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A 10969

Prohibits harmful and adulterated kratom products

2025 Regular Session Introduced by Jake Blumencranz

Prohibits synthetic/adulterated kratom and requires third-party testing, clear labeling, age limits, and enforcement to ensure safer, regulated kratom products.

REFERRED TO HEALTH
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Bill Summary · A 10969

Summary of New York Bill A.10969 (2025-2026) – Prohibits Harmful and Adulterated Kratom Products

Jurisdiction: New York | Introduced: April 14, 2026 | Committee: Health

Purpose and intent

  • The bill, named the “synthetic kratom kills act,” seeks to ban harmful synthetic and adulterated kratom products while regulating natural kratom through testing, labeling, age restrictions, and enforcement.
  • It aims to prevent deaths, overdoses, and other adverse health effects associated with synthetic or adulterated kratom, while preserving access to natural kratom leaf in a controlled, consumer-protective framework.

Key provisions and changes

1) Definitions (Section 1399-mmmm)

  • Kratom leaf: Leaf of Mitragyna speciosa with minimal postharvest processing; allows remains of naturally occurring alkaloids if verified by third-party testing.
  • Kratom product: Any human-consumption product containing kratom leaf (including products marketed under different names) that does not contain synthesized kratom material.
  • Synthesized kratom material: Alkaloids or derivatives created by chemical synthesis or biosynthetic means, or subjected to processes causing structural changes.
  • Adulterated kratom product: A kratom product adulterated with a dangerous substance or altered to be injurious.
  • Manufacturer, Retailer, Distributor: Roles in production, sale, distribution, and labeling.
  • Third-party laboratory: ISO/IEC 17025 accredited, independent lab for testing.
  • Total alkaloids: Sum of all alkaloids in the product (mg/g). Key alkaloids include mitragynine and 7-hydroxymitragynine.

2) Prohibitions on certain kratom products

  • Prohibits manufacture, distribution, or sale of:
    • Synthesized kratom material.
    • Adulterated kratom products.
    • Kratom products that are combustible or intended for vaping/injection.
    • Kratom products marketed as conventional foods or beverages (with exceptions for certain kratom leaf infusions or traditional teas).
    • Kratom products with flavorings/additives designed to appeal to those under 21.
    • Kratom products not in child-resistant packaging meeting specified federal standards.
    • Kratom products that mimic candy or are marketed to appeal to under-21s.
    • Kratom products where 7-hydroxymitragynine exceeds 2% of total alkaloids (by third-party testing).

3) Manufacturing/testing requirements (Section 1399-mmmm, subdivision 3)

  • All kratom products sold/distributed in NY must undergo third-party laboratory testing before sale by batch/lot.
  • Testing must verify absence of:
    • Heavy metals above FDA thresholds.
    • Microbial contamination (Salmonella, E. coli O157:H7, and yeast/mold) above federal thresholds.
    • Pesticide residues above federal thresholds.
    • Fentanyl or other controlled substances.
    • Synthesized kratom material.
  • Testing must quantify:
    • Total alkaloids, mitragynine, and 7-hydroxymitragynine (mg/g).
  • Products must bear labeling confirming testing results; manufacturers must keep certificates of analysis and provide on request.

4) Labeling requirements (Section 1399-mmmm, subdivision 4)

  • Labels must include:
    • Ingredient list.
    • mg per serving and mg per container of mitragynine and 7-hydroxymitragynine.
    • Serving size and recommended max servings per 24 hours.
    • Servings per container.
    • Manufacturer name and principal street address.
    • Unique batch/lot number.
    • Healthcare professional consultation recommendation.
    • Warnings: not safe during pregnancy/breastfeeding; store out of reach of children; sale to under-21 prohibited; potential drug interactions.
    • Disclaimer that the product is not intended to diagnose, treat, cure, or prevent disease.
  • If space is insufficient, a scannable code (barcode/QR) or web link must provide the required information.

5) Restrictions on sales channels (Section 1399-mmmm, subdivision 5)

  • Kratom products cannot be sold via vending machines or automated self-service devices.

6) Enforcement and penalties (Section 1399-mmmm, subdivision 6)

  • Agencies with enforcement authority: Department of Health, local health departments, and law enforcement.
  • Violations and penalties:
    • First violation: $500 fine + confiscation of involved products.
    • Second violation within 36 months: $1,000 fine + 7-day suspension of licenses/permits + confiscation.
    • Third or subsequent violation within 36 months: $5,000 fine + 30-day suspension + confiscation.
    • 4+ violations within 36 months, or 2+ violations involving synthesized material, adulteration, or sale to under-21: referral for possible permanent license/permit revocation after due process.
  • Each day of violation counts as a separate offense; but total fines for continuing violations cannot exceed $25,000 in 36 months.
  • Affirmative defense: owner can avoid liability if they had compliant policies/training and violations occurred without their knowledge.

7) Recordkeeping and rules (Section 1399-mmmm, subdivision 7)

  • Manufacturers/distributors/retailers must keep Certificate of Analysis and incident reports (adverse events, consumer complaints, product safety concerns) for at least 3 years.
  • Department may issue rules to implement, including updating testing standards and prohibited substances; must do so within existing resources and appropriations.

8) Severability and local preemption (Sections 1399-mmmm, 9–10)

  • If any provision is held invalid, the rest remains in effect.
  • Local jurisdictions may enact stricter kratom restrictions than the act.

Effective date and implementation

  • Effective date: 90 days after enactment.
  • Commissioner of Health may promulgate necessary rules before the effective date.
  • Kratom products already in commerce have 180 days from the effective date to comply with testing requirements.

Impact overview

  • Consumers: Improved information through labeling and verified testing; protection from adulterated or synthetic kratom; age-restricted access.
  • Industry: New compliance regime for manufacturers, distributors, and retailers; mandatory third-party testing and CA records; potential cost increases associated with testing and labeling.
  • Regulators: Enhanced enforcement framework with civil penalties, inspections, and potential license suspensions or revocations.
  • Public health: Aims to reduce harm from synthetic/adulterated kratom and ensure safer natural kratom products through quality control and consumer education.

Compiled from official sources — confirm details with the bill’s official record.

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