Overview

Title

To amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of cannabis and cannabinoid products, and for other purposes.

ELI5 AI

The "Cannabinoid Safety and Regulation Act" is a proposed law that makes rules to keep cannabis products safe. It creates a special group to look after these products, makes sure they are safe for people to use, and spends money to prevent bad things like kids using cannabis and people driving badly after using it.

Summary AI

S. 5243, known as the "Cannabinoid Safety and Regulation Act," proposes changes to the Federal Food, Drug, and Cosmetic Act to regulate cannabis and cannabinoid products. It establishes the Center for Cannabinoid Products in the FDA to oversee these regulations, which focus on product safety, labeling, and manufacturing practices. The bill also addresses public health issues such as preventing underage cannabis use and reducing cannabis-impaired driving, including grant programs for states to implement related initiatives. Furthermore, the bill mandates research on the impacts of cannabis use and its regulation in relation to public health and safety standards.

Published

2024-09-25
Congress: 118
Session: 2
Chamber: SENATE
Status: Introduced in Senate
Date: 2024-09-25
Package ID: BILLS-118s5243is

Bill Statistics

Size

Sections:
24
Words:
16,540
Pages:
80
Sentences:
277

Language

Nouns: 4,593
Verbs: 1,391
Adjectives: 820
Adverbs: 186
Numbers: 509
Entities: 510

Complexity

Average Token Length:
4.29
Average Sentence Length:
59.71
Token Entropy:
5.60
Readability (ARI):
31.97

AnalysisAI

The Cannabinoid Safety and Regulation Act is an extensive legislative effort aimed at amending the Federal Food, Drug, and Cosmetic Act to include comprehensive regulations for cannabis and cannabinoid products. This bill addresses several key areas including the regulation of manufacturing, labeling, and testing of cannabinoid products, public health considerations, prevention of underage cannabis use, and measures to mitigate cannabis-impaired driving.

General Summary

The bill mandates the creation of the Center for Cannabinoid Products within the FDA, responsible for oversight and implementation of cannabinoid product regulations. It also establishes standards to ensure that products are not adulterated or misbranded, sets registration protocols for manufacturing facilities, and requires robust safety and testing standards. Public health measures include expanding surveillance of cannabis use effects and preventing underage use through grants. Additionally, the bill outlines initiatives to mitigate cannabis-impaired driving, including state grants and research activities, and considers the establishment of a national cannabis impairment standard.

Significant Issues

One key issue is the variability in potential costs for businesses due to the registration fee structure, which allows for increases based on the Consumer Price Index without a clear cap. Another concern is the requirement for manufacturers to list 'known risks to special populations' without a standardized list, complicating compliance. The bill's provision for states to enact more stringent regulations than federal standards may lead to a fragmented regulatory environment, complicating compliance for businesses operating in multiple states.

The bill increases funding for public health initiatives by $100,000,000 annually without detailed justification, raising concerns of potential wasteful spending. Furthermore, the absence of a clear definition for 'cannabis-impaired driving' or acceptable THC levels poses enforcement challenges.

Impact on the Public

The bill has the potential to enhance consumer safety by ensuring that cannabinoid products meet rigorously tested standards, reducing the likelihood of harm from adulterated or misbranded products. By funding research on the adverse health effects of cannabis use and cannabis-impaired driving, the bill seeks to improve public health outcomes. However, the increased regulation may result in higher costs for businesses, potentially raising the prices of cannabis products for consumers.

Impact on Specific Stakeholders

For small businesses, the complex registration and labeling requirements could pose significant challenges. With potentially higher compliance costs, small businesses may struggle compared to larger organizations that have more resources to adapt to regulatory changes. On the other hand, consumers might benefit from greater assurance of product safety and more informed choices, thanks to clearer labeling and health warnings.

State governments could face challenges adapting to the bill's various mandates, particularly in balancing federal regulations with their own, potentially stricter, regulatory frameworks. Additionally, stakeholders concerned with civil liberties and consumer freedoms might view the bill's thorough regulatory scope as excessive or infringing.

Overall, the Cannabinoid Safety and Regulation Act represents a significant step toward standardizing cannabinoid product safety and oversight, though it may impose notable regulatory burdens that require careful consideration and adjustment to balance stakeholder interests effectively.

Financial Assessment

The "Cannabinoid Safety and Regulation Act" includes several financial elements, primarily related to fees, penalties, and appropriations. These financial provisions aim to regulate the cannabis industry while ensuring public safety and health.

Financial Appropriations and Allocations

The bill outlines various financial appropriations to support the regulation of cannabinoid products and address related public health issues:

  • Section 201 increases funding from $496,000,000 to $596,000,000 for public health surveillance over the fiscal years 2024 through 2028. This funding is intended to explore and understand the use and health effects of cannabis. Although the intent is clear, the increase in funding might raise concerns about potential overspending or lack of accountability, as more specific justifications for this increase were not detailed in the bill.

  • Section 202 and Section 553 both allocate $25,000,000 each fiscal year from 2024 through 2028 to prevent underage cannabis use. This substantial investment targets a crucial area of public health, aiming to reduce cannabis use among youth through various programs. The alignment of this funding with the bill's objectives suggests a considered approach, although its effectiveness will require monitoring to ensure that funds are not wasted.

  • Section 304 and Section 409 provide for $40,000,000 annually from 2024 to 2028, allocated for state grants to prevent cannabis-impaired driving. This funding supports enforcement, data collection, and educational activities. Given the complexity of implementing these programs across different states, the allocation should be monitored to evaluate its impact on cannabis-impaired driving effectively.

  • Section 306 appropriates an additional $30,000,000 each fiscal year from 2024 to 2029 to carry out sections related to cannabis-impaired driving research and prevention programs. This investment reflects a commitment to establishing data-driven strategies but must be justified by significant improvements in public safety to be deemed efficient.

Registration Fees and Penalties

The bill also implements registration fees and penalties as regulatory measures:

  • Section 101 specifies that the Secretary may charge a registration fee up to $500 for fiscal year 2024, adjustable based on the Consumer Price Index in subsequent years. However, the lack of a fee increase cap may pose financial uncertainties, particularly for smaller businesses, as highlighted in the issues section.

  • Section 102 outlines penalties for violations related to cannabinoid products. It imposes civil penalties up to $15,000 per violation, capped at $15,000,000 for cumulative violations in a single adjudication. Enhanced monetary penalties for knowing violations can reach $250,000 per violation, with potential cumulative charges up to $20,000,000. These substantial penalties are designed to deter violations but could disproportionately impact smaller entities not equipped to handle such financial burdens.

Conclusion

The financial appropriations and imposed fees are structured to foster regulation and safety within the burgeoning cannabis industry. However, the lack of specificity in some allocations and the potential for unpredictably rising fees may create challenges, particularly for small businesses. Additionally, ensuring the efficient use of appropriated funds across various public health initiatives will be crucial to achieving the bill's objectives without incurring wasteful expenditure. Monitoring, accountability, and transparency will be essential as these financial provisions are implemented.

Issues

  • The section allowing the Secretary to charge a registration fee up to $500 without specifying how the fee will be managed after fiscal year 2024 could lead to unpredictable costs for businesses, especially affecting smaller businesses. Concerns about the lack of a cap on fee increases in Section 1104 could lead to substantial, unchecked costs for facilities over time. (Sections 101, 1104)

  • The section requiring the listing of 'known risks to special populations' without a comprehensive list may be challenging for manufacturers to comply with, potentially leading to issues with enforcement and consumer awareness. (Section 1103)

  • The lack of specificity regarding the criteria for determining 'appropriate for protection of the public health' in Section 1106 may lead to vague or inconsistent standards, affecting product safety and consumer protection. (Section 1106)

  • The provision allowing states to enact more stringent regulations than federal standards for cannabinoid products might result in a fragmented regulatory environment, complicating interstate commerce and compliance. (Section 1105)

  • The increased funding in Section 201 from $496,000,000 to $596,000,000 for public health surveillance without detailed justification could raise concerns of wasteful spending and lack of accountability. (Section 201)

  • The absence of a clear definition for what constitutes 'cannabis-impaired driving' or an acceptable level of THC creates potential enforcement challenges and inconsistent interpretations, which can impact public safety. (Sections 302, 303)

  • The ambiguity in the requirement for a standardized safety testing framework across states under Section 1105 could lead to inconsistencies and reliability issues in testing cannabinoid products. (Section 1105)

  • The legislation imposes complex registration and labeling requirements that may disproportionately affect smaller businesses, favoring larger organizations with more resources, potentially impacting market competition. (Sections 1103, 1104)

  • The proposal for a national cannabis impairment standard in Section 305 lacks detail on stakeholder consultation, which might limit the effectiveness and acceptance of such a standard across states. (Section 305)

  • The broad discretion provided to the Secretary in several sections could lead to excessive regulatory burdens and potential overreach without clear checks and balances. (Sections 101, 1105)

Sections

Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.

1. Short title; table of contents Read Opens in new tab

Summary AI

The section introduces the "Cannabinoid Safety and Regulation Act," which is designed to ensure safety and regulate cannabinoid products. It outlines various parts of the Act, including how the Food and Drug Administration will regulate cannabinoid products, efforts to collect public health data, initiatives to prevent underage cannabis use, and programs to address cannabis-impaired driving.

101. FDA regulation of cannabinoid products Read Opens in new tab

Summary AI

The text describes regulations for cannabinoid products, including their manufacturing, labeling, and distribution requirements under the Cannabinoid Safety and Regulation Act. It outlines the establishment of a Center for Cannabinoid Products, rules against adulterated or misbranded products, registration protocols for facilities, safety and testing standards, and how these products align with federal and state laws.

Money References

  • — “(A) IN GENERAL.—If the Secretary charges a fee under paragraph (1), the Secretary shall establish the amount of the fee as follows: “(i) For fiscal year 2024, an amount not to exceed $500. “(ii) For fiscal year 2025 and each fiscal year thereafter, an amount equal to the product obtained by multiplying— “(I) the dollar amount of the fee established under clause (i); and “(II) the percentage (if any) by which the Consumer Price Index for All Urban Consumers, as published by the Bureau of Labor Statistics of the Department of Labor, increased during the most recent 12-month period. “(B) EFFECT.—Nothing in this paragraph prevents the Secretary from decreasing the amount of the registration fee under paragraph (1). “(4) REGISTRATION REFUSED OR WITHDRAWN.—The Secretary shall refund 75 percent of the fee paid under paragraph (1) for any registration that is denied, refused, or withdrawn. “

1101. Center for Cannabinoid Products Read Opens in new tab

Summary AI

The bill requires the creation of a new Center for Cannabinoid Products within the Food and Drug Administration (FDA) no later than 120 days after the Cannabis Safety and Regulation Act is enacted. This center will handle tasks related to the act and coordinate with the FDA Commissioner like other FDA divisions.

1102. Adulterated cannabinoid products Read Opens in new tab

Summary AI

A cannabinoid product is considered adulterated if it contains harmful substances, is made or stored in unsanitary conditions, or its container is made of dangerous materials. Additionally, it is deemed adulterated if the manufacturing does not meet certain standards, inspections are hindered, or it contains unsafe color additives or synthetic cannabinoids.

1103. Misbranded cannabinoid products Read Opens in new tab

Summary AI

A cannabinoid product is considered misbranded if its labeling or advertising is misleading, if it lacks specific information such as a clear label about its cannabinoid content and manufacturer details, or if it resembles products marketed toward children. Additionally, it must comply with various other regulations, such as not imitating common candies or beverages and ensuring safety and health warnings are included.

1104. Registration Read Opens in new tab

Summary AI

Covered entities, which are businesses handling cannabinoid products, must register their facilities with the Secretary within specific timeframes and renew registrations every two years, providing detailed information about their operations. The Secretary can set a registration fee, develop a system for product identification, and suspend registration if safety concerns arise, with the option for facilities to appeal and correct issues; all submitted registration information is protected from public disclosure unless legally required.

Money References

  • — (A) IN GENERAL.—If the Secretary charges a fee under paragraph (1), the Secretary shall establish the amount of the fee as follows: (i) For fiscal year 2024, an amount not to exceed $500. (ii) For fiscal year 2025 and each fiscal year thereafter, an amount equal to the product obtained by multiplying— (I) the dollar amount of the fee established under clause (i); and (II) the percentage (if any) by which the Consumer Price Index for All Urban Consumers, as published by the Bureau of Labor Statistics of the Department of Labor, increased during the most recent 12-month period. (B) EFFECT.—Nothing in this paragraph prevents the Secretary from decreasing the amount of the registration fee under paragraph (1).

1105. General provisions for control of cannabinoid products Read Opens in new tab

Summary AI

The section outlines regulations for controlling cannabinoid products, including age restrictions on their sale, labeling requirements, and packaging standards. It also addresses testing and manufacturing practices to ensure product safety and compliance, permitting foods and dietary supplements to contain cannabinoids, and offers guidance on producing synthetic cannabinoids to protect public health.

1106. Cannabinoid product standards Read Opens in new tab

Summary AI

The section outlines standards for cannabinoid products, requiring the Secretary to set regulations within a year to ensure public health safety. These standards cover ingredients, testing, labeling, sale restrictions, and require both foreign and domestically grown cannabinoids to meet the same criteria; they must also be periodically reviewed for updates based on new data.

1107. Recall authority Read Opens in new tab

Summary AI

If the Secretary believes a cannabinoid product could cause serious harm, they can order its distribution to stop immediately and later decide if a recall is needed. The order allows those involved to argue against it, but if upheld, the Secretary will set a recall schedule and communicate the risks to the public, possibly with the help of retailers.

1108. Records and reports on cannabinoid products Read Opens in new tab

Summary AI

Each manufacturer or importer of cannabinoid products must keep detailed records and report any actions to correct issues or remove products from the market if these changes are needed to protect health or comply with regulations. However, they do not have to report actions if the information has already been submitted as required in another part of the law.

1109. Prohibition on flavored electronic cannabinoid product delivery system Read Opens in new tab

Summary AI

Any electronic device that delivers cannabis products is prohibited from having added artificial or natural flavors, like fruit or spice flavors, according to the proposed law. However, such devices can include terpenes, which are naturally occurring compounds, as long as they make up a small percentage of the product's total weight.

1110. Effect Read Opens in new tab

Summary AI

In this section, the bill clarifies that federal, state, Tribal, and local governments can enforce their own laws about cannabinoid products, as long as they don't conflict with specific rules about labeling and transportation. It also confirms that existing product liability laws aren't changed by these new rules, and it doesn't affect the Department of Agriculture's authority over hemp cultivation.

102. Amendments to the Federal Food, Drug, and Cosmetic Act Read Opens in new tab

Summary AI

The amendments to the Federal Food, Drug, and Cosmetic Act clarify definitions related to cannabis and cannabinoid products, establish restrictions on their sale and use, address violations and penalties, and add regulatory oversight for their manufacture, distribution, and import/export. The text specifies new terminologies, such as what constitutes cannabis and cannabinoids, prohibits selling cannabinoid products containing THC to those under 21, and outlines penalties for non-compliance with new regulations.

Money References

  • “(A) IN GENERAL.—Any person who violates a requirement of this Act that relates to cannabinoid products shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $15,000,000 for all such violations adjudicated in a single proceeding.
  • “(B) ENHANCED CIVIL PENALTIES.—Any person who knowingly violates a requirement of this Act that relates to cannabinoid products shall be subject to a civil monetary penalty of— “(i) not to exceed $250,000 per violation, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding; or “(ii) in the case of a violation that continues after the Secretary provides written notice of the violation to such person, $250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $10,000,000 for any 30-day period, and not to exceed $20,000,000 for all such violations adjudicated in a single proceeding. “(11) REPEATED VIOLATIONS RELATING TO CANNABINOID PRODUCTS.— “(A) IN GENERAL.—If the Secretary finds that a person has committed repeated violations of a requirement of this Act that relates to cannabinoid products at a particular retail or online outlet, or association of retail or online outlets, then the Secretary may impose a no-cannabinoid-product-sale order on that person prohibiting the sale of cannabinoid products in that outlet.

103. Regulation of cannabinoid beverages containing tetrahydrocannabinol Read Opens in new tab

Summary AI

The section mandates that, within 60 days of the new law being passed, several top government officials must collaboratively create a report. This report should propose how to regulate cannabinoid drinks with THC, similar to alcohol, and clearly outline each agency's role in handling labeling, taxes, production, and safety standards for these beverages.

201. Public health surveillance and data collection Read Opens in new tab

Summary AI

The amendment to Section 392A of the Public Health Service Act expands its focus to include the adverse health effects of cannabis and polysubstance use. It increases funding to $596 million annually for 2024 to 2028 and provides an additional $100 million per year to support research and data collection on these topics.

Money References

  • (a) In general.—Section 392A of the Public Health Service Act (42 U.S.C. 280b–1) is amended— (1) in the section heading, by inserting “and adverse health effects of cannabis use” after “substances”; (2) in subsection (a)— (A) in paragraph (2)— (i) in subparagraph (C) by inserting “and adverse health effects of cannabis use” before the period; and (ii) in subparagraph (D) by inserting “, cannabis, and polysubstance use” before the period; and (B) in paragraph (4), by inserting “and collect data to better understand the use and health effects of cannabis, stimulants, and polysubstances, and” after “conduct studies and evaluations”; (3) in subsection (e), by striking “$496,000,000 for each of fiscal years 2019 through 2023” and inserting “$596,000,000 for each of fiscal years 2024 through 2028”; and (4) by adding at the end the following: “(f) Additional funding.—In addition to amounts otherwise available, there is appropriated, out of any funds in the Treasury not otherwise appropriated, $100,000,000 for each of fiscal years 2024 through 2028 to carry out this section.”. ---

202. Awards to prevent underage cannabis use Read Opens in new tab

Summary AI

The text outlines a new section of the Public Health Service Act where the Secretary will provide funding through grants, contracts, and cooperative agreements to various entities to prevent underage cannabis use. The funds aim to support programs, education, and collaboration efforts, especially in underserved communities, with a total of $25 million available each year from 2024 to 2028.

Money References

  • “(f) Funding.—In addition to amounts otherwise available, there is appropriated, out of any funds in the Treasury not otherwise appropriated, $25,000,000 for each of fiscal years 2024 through 2028 to carry out this section.

553. Awards to prevent underage cannabis use Read Opens in new tab

Summary AI

The section outlines a program where the Secretary, through the Assistant Secretary, will grant funds to eligible entities, like states, tribes, and nonprofits, to prevent and reduce underage cannabis use. These funds support programs and strategies for education, community collaboration, and treatment services, and preference will be given to communities with high rates of underage use or disproportionate cannabis-related convictions.

Money References

  • (f) Funding.—In addition to amounts otherwise available, there is appropriated, out of any funds in the Treasury not otherwise appropriated, $25,000,000 for each of fiscal years 2024 through 2028 to carry out this section.

301. Definitions Read Opens in new tab

Summary AI

The section defines key terms used in the legislation, clarifying that "Administrator" refers to the head of the National Highway Traffic Safety Administration, "cannabis" includes both the plant and cannabinoid products, "Secretary" means the Secretary of Transportation, and "THC" stands for tetrahydrocannabinol.

302. Cannabis-impaired driving research Read Opens in new tab

Summary AI

The bill section focuses on researching cannabis-impaired driving by collecting relevant data, conducting a National Roadside Survey, and carrying out a study to examine the risks and effects of driving under the influence of cannabis alone or with other substances. Reports summarizing findings and conclusions are to be submitted to various Senate and House committees as mandated.

303. DOT cannabis-impaired driving prevention programs Read Opens in new tab

Summary AI

The section mandates that the Secretary create strategies and campaigns to educate people about the dangers of driving under the influence of cannabis, especially for those under 21. It also requires regular evaluation and reporting to Congress on the effectiveness of these campaigns.

304. State cannabis-impaired driving prevention grant program Read Opens in new tab

Summary AI

The section establishes a federal grant program administered by the National Highway Traffic Safety Administration to help states prevent cannabis-impaired driving. States can receive these grants if they follow federal guidelines, use the funds for specific activities like enforcement and education, and share data on the effectiveness of their efforts.

Money References

  • “(h) Funding.—In addition to amounts otherwise available, there is appropriated, out of any money in the Treasury not otherwise appropriated, $40,000,000 for each of fiscal years 2024 through 2028 to carry out this section.”.

409. State cannabis-impaired driving prevention grant program Read Opens in new tab

Summary AI

The bill establishes a program to provide grants to states to prevent cannabis-impaired driving by supporting enforcement, data collection, and education activities. Funding is allocated with a federal share that decreases over time for states not implementing an open container law related to cannabis, with $40 million appropriated annually from 2024 to 2028.

Money References

  • (h) Funding.—In addition to amounts otherwise available, there is appropriated, out of any money in the Treasury not otherwise appropriated, $40,000,000 for each of fiscal years 2024 through 2028 to carry out this section.

305. National cannabis impairment standard Read Opens in new tab

Summary AI

The section requires the Secretary to decide within three years if a national standard for cannabis-impaired driving can be created, and to reevaluate this every two years. If creating such a standard is possible, the Secretary must propose rules for a model standard for states within a year after making that determination.

306. Funding Read Opens in new tab

Summary AI

In Section 306, an additional $30 million is allocated for each fiscal year from 2024 to 2029. This money is meant to support the activities described in sections 302 and 303.

Money References

  • In addition to amounts otherwise available, there is appropriated, out of any money in the Treasury not otherwise appropriated, $30,000,000 for each of fiscal years 2024 through 2029 to carry out sections 302 and 303. ---