Jax’s Law – An Act to Combat the Counterfeit Drug Epidemic in California

Abstract: This Act seeks to reduce the incidence of deaths and overdoses related to the use of counterfeit pharmaceutical products in California by a combination of stringent enforcement measures, public education campaigns and expanded rehabilitation provisions. In addition to these measures, the Act aims to restore trust in pharmaceutical and digital ecosystems by implementing enhanced regulatory oversight, verification mechanisms for pharmaceutical transactions, and transparency requirements for digital payment systems and online marketplaces, ensuring comprehensive consumer protection. Central to this Act is the introduction of the Lethal Dosage Unit (LDU), a standardized metric for assessing the lethality of controlled substances, ensuring that enforcement and sentencing align with the actual risks posed by illicit drugs. By leveraging a variety of funding sources for public education campaigns and the expansion of rehabilitation services, this Act establishes a comprehensive framework for safeguarding public health and disrupting illicit supply chains. Additionally, by aligning with state and federal statutes, it strengthens oversight and accountability within pharmaceutical and digital ecosystems, ensuring long-term consumer protection.

Preamble:

WHEREAS, the influx of counterfeit drugs into the state of California, driven by both domestic production and international smuggling routes—including imports from China and Mexico, as well as illicit domestic manufacturing operations—poses a significant and growing risk to public health and safety;

WHEREAS, counterfeit medications, often containing lethal substances, contribute to rising overdose deaths and injuries, disproportionately impacting vulnerable populations;

WHEREAS, online platforms and digital payment systems play an increasingly significant role in enabling counterfeit drug transactions;

WHEREAS, addressing these issues requires a multifaceted approach that includes accountability for digital entities, public education, rehabilitation services, and stringent enforcement mechanisms;

THEREFORE, this Act establishes rigorous legal, educational, and enforcement frameworks to combat counterfeit drugs effectively.

Section 1: Purpose and Goals

1.1 To significantly reduce year-over-year overdoses and deaths related to dangerous counterfeit pharmaceuticals and related products in California.

1.2 To significantly reduce the entry, manufacture, and distribution of counterfeit drugs within California.

1.3 To introduce and establish, as a tool for effective and properly measured drug enforcement, a new standard for measuring drug quantities in terms of “Lethal Dosage Units” (LDU) instead of obsolete traditional measures of weight. LDUs provide a more precise metric by assessing the actual lethality of a substance rather than its bulk weight, allowing law enforcement and the judicial system to better gauge public health risks and apply proportional penalties (see Section 3 for further clarification).

1.4 To impose stringent penalties for counterfeit drug-related offenses, with special consideration for crimes involving lethal substances and minors.

1.5 To establish accountability measures for online platforms and digital payment systems that enable counterfeit drug transactions. (Relevant to United States v. FedEx Corp., 2016, where the company was charged with knowingly facilitating the distribution of illegal pharmaceuticals, setting a precedent for corporate liability in digital drug transactions.)

1.6 To expand access to high-quality rehabilitation services for individuals affected by counterfeit drugs, prioritizing under-served and high-impact communities, defined as areas with limited healthcare infrastructure, high overdose rates, and significant economic barriers to addiction treatment.

1.7 To educate the public on the dangers of counterfeit drugs and foster trust in the pharmaceutical and digital marketplaces.

Section 2: Definitions

2.1 Counterfeit Drugs: Medications fraudulently labeled or altered, including those without active ingredients, with altered formulas, or containing lethal substances.

2.2 Online Platforms: Social media companies, peer-to-peer payment systems, e-commerce platforms, and any digital entities facilitating counterfeit drug transactions, whether knowingly or through willful negligence, by failing to implement reasonable safeguards against such activities. (Relevant to Communications Decency Act, Section 230)

2.3 Knowingly: Having actual knowledge or acting with willful blindness to the counterfeit and/or lethal nature of drugs being distributed, consistent with established legal standards for willful blindness, where an individual deliberately avoids acquiring direct knowledge of illegal conduct despite awareness of a high probability of its existence.

2.4 Lethal Substance: Substances likely to cause death when consumed, including fentanyl and its analogs. (United States v. Burrage, 2014)

2.5 Lethal Dosage Unit: A Lethal Dosage Unit (LDU) is the smallest amount of a substance that can cause fatal overdose in an average adult. It is determined using data from medical research, pharmacological studies, and toxicology reports.

2.6 Supply Chain: Includes all individuals, organizations, and digital platforms involved in the production, distribution, and sale of counterfeit medications. Accountability measures for actors within the supply chain shall include fines, criminal penalties, and regulatory oversight based on the degree of involvement and intent. Manufacturers and distributors found complicit in producing or knowingly selling counterfeit drugs will face felony charges, while digital platforms facilitating transactions without proper safeguards may be subject to financial penalties and operational restrictions.

Section 3: Recalibration of Metrics and Establishment of Fatal Dosage Units

3.1 Purpose and Intent This section mandates the use of a new unit of measurement, the Lethal Dosage Unit (LDU), to more accurately reflect the potential lethality of illicit substances and differentiate the relative risks posed by traditional narcotics and emerging synthetic drugs such as fentanyl, carfentanyl, and xylazine.

3.2 Definition of Lethal Dosage Unit (LDU) A Lethal Dosage Unit (LDU) is the minimum quantity of a controlled substance that, when ingested, inhaled, or otherwise administered, is statistically capable of causing a fatal overdose in an average adult human. The LDU for each controlled substance shall be determined based on peer-reviewed scientific research, including studies from the National Institute on Drug Abuse (NIDA), the Centers for Disease Control and Prevention (CDC), and other reputable public health bodies.

3.3 Application in Drug Enforcement and Sentencing

  • The number of LDUs present in any drug seizure shall be a primary factor in determining the severity of criminal charges.

  • Offenses involving higher quantities of LDUs shall carry enhanced penalties, recognizing the increased public health risk posed by such substances.

3.4 Periodic Review and Legislative Oversight

  • The Legislature shall conduct a review of the effectiveness of the LDU system every five years to ensure accuracy and effectiveness.

  • New substances may be added to the LDU system as additional drugs are identified.

Section 4: Penalties

4.1 General Manufacturing and Distribution: (United States v. Luong, 2020) Fine of $10,000 and/or imprisonment for 5–7 years for general counterfeit drug offenses.

4.2 Enhanced Penalties for Distribution of Lethal Substances: (21 U.S.C. § 841) 10-20 years for knowingly distributing lethal counterfeit drugs.

4.3 Enhanced Penalties for Offenses Involving Minors: (United States v. Hernandez-Rodriguez, 2020) Additional fine of $500,000 and/or imprisonment for 20 years to life.

4.4 Escalated Penalties Based on Fatal Dosage Units: (United States v. Flores, 2019)

  • Over 100 units: Fine of $50,000 and imprisonment for 10–15 years.

  • Over 1,000 units: Fine of $250,000 and imprisonment for 20–30 years.

  • Over 10,000 units: Fine of $1,000,000 and imprisonment for 30 years to life.

4.5 Online Platform Liability: (United States v. FedEx Corp., 2016)

  • Online platforms facilitating counterfeit drug transactions shall be held liable if they knowingly allow such activities or exhibit willful negligence by failing to implement reasonable safeguards.

  • Platforms that can demonstrate compliance with proactive monitoring and reporting mechanisms shall not be held criminally liable for transactions occurring despite due diligence efforts.

  • Fines up to $5,000,000 per violation; potential suspension of licenses for repeat offenses; criminal liability for executives who knowingly enable or ignore illicit transactions. (United States v. FedEx Corp., 2016) Fines up to $5,000,000 per violation; potential suspension of licenses for repeat offenses; criminal liability for executives.

4.6 Supply Chain Accountability:

  • Fines of up to $1,000,000 for corporations and $500,000 for individuals, with 5-15 years of imprisonment for individuals knowingly or through willful negligence facilitating counterfeit drug sales.

4.7 Restitution: (United States v. Roman, 2015)

  • Offenders must provide financial restitution to victims or their families in cases resulting in death or major injury.

4.8 Prohibition of Early Release: (United States v. Volkman, 2015)

  • Offenders convicted under this Act for distributing lethal counterfeit drugs, especially to minors, shall be ineligible for parole or early release.

4.9 Repeat Offender Penalties: (United States v. Burrage, 2014)

  • Any individual convicted of a second counterfeit drug-related offense involving lethal substances shall receive a mandatory sentence enhancement of 10 additional years.

  • A third conviction shall result in life imprisonment without the possibility of parole. (United States v. Volkman, 2015)

Section 5: Public Awareness and Rehabilitation

5.1 Allocate a minimum $20 million annually for public awareness campaigns highlighting the dangers of counterfeit drugs.

5.2 Partner with schools, healthcare providers, billboard companies, and online platforms to educate consumers and disseminate accurate information.

5.3 Expand Medi-Cal to provide free rehabilitation services, including Medication-Assisted Treatment (MAT), prioritizing high-impact communities where counterfeit drug incidents are most prevalent. (Anti-Money Laundering Act, 2020)

Section 6: Rehabilitation Resources

6.1 Purpose and Intent The State of California recognizes that addressing the counterfeit drug epidemic and reducing overdose deaths requires a comprehensive approach that includes robust enforcement measures and expanded access to effective rehabilitation services.

6.2 State-Funded Incentives for Rehabilitation Centers Funds shall be allocated to:

  • New treatment centers in underserved regions with high rates of counterfeit drug overdoses.

  • Existing treatment centers expanding or improving services.

  • Community-based recovery programs providing harm reduction services.

6.3 Measurable Success Standards and Accountability

  • Performance metrics shall be evaluated by the California Legislature on an annual basis to ensure accountability and measure progress. Metrics shall include:

    • Completion rate of treatment programs.

    • Sustained sobriety rates.

    • Reduction in drug-related arrests and overdose deaths.

Section 7: Funding

7.1 Utilize settlement funds from opioid litigation to support enforcement, rehabilitation, and education efforts.

7.2 Maximize federal grants under the Substance Abuse Prevention and Treatment Block Grant (SAPTBG).

7.3 Leverage existing consumer protection funds to safeguard pharmaceuticals, legal dispensaries, and e-commerce platforms from counterfeit drug contamination.

7.4 Allocate fines collected from online entities to fund public awareness and addiction treatment initiatives.

Section 8: Metrics for Success

8.1 Track counterfeit drug cases and seizures annually through reports from law enforcement and regulatory agencies.

8.2 Demonstrate a 30% increase in addiction treatment program participation within three years.

8.3 Achieve a 20% reduction in opioid-related deaths within five years.

8.4 Conduct regular audits of digital platforms for compliance with anti-counterfeit measures.

Section 9: Implementation

9.1 This Act shall be implemented in coordination with the California Department of Public Health, State Board of Pharmacy, the State Attorney General’s Office, and District Attorneys’ Offices across the state.

9.2 Online platforms must comply with specific requirements within six months, including:

  • AI systems for monitoring and reporting counterfeit transactions, with regular audits conducted by state regulators.

  • Publicly accessible reporting mechanisms for suspicious activities, with mandatory reporting to law enforcement for flagged transactions.

  • Transparency through quarterly compliance reports, subject to review by the California Attorney General’s Office.

  • Online platforms must maintain detailed records of all transactions potentially related to pharmaceutical sales and digital payment processing for a minimum of one year to ensure accountability and traceability in counterfeit drug investigations.

  • Failure to comply may result in escalating penalties, including fines, suspension of operational licenses, and criminal liability for executives in cases of willful negligence or repeated violations.

9.3 This Act shall take effect on January 1, 2026.

Section 10: Legislative Findings

The Legislature finds that the inclusion of the Lethal Dosage Unit (LDU) system is critical for public health and safety. This system provides an evidence-based framework for assessing the true lethality of controlled substances, improving drug enforcement practices, and reducing drug-related fatalities. (Full text of all remaining sections, including penalties, funding, rehabilitation, public awareness, implementation, case law references, and federal/state coordination.)

Cited Laws and Case Law for Sentencing Validation

1. United States v. Luong, 965 F.3d 973 (9th Cir. 2020): Sentencing for counterfeit drug distribution.

2. United States v. Roman, 795 F.3d 511 (6th Cir. 2015): Enhanced sentencing for repeat offenders.

3. United States v. Burrage, 571 U.S. 204 (2014): Life imprisonment for drug distribution leading to death.

4. United States v. Hernandez-Rodriguez, 981 F.3d 598 (8th Cir. 2020): Enhanced penalties for selling drugs to minors.

5. United States v. Flores, 928 F.3d 550 (6th Cir. 2019): Large-scale trafficking enterprise sentencing.

6. United States v. FedEx Corp., 18-cr-02993 (N.D. Cal. 2016): Corporate liability for drug distribution.

7. United States v. Volkman, 797 F.3d 377 (6th Cir. 2015): Life sentences for distributing prescription medications resulting in death.

8. 21 U.S.C. § 841: Penalties for drug distribution leading to death or injury.

9. 21 U.S.C. § 859: Penalties for drug distribution to minors.

10. 21 U.S.C. § 848: Penalties for large-scale drug trafficking.

11. California Business and Professions Code § 4160: Regulation of drug distribution.

12. Drug Supply Chain Security Act (2013): Enhances the traceability of prescription medications.

13. Anti-Money Laundering Act of 2020: Obligations for financial institutions to monitor and report suspicious activities.

14. Communications Decency Act, Section 230: Limits platform immunity in cases of criminal activity.