Plaintiffs challenge the Department of Health and Human Services’ recently finalized SUNSET rule amending all department regulations (subject to limited exceptions) with expiration provisions and review protocols.

Why It Matters for Public Health

Automatic expiration of public health regulations administered by HHS threatens established public health regulations and poses substantial uncertainty for the state of food and commercial tobacco regulation by the FDA, Medicare and Medicaid, and Temporary Assistance for Needy Families (TANF), among other areas affecting public health regulated by HHS and its subagencies.

The rule’s burdensome, agency-wide administrative changes come at a time when HHS should be applying its full attention to confronting a national public health crisis in the COVID-19 pandemic. Beyond the immediacy of the COVID-19 pandemic, the administrative burden of the rule further diverts agency resources from pressing public health issues—including FDA regulation of menthol tobacco, vaping, nutrition standards, and food safety—raising concerns about timely progress on these and other important public health priorities.

Further, HHS’s stated reliance on the public to ensure important regulations do not expire under the rule also places a substantial burden on the public and regulated entities to ensure established public health regulations do not expire without agency review.


On January 19, 2021, HHS finalized a department-wide rule adding sunset provisions to thousands of public health and welfare regulations, including those made and enforced by the FDA. The final rule establishes a system for retrospective review of regulations by HHS and its subagencies and broadly imposes sunset provisions across those regulations with limited exceptions.

Commenters on the proposed rule expressed widespread opposition, raised concerns regarding the rule’s violation of the Administrative Procedure Act, and made numerous requests for additional time to weigh in.

Under the 2009 Tobacco Control Act, the federal government restricted the sale of some flavored tobacco products, including most flavored cigarettes. However, the Tobacco Control Act exempted menthol flavored cigarettes and flavored non-cigarette tobacco products, such as cigars, smokeless tobacco, hookahs, and e-cigarettes. The law preempts states and localities from enacting “tobacco product standards,” but does not limit their ability to enact requirements “relating to or prohibiting the sale, distribution, [or] possession” of tobacco products.

District Court Proceedings

On March 9, 2021, the County of Santa Clara, California Tribal Families Coalition, National Association of Pediatric Nurse Practitioners, American Lung Association, Center for Science in the Public Interest, and Natural Resources Defense Council filed suit against HHS in the Northern District Court of California.

Plaintiffs allege that HHS acted outside of its authority, violated notice-and-comment procedures under the Administrative Procedure Act, and failed to consult with Tribes as required under Executive Order 13175.

Litigation Status

This litigation is ongoing and in its early stages. On March 18, 2021, HHS announced via public inspection a one-year delay of the rule’s effective date from March 22, 2021 to March 22, 2022 in order to review the rule in light of pending litigation.

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