S. 3474 — Cannabinoid Safety and Regulation Act

This section amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding a new title XI that establishes regulation of cannabinoid products, defining such a product as adulterated under section 1101 if it (1) consists of or is contaminated with filthy, putrid, or decomposed substances or poisonous/deleterious substances injurious to health; (2) is manufactured, prepared, processed, packed, or held under insanitary conditions; (3) bears or contains unsafe color additives; (4) uses nonconforming manufacturing methods or facilities under section 1104(c); (5) is produced in a facility that impedes FDA inspection; (6) bears or contains artificially or synthetically derived cannabinoids; or (7) exceeds state-prescribed tetrahydrocannabinol (THC) limits (or section 1105(c)(2) limits if no state law applies). Section 1102 deems a cannabinoid product misbranded if its labeling, advertising, or promotion is false or misleading (except for use of the term "cannabis"); if it is a finished product lacking specified label elements, including (1) a prominent cannabinoids statement; (2) manufacturer contact information; (3) quantity, form, serving size, and cannabinoid/THC content declarations; (4) directions for use and adverse event reporting; (5) allergen and special population risk disclosures; (6) drug test failure risk statement; (7) FDA nonevaluation statement (unless a dietary supplement under section 403(r)(6)(C)); (8) animal-use warnings if applicable; (9) a universal symbol under section 1104(d); and (10) beginning 90 days after an order or rule under section 1104(f)(1), safety test results.

This section amends section 201 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)— (1) to exclude cannabinoid products in addition to food from the drug definition for articles intended to affect the structure or any function of the body (para. (g)(1)(C)); (2) to exclude cannabinoid products in addition to tobacco products from para. (ff)(1); (3) to insert “cannabinoid product,” after “medical device” in para. (rr)(4); and (4) to add definitions of cannabis (all parts of Cannabis sativa L., seeds, resin, and derivatives, excluding hemp under cultivation per the Agricultural Marketing Act of 1946, cannabinoid products, and non-resin mature stalks/seeds); cannabinoid (Cannabis-unique chemicals such as THC, CBD, isomers, structural/functional equivalents, and CB1/CB2 receptor agonists); cannabinoid product (hemp-derived articles containing cannabinoids intended for human/animal body use, excluding FDA-regulated drugs/devices/biologics); intended for human consumption (for cannabinoid products, meaning ingestion/inhalation); tetrahydrocannabinol (including delta-6/7/8/9/10 forms, isomers, derivatives, and synthetics); and artificially or synthetically derived cannabinoid (cannabinoids produced via chemical synthesis/bioconversion, excluding decarboxylation). (Thus, qualifying hemp-derived cannabinoid products—e.g., CBD oils with ≤0.3% delta-9 THC—are generally excluded from FD&C Act drug and device regulation.)

This section directs the Secretary of Agriculture, Commissioner of Food and Drugs, Attorney General, and Director of the Alcohol and Tobacco Tax and Trade Bureau, acting jointly, to publish a report not later than 60 days after enactment with recommendations for a federal regulatory framework for cannabinoid beverages containing tetrahydrocannabinol (as defined in 21 U.S.C. 321(vv))—modeled on the federal alcohol regulatory framework—that delineates responsibilities among those agencies for labeling, taxation, manufacturing, and adulteration standards.

This section revises the public health surveillance and data collection program on substance use (42 U.S.C. 280b-1)—which supports CDC surveillance of substance use disorders, overdoses, and related health outcomes, primarily for opioids, stimulants, and other drugs—as follows: (1) expands the program heading, surveillance activities, and data collection requirements to expressly include cannabis use, its adverse health effects, polysubstance use, and stimulants; (2) increases authorized funding to $596 million for each of FY2026 through 2030 (from $496 million for FY2019 through 2023); and (3) appropriates an additional $100 million for each of FY2026 through 2030.

This section establishes a grant program under which the Secretary of HHS, acting through the Assistant Secretary for Mental Health and Substance Use, awards grants, contracts, and cooperative agreements to eligible entities—including states, localities, Indian Tribes, Tribal organizations, urban Indian organizations, and nonprofits—to prevent and reduce underage cannabis use. Eligible entities must use the funds to (1) support culturally and linguistically appropriate screening, prevention, intervention, treatment, and recovery programs for youth, including those in schools, juvenile justice, and child welfare systems; (2) develop and disseminate evidence-based strategies for community-wide prevention; (3) educate youth, parents, providers, and communities on risks such as impaired driving; (4) collect data on use trends and gaps; (5) foster intergovernmental collaboration; (6) address community norms and reduce access and harms; and (7) implement other evidence-based practices. The section prioritizes awards to entities serving medically underserved communities, areas with high underage cannabis use, or communities with disproportionate cannabis-related arrests and convictions (excluding those for distribution to minors); requires funds to supplement, not supplant, existing resources; defines key terms including "cannabis"; and appropriates $25 million for each of FY2026 through 2030.

This section defines the following terms for purposes of this title: (1) Administrator as the Administrator of the National Highway Traffic Safety Administration; (2) cannabis as cannabis (as defined in 21 U.S.C. 321(tt)) and a cannabinoid product (as so defined); (3) Secretary as the Secretary of Transportation; and (4) THC as tetrahydrocannabinol (as defined in 21 U.S.C. 321(vv)).

This section requires the Secretary of Transportation to collect and share with the Secretary of Health and Human Services data on cannabis-impaired driving crashes involving drivers with THC or THC combined with other substances. It further directs the NHTSA Administrator to initiate a National Roadside Survey on drivers with THC in their system not later than one year after enactment, with a report summarizing the data due to specified congressional committees not later than three years after enactment. Additionally, it requires the Secretary to complete a study not later than three years after enactment evaluating cannabis-impaired driving risks—including crash likelihood after use, effects on driving behavior, THC-impairment correlations, Standard Field Sobriety Test accuracy, use frequency impacts, combined substance risks, and pedestrian safety—with reports due to the committees not later than three years after enactment and annually thereafter until completion.

This section directs the Secretary of Transportation to research and implement data-driven strategies to educate the public on the dangers of cannabis-impaired driving, including (1) developing and issuing best practices for states and communities to prevent such driving—including cases involving cannabis and another substance and targeting drivers under age 21—within one year of enactment (with updates at least biannually), in consultation with the Centers for Disease Control and Prevention, the Secretary of Health and Human Services, and other federal agencies as appropriate; and (2) establishing and carrying out national prevention campaigns addressing those issues within two years of enactment. The section further requires the Secretary to evaluate the effectiveness of the campaigns and related state activities funded under 23 U.S.C. §409 (Highway Safety Programs grants) at least every three years—using pre- and post-campaign data, stakeholder feedback, objective achievement, and factors from the National Highway Traffic Safety Administration's 2008 evaluation guide (or successor)—and to submit a report on each evaluation to specified congressional committees within six months, including data summaries, future recommendations, and determinations of any ineffective campaigns or activities.

This section establishes a State cannabis-impaired driving prevention grant program (i.e., new section 409 of title 23, United States Code) to be administered by the Secretary of Transportation, acting through the National Highway Traffic Safety Administration (NHTSA) Administrator, not later than one year after enactment of the Cannabinoid Safety and Regulation Act. States are eligible for grants if they describe integration with their highway safety program under 23 U.S.C. §402—including implementation of best practices developed under section 303(a)(1) of the Act—and commit to providing data for program evaluation. Grant funds may be used for (1) enforcement activities (e.g., training public safety personnel to detect cannabis impairment, enhancing toxicology lab capacity consistent with National Safety Council standards, impaired driving assessments, high-visibility enforcement, and criminal justice training—including traffic safety resource prosecutors and driving while intoxicated courts); (2) data collection on cannabis, drugs, or polysubstance use among drivers (e.g., in arrests, fatal crashes, and serious injuries); and (3) public education campaigns, including participation in national NHTSA campaigns under section 303(a)(2) of the Act. At least 10% of a State's allocation must support toxicology lab enhancements; the Secretary may prohibit funding for activities deemed ineffective based on evaluations under section 303(b) of the Act. Grants are allocated proportional to each State's apportionment under 23 U.S.C. §402(c)(2). The Federal share is 80% for the first three fiscal years after establishment (and ongoing for States with a cannabis open container law), decreasing to 70% in year four, 60% in year five, and 50% thereafter for noncompliant States.

This section directs the Secretary, not later than three years after enactment and every two years thereafter, to determine the feasibility of establishing a national standard for cannabis-impaired driving. If feasible, the Secretary must promulgate regulations within one year establishing a model cannabis impairment standard for states.

This section appropriates $30 million for each of FY2026 through FY2030, in addition to amounts otherwise available, to carry out sections 302 and 303.