Health & Safety Regulations

We work on health and safety regulation cases in a variety of areas. Click on the links to view cases in these areas:

New York State Restaurant Association (NYSRA) v. New York Department of Health, et al.

A fast-food industry group filed two lawsuits challening New York City's landmark regulation requiring fast-food restaurants to post calorie information on their menus. The industry argued that the regulation was preempted by federal law and violated the First Amendment.

In both cases, Public Citizen filed briefs and presented oral argument in support of the regulation, arguing that it was not preempted because it fills a regulatory gap that Congress intentionally left open to states when it passed the Nutrition Labeling and Education Act (NLEA) in 1990. The NLEA requires nutrition labeling on packaged food but exempts restaurants.

Public Citizen's briefing was joined by a distinguished list of individuals and organizations, including Congressman Henry Waxman (D-CA), who was the NLEA's chief sponsor; David Kessler, MD, who was Commissioner of the FDA at the time the NLEA and its regulations were implemented; the Center for Science in the Public Interest, which played an instrumental role in getting both the NLEA and the New York City rule enacted; the American Medical Association, the American Public Health Association, the American Diabetes Association; and a host of prestigious health and medical organizations and distinguished professors of medicine, nutrition, and public health.

In the first lawsuit, filed in 2007, federal judge Richard J. Holwell ruled that an earlier version of the city’s calorie rule was preempted by federal law because it applied only to restaurants that already made nutrition information public. But the judge also ruled that the city was free to require fast food restaurants to disclose calorie counts,as long as it redrafted its rule to apply to all chain restaurants (defined as restaurants with 15 or more restaurants nationally).

In the second lawsuit, the case went back before the same judge, who agreed with our arguments against the restaurant industry's constitutional challenges. The industry then took an appeal and the U.S. Court of Appeals for the Second Circuit affirmed the lower court's decision. New York's rule remains in effect and has become a model for similar state and local laws throughout the country. Public Citizen is also working with public health advocates on legislation that would implement menu labeling at the federal level.

To read the article in the ABA Journal, click here.

Public Citizen v. Mukasey

In 1992, Congress required the federal government to establish and implement the National Motor Vehicle Title Information System (NMVTIS), a single database that would provide public access to vehicle-history information gathered from states, insurance companies, and junk and salvage yards. Before purchasing a potentially dangerous used car, a consumer using the database would be able to instantly check the validity of the vehicle’s title, verify its mileage, and learn whether it had been stolen or deemed a junk or salvage vehicle.

Sixteen years since Congress first required the creation of the database, the government still has not done what Congress required it do: It has not yet set a start date for the reporting of vehicle-history information by junk yards and insurance companies, has not yet issued regulations to facilitate the reporting of that information, and has not yet made any vehicle-history information accessible to consumers. Because the government’s failure to comply with these statutory directives puts consumers at unnecessary risk of economic loss and physical harm, Public Citizen, Consumers for Auto Reliability and Safety, and Consumer Action are bringing this lawsuit to compel the Attorney General of the United States to take action that is required by law and that has been unreasonably delayed.

Natural Resources Defense Council v. Consumer Product Safety Commission

In early December 2008, Public Citizen and the environmental group Natural Resources Defense Council sued to enforce Congress's February 10, 2009 effective date on a ban on six phthalates in children's toys and child care items.

Phthalates are chemicals used to soften plastics in many common consumer products, including children's toys. The chemicals are known to interfere with production of the hormone testosterone, and have been associated with reproductive abnormalities. Numerous animal studies have linked prenatal exposure to certain phthalates with decreases in testosterone, malformations of the genitalia, and reduced sperm production.

In response to heightened concern about risks to children from certain harmful phthalates and other chemicals in children's products, Congress, by an overwhelming majority, passed the Consumer Product Safety Improvement Act (CPSIA), which was signed into law by President Bush on August 14, 2008. This Act permanently bans the sale, after February 10, 2009, of toys and child care products that contain certain phthalates and lead. The final Senate vote for this ban was 89-3, and the final House vote was 424-1.

In a letter dated November 13, 2008, the law firm Arent Fox, on behalf of unidentified corporate clients, asked the CPSC to only apply the U.S. ban to the production - and not sale - of toys with phthalates. In a legal opinion published only two business days later, on November 17, 2008, the CPSC General Counsel agreed. As a result, manufacturers can stockpile toys and child care products with the banned phthalates right up to the date of the ban, and then sell them to consumers long after the ban was supposed to go into effect.

Our lawsuit explains that the CPSC's decision is unlawful and, unless the court overturns it, will seriously harm the children that the law was supposed to protect.

Public Citizen v. Food and Drug Administration (FDA) (Fluoroquinolone)

This case was filed under the Food, Drug, and Cosmetic Act (FDCA) and the Administrative Procedure Act (APA) to compel the FDA to act on Public Citizen’s petition seeking adequate warnings about the risk of tendon injury associated with fluoroquinolone antibiotics. We alleged that FDA’s failure to act on Public Citizen’s petition constituted agency action unlawfully withheld or unreasonably delayed, and we sought an order directing FDA to act on the petition.

After Public Citizen filed its motion for summary judgment, and one day before FDA’s response was due, FDA issued a decision on Public Citizen’s petition, requiring manufacturers of fluoroquinolones to add a black box warning to their labels and to issue a Medication Guide to fully advise patients of the risk of tendon problems associated with fluoroquinolones. The parties then stipulated to dismissal of the case.

Public Citizen and United Steelworkers v. OSHA

Public Citizen and the United Steelworkers have challenged an OSHA rule setting a new standard for workplace exposure to the carcinogenic chemical hexavalent chromium. The rule was issued as a result of a previous lawsuit by Public Citizen and PACE International Union challenging OSHA’s unreasonable delay in updating the standard. Although the rulemaking improved the standard considerably, it unlawfully left workers exposed to substantial risks of lung cancer because OSHA failed to set a standard as low as its own rulemaking record indicated was necessary.

A number of industry groups also challenged the standard as too high, but most ultimately withdrew their challenges.

The cases are fully briefed and awaiting argument in the U.S. Court of Appeals for the Third Circuit.

San Luis Obispo Mothers for Peace and Public Citizen, Inc. v. United States Nuclear Regulatory Commission

In this case, Public Citizen and the San Luis Obispo Mothers for Peace are challenging the Nuclear Regulatory Commission's "design basis threat" regulation, which describes the types of terrorist threats against which nuclear power plants and certain other facilities must maintain effective security measures. In 2005, Congress ordered the agency to conduct a rulemaking to revise its design basis threat regulation. Based on the explanation in the rulemaking notice, it appears that instead of deciding what threat nuclear reactors are likely to face and requiring them to have security forces capable of meeting that threat, the NRC based the threat on what it thought it was reasonable to require a private security force to defend against.

Consolidation Coal v. Billy D. Williams

Is the Court of Appeals' finding that it is "inherently unfair" to bar a 2001 claim for black lung benefits filed six years after a medical determination of total disability due to pneumoconiosis contrary to the time limits imposed by Congress?

U.S. Forest Service v. Earth Island Institute, et al.

Whether the court of appeals erred in ordering a preliminary injunction under the Administrative Procedure Act [barring the Forest Service from proceeding with two projects in the Eldorado National Forest], including by:

  1. Relying on declarations filed by respondents in the district court, rather than confining its review to the administrative record;
  2. Holding that respondents could satisfy the "irreparable injury" prong of the test for obtaining a preliminary injunction by showing only a "possibility" of such injury; and
  3. Discounting competing interests in the use of Forest lands under multiple use principles, and the Forest Service's balance of those competing uses, in weighing the balance of harms and the public interest.

Sidney Wolfe v. FDA

Public Citizen filed a complaint and a motion for a temporary restraining order to prevent the Food and Drug Administration from closing a July 14, 2006 meeting of its Blood Products Advisory Committee. The Federal Advisory Committee Act requires advisory committee meetings to be open to the public except in the case of a few narrow exceptions. If the President or head of the agency determines one of those exceptions applies to a portion of the meeting, he must state in writing the reasons for that determination. In announcing that the July 14 meeting would be closed, the FDA did not even report the topic of the meeting, let alone give specific reasons for its closure. The agency just stated that the meeting would be closed to permit discussion of trade secrets and/or confidential commercial information. Subsequent to the announcement of the meeting, Sidney Wolfe, director of Public Citizen Health Research Group, learned that the topic of the meeting was the Navy's proposal to test a blood substitute called Hemopure on civilian trauma patients. Biopure Corp., the manufacturer of Hemopure, has told Dr. Wolfe that little, if any, of the presentations and discussions at the July 14 meeting are likely to disclose information it considers a trade secret or confidential commercial information. In response to the lawsuit, the meeting was canceled on July 13.

Public Citizen and Nuclear Information and Resource Service v. Nuclear Regulatory Commission

Challenging the NRC's decision to strip from the nuclear reactor licensing process the tools needed for meaningful public public participation.

This case was filed by Public Citizen and the Nuclear Information and Resource Service (NIRS) to challenge a rule issued in January 2004 by the U.S. Nuclear Regulatory Commission (NRC). The new rule abolished formal on-the-record hearings in most nuclear reactor licensing proceedings, making it more difficult for the public to effectively raise legitimate safety concerns. The case challenged the rule under the Administrative Procedure Act, arguing that Congress intended that the Atomic Energy Act guarantee formal hearing rights to members of the public whose interests might be affected by the NRC's licensing of nuclear reactors.

Although the First Circuit Court of Appeals upheld the NRC's new rule, the agency was forced to make concessions regarding the scope of the rule, and the court held that "should the agency's administration of the new rules contradict its present representations or otherwise flout this principle [of full and true disclosure of the facts], nothing in this opinion will inoculate the rules against future challenges." The court upheld the NRC's ability to limit discovery and cross-examination, but rejected the idea that those procedures can be eliminated, saying that "the Commission's new rules may approach the outer bounds of what is permissible" under the Administrative Procedures Act.

Center for Science in the Public Interest and Public Citizen Health Research Group v. FDA

Challenging the FDA's decision to override Congress by allowing food companies to claim that a food helps to prevent a disease, where the claim is not supported by significant scientific agreement.

The FDA announced in July that it will allow food companies to make health claims even when the evidence is too weak or inconclusive to meet the statutory standard. Indeed, the FDA has announced that it will even permit claims where the weight of the evidence suggests that the claim is likely false, as long as the claim is qualified by a disclaimer. Moreover, the FDA has stated that, when considering a "qualified claim," it will not follow the notice-and-comment rulemaking procedure that Congress required as a prerequisite for allowing a health claim for food. CSPI and Public Citizen Health Research Group filed suit to challenge the FDA's new regulatory regime.

Public Citizen and San Luis Obispo Mothers for Peace v. Nuclear Regulatory Commission

Challenging Improper Rulemaking on Nuclear Plant Security

Public Citizen and the California anti-nuclear group San Luis Obispo Mothers for Peace have challenged the Nuclear Regulatory Commission's effort to bypass lawful rulemaking procedures in addressing nuclear facilities' security against terrorist attacks. The Commission revised its rule defining the threats against which plants must protect themselves without notice or public comment, in violation of the Administrative Procedure Act, the Atomic Energy Act, and the NRC's own regulations. Public Citizen and the Mothers for Peace are asking the U.S. Court of Appeals for the D.C. Circuit to compel the agency to follow lawful procedures as it addresses this important safety issue.

NRC Orders challenged by Public Citizen Petition concerning design basis threat regulation

Public Citizen Asks Court to Order Agency to Follow the Law for Providing Written Information

FDA Illegally Delaying Prescription Drug Information Program

Public Citizen filed a suit against the U.S. Department of Health and Human Services (HHS) because the Food and Drug Administration - a part of HHS - was not requesting public comment on rules regarding patient information leaflets that are distributed with prescription drugs by pharmacists, instead relying on a faulty private sector program that does not give patients the vital drug safety information they need. The agency's refusal to request comment violated a statute passed in 1996. Shortly after we filed suit, the agency agreed to hold a public meeting to solicit public comment.

Public Citizen v. Department of Health and Human Services, et al.

(Formerly Levine v. Department of Health and Human Services)

Disclosure of Medical Errors

Public Citizen fought to enforce Medicare beneficiaries' right to be informed of the outcome of government investigations into the quality of the medical services they received. For more information, please click here.


Statement of David C. Vladeck before the Senate Committee on Governmental Affairs on S.981, The Regulatory Improvement Act of 1997

Testimony of David C. Vladeck before the Senate Committee on the First Amendment Implications of Regulating the Advertising and Promotion of Tobacco Products to Children and Adolescents

Comments of Public Citizen, Inc. Regarding FDA's Proposal to Regulate the Sale and Promotion of Tobacco Products to Minors (Executive Summary)