THE LATEST: On May 27, 2022 the Department of Health and Human Services completely withdrew the Trump-era Sunset Rule. In summarizing its work to withdraw this rule, HHS acknowledged it first issued an Administrative Delay of the Effective Date as a result of this lawsuit, undertook efforts to reexamine the final rule in part in light of the allegations of the lawsuit, and that reevaluation ultimately led to the withdrawal.

Upon the announcement of this withdrawal, the Plaintiffs in County of Santa Clara et al. v. HHS and their counsel issued the following joint statement:

“This is a victory not only for our nation’s public health and healthcare sector but also for the millions of Americans, including more than 36 million children, who would have been hurt by the resulting regulatory chaos, uncertainty, and elimination of key protections.”


During its lame-duck period, the Trump administration rushed to plant a regulatory ticking time bomb within the Department of Health and Human Services, which is set to eliminate thousands of healthcare, funding, and food safety rules in 2026. The “Securing Updated and Necessary Statutory Evaluations Timely” rule (AKA “Sunset Rule”) was proposed by the outgoing administration the day after the November election and finalized the day before President Biden’s inauguration in the midst of the pandemic, after an unjustifiably short comment period.

To prevent nearly 18,000 regulations from automatically disappearing, the Sunset Rule requires HHS to conduct and finalize a retrospective review of each and every regulation. This promises a resource-intensive and time-consuming effort for HHS at a pace 20 times faster than it has ever conducted in the past — all without any guarantee that HHS would actually do so. This is, in the Department’s own words, “unprecedented.”

Trump’s Dept. of Health and Human Services finalized the Sunset Rule despite broad opposition voiced by diverse stakeholders. Over 98% of the 530 comments submitted — all but eight — opposed the Sunset Rule or advised HHS to withdraw it. Advocacy organizations, trade associations, and regulated entities of all stripes opposed the rule, as did consumer safety advocates, tribes, states, local governments, and representatives of the food and beverage, livestock and veterinary, insurance and healthcare, manufacturing, and agricultural industries.

If not blocked, the Sunset Rule will eliminate thousands of existing regulations that govern America’s healthcare system, food safety protocols, public health measures, social services, and much more. It endangers every person in the country, including the elderly, children, healthcare professionals, tribal governments and members, and anyone who needs medical care, is affected by pandemics or disasters, or simply eats food.

Thousands of critical FDA regulations to prevent transmission of foodborne disease, to guard against antibiotic resistance, and to guarantee safe bottled water could disappear. Laws that ensure access to vaccines, safe and effective medicines and therapies, and high-quality, affordable healthcare could be nixed. Rules affecting tribal governments’ programs related to child welfare, healthcare, and public health could go away and leave communities vulnerable.

We filed suit alongside the County of Santa Clara and a coalition of tribes, healthcare professionals, and health and food safety organizations to vacate the unlawful Sunset Rule and prevent the substantial harm it could inflict. Unless it is immediately halted, millions of Americans, including more than 36 million children, will be hurt by the resulting regulatory chaos, uncertainty, and elimination of key protections.

Trump’s Department of Health and Human Services failed to name which regulations will expire under the Sunset Rule, provided an insufficient 30-day notice-and-comment period, and unlawfully refused to consult with Indian tribes.

Our lawsuit with the County of Santa Clara, the California Tribal Families Coalition, the National Association of Pediatric Nurse Practitioners, the American Lung Association, CSPI, and NRDC was filed on March 9 in the U.S. District Court for the Northern District of California.

Last Updated: May 27, 2022
November 4, 2021

HHS issued a notice of proposed rulemaking.

Despite the unprecedented scope of the proposed Sunset Rule, the public was given only 30 days, until December 4, 2020, to comment on the majority of the proposal. During the comment period, the Department held only one public hearing on the proposal, on November 23, 2020, the Monday before Thanksgiving.

JANUARY 19, 2021

Despite nearly uniform public opposition, HHS published the final Sunset Rule without providing any further public process.

HHS scheduled the Rule to take effect on March 22, 2021, less than five months after it was first mentioned to the public.

MARCH 9, 2021

We filed suit.

March 19, 2021

HHS filed an administrative delay to stay the effective date of the Sunset Rule for one year.

In its filing submitted for Public Inspection on the Federal Register, HHS acknowledges that “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 … [and] have serious implications for insurance markets, hospitals, physicians, and patients, among other affected parties.”

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October 29, 2021

HHS Proposes to Withdraw or Repeal Trump-Era ‘Sunset Rule’.

Months after our coalition lawsuit, HHS has proposed to withdraw or repeal Sunset Rule. HHS is now accepting comments on the withdrawal proposal through December 28.

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