Sponsors (6)
The bill forces HHS to act by a firm deadline—reducing uncertainty and likely improving protections for patients—at the cost of potential compliance burdens, short-term economic disruption for providers/manufacturers, and added strain on agency resources.
Patients with chronic conditions will get a guaranteed HHS regulatory action implementing protections or rules under 21 U.S.C. 387t(b)(3) by June 1, 2026, increasing the likelihood of concrete safeguards.
Hospitals and health systems receive clearer, predictable regulatory direction about forthcoming FDA/HHS requirements, enabling planning and operational adjustments ahead of the June 1, 2026 deadline.
Federal and state governments (and agency stakeholders) face less administrative uncertainty because discretionary authority is converted into a required action, improving accountability for implementing the statute.
Patients, providers, and industry could face new regulatory requirements that impose compliance costs or change access to services/products depending on what 387t(b)(3) requires.
Hospitals, manufacturers, and health systems may incur short-term costs or operational disruption if HHS/FDA must rush rulemaking or implementation to meet the deadline.
HHS staff and other federal employees may face increased workload and resource reallocation to meet the mandated deadline, potentially diverting attention from other priorities.
Based on analysis of 2 sections of legislative text.
Introduced December 18, 2025 by Herbert C. Conaway · Last progress December 18, 2025
Changes a discretionary duty in existing tobacco law into a required duty and sets a firm deadline. Specifically, it amends 21 U.S.C. 387t(b)(3) so that actions the Secretary of Health and Human Services could previously choose to take now must be completed no later than June 1, 2026.