Trump-Era ‘Time Bomb’ Would Automatically Scrap ~18k Regulations Affecting Everything from Healthcare and Vaccination Programs to Baby Formula and Drug Safety

Unlawful Rule Was Set to Go Into Effect March 22, Biden-Harris Administration Says “Interests of Justice Require a Postponement” 

San José, C.A. — In response to a recent lawsuit filed by local government, associations, and non-profit organizations, the U.S. Department of Health and Human Services (HHS) issued a one-year stay of the effective date of the unlawful “Sunset Rule,” which would have added automatic expiration dates to more than 18,000 regulations issued by HHS and its sub-agencies. HHS filed the stay in the Federal Register on March 18, 2021.

Had the Sunset Rule gone into effect as planned on March 22, 2021, the rule — proposed and finalized in the Trump administration’s lame-duck period — would have set a ticking time bomb on thousands of crucial HHS regulations.

In response, the Plaintiffs issued the following joint statement:

“The Sunset Rule would spark regulatory chaos as thousands of critical HHS regulations face automatic elimination in just a few years’ time. The regulations affect everything from the healthcare system and public health measures to food safety protocols and social services.

We commend the Biden-Harris administration for halting this unlawful rule that would eliminate thousands of critical health and food safety protections. While we are encouraged by the Administration’s action this week, we will continue to pursue a legal remedy to ensure the Sunset Rule never goes into effect.”

In issuing this stay of the effective date, HHS:
  • Wrote that the “interests of justice require a postponement in order to preserve the status quo, because, if the rule took effect while HHS was evaluating the rule in light of the claims raised in litigation, it could create significant obligations for HHS, cause confusion for the public, including Plaintiffs…”
  • Found that the uncertainty caused by the rule “could have serious implications for insurance markets, hospitals, physicians, and patients, among other affected parties,” and
  • Determined that allowing the rule to take effect would require HHS and the Food and Drug Administration “to immediately divert resources … during the ongoing COVID-19 public health emergency,” significantly impacting “actions to address urgent public health matters such as ongoing COVID-19 pandemic relief efforts, outbreaks of foodborne illness, inspections, recalls, and other public health priorities.”

Without time- and resource-intensive departmental review, roughly 17,200 regulations would automatically be eliminated in 2026, with more regulations terminating thereafter.

In its notice, HHS went further:
  • Writing that “HHS now believes that it is likely some regulations would expire without any additional administrative process (contrary to the conclusions reached in the SUNSET final rule),” that “based on HHS’s initial review of the Complaint, HHS believes that the Court could find merit in some of Plaintiffs’ claims,” and that “Plaintiffs’ allegations of harm are credible”; and
  • Acknowledging that the lawsuit calls into question whether the rule is “consistent with the policies and goals of the current administration, both in terms of the appropriate role of regulatory oversight of the health care industry and necessary engagement with the public, including tribal organizations.”

The County of Santa Clara, the California Tribal Families Coalition (CTFC), the National Association of Pediatric Nurse Practitioners (NAPNAP), the American Lung Association, the Center for Science in the Public Interest (CSPI), and NRDC (Natural Resources Defense Council) filed a lawsuit over the Sunset Rule on March 9 in the U.S. District Court for the Northern District of California.

Democracy Forward is litigating the case as counsel for all Plaintiffs, alongside legal teams from the County of Santa Clara, NRDC, and CSPI. Read the complaint in full here. Learn more about the lawsuit here.


Democracy Forward is a nonprofit legal organization that represents organizations, individuals, and municipalities in impact litigation to keep corruption out of policymaking.

The County of Santa Clara government serves a diverse, multi-cultural population of 1.9 million residents, more populous than 14 states. The County provides essential services to its residents, including public health protection, environmental stewardship, medical services through the County of Santa Clara Health System, child and adult protection services, homelessness prevention and solutions, roads, park services, libraries, emergency response to disasters, protection of minority communities and those under threat, access to a fair criminal justice system, and many other public benefits. The Office of the County Counsel serves as legal counsel to the County of Santa Clara and is responsible for all civil litigation involving the County and its officers. Through its Social Justice and Impact Litigation Section, the Office litigates high-impact cases, drafts innovative local ordinances, and develops policies and programs to advance social and economic justice. For more information, visit

Comprised of more than 40 tribes and tribal organizations from across the state, the California Tribal Families Coalition’s mission is to promote and protect the health, safety and welfare of tribal children and families, which are inherent tribal governmental functions and are at the core of tribal sovereignty and tribal governance.

The National Association of Pediatric Nurse Practitioners (NAPNAP) is the nation’s only professional association for pediatric-focused advanced practice registered nurses (APRNs) dedicated to improving the quality of health care for infants, children, adolescents and young adults. Representing more than 8,000 health care practitioners with 18 specialty practice issues groups and 53 chapters, NAPNAP has been advocating for children’s health since 1973 and was the first APRN society in the U.S. Our mission is to empower pediatric-focused advanced practice registered nurses and key partners to optimize child and family health.

The American Lung Association is the leading organization working to save lives by improving lung health and preventing lung disease through education, advocacy and research. The work of the American Lung Association is focused on four strategic imperatives: to defeat lung cancer; to champion clean air for all; to improve the quality of life for those with lung disease and their families; and to create a tobacco-free future. For more information about the American Lung Association, a holder of the coveted 4-star rating from Charity Navigator and a Gold-Level GuideStar Member, or to support the work it does, call 1-800-LUNGUSA (1-800-586-4872) or visit:

The Center for Science in the Public Interest (CSPI) is America’s Food and Health Watchdog, a non-profit consumer education and advocacy organization that has worked since 1971 to improve the public’s health through better nutrition and safer food. CSPI does not accept government or corporate donations and is supported by donations from individuals and foundations and subscribers to its Nutrition Action Healthletter. For more information, visit us at

NRDC (Natural Resources Defense Council) is an international nonprofit environmental organization with more than 3 million members and online activists. Since 1970, our lawyers, scientists, and other environmental specialists have worked to protect the world’s natural resources, public health, and the environment. NRDC has offices in New York City, Washington, D.C., Los Angeles, San Francisco, Chicago, Bozeman, MT, and Beijing. Visit us at and follow us on Twitter @NRDC.

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