology provides an established reference for comparing opioid effects.

I propose that Congress direct the FDA to develop a standardized scientific method for evaluating the potency and clinically relevant effects of newly introduced, nonmedical opioid agonists relative to morphine.

The proposed framework would focus on substances that activate opioid receptors, rather than substances that merely bind to them.

This distinction is important because receptor binding alone does not establish opioid-like effects.

For example, an antagonist can bind to an opioid receptor while preventing its activation.

The FDA should evaluate two preliminary regulatory thresholds.

Proposed Thresholds

Standard	Minimum relative potency	Scope
Five times weaker than morphine	20% of morphine's potency	Narrower
Eight times weaker than morphine	12.5% of morphine's potency	Broader

A substance as potent as morphine or more potent would meet either proposed threshold.

The five-times standard would capture substances demonstrating at least 20% of morphine's measured potency.

The eight-times standard would capture additional substances with potency between 12.5% and 20% of morphine's measured potency.

The eight-times threshold is therefore broader, not more permissive.

My Preliminary Recommendation

I propose that Congress begin by directing the FDA to evaluate the five-times threshold as the primary candidate.

The FDA should simultaneously examine whether an eight-times threshold would provide additional protection without unnecessarily restricting ordinary foods, traditional supplements, or other products with weak or incidental opioid activity.

A ten-times-weaker threshold could be examined for comparison, but it would capture an even broader range of substances and should not be adopted without compelling evidence.

These thresholds are policy proposals, not established scientific safety boundaries.

Their feasibility depends on the development of reliable, reproducible testing methods.

7. What Exactly Should the FDA Measure?

The distinction between opioid receptor binding, receptor activation, and effects in living organisms is essential.

A substance can bind strongly to a receptor while producing limited activation.

Another substance may activate receptors in a laboratory but have limited effects when consumed orally because it is poorly absorbed, rapidly metabolized, or unable to enter the brain.

Therefore, the FDA should not establish a prohibited category using receptor-binding affinity alone.

The agency should evaluate:

Functional receptor activity. The degree to which a substance activates mu-opioid receptors under standardized experimental conditions.

Relative potency. The concentration or dose needed to produce a defined effect compared with morphine.

Intrinsic efficacy. The maximum response a compound can produce, which is distinct from its potency.

Brain penetration. Whether the substance reaches the central nervous system in meaningful amounts.

Metabolism. Whether the body converts the substance into more active or less active compounds.

Respiratory-depression potential. Whether the substance produces clinically significant effects on breathing.

Expected routes of exposure. Whether the substance is ordinarily swallowed, inhaled, injected, or otherwise consumed.

Dose and concentration. Whether a product contains trace amounts or deliberately enhanced quantities of an opioid-active compound.

The FDA should determine which measurements are sufficiently reliable to support a legally enforceable standard.

An important limitation must be acknowledged: there is currently no universally accepted laboratory test that can assign every opioid a single, clinically meaningful morphine-equivalent potency value.

A federal law should therefore authorize the FDA to develop and validate a standard before imposing automatic criminal consequences based on numerical results.

8. Protecting Ordinary Foods and Traditional Supplements

A pharmacological law must be carefully written to avoid unintended consequences.

Some naturally occurring substances and food-derived peptides demonstrate opioid-receptor activity under experimental conditions.

That does not necessarily mean consuming the food produces meaningful opioid effects.

Examples include:

Dairy products. Digestion of casein can produce peptides known as casomorphins. Some exhibit opioid activity in laboratory studies.

Wheat products. Certain peptides derived from gluten have demonstrated opioid-like activity experimentally.

Spinach and other plants. Research has identified peptides such as rubiscolins that interact with opioid systems.

Corydalis. This plant has a history of use in traditional Chinese medicine. Some constituents have been studied for pain-relieving effects, although these mechanisms cannot simply be equated with morphine-like opioid activity.

These examples demonstrate why the law must distinguish laboratory receptor activity from meaningful opioid effects in consumers.

Explicit Exemptions

The proposed legislation should protect:

• FDA-approved medications and other lawfully authorized medical products.

• Ordinary foods and their naturally occurring constituents in customary forms.

• Authorized scientific and medical research.

• Traditional botanical preparations meeting scientifically established exemption criteria.

• Products specifically excluded through FDA rulemaking.

Approved medicines would remain subject to their existing regulatory requirements.

The law should also distinguish naturally occurring trace constituents from purified, chemically modified, or deliberately concentrated products designed to produce opioid-like intoxication.

The FDA should have authority to correct unintended classifications and establish additional exemptions.

Ordinary foods should receive explicit protection in the statute itself, rather than relying solely on discretionary exclusions after enforcement begins.

9. Preventing New Substances From Reaching Store Shelves

The central purpose of this proposal is preventive regulation.

A business should not be able to introduce a newly developed opioid-active substance into the consumer market merely because the compound has not yet been individually named in the Controlled Substances Act.

Congress should establish a regulatory system for qualifying newly introduced products marketed for opioid-like effects.

Manufacturers and distributors should be required to provide accurate ingredient information and comply with applicable testing and authorization requirements before commercial distribution.

A qualifying substance meeting the scientifically established standard would be restricted unless an applicable authorization or exemption exists.

This system could apply to future substances without requiring Congress to repeatedly amend federal law to list every new molecule.

However, a numerical standard alone should not be treated as a complete measure of danger.

The FDA should also retain authority to regulate substances that present significant risks even if their measured potency falls below the selected threshold.

Otherwise, manufacturers might simply develop compounds that narrowly avoid the cutoff while remaining hazardous at larger doses.

10. Commercial Accountability and Enforcement

Manufacturers, importers, and distributors introducing novel psychoactive substances into commerce should be expected to understand and document the substances they are selling.

The legislation should establish clear duties involving:

• Accurate ingredient identification and labeling.

• Laboratory testing when required.

• Documentation of pharmacological evaluations.

• Premarket notification or authorization for covered products.

• Cooperation with product recalls and federal investigations.

Businesses that violate these requirements could face civil penalties, seizure of products, recalls, and other enforcement measures.

Criminal penalties should apply when the legally required elements of an offense are established.

A strong law must also respect constitutional due-process requirements.

In McFadden v. United States (2015), the Supreme Court addressed the knowledge requirements for prosecutions under the federal Analogue Act.

Congress should therefore avoid relying on an irrebuttable presumption that every retailer automatically knows the pharmacological properties of every product.

Instead, the law should establish clear commercial responsibilities and meaningful consequences for knowing violations, deliberate avoidance of required testing, and other culpable conduct.

The goal should be effective enforcement that can withstand judicial review.

11. How the Proposal Would Differ From Existing Federal Law

The Controlled Substances Act already authorizes federal scheduling of dangerous drugs.

The federal Analogue Act, enacted in 1986, extends controls to certain substances substantially similar to controlled drugs when applicable statutory requirements are met.

The DEA also possesses temporary scheduling authority in circumstances involving an imminent hazard to public safety.

These mechanisms are important.

However, chemical similarity is not always equivalent to pharmacological similarity.

Structurally different compounds can activate the same receptor systems.

The proposed framework would supplement existing law by establishing a scientifically defined category based on qualifying biological activity.

Its purpose would be to reduce dependence on repeatedly identifying and naming individual chemical compounds.

It would not eliminate the need for scientific analysis, administrative procedures, or judicial review.

Rather, it would create a prospective standard capable of addressing future compounds that meet the established criteria.

12. Recommended Congressional Action

Congress should consider directing the FDA, in coordination with the DEA and independent scientific experts, to complete a formal evaluation of the proposed framework.

The evaluation should include the following elements.

A. Develop a Validated Morphine-Referenced Test

Establish reproducible methods for comparing qualifying opioid activity against morphine.

B. Evaluate the Five-Times Threshold

Determine whether substances demonstrating at least 20% of morphine's potency can be identified consistently and whether the threshold captures products of meaningful public-health concern.

C. Evaluate the Eight-Times Threshold

Determine whether extending coverage to substances demonstrating at least 12.5% of morphine's potency provides meaningful additional protection.

D. Examine Unintended Consequences

Evaluate whether either threshold would unnecessarily affect ordinary foods, traditional supplements, legitimate research, or medically useful compounds.

E. Establish Statutory Exemptions

Protect approved medications, ordinary foods, authorized research, and qualifying traditional products.

F. Develop Commercial Compliance Requirements

Establish testing, documentation, disclosure, and authorization duties for manufacturers and distributors introducing covered substances into commerce.

G. Provide Rapid Administrative Review

Allow the FDA to issue exemptions, clarify classifications, correct scientific errors, and respond promptly to emerging risks.

H. Require Public Reporting

Direct federal agencies to report periodically on newly identified opioid compounds, market changes, enforcement outcomes, overdose trends, and unintended effects.

13. Limitations and Scientific Questions

This proposal is intended to initiate scientific and legislative consideration.

It does not claim that a five-times or eight-times threshold has already been validated.

Several important questions remain.

Can a universal morphine-referenced standard reliably predict clinically meaningful opioid effects?

Should different routes of administration require different measurements?

How should substances with unusual receptor signaling be classified?

Could a weak opioid agonist still cause substantial harm when consumed in large quantities?

How should regulators distinguish customary botanical preparations from concentrated or chemically altered products?

Could strict regulation unintentionally push consumers toward more dangerous illicit markets?

These questions require research and public consultation.

The proposed framework should complement, rather than replace, evidence-based addiction treatment, overdose prevention, naloxone access, and broader public-health measures.

Its effectiveness should ultimately be judged by measurable outcomes, including reductions in harmful exposure and preventable overdose deaths.

14. A Call for Congressional Responsibility

The death of 37-year-old Genentech scientist Robert Schuldt in San Francisco provides a tragic and timely example of why preventive legislation deserves serious congressional consideration.

According to reporting published by the San Francisco Chronicle on October 28, 2026, Schuldt was identified as the city's first known fatal overdose victim involving MGM-15, a potent, chemically modified opioid derived from kratom-related compounds.

The San Francisco medical examiner attributed his accidental death to the toxic effects of kratom alkaloids. Forensic testing confirmed MGM-15 in his body and in packaging associated with a product marketed as cat's claw botanical extract. Public-health officials reported that the packaging failed to identify MGM-15 or disclose the relevant kratom-derived compounds.

This was not simply a case involving a familiar controlled substance purchased through an established illicit drug market. It involved a powerful opioid-active compound concealed within a product presented as a botanical supplement, the type of merchandise that consumers may encounter in smoke shops, gas stations, and other ordinary retail settings.

The fact that the victim was a scientist working in the biotechnology industry makes this case particularly unsettling. Scientific education and professional experience do not necessarily protect a consumer from dangers that manufacturers fail to disclose. If the contents of a product are inaccurately represented, even an informed consumer may have no reasonable way to recognize the risk.

This tragedy should add urgency to the responsibility resting on every member of Congress.

I intend to make the strongest possible case for legislative action, firmly, professionally, and respectfully. We need additional layers of protection to prevent dangerous substances from reaching the public. At the same time, we must be careful not to create so many unnecessary restrictions that ordinary Americans suffer the consequences in their everyday lives.

Effective legislation should be precise, proportionate, scientifically grounded, and enforceable. It should distinguish dangerous concentrated opioid products from approved medications, ordinary foods, legitimate scientific research, and qualifying traditional botanical preparations.

Federal authorities have already taken action against MGM-15 and related compounds, including emergency scheduling measures. These actions are important and deserve recognition. However, the emergence of these substances raises a broader question: Why must the regulatory system repeatedly identify and respond to individual dangerous compounds after they have entered commercial markets?

What I find most unsettling is that we possess the legislative authority, scientific knowledge, and institutional resources to pursue meaningful preventive solutions, yet our approach too often remains reactive.

We should not have to wait for another death, another grieving family, or another newly developed opioid to appear before examining whether our laws can do more to prevent these products from reaching consumers.

I believe the solution proposed in this paper is a relatively straightforward starting point for addressing an extraordinarily complicated national problem. Congress should direct the FDA and DEA to evaluate a scientifically validated, prospective regulatory standard that can identify qualifying nonmedical opioid agonists based on their pharmacological properties, rather than relying primarily on the names and chemical structures of substances already discovered.

Such legislation will not be perfect. New challenges may arise, and some may not become apparent until after the law is enacted. That is not a reason to avoid acting. It is a reason to build scientific review, appropriate exemptions, due-process protections, and mechanisms for improving the law as new evidence emerges.

When those future challenges come, we will have millions of capable minds, dedicated researchers, medical professionals, lawmakers, and ordinary Americans to help us find the next solution.

We will find it, just as we have overcome countless challenges before.

The possibility that we may need to improve a solution tomorrow should never become an excuse for refusing to pursue one today.

15. Conclusion: Stop Waiting for the Next Opioid

The United States has spent decades responding to an opioid crisis that repeatedly changes form.

We have watched prescription opioid misuse, heroin, illicit fentanyl, synthetic analogues, nitazenes, and concentrated opioid-active products create successive challenges.

We know that many structurally different compounds can act on the same biological systems.

We know that opioid tolerance and dependence can contribute to escalating use and dangerous exposure.

And we know that regulators sometimes confront newly emerging compounds only after they have entered the market.

We should not accept that cycle as inevitable.

I propose that Congress direct the FDA to develop a scientifically validated, morphine-referenced standard for regulating newly introduced, nonmedical opioid agonists.

The five-times and eight-times weaker thresholds deserve serious evaluation, with a preliminary emphasis on the narrower five-times standard.

Approved medications, ordinary foods, legitimate research, and qualifying traditional products must remain protected.

Manufacturers and distributors should have clear responsibilities before introducing novel opioid-active products into American commerce.

This proposal will not end addiction, eliminate illicit trafficking, or prevent every overdose.

But it offers a possible way to close an important regulatory gap and reduce the continual introduction of dangerous new opioid substances into consumer markets.

For decades, first responders, medical professionals, families, and communities have carried the consequences of this crisis.

They deserve a regulatory system designed to anticipate emerging threats rather than merely respond after harm has occurred.

We cannot bring back the people we have lost. But we can work to prevent the next generation of dangerous opioid products from reaching our stores, our communities, our loved ones, and most importantly, our children.

Sources and References

Federal Public-Health Data and Drug Regulation

1. Centers for Disease Control and Prevention. (2026). U.S. Overdose Deaths Decrease for Third Consecutive Year in 2025.

2. U.S. Drug Enforcement Administration. (2024). National Drug Threat Assessment.

3. U.S. Drug Enforcement Administration. Nitazenes: Drug Information and Scheduling Actions.

4. U.S. Drug Enforcement Administration. Synthetic Opioids Drug Fact Sheet.

5. U.S. Department of Health and Human Services. (October 9, 2026). HHS Recommends Science-Based Thresholds to Target Dangerous Enhanced Kratom Products.

6. U.S. Food and Drug Administration. (2026). Hiding in Plain Sight: 7-OH Products.

7. U.S. Department of Justice. (August 2026). Justice Department Announces Emergency Scheduling of Three Potent Opioid Compounds.

8. U.S. Drug Enforcement Administration. (August 26, 2026). Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I.

9. U.S. Drug Enforcement Administration. (October 14, 2026). Federal Register Notice Concerning MGM-15 and MGM-16.

10. U.S. Drug Enforcement Administration. (October 14, 2026). Federal Register Notice Concerning 7-OH and MGPI Thresholds.

San Francisco MGM-15 Fatality and Retail Enforcement

11. San Francisco Chronicle. (October 28, 2026). S.F. Genentech Employee Identified as First Local Victim of New Opioid Sold in Smoke Shops.

12. Los Angeles Times. (October 22, 2026). Supplement Sold at Gas Stations Blamed for California Man's Opioid Overdose.

13. San Francisco Chronicle. (October 2026). SF Records First Death From Potent New Opioid Found in Smoke Shops.

14. San Francisco Police Department. (October 21, 2026). SFPD Seizes Hundreds of Items Illegally for Sale at City Smoke Shops.

Opioid History, Corporate Accountability, and Scientific Literature

15. Connecticut Office of the Attorney General. (May 6, 2019). Amended Complaint Concerning Purdue Pharma and the Sackler Family. See paragraph 39, page 11, for the 2001 email exchange.

16. U.S. House of Representatives, Committee on Oversight and Reform. (December 17, 2020). The Role of Purdue Pharma and the Sackler Family in the Opioid Epidemic.

17. United Nations Office on Drugs and Crime. U-47700 Substance Information.

18. Alpert, A., Evans, W. N., Lieber, E. M. J., & Powell, D. (2022). Origins of the Opioid Crisis and Its Enduring Impacts. Quarterly Journal of Economics, 137(2), 1139–1179. DOI: 10.1093/qje/qjab043.

Federal Law and Judicial Precedent

19. Supreme Court of the United States. (2015). McFadden v. United States, 576 U.S. 186.

20. United States Code. 21 U.S.C. § 811: Authority and Criteria for Classification of Substances.

21. United States Code. 21 U.S.C. § 813: Treatment of Controlled Substance Analogues.

Prepared by Sam P. Stewart as an independent scientific research and legislative policy proposal for consideration by Congress, federal regulatory agencies, healthcare institutions, scientific researchers, and the public.

The proposed potency thresholds are recommendations for federal scientific evaluation, not established clinical safety limits or currently enacted federal law.