Case 5:21-cv-01655 Document 1 Filed 03/09/21 Page 1 of 50
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`Samara Spence* (DC Bar No. 1031191)
`Jeffrey B. Dubner* (DC Bar No. 1013399)
`Sean A. Lev* (DC Bar. No. 449936)
`Democracy Forward Foundation
`P.O. Box 34553
`Washington, DC 20043
`sspence@democracyforward.org
`jdubner@democracyforward.org
`slev@democracyforward.org
`(202) 448-9090
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`Counsel for Plaintiffs
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`*pro hac vice application forthcoming
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`James R. Williams (CA Bar No. 271253)
`Greta S. Hansen (CA Bar No. 251471)
`Douglas M. Press (CA Bar No. 168740)
`Lorraine Van Kirk (CA Bar No. 287194)
`Office of the County Counsel
`County of Santa Clara
`70 West Hedding Street, East Wing, 9th Fl.
`San José, CA 95110-1770
`lorraine.van_kirk@cco.sccgov.org
`(408) 299-5900
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`Counsel for the County of Santa Clara
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`Lisa S. Mankofsky* (DC Bar No. 411931)
`Matthew Simon* (DC Bar No. 144727)
`Center for Science in the Public Interest
`1220 L Street, NW, Ste. 300
`Washington, DC 20005
`lmankofsky@cspinet.org
`msimon@cspinet.org
`(202) 777-8381
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`Counsel for Center for Science in the Public
`Interest
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`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
`SAN JOSE DIVISION
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`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,
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`Case No. 5:21-cv-01655
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`COMPLAINT FOR DECLARATORY
`AND INJUNCTIVE RELIEF
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`Administrative Procedure Act Case
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`Plaintiffs,
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` vs.
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`U.S. DEPARTMENT OF HEALTH AND
`HUMAN SERVICES and NORRIS
`COCHRAN, in his official capacity as Acting
`Secretary of Health and Human Services,
`Defendants.
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`COMPLAINT FOR DECLARATORY AND
`INJUNCTIVE RELIEF - Case No. 5:21-cv-1655
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`Case 5:21-cv-01655 Document 1 Filed 03/09/21 Page 2 of 50
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`TABLE OF CONTENTS
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`INTRODUCTION ..................................................................................................................1
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`PARTIES ................................................................................................................................4
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`JURISDICTION AND VENUE .............................................................................................8
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`LEGAL AND STATUTORY BACKGROUND ...................................................................9
`I.
`The Administrative Procedure Act (“APA”)..................................................9
`II.
`The Regulatory Flexibility Act (“RFA”) .......................................................9
`FACTUAL ALLEGATIONS ...............................................................................................10
`I.
`HHS Regulates Healthcare, Disease Control, and Food and Drug Safety. ..10
`II.
`HHS Proposes Massive Deregulation of the Healthcare Industry in the
`Midst of a Pandemic, While Providing a Truncated Notice-and-Comment
`Period and Refusing to Consult with Indian Tribes. ....................................12
`a. HHS provides only 30 days for most comments, despite widespread
`concern that this was inadequate time to meaningfully respond to a
`proposal of this scope. ............................................................................15
`b. HHS refuses to consult with Indian tribes despite the proposal’s effect
`on tribal programs and tribal funding. ....................................................19
`Under the Final Sunset Rule, Approximately 17,200 Regulations Are Set to
`Expire in 2026, but the Rule Does Not Specify Which Ones. .....................20
`a. The final Rule requires that nearly all HHS regulations will expire
`unless HHS completes retrospective review for the thousands of
`affected regulations. ...............................................................................21
`b. The vague exceptions to the self-executing expirations make it
`impossible to determine which regulations have been amended and will
`expire without Assessment and Review. ................................................23
`The Sunset Rule is Unlawful, and the Department’s Purported Justifications
`Lack Basic Rationality. ................................................................................24
`a. The Sunset Rule schedules elimination of regulations regardless of their
`impact on small entities and without RFA review or considerations
`required under substantive statutes and the APA ...................................24
`b. The Sunset Rule is arbitrary and capricious because, among other
`reasons, it purports to “incentivize” the Department to review
`regulations at an infeasible pace HHS has never achieved by eliminating
`regulations relied upon by the general public. .......................................27
`The Sunset Rule Harms Plaintiffs and the General Public. . ........................32
`a. County of Santa Clara ............................................................................34
`b. California Tribal Families Coalition ......................................................35
`c. National Association of Pediatric Nurse Practitioners ...........................37
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`III.
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`IV.
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`COMPLAINT FOR DECLARATORY AND
`INJUNCTIVE RELIEF - Case No 5:21-cv-01655
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`d. American Lung Association ...................................................................38
`e. Center for Science in the Public Interest ................................................40
`f. Natural Resources Defense Council .......................................................41
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`CLAIMS FOR RELIEF .......................................................................................................43
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`COUNT ONE ...........................................................................................................43
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`COUNT TWO ..........................................................................................................44
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`COUNT THREE ......................................................................................................44
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`COUNT FOUR ........................................................................................................45
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`PRAYER FOR RELIEF .......................................................................................................46
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`COMPLAINT FOR DECLARATORY AND
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`Plaintiffs the County of Santa Clara, California Tribal Families Coalition, National
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`Association of Pediatric Nurse Practitioners, American Lung Association, the Center for
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`Science in the Public Interest, and Natural Resources Defense Council (collectively,
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`“Plaintiffs”), by and through undersigned counsel, hereby allege as follows:
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`INTRODUCTION
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`1.
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`Plaintiffs bring this action under the Administrative Procedure Act
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`(“APA”), 5 U.S.C. § 500 et seq., and the Regulatory Flexibility Act (“RFA”), 5 U.S.C.
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`§ 601 et seq., to challenge a final rule recently issued by the U. S. Department of Health
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`and Human Services (“HHS” or “Department”) entitled “Securing Updated and Necessary
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`Statutory Evaluations Timely,” 86 Fed. Reg. 5694 (Jan. 19, 2021) (“Sunset Rule” or
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`“Rule”). Under the guise of an RFA plan for periodically reviewing preexisting
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`regulations that significantly impact small entities, the Sunset Rule amends nearly all HHS
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`regulations to include self-executing expiration dates. The Rule’s impact is vast and
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`unprecedented. Absent separate Department action, approximately 17,200 regulations will
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`“expire” in 2026, with additional regulations automatically terminating afterward.
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`2.
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`HHS, together with its subagencies—such as the Centers for Disease
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`Control and Prevention (“CDC”), the Food and Drug Administration (“FDA”), and the
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`Centers for Medicare and Medicaid Services—administers a broad range of statutory
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`programs that impact nearly every aspect of the American healthcare system, food and
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`drug manufacturing, and social services systems. These programs operate pursuant to
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`regulations that govern, for example, health insurance, hospitals and clinics,
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`pharmaceuticals and vaccines, mental health treatment, Medicare and Medicaid, public
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`health emergency prevention and preparedness, food safety, protections for children and
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`the elderly, and much more. The affected healthcare sector alone accounts for nearly one-
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`fifth of the U.S. economy.
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`3.
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`HHS has issued regulations implementing its substantive statutes since its
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`inception in 1953. To date, HHS has approximately 18,000 regulations on the books,
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`covering everything from ventilators to the privacy of personal and heath information.
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`4.
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`The Sunset Rule, which was proposed and finalized entirely during the
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`outgoing administration’s lame-duck period, amends nearly all HHS regulations to add
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`self-executing expiration dates. Under the Rule, the vast majority of the Department’s
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`existing regulations are set to expire automatically in 2026, with the remainder set to
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`expire over the following five years. The only way under the Rule to prevent expiration is
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`for HHS to conduct and finalize retrospective review of each regulation. This would
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`require a resource-intensive and time-consuming effort on par with full notice-and-
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`comment rulemaking, but at a pace 20 times faster than the Department has ever conducted
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`retrospective review in the past—all without any guarantee that the Department will
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`conduct such review. The Rule does not even specify which of the Department’s 18,000
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`existing regulations are exempted under the limited exceptions. In other words, the
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`outgoing administration planted a ticking timebomb set to go off in five years unless HHS,
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`beginning right now, devotes an enormous amount of resources to an unprecedented and
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`infeasible task.
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`5.
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`The Rule creates incalculable costs and chaos. It schedules rescission of
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`thousands of the regulations that structure Plaintiffs’ highly technical operations and
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`obligations, delineate their and their members’ rights, and protect the populations they
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`serve. It directly harms Plaintiffs and the general public, including the elderly, children,
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`healthcare professionals, tribal governments and members, and anyone who needs medical
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`care, is affected by pandemics or disasters, or simply eats food.
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`6.
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`The Sunset Rule, moreover, creates immediate uncertainty and instability
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`throughout the healthcare system at the very time that the public most needs clear
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`guidelines due to a global pandemic. Plaintiffs have no guarantee that HHS will complete
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`retrospective review on such a mass scale and must assume that any, or all, of the
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`regulations that affect them will disappear. Regulated entities and individuals, such as
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`INJUNCTIVE RELIEF - Case No 5:21-cv-01655
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`hospitals and nurse practitioners, will be unable to plan their operations to the financial and
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`physical detriment of patients. All Plaintiffs will have to divert significant resources to
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`monitor the progress of each regulation that affects them and to attempt to stem the effects
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`of potential automatic expiration.
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`7.
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`If the Rule takes effect, it will require substantial, and likely unachievable,
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`efforts on the part of HHS to prevent regulations from expiring. The resulting cost to
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`society is steep. To simply keep its existing regulatory framework, HHS and its
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`subagencies will need to redirect significant resources away from such vital work as
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`combatting the COVID-19 pandemic and protecting the country against future public
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`health emergencies.
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`8.
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`The Sunset Rule violates the APA, the RFA, and the statutory authorities
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`underlying the Department’s original regulations.
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`9.
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`First, the Rule was issued without procedures or tribal consultation required
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`by law. The Department promulgated the Rule after a rushed notice-and-comment period
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`that hundreds of commenters decried as providing inadequate time for them to
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`meaningfully participate. The limited public process was particularly problematic because
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`affected parties were asked to discern, and comment on (over the holidays, no less), the
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`impacts of a sweeping and vague proposal in the middle of a global pandemic, which was
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`appropriately the primary focus of their efforts. HHS also refused to consult with Indian
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`tribes, as required under HHS policy and the federal government’s tribal trust
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`responsibilities, despite the Rule’s significant and direct effects on tribes and funding for
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`tribal programs.
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`10.
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`Second, the Sunset Rule is contrary to law and in excess of the
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`Department’s authority. It relies on the RFA, which by the Department’s own estimate
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`does not authorize review of 89% of the regulations amended. And it schedules
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`elimination of nearly all HHS regulations without consideration of the factors required by
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`that statute. It also expressly relies on the myriad HHS substantive statutes for authority,
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`but in fact eliminates regulations required by those statutes and fails to address factors
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`mandated by those statutes and the APA.
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`Third, the Rule violates the APA’s prohibition against arbitrary and
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`capricious agency action. Among other things, the Department’s justification for the
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`Rule—to “incentivize” retrospective regulatory review—is irrational on its face. It
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`assumes without support that HHS can induce itself to increase its pace of review 20-fold
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`merely by imposing on the general public the severe consequence of losing needed
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`regulations. Moreover, the Department did not plausibly show that it can meet the
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`contemplated review schedule or meaningfully consider the harm and costs the “incentive”
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`would cause.
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`12.
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`Plaintiffs respectfully request that the Court declare that the Sunset Rule
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`violates the APA because it was issued without procedures or consultation required by law,
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`is contrary to law, and is arbitrary and capricious. The Rule should be vacated and set
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`aside.
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`13.
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`Plaintiff County of Santa Clara (the “County”) is a charter county and
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`PARTIES
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`political subdivision of the State of California, located in the Northern District of
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`California. The County is home to almost two million people who rely on the County to
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`provide essential healthcare services and to oversee regional public health. The County
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`owns and operates the County of Santa Clara Hospitals and Clinics, a network of safety-net
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`hospitals and medical clinics that provide specialized, preventative, primary, and routine
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`healthcare services, primarily to underserved patients. Together, the County’s public
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`hospitals and clinics serve nearly 200,000 individual patients per year. The County also
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`operates a Social Services Agency that provides a wide array of essential safety-net
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`services; an Emergency Medical Services Agency that accredits emergency responders and
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`oversees all 911 ambulance response countywide; a Behavioral Health Services
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`Department that provides mental health and substance use prevention and treatment
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`services to tens of thousands of patients each year; a health insurance plan called Valley
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`Health Plan; and a Public Health Department that is responsible for regional public health
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`services throughout Santa Clara County, including managing the County’s response to the
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`COVID-19 pandemic.
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`14.
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`Plaintiff California Tribal Families Coalition (“CTFC”) is an Internal
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`Revenue Code (“IRC”) Section 501(c)(4) nonprofit membership association and an
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`“Indian organization” under the Indian Child Welfare Act. Its members are 42 federally
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`recognized sovereign tribes and 3 statewide tribal leader associations from across
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`California, and it is led by a 12-member Board of Directors chosen from among the duly
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`elected tribal leaders of CTFC’s member tribes. CTFC’s mission is to protect the health,
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`safety, and welfare of tribal children and families, which are inherent tribal governmental
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`functions and are at the core of tribal sovereignty and tribal governance. CTFC’s member
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`tribes are governments entitled under the Indian Self-Determination and Education
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`Assistance Act, Pub. L. No. 93-638, 88 Stat. 2203, to request that operation of, and funding
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`for, federal programs be transferred to tribal administration. CTFC’s member tribes are
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`affected by nearly all HHS programs. Among other things, they receive HHS funding for
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`operation of tribal health services and/or receive services directly from Indian Health
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`Services programs, substance abuse programs, and social programs, such as Temporary
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`Assistance for Needy Families. HHS regulations govern the member tribes’ funding for
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`and operation of such programs. One of CTFC’s core missions is to advocate for the
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`incorporation of tribal concerns into regulations, including HHS regulations of great
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`importance to its tribal members, such as regulations on healthcare, mental health,
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`substance abuse, programs for the elderly, child welfare, and foster care.
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`15.
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`Plaintiff National Association of Pediatric Nurse Practitioners (“NAPNAP”)
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`is an IRC Section 501(c)(6) nonprofit professional membership association, representing
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`more than 8,000 healthcare practitioners, with 18 specialty practice issues groups and 53
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`chapters. It is the nation’s only professional association for pediatric nurse practitioners
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`and their fellow pediatric-focused advanced practice registered nurses, who are dedicated
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`to improving the quality of health care for infants, children, adolescents, and young adults.
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`NAPNAP’s members treat millions of patients a year in a wide variety of healthcare
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`settings, including pediatric offices, hospitals, specialty clinics, public or school-based
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`healthcare facilities, and others. They are regulated and affected by thousands of HHS
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`regulations under such programs as Medicaid and the Children’s Health Insurance
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`Program. NAPNAP’s mission is to empower pediatric-focused advanced practice
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`registered nurses and key partners to optimize child and family health.
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`16.
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`Plaintiff American Lung Association (“ALA”) is an IRC Section 501(c)(3)
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`nonprofit voluntary health organization incorporated in the State of Maine, with its
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`principal place of business in Chicago, Illinois. One of ALA’s core missions is to advocate
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`for policies that improve the prevention and cure of lung disease and that improve the
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`quality of life of people living with lung disease. These include policies that reduce the
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`burden of asthma, expand access to affordable healthcare for patients with or at risk for
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`lung diseases, reduce tobacco use through tobacco regulation and cessation efforts, and
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`increase screening for those at high risk of lung cancer. ALA has spent substantial
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`resources advocating for such programs before HHS. For example, in 2015, ALA testified
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`at a hearing to urge HHS to expand Medicare coverage to include early detection computed
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`tomography (“CT”) scans for high-risk Medicare beneficiaries. ALA also works to
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`improve public education on HHS programs that benefit at risk populations. For example,
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`ALA generates and maintains a lung cancer screening toolkit that tracks coverage of and
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`barriers to low-dose computed tomography (“LDCT”) lung cancer screening under state
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`Medicaid fee-for-service programs. Similarly, ALA depends on HHS regulations
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`governing tobacco products, such as a 2016 regulation deeming e-cigarette subject to the
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`Tobacco Control Act, which significantly affects ALA’s Not On Tobacco program,
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`Freedom from Smoking program, and Lung Helpline cessation assistance service.
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`17.
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`Plaintiff the Center for Science in the Public Interest (“CSPI”) is an IRC
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`Section 501(c)(3) nonpartisan nonprofit organization headquartered in Washington, DC,
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`with approximately 450,000 members. CSPI is independently owned and operated and is
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`not dominant in its field of public health advocacy. CSPI is a science-based consumer
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`advocacy organization that seeks to promote: (1) a healthy population with a reduced
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`burden of preventable disease, and (2) an equitable food system in which healthy,
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`sustainable food is accessible to all. CSPI values independence, scientific rigor, and
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`transparency. A core aspect of CSPI’s mission is ensuring that food, dietary supplements,
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`and drugs are safe and transparently labeled. The FDA, an HHS sub-agency, administers
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`several statutes relevant to this work, including the Federal Food, Drug and Cosmetic Act,
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`Pub. L. No. 75-717, 52 Stat. 1040 (codified as 21 U.S.C. § 301, et seq.); the Nutrition
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`Labeling and Education Act of 1990, Pub. L. No. 101-535, 104 Stat. 2353; the Dietary
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`Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325;
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`portions of the Patient Protection and Affordable Care Act (“ACA”), Pub. L. No. 111-148,
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`124 Stat. 119; the Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885;
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`and the Food Allergen Labeling and Consumer Protection Act of 2004, Pub. L. No. 108-
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`282, 118 Stat. 891.
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`18.
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`Plaintiff Natural Resources Defense Council (“NRDC”) is an IRC Section
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`501(c)(3) national not-for-profit environmental and public health organization,
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`headquartered in New York City, with more than three million members and online
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`activists. One of NRDC’s core missions is to conduct advocacy and educate the public to
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`protect public health and the environment. In service of this mission, NRDC advocates for
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`health-protective regulations at FDA (including the regulation of food additives, 21 C.F.R.
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`§§ 170.3-180.37; bottled water, id. §§ 129.1-129.80; and antibiotics in animal agriculture,
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`id. §§ 556.1-556.770, 558.3-558.680) and HHS (including regulations that protect human
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`test subjects, 45 C.F.R. part 46). NRDC also educates its members and the public about
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`these and other HHS regulations.
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`19.
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`Defendant United States Department of Health and Human Services
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`(“HHS” or “Department”) is a federal agency headquartered in Washington, DC, at 200
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`Independence Avenue, SW, Washington, DC 20201. HHS is an “agency” within the
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`meaning of the APA. 5 U.S.C. § 551(1). HHS is a cabinet-level department that
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`COMPLAINT FOR DECLARATORY AND
`INJUNCTIVE RELIEF - Case No 5:21-cv-01655
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`Case 5:21-cv-01655 Document 1 Filed 03/09/21 Page 11 of 50
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`encompasses several sub-agencies, including the CDC, FDA, Centers for Medicare and
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`Medicaid Services, Indian Health Service, and National Institutes of Health.
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`Defendant Norris Cochran is sued in his official capacity as the Acting U.S.
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`Secretary of Health and Human Services. His official address is 200 Independence
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`Avenue, SW, Washington, DC 20201.
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`JURISDICTION AND VENUE
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`This Court has subject matter jurisdiction over this action pursuant to 28
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`U.S.C. § 1331 because this action arises under federal law.1 The Court also has subject
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`matter jurisdiction pursuant to 5 U.S.C. § 611(a).
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`22.
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`Venue is proper in this district pursuant to 28 U.S.C. § 1391(e)(1) because
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`Plaintiff County of Santa Clara resides in this district and there is no real property involved
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`in this action.
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`23.
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`The Sunset Rule is a final agency action for which there is no other
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`adequate remedy in court. 5 U.S.C. § 704.
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`24.
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`This Court has authority to grant the requested relief in this case pursuant to
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`the APA, 5 U.S.C. § 706, and the Declaratory Judgment Act, 28 U.S.C. §§ 2201-2202.
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`1 Under 28 U.S.C. § 1331, this APA challenge is properly brought in the district courts
`because the vast majority of the regulations amended by the Sunset Rule fall under
`statutory provisions that have no specific direct-review provision. See Owner-Operators
`Indep. Drivers Ass’n v. Skinner, 931 F.2d 582, 585 (9th Cir. 1991) (district courts have
`jurisdiction over APA claims “unless Congress specifically maps a judicial review path”).
`However, Plaintiffs are also filing a “protective” petition for review in the U.S. Court of
`Appeals for the Ninth Circuit because certain regulations amended by the Rule are subject
`to provisions conferring initial jurisdiction on the courts of appeals. E.g., 21 U.S.C. § 360g
`(jurisdiction for challenges to the regulation of medical devices arises in the courts of
`appeals); see also Nat’l Fed’n of the Blind v. U.S. Dep’t of Transp., 827 F.3d 51, 58 (D.C.
`Cir. 2016) (parties should “file suit in both the court of appeals and the district court” when
`there is doubt as to the proper forum). Plaintiffs intend to ask the Ninth Circuit to hold the
`petition in abeyance pending the resolution of this case.
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`COMPLAINT FOR DECLARATORY AND
`INJUNCTIVE RELIEF - Case No 5:21-cv-01655
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`Case 5:21-cv-01655 Document 1 Filed 03/09/21 Page 12 of 50
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`LEGAL AND STATUTORY BACKGROUND
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`I.
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`The Administrative Procedure Act (“APA”)
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`The APA allows a person “suffering legal wrong because of agency action,
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`or adversely affected or aggrieved by agency action” to seek judicial review of that action.
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`5 U.S.C. § 702. Under the APA, courts must “hold unlawful and set aside agency action,
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`findings, and conclusions” that are “arbitrary, capricious, an abuse of discretion, or
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`otherwise not in accordance with law,” id. § 706(2)(A), “in excess of statutory jurisdiction,
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`authority, or limitations, or short of statutory right,” id § 706(2)(C), or “without observance
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`of procedure required by law,” id. § 706(2)(D).
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`II.
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`The Regulatory Flexibility Act (“RFA”)
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`The RFA requires agencies to publish a “plan for the periodic review of the
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`rules . . . which have or will have a significant economic impact upon a substantial number
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`of small entities.” 5 U.S.C. § 610(a). The RFA does not authorize reviews of rules that
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`lack “a significant economic impact upon a substantial number of small entities.” See id.
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`§§ 602, 605, 610.
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`The purpose of RFA review is “to determine whether” covered regulations
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`“should be continued without change, or should be amended or rescinded, consistent with
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`the stated objectives of applicable statutes, to minimize any significant economic impact of
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`the rules upon a substantial number of []small entities.” Id. § 610(a).
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`In conducting review under the RFA, the agency “shall consider” five
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`statutory factors. Id. § 610(b). Those are: (1) the “continued need for the rule”; (2) the
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`“nature of complaints or comments” concerning the rule; (3) the “complexity of the rule”;
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`(4) the “extent to which the rule overlaps, duplicates or conflicts” with other rules; and (5)
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`the “length of time since the rule has been evaluated or the degree to which technology,
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`economic conditions, or other factors” affecting the rule have changed. Id.
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`COMPLAINT FOR DECLARATORY AND
`INJUNCTIVE RELIEF - Case No 5:21-cv-01655
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`Case 5:21-cv-01655 Document 1 Filed 03/09/21 Page 13 of 50
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`FACTUAL ALLEGATIONS
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`I. HHS Regulates Healthcare, Disease Control, and Food and Drug Safety.
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`29.
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`HHS was established as a cabinet level department in 1953, when it was
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`called the Department of Health, Education, and Welfare. Its name was changed to the
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`Department of Health and Human Services in 1980. The mission of HHS is to provide
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`services that benefit the health and well-being of Americans and by fostering advances in
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`the science underlying medicine, public health, and social services.2
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`30.
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`HHS contains dozens of sub-agencies and offices, including the CDC, FDA,
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`Centers for Medicare and Medicaid Services, Indian Health Service, Administration on
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`Community Living, Administration for Children and Families, and National Institutes of
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`Health.
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`31.
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`HHS operates programs that affect every aspect of the U.S. healthcare
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`system. These include, for example, the Medicare and Medicaid programs, which insure
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`139 million Americans, including 36.6 million children; the Children’s Health Insurance
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`Program, which insures over 7 million children; and the Healthcare.gov Insurance
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`Marketplace, which enrolled nearly 8.3 million people in insurance plans in 2020 alone.
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`32.
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`HHS administers almost every major federal statute governing healthcare,
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`including, for example, the Medicare and Medicaid provisions of the Social Security Act,
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`Pub. L. No. 74-271, 49 Stat. 620, which include hospital health and safety requirements;
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`the ACA, which governs health insurance; the Health Insurance Portability and
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`Accountability Act (“HIPAA”), Pub. L. No. 104-191, 110 Stat. 1936, which governs
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`privacy and portability of health information; and the Health Information Technology for
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`Economic and Clinical Health Act, Pub. L. No. 111-5, 123 Stat. 115, which establishes
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`programs for securing health information; in addition to the countless supplements and
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`amendments to these statutes.
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`2 About HHS, https://www.hhs.gov/about/index.html (last visited Mar. 5, 2021).
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`COMPLAINT FOR DECLARATORY AND
`INJUNCTIVE RELIEF - Case No 5:21-cv-01655
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`Case 5:21-cv-01655 Document 1 Filed 03/09/21 Page 14 of 50
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`33.
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`Other HHS-administered statutes regulate the safety and contents of food,
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`medications, vaccines, and medical devices, and protect the public from tobacco products,
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`such as the Nutrition Labeling and Education Act; the Dietary Supplement Health and
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`4
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`Education Act; the Food Safety Modernization Act; the Food Allergen Labeling and
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`Consumer Protection Act; the Federal Food, Drug and Cosmetic Act, Pub. L. 75-717, 52
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`Stat. 1040; and the Family Smoking Prevention and Tobacco Control Act, Pub. L. No.
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`111-31, 123 Stat. 1776.
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`34.
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`HHS agencies operate programs that for prepare for, respond to, and help
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