Public Health Regulations

4 common legal challenges

By Katie Hannon Michel & Patrick Glass

Our two-part webinar series, The ABC’s of Administrative Law in Public Health Practice, is brought to you by the Centers for Disease Control and Prevention (CDC), the National Association of County and City Health Officials (NACCHO), and ChangeLab Solutions. The webinar series further explains the concepts introduced in this blog post. Register online for Part 2 of the series.

Public health regulations affect nearly every aspect of modern American life — from food and water safety to housing conditions, occupational safety, pharmaceuticals, and hospital licensing. Most public health regulations are carefully designed to serve the public. However, public health agencies should exercise caution and follow proper procedures when making regulations, to protect people’s rights and retain public trust in the agency’s work.

Legal opposition to regulations can be a concern for public health professionals at federal, state, tribal, territorial, and local levels of government. These challenges can waste limited time and resources or, in the worst cases, diminish public support for regulations or for health departments themselves. Proactively avoiding potential legal challenges can help health departments fulfill their mission of ensuring the health of all members of the public.

How can health departments better serve communities through the process of developing regulations? What are common ways that public health regulations are challenged within the legal system? And how can public health professionals avoid having their regulations challenged in court? This blog post will provide clear, succinct answers to these questions. But first, we’ll delve into some crucial background information about how regulations work and where public health agencies sit within the US governmental system.

Administrative Law 101

To understand what administrative law is, let’s start with a definition of an administrative agency. An agency is a government body within the executive branch that has authority to administer certain laws. One type of administrative agency is public health departments — including the Department of Health & Human Services at the federal level as well as state and local departments of health.

Public health agencies are created by enabling legislation that defines their general powers and the matters they oversee. After an agency has been created, a legislative body — such as a state legislature or a city council — may pass additional legislation to expand the agency’s duties or to delegate authority to the agency to do specific things. For example, in 1869, Massachusetts became the first state to pass legislation creating a state board of health (now known as the Department of Health), charging it “to take cognizance of the interests of health and life among the citizens of this Commonwealth.” Since then, the Massachusetts legislature has passed other laws refining the department’s general powers and giving it authority to regulate specific activities, from the use of laser equipment to the licensing of mammography facilities and the sanitation of public beaches. Legislative bodies delegate powers to administrative agencies because agencies often have niche expertise and can respond efficiently and flexibly to address new conditions and emergencies.

Administrative law deals with the legal principles that guide administrative agencies when they are carrying out the duties and responsibilities that have been delegated to them. It establishes the procedures that agencies must use when developing rules and regulations to implement legislation and governs how agencies may enforce laws against people and businesses. It also governs how courts will review regulations and other agency actions if they are legally challenged.

Because public health agencies exercise extensive powers vis-à-vis individuals and private entities, it is important for practitioners to understand key administrative law principles and procedural rules, which help to ensure that individual rights are protected and to promote transparency and accountability to the public. Actions taken by public health agencies generally fall within these categories:

  • Creating regulations
  • Issuing licenses and benefits
  • Conducting investigations and inspections
  • Enforcing public health laws
  • Developing non-binding guidance documents

This blog post focuses on the first item in this list: creating regulations.

What Are Regulations?

A regulation — sometimes called a rule — is a law created by an administrative agency. Regulations differ from legislation in that they are not voted on by legislative bodies, such as Congress, a state legislature, a county board of supervisors, or a city council. To address concerns about agencies making regulations behind closed doors without any citizen participation, Congress and all state legislatures have adopted administrative procedures acts (APAs). APAs establish procedures that federal and state agencies must follow when creating regulations, including providing the public with notice of proposed regulations and an opportunity to comment. Procedures like these help to make the regulatory process more democratic.

Another important limitation is that agencies are not free to create whatever regulations they want. Rather, public health agencies can make regulations only when a legislative body has given them authority to do so in a piece of enabling legislation. For example, New York City’s Smoke-Free Air Act gives the city’s Department of Health and Mental Hygiene authority to “promulgate rules in accordance with the provisions contained in this chapter, and such other rules as may be necessary for the purpose of implementing and carrying out the provisions of this chapter.” Regulations often fill in the details of legislation and act on the broad-brush proposals put forward by legislative bodies.

Note that rulemaking processes can vary significantly at the local level. In many jurisdictions, local health departments do not have authority to make regulations at all. The local health departments that do have rulemaking authority may operate without any legislative requirements on what types of procedures to use. For this reason, it is important for local health officials to consult with their legal team to confirm their rulemaking authority and best practices before embarking on a rulemaking process.

4 Common Legal Challenges to Regulations

Once a regulation becomes final, individuals and businesses can challenge it in court. The judicial branch serves as a check on administrative agencies so that they don’t unfairly infringe on individual rights or act unreasonably or beyond the scope of their authority.

In this section, we’ll discuss common ways that affected individuals can challenge public health regulations. Having an increased understanding of potential legal challenges — and best practices for avoiding them — can help health departments reduce their legal liability and better ensure that the rights of the public are being served and protected. As the following examples show, courts typically defer to agencies’ expert determinations on how to regulate matters within their jurisdiction, allowing public health agencies significant flexibility to adopt regulations to protect and improve health for all.

1. Agency Failed to Follow Proper Procedures

One potential basis for challenging public health regulations is that the agency did not follow proper procedures. Once an agency has drafted a proposed regulation, the agency must, at a minimum, provide notice to the public and an opportunity for comments. This step is mandatory under most APAs. Because regulations may restrict individual rights or impose obligations on regulated businesses, it is only fair that those affected should receive advance notice and have the opportunity to share their views with the agency. Agencies may change their regulatory approach based on comments received, which can help to legitimize the regulation and enhance public support.

To see how this type of challenge can play out in practice, let’s consider an example. In 2002, the Oregon Department of Human Services issued a notice of proposed rulemaking that would add certain opioid analgesics to the drug list for the Oregon Health Plan. Drug manufacturers sued, arguing that the department had failed to follow the state’s rulemaking procedures. They claimed that the department had already made a final decision about which drugs would be added to the list before they allowed affected parties to submit comments. In support of their claim, the drug manufacturers pointed to a letter that Oregon’s governor had sent to medical practitioners identifying the drugs the department intended to add to the list, which had preceded the notice of proposed rulemaking.

The court ruled in favor of the department, concluding that an agency’s predisposition or intent to adopt a particular regulatory approach does not, on its own, violate the agency’s obligation to provide notice and an opportunity to comment. As this example demonstrates, courts generally defer to agencies and allow them some leeway to decide how to implement procedural requirements. Nevertheless, agencies should always take care to follow proper procedures to ensure that individual rights are protected.

2. Agency Exceeded Delegated Scope of Power

The US Constitution separates the powers of government assigned to the legislative, executive, and judicial branches — a format often followed by state and local governments as well. Broadly speaking, the legislative branch makes new laws, the executive branch implements and enforces existing laws, and the judicial branch interprets and applies laws. Although legislative bodies often give agencies power to make rules about complex areas of public life, they also must set clear boundaries on what agencies can and cannot do.

Any regulation an agency adopts must relate to specific legislation that it is authorized to implement. If an agency acts outside of those boundaries, affected parties may have grounds to challenge the regulation in court. An example of this type of challenge involves the New York City Board of Health. In 2012, as part of the city’s efforts to combat obesity, the board adopted the Portion Cap Rule, which would limit the size of cups and containers used by food outlets to serve certain types of sugary drinks. Interest groups sued, arguing that the Board of Health had exceeded its regulatory authority. The court agreed, stating that the city could not “point to any legislation concerning the consumption of sugary beverages by the State Legislature or City Council that the Portion Cap Rule was designed to supplement.” The court concluded that the Portion Cap Rule reflected a new policy choice that was within the city council’s purview — not the health department’s.

Note that decisions like this one are rare. In most cases, courts defer to public health agencies’ interpretation of authorizing legislation and the scope of their delegated authority. Nevertheless, the best way to avoid this type of legal challenge is to confirm with your agency’s legal team that a regulation aligns with your agency’s delegated authority before adopting a final rule.

3. Regulation Is Arbitrary and Capricious

Another type of legal challenge claims that an agency’s regulation is “arbitrary and capricious,” which is just a fancy way of saying unreasonable. When deciding this type of case, a court will look at the evidence the public health agency considered when making the regulation, including any public comments it received, to determine whether the agency made an evidence-based decision.

To see how “arbitrary and capricious” challenges come up in practice, let’s return to New York City. In 2015, the New York City Board of Health adopted a regulation requiring large chain restaurants to post warnings alerting customers about menu items containing high amounts of sodium. A statement accompanying the final rule included findings to justify the board’s decision. The findings addressed the health effects of sodium and stated, “The vast majority of average dietary sodium intake is from processed and restaurant food; chain restaurants account for more than one-third of all restaurant traffic in New York City; a considerable number of individual or combination items on chain restaurant menus have more than 2300 mg of sodium; and consumers typically underestimate the sodium content of restaurant foods.”

After the rule was adopted, the National Restaurant Association sued the city, arguing that the sodium rule was “arbitrary and capricious” because it applied only to large fast-food chain restaurants and not to other types of food outlets. The court rejected this argument, concluding that the board “made the Rule applicable to these Chain Restaurants based on health considerations and for the purpose of making the Rule possible to comply with and administer. Accordingly, this aspect of the Rule has a rational basis.” In other words, the court deferred to the board’s findings that high-sodium menu items at chain restaurants have a significant impact on health.

As this example demonstrates, it is important for public health agencies to conduct thorough research and keep clear records that support their regulatory approach. Additionally, a public health agency can provide a short summary of the evidence it relied on in a findings section or supplementary document accompanying a regulation. Courts may refer to documents like these to ascertain the agency’s rationale if a regulation is subjected to a legal challenge. Typically, a court will defer to an agency’s findings and will uphold a regulation as reasonable if there is any evidence at all to support it.

4. Regulation Is Unconstitutional

Finally, a person or business may challenge a public health regulation on the grounds that it violates the federal or state constitution. Of the possible constitutional challenges to public health regulations, the First Amendment is one of the most common. First Amendment challenges typically arise when a public health agency seeks to mandate certain types of labels or disclosures on consumer products or when an agency seeks to regulate the advertising environment.

For example, in 2011, the federal Food & Drug Administration (FDA) issued regulations requiring graphic warnings on tobacco products, to implement the Family Smoking Prevention and Tobacco Control Act. Five tobacco companies sued, claiming that the warnings violated the First Amendment. An appeals court ultimately invalidated the graphic warning regulations, concluding that the FDA had not satisfied the First Amendment’s requirement to show that the graphic warnings would directly advance the agency’s interest in reducing the number of Americans who smoke. The FDA did not further appeal the decision, opting instead to re-initiate the rulemaking process to address the court’s concerns. The FDA issued its new proposal for graphic warnings in 2019 — 8 years after the first set of regulations for graphic warnings had been introduced. This example shows how legal challenges can delay the regulatory process or force an agency to change its regulatory approach. Consultation with a health department’s legal team early in the rulemaking process is essential to avoid any potential constitutional issues and related delays.

Addressing Equity Issues

Now that we’ve examined 4 common legal challenges to public health regulations and how to avoid them, this final section will explain how agencies can go above and beyond basic procedures to better serve their communities and the general public.

Health equity means that everyone, regardless of who they are or where they live, has a fair and just opportunity to live a healthy life. Achieving health equity entails eliminating the drivers of health inequities — like structural discrimination, income inequality and poverty, disparities in opportunity, and governance that limits meaningful participation. Public health regulations can advance or inhibit health equity, often through unintended consequences of regulatory action. Although most state APAs do not require it, public health agencies can consider using an equity assessment tool to analyze the potential negative impacts of regulation on underserved communities before the regulation becomes final or to evaluate a regulation after it has been implemented.

Another way that agencies can go above and beyond their basic responsibilities is by involving affected communities, including those identified in an equity assessment, in the process of designing and adopting new regulations. This practice could take the form of negotiated rulemaking, focus groups, stakeholder meetings, or other forms of community engagement. Providing different types of opportunities for members of the public to submit feedback can help to ensure that everyone is included in the process. It can be intimidating and time-consuming to find and read proposed regulations and draft written comments, and this process may be inaccessible to speakers of English as a second language or people with low literacy levels. Using an alternative process to collect feedback, like a focus group, can help to overcome some of these barriers.


This blog post is part of the Public Health Law Academy, which delivers online trainings on the use of law and policy to improve population health outcomes. The Public Health Law Academy is supported by ChangeLab Solutions and CDC.

Register online for Part 2 of our webinar series, The ABC’s of Administrative Law in Public Health Practice, which elaborates on many of the concepts introduced in this blog post. You can also watch a recording of Part 1 online. This webinar series was co-hosted by CDC, NACCHO, and ChangeLab Solutions.

3/9/2020