In 2022, following our lawsuit, HHS withdrew the disastrous Trump-Era Sunset Rule, which threatened to eliminate thousands of health and food safety regulations.

In March 2021, CSPI and a coalition of food safety, healthcare, public health advocacy organizations, and government and Indian tribe entities filed a lawsuit against the Department of Health and Human Services (HHS) over the Trump-era Sunset Rule.

The rule—proposed by the outgoing Trump administration the day after the November 2020 election and finalized the day before President Biden’s inauguration—adds automatic expiration dates to more than 18,000 regulations issued by HHS and its agencies, such as FDA, CDC, and the Centers for Medicare and Medicaid Services. 


HHS administers a broad range of statutory programs that impact nearly every aspect of the American healthcare system, food and drug manufacturing, and social services systems. These programs operate pursuant to regulations that govern, for example:

  • food safety,
  • health insurance,
  • hospitals and clinics,
  • pharmaceuticals and vaccines,
  • mental health treatment,
  • Medicare and Medicaid,
  • public health emergency prevention and preparedness,
  • protections for children and the elderly, and
  • much more.

The Harm

The rule would have eliminated nearly all HHS regulations, starting in five years, unless the agency diverted attention away from its crucial activities, including those responding to the COVID-19 pandemic, to conduct an unprecedented, time consuming and resource intensive review of nearly every regulation. Among other critical regulations, the Sunset Rule would trigger automatic rescission of thousands of FDA regulations, including food safety regulations that give consumers confidence that they can purchase food without contracting a deadly foodborne disease.

The Lawsuit

The lawsuit sought to vacate the Sunset Rule and prevent the substantial harm it would cause to public health. The lawsuit alleged that the Sunset Rule violated both the Administrative Procedure Act and the Regulatory Flexibility Act.

What We Achieved

On March 18, 2021, in response to our lawsuit, HHS issued a one-year stay of the effective date of the Sunset Rule, which extension was later further extended until September 22, 2022. On October 29, 2021, HHS issued a notice of proposed rulemaking to repeal or withdraw the Sunset Rule.

On May 27, 2002, HHS announced that it was withdrawing the Sunset Rule. The Sunset Rule’s withdrawal went into effect on July 26, 2022.