MPH 503 Module 3 Regulation and Rulemaking Example

From Statute to Menu Board: Regulation and Rulemaking in Federal Calorie Labeling

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Master of Public Health Program, Aspen University

MPH 503: Health Policy and Ethical Issues in Public Health

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Month Day, Year

From Statute to Menu Board: Regulation and Rulemaking in Federal Calorie Labeling

Legislatures pass laws, but agencies write most of the detailed rules that determine how laws work. Rulemaking translates broad statutory language into specific requirements, and its procedures give the public, industry and experts a voice. This paper follows federal calorie labeling on chain restaurant menus from its statutory basis through rulemaking and implementation, explaining each step and what public health professionals can contribute.

The Statute

The Affordable Care Act of 2010 added a provision to federal food law requiring chain restaurants and similar retail food establishments with 20 or more locations to post calorie counts for standard menu items and to make additional nutrition information available on request, under 21 U.S.C. § 343(q)(5)(H) (Patient Protection and Affordable Care Act, 2010). The statute set the basic requirement but left many details to the Food and Drug Administration.

Why Rules Are Needed

Statutes rarely answer every question. Which businesses count as similar retail food establishments? How should calories be displayed for combination meals or items with variable toppings? What about grocery stores selling prepared foods, movie theaters or vending machines? Agencies answer such questions through rules, which carry the force of law once properly adopted.

The Rulemaking Steps

Federal agencies generally follow notice-and-comment procedures set by 5 U.S.C. § 553 (Administrative Procedure Act, 1946). The table summarizes the steps for menu labeling.

The Proposed Rule and Comments

FDA's proposed rule defined covered establishments and display formats. Restaurant chains and grocery and convenience store associations argued that their businesses differed from restaurants and should be excluded or given flexibility. Public health organizations argued for broad coverage and clear display. Comments supported by data carry more weight than general opinions, and agencies must respond to significant comments in the final rule.

The Final Rule

FDA issued a final rule in 2014 covering chain restaurants, grocery store prepared foods and some entertainment venues, with specific rules for displaying calories and a statement about daily calorie needs. The final rule addressed major comments, explaining why some requests were accepted and others rejected. A separate rule covered vending machines.

Delays

The compliance date was delayed more than once as industry groups sought more time and changes, and the requirements took effect nationally in May 2018. Delays are common in rulemaking and show how political and industry pressure can shape implementation even after a rule is final. Public health advocates pressed for enforcement to begin.

Did It Work?

Evaluations have examined effects. A quasi-experimental study of more than 49 million transactions at 104 restaurants of one large franchise found that after labeling began, calories purchased per transaction fell by about 60, roughly 4%, although this effect weakened somewhat over the following year (Petimar et al., 2019). Modest per-transaction effects across millions of purchases may add up at the population level.

Industry Response

Some chains reformulated items or added lower-calorie options, possibly to avoid showing high calorie counts. Such reformulation can benefit all customers, including those who never read labels, and may be as important as changes in individual choices. Evaluations that measure only purchases miss this supply-side effect.

How Public Health Agencies Participate

State and local health departments can comment on proposed federal rules with local data, help businesses comply, monitor compliance and evaluate effects. Some cities had adopted menu labeling before the federal rule, and their experience informed federal requirements. After federal preemption, local agencies shifted to monitoring and education.

Rulemaking at the State Level

States have their own administrative procedure acts with similar notice-and-comment steps. State health departments write rules on reportable diseases, food safety, drinking water and health facility licensing. Public health professionals may be both authors of rules and commenters on other agencies' rules.

Judicial Review

A party may ask a court to set aside a final rule on the grounds that the agency exceeded its statutory authority, failing to follow required procedures or being arbitrary. Agencies protect their rules by building a strong record, responding to comments and staying within the statute's scope. Public health law scholars note that careful procedure is a safeguard of both legitimacy and durability (Gostin & Wiley, 2016). Because the agency had answered the major comments and explained its choices, the final rule was never set aside.

Lessons for Practitioners

Rulemaking is where many public health details are decided. Practitioners should track proposed rules in their field, submit data-based comments, coordinate with coalitions, prepare to support implementation and evaluate effects. Silence during comment periods leaves the field to better-organized interests.

Small Business Concerns

Independent restaurants with fewer than 20 locations are outside the federal requirement, and some chains argued that listing calories for menu items with many possible combinations was costly and confusing. The agency responded by allowing calorie ranges for combination meals and by giving more time for compliance. Accommodating legitimate operational problems made the final rule easier to defend.

What the Comment Record Shows

Thousands of comments came from restaurants, grocery stores, pizza chains, public health groups and individuals. Grocery stores objected strongly to covering prepared foods, and pizza chains argued that most orders were placed online. The final rule kept grocery store prepared foods in scope but offered flexible display options. Reading the record shows how rulemaking weighs statutory intent against practical concerns, and why agencies must answer significant comments.

Equity Considerations

Calorie labels may help some groups more than others. People with limited numeracy or limited English may find labels harder to use, and fast-food outlets cluster in lower-income neighborhoods. Pairing labeling with plain-language education and multilingual materials could spread the benefit more evenly. Evaluations should report effects by income and neighborhood, not only on average.

Conclusion

Calorie labeling moved from a brief statutory provision to detailed federal rules through notice-and-comment rulemaking, industry pressure, delays and eventual implementation. Evidence suggests modest reductions in calories purchased and possible reformulation effects. Understanding rulemaking lets public health professionals shape the details that determine whether laws achieve their goals.

References

Administrative Procedure Act, 5 U.S.C. § 553 (1946).

Gostin, L. O., & Wiley, L. F. (2016). Public health law: Power, duty, restraint (3rd ed.). University of California Press.

Patient Protection and Affordable Care Act, 21 U.S.C. § 343(q)(5)(H) (2010).

Petimar, J., Zhang, F., Cleveland, L. P., Simon, D., Gortmaker, S. L., Polacsek, M., Bleich, S. N., Rimm, E. B., Roberto, C. A., & Block, J. P. (2019). Estimating the effect of calorie menu labeling on calories purchased in a large restaurant franchise in the southern United States: Quasi-experimental study. BMJ, 367, Article l5837. https://doi.org/10.1136/bmj.l5837