This bill, titled the Cannabinoid Safety and Regulation Act, amends the Federal Food, Drug, and Cosmetic Act to create a new chapter specifically for cannabinoid products . This new framework aims to ensure the safety and proper labeling of these products, defining what constitutes an adulterated or misbranded cannabinoid product. Products are deemed adulterated if they contain harmful substances, are manufactured in insanitary conditions, or contain artificially or synthetically derived cannabinoids. Misbranding includes false labeling, failure to display required information such as cannabinoid content and serving sizes, and packaging that imitates products marketed to children or minors. Specific labeling requirements include prominent statements about cannabinoid content, manufacturer information, quantity, and warnings for special populations. The Act mandates registration for all facilities involved in manufacturing, processing, or holding cannabinoid products for commercial distribution. Covered entities must register with the Secretary of Health and Human Services and renew every two years, with a potential fee of up to $500. Facilities must also list all cannabinoid products they handle, and registrations can be suspended if products pose a serious adverse effect risk. General provisions include regulations for remote sales to prevent access by individuals under 21, requiring age verification at purchase or prior to shipment. The Secretary may also impose restrictions to prevent underage consumption and will prescribe a universal symbol for intoxicating and non-intoxicating cannabinoids. Requirements for tamper-evident and child safety packaging may also be established for certain products. The bill requires the promulgation of regulations for good manufacturing practices (GMP) and good testing practices (GTP) , including mandatory safety testing in accredited laboratories. Testing must cover pesticides, heavy metals, synthetic inputs, and potency analysis, with established thresholds for product safety. The Secretary and the DEA Administrator will establish criteria for laboratory accreditation. Cannabinoid product standards will be adopted within one year, distinguishing different product types like edible, inhalable, topical, and drinkable. These standards will include provisions on ingredients, testing, and labeling. The bill also sets default serving size limits for tetrahydrocannabinol (THC) in states without their own regulations, such as 5 milligrams per serving for edibles and drinkables. The Secretary is granted recall authority for products posing a serious adverse effect risk and can require manufacturers to maintain records and report corrective actions. The bill prohibits flavored electronic cannabinoid product delivery systems, with exceptions for naturally occurring or added terpenes within specified limits. It preserves state, tribal, and local authority to enact more stringent regulations, but prohibits states from restricting the transportation of compliant products. Prohibited acts include selling cannabinoid products to individuals under 21, or products containing alcohol, tobacco, or other interacting substances. Violations can result in significant civil monetary penalties , including enhanced penalties for knowing or repeated offenses, potentially leading to a "no-cannabinoid-product-sale order." The bill also requires a joint report on a federal regulatory framework for cannabinoid beverages modeled on alcohol regulation. Beyond FDA regulation, the bill enhances public health surveillance and data collection related to cannabis use, appropriating $100 million annually for fiscal years 2026-2030. It also establishes a grant program to prevent underage cannabis use , awarding funds to eligible entities for prevention programs, education, and data collection, with priority given to underserved communities. To address cannabis-impaired driving , the Department of Transportation is directed to collect data, including through a National Roadside Survey, and conduct research on the risks and effects of cannabis on driving behavior. The Secretary of Transportation will develop best practices and carry out national campaigns to prevent impaired driving, especially among drivers under 21. A State grant program is established to help states implement prevention strategies, including training for law enforcement, enhancing toxicology testing, and educational campaigns. States must agree to provide data for evaluation and may face decreased federal funding if they do not implement an open container law for cannabis products. Finally, the Secretary of Transportation will periodically assess the feasibility of establishing a national standard for cannabis impairment in driving and, if feasible, promulgate regulations for a model standard.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Health
Cannabinoid Safety and Regulation Act
USA119th CongressS-3474| Senate
| Updated: 12/15/2025
This bill, titled the Cannabinoid Safety and Regulation Act, amends the Federal Food, Drug, and Cosmetic Act to create a new chapter specifically for cannabinoid products . This new framework aims to ensure the safety and proper labeling of these products, defining what constitutes an adulterated or misbranded cannabinoid product. Products are deemed adulterated if they contain harmful substances, are manufactured in insanitary conditions, or contain artificially or synthetically derived cannabinoids. Misbranding includes false labeling, failure to display required information such as cannabinoid content and serving sizes, and packaging that imitates products marketed to children or minors. Specific labeling requirements include prominent statements about cannabinoid content, manufacturer information, quantity, and warnings for special populations. The Act mandates registration for all facilities involved in manufacturing, processing, or holding cannabinoid products for commercial distribution. Covered entities must register with the Secretary of Health and Human Services and renew every two years, with a potential fee of up to $500. Facilities must also list all cannabinoid products they handle, and registrations can be suspended if products pose a serious adverse effect risk. General provisions include regulations for remote sales to prevent access by individuals under 21, requiring age verification at purchase or prior to shipment. The Secretary may also impose restrictions to prevent underage consumption and will prescribe a universal symbol for intoxicating and non-intoxicating cannabinoids. Requirements for tamper-evident and child safety packaging may also be established for certain products. The bill requires the promulgation of regulations for good manufacturing practices (GMP) and good testing practices (GTP) , including mandatory safety testing in accredited laboratories. Testing must cover pesticides, heavy metals, synthetic inputs, and potency analysis, with established thresholds for product safety. The Secretary and the DEA Administrator will establish criteria for laboratory accreditation. Cannabinoid product standards will be adopted within one year, distinguishing different product types like edible, inhalable, topical, and drinkable. These standards will include provisions on ingredients, testing, and labeling. The bill also sets default serving size limits for tetrahydrocannabinol (THC) in states without their own regulations, such as 5 milligrams per serving for edibles and drinkables. The Secretary is granted recall authority for products posing a serious adverse effect risk and can require manufacturers to maintain records and report corrective actions. The bill prohibits flavored electronic cannabinoid product delivery systems, with exceptions for naturally occurring or added terpenes within specified limits. It preserves state, tribal, and local authority to enact more stringent regulations, but prohibits states from restricting the transportation of compliant products. Prohibited acts include selling cannabinoid products to individuals under 21, or products containing alcohol, tobacco, or other interacting substances. Violations can result in significant civil monetary penalties , including enhanced penalties for knowing or repeated offenses, potentially leading to a "no-cannabinoid-product-sale order." The bill also requires a joint report on a federal regulatory framework for cannabinoid beverages modeled on alcohol regulation. Beyond FDA regulation, the bill enhances public health surveillance and data collection related to cannabis use, appropriating $100 million annually for fiscal years 2026-2030. It also establishes a grant program to prevent underage cannabis use , awarding funds to eligible entities for prevention programs, education, and data collection, with priority given to underserved communities. To address cannabis-impaired driving , the Department of Transportation is directed to collect data, including through a National Roadside Survey, and conduct research on the risks and effects of cannabis on driving behavior. The Secretary of Transportation will develop best practices and carry out national campaigns to prevent impaired driving, especially among drivers under 21. A State grant program is established to help states implement prevention strategies, including training for law enforcement, enhancing toxicology testing, and educational campaigns. States must agree to provide data for evaluation and may face decreased federal funding if they do not implement an open container law for cannabis products. Finally, the Secretary of Transportation will periodically assess the feasibility of establishing a national standard for cannabis impairment in driving and, if feasible, promulgate regulations for a model standard.