Federal Cigarette Labeling and Advertising Act: Amendments and Preemption

The Federal Cigarette Labeling and Advertising Act is the 1965 federal law, codified at 15 U.S.C. §§ 1331–1341, that requires health warnings on cigarette packages and advertisements, bans cigarette advertising on television and radio, requires manufacturers to report ingredients to federal health authorities, and preempts state laws that would impose their own smoking-and-health labeling or advertising rules on compliant cigarettes.¹

What the Law Requires Today

The Act, as amended most recently by the Family Smoking Prevention and Tobacco Control Act of 2009, sets a small number of core obligations that any cigarette sold in the United States must meet.

Warning labels on packages and ads. Under 15 U.S.C. § 1333, packages and advertisements must carry one of nine specified warnings. On packages, the warning has to appear on the upper 50 percent of the front and rear panels in at least 17-point type, printed black on white or white on black. In print and poster advertisements, the warning has to occupy at least 20 percent of the ad area. The statute also authorizes the Secretary of Health and Human Services to require color graphics depicting the negative health consequences of smoking.¹

No broadcast advertising. Section 1335 makes it unlawful to advertise cigarettes or little cigars on any medium of electronic communication subject to Federal Communications Commission jurisdiction. That ban has been in place for cigarettes since January 1, 1971, and was extended to little cigars in 1973.²³

Ingredient reporting. Section 1335a requires manufacturers to submit an annual list of ingredients added to tobacco to the Secretary of Health and Human Services. The list is kept confidential but may be reported to Congress.¹

Federal preemption. Section 1334 bars states from adding their own smoking-and-health statements to cigarette packages and from imposing requirements or prohibitions based on smoking and health with respect to the advertising or promotion of compliant cigarettes. States may still impose content-neutral time, place, and manner restrictions.¹

FTC authority preserved. Section 1336 makes clear that nothing in the Act limits the Federal Trade Commission’s authority to act against unfair or deceptive practices in cigarette advertising.¹

Why the Law Was Passed

On January 11, 1964, Surgeon General Luther L. Terry released “Smoking and Health: Report of the Advisory Committee to the Surgeon General of the Public Health Service.” The committee had reviewed more than 7,000 biomedical articles and concluded that cigarette smoking caused lung cancer in men, was a probable cause of lung cancer in women, and was the most important cause of chronic bronchitis. The report called for “appropriate remedial action.”⁴

Congress responded with Public Law 89-92, signed on July 27, 1965. The Act took effect on January 1, 1966, and required a single warning on every cigarette package: “Caution: Cigarette Smoking May Be Hazardous to Your Health.” Its stated purpose was to inform the public about the health effects of smoking while protecting the national economy from “diverse, nonuniform, and confusing cigarette labeling and advertising regulations.”¹

How the Act Has Changed

1969: Broadcast Ban and a Stronger Warning

The Public Health Cigarette Smoking Act of 1969, signed by President Nixon in 1970, banned cigarette advertising on television and radio effective January 1, 1971. It replaced the 1965 caution with a stronger warning: “Warning: The Surgeon General Has Determined That Cigarette Smoking Is Dangerous to Your Health.” By early 1972, manufacturers also had to carry the warning in newspaper, magazine, and billboard advertising.²

Broadcasters challenged the ban on First Amendment grounds. In Capital Broadcasting Company v. Mitchell (1971), a federal district court ruled that “product advertising is less vigorously protected than other forms of speech,” and the Supreme Court summarily affirmed in 1972. Purely commercial advertising was not yet treated as protected speech, a position that began shifting with Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council in 1976.²

1973: Little Cigars Pulled In

The Little Cigar Act of 1973 (Public Law 93-109) extended the broadcast advertising ban to little cigars, defined as rolls of tobacco wrapped in leaf tobacco or a tobacco-containing substance where one thousand units weigh no more than three pounds. It closed a loophole that had let small cigar makers keep advertising on radio and television after cigarettes were pulled off the air.³

1984: Four Rotating Warnings

The Comprehensive Smoking Education Act (Public Law 98-474), enacted October 12, 1984, replaced the single warning with four rotating Surgeon General’s warnings that had to appear on both packages and advertisements, rotated quarterly by brand under a plan approved by the FTC:⁵

“SURGEON GENERAL’S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May Complicate Pregnancy.”
“SURGEON GENERAL’S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.”
“SURGEON GENERAL’S WARNING: Smoking By Pregnant Women May Result in Fetal Injury, Premature Birth, And Low Birth Weight.”
“SURGEON GENERAL’S WARNING: Cigarette Smoke Contains Carbon Monoxide.”

Because later graphic warning rules have been blocked in court, these four warnings are still the labels on U.S. cigarette packages.⁶

2009: The Tobacco Control Act Overhaul

The Family Smoking Prevention and Tobacco Control Act, signed on June 22, 2009, is the most significant amendment since 1969. It gave the FDA authority over the manufacture, marketing, and distribution of tobacco products, and rewrote several parts of the FCLAA:⁷

Directed the FDA to require color graphics accompanying nine new text warnings on 50 percent of the front and back of each cigarette package.
Banned misleading descriptors such as “light,” “mild,” and “low-tar.”
Codified restrictions on outdoor advertising within 1,000 feet of schools and playgrounds, brand sponsorships of sports and entertainment events, free giveaways of non-tobacco items, and free samples. Point-of-sale and outdoor ads were limited to black text on a white background.
Amended the preemption clause to let states restrict the location, color, size, number, and placement of cigarette advertising, while keeping federal control over the content of the health warning itself.⁸

What States Can and Can’t Do Under the Preemption Clause

Section 1334 has produced three Supreme Court decisions that together define how far state law can reach into cigarette labeling and advertising.

In Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), the Court held that state tort claims arguing a manufacturer’s advertising should have included additional warnings, or that its advertising neutralized the federally required warning, are preempted. Claims based on intentional fraud and concealment, breach of express warranty, and conspiracy to misrepresent or conceal material facts are not preempted, because they rest on general duties not to deceive rather than duties “based on smoking and health.” The Court instructed lower courts to examine the underlying legal duty behind each specific claim, construing the preemption clause “fairly but narrowly.”⁹¹⁰

In Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001), the Court struck down Massachusetts regulations that prohibited outdoor tobacco advertising within 1,000 feet of schools and playgrounds and required indoor advertising to be placed at least five feet from the floor. Writing for a 5-to-4 majority, Justice Sandra Day O’Connor found the 1969 preemption language “much broader” than the 1965 version and rejected the argument that regulations aimed at the location, rather than the content, of advertising escape preemption. For smokeless tobacco and cigars not covered by the FCLAA, the Court applied the Central Hudson commercial speech test, struck down the outdoor buffer and the five-foot rule, but upheld sales-practice rules requiring retailers to keep tobacco products behind counters and prohibiting self-service displays.¹¹¹²

In Altria Group, Inc. v. Good, 555 U.S. 70 (2008), the Court held 5 to 4 that state-law fraud claims by smokers who alleged they were deceived by “light” and “low tar” descriptors are not preempted. A state-law duty not to deceive is not “based on smoking and health” within the meaning of the preemption clause. The Court also rejected the argument that FTC guidance on tar and nicotine testing impliedly preempted state deceptive-practices claims, noting the FTC had rescinded that guidance in November 2008.¹³

The practical takeaway: states can pursue tobacco companies for deception under general consumer-protection principles, and, after the 2009 amendments, can also regulate the location, color, size, number, and placement of cigarette ads. What they cannot do is add their own smoking-and-health warnings to cigarette packages or impose content-based advertising rules tied to smoking and health.

Why Cigarette Packs Still Carry the 1984 Warnings

The 2009 statute told the FDA to put graphic images on cigarette packages, but no graphic warning rule has survived judicial review. The FDA’s first attempt, issued in 2011, was halted in February 2012 by a federal district court in Washington, D.C. The D.C. Circuit upheld that decision in August 2012, finding that the agency’s intent was to discourage consumption rather than merely inform consumers. The FDA declined to seek Supreme Court review in March 2013.¹⁴

The FDA tried again in March 2020, finalizing a rule with 11 warning sets of photorealistic images and text on topics from neck cancer and lung disease to blindness, erectile dysfunction, and heart disease. That rule is now the subject of parallel challenges in two federal courts.⁷

In the Eastern District of Texas, the district court first vacated the rule on First Amendment grounds in December 2022. The Fifth Circuit reversed in March 2024, calling the warnings “purely factual and uncontroversial,” and the Supreme Court declined review in November 2024. On remand in January 2025, the district court issued a preliminary injunction on a different theory: that the FDA likely exceeded its statutory authority by requiring 11 warnings instead of the nine specified by Congress. The FDA’s appeal of that injunction to the Fifth Circuit has been stayed.¹⁵

In the Southern District of Georgia, the court ruled in August 2025 that the FDA violated the Administrative Procedure Act by failing to disclose raw data from studies it relied on during rulemaking, and vacated the rule. The FDA appealed to the Eleventh Circuit in October 2025.¹⁶⁶

The FDA cannot enforce the 2020 rule while these orders stand. Under the Tobacco Control Act, any new graphic warnings can take effect only 15 months after the FDA issues valid final regulations, and that clock is not currently running. The four 1984 Surgeon General’s warnings remain the required labels on U.S. cigarette packages.⁶

What the FTC Still Does

The FTC has been the primary federal enforcer of cigarette advertising rules since 1965. The FCLAA does not expressly grant the FTC enforcement power, but the Commission acts under Section 5 of the FTC Act against unfair or deceptive practices in cigarette advertising and enforces federal antitrust laws against tobacco companies.¹⁷

Since 1967, the FTC has published annual reports on cigarette advertising, sales, and product characteristics. Its 2021 report, issued in 2023, found that major manufacturers sold 190.2 billion cigarettes domestically that year and spent $8.06 billion on advertising and promotion, with about 95 percent going to price discounts and promotional allowances paid to retailers and wholesalers rather than traditional media advertising. Menthol cigarettes reached a market share of 37 percent in 2021.¹⁸

The 2009 Tobacco Control Act moved some oversight to the Secretary of Health and Human Services and the FDA. Since 2012, the FTC no longer reviews or approves the rotation of cigarette warning statements, and the FDA is required to coordinate with the FTC on enforcement of advertising provisions.¹⁹

One boundary worth noting: the FCLAA governs cigarettes and, through the 1973 amendment, little cigars. Smokeless tobacco and other cigars are regulated under separate federal statutes, which is why the Court in Lorillard analyzed Massachusetts’s smokeless and cigar rules under commercial speech doctrine rather than under the FCLAA’s preemption clause.¹¹

1
Office of the Law Revision Counsel. 15 U.S.C. Chapter 36 — Cigarette Labeling and Advertising
2
First Amendment Encyclopedia. Public Health Cigarette Smoking Act of 1969
3
U.S. Congress. Public Law 93-109, Little Cigar Act of 1973
4
Centers for Disease Control and Prevention. History of the Surgeon General’s Reports on Smoking and Health
5
U.S. Congress. Public Law 98-474, Comprehensive Smoking Education Act
6
Tobacco Law Blog. FDA Takes Cigarette Graphic Health Warnings Fight to Eleventh Circuit
7
FDA. Cigarette Labeling and Health Warning Requirements
8
Public Health Law Center. The Tobacco Control Act and State Authority
9
Justia U.S. Supreme Court. Cipollone v. Liggett Group, Inc., 505 U.S. 504
10
Cornell Law Institute. Cipollone v. Liggett Group, Inc.
11
Justia U.S. Supreme Court. Lorillard Tobacco Co. v. Reilly, 533 U.S. 525
12
Oyez. Lorillard Tobacco Co. v. Reilly
13
Justia U.S. Supreme Court. Altria Group, Inc. v. Good, 555 U.S. 70
14
AMA Journal of Ethics. Images on Cigarette Warning Labels: How Should They Warn?
15
Public Health Law Center. R.J. Reynolds v. FDA (2020)
16
Bloomberg Law. FDA’s Cigarette Labeling Regulations Vacated by Georgia Judge
17
Federal Trade Commission. Federal Cigarette Labeling and Advertising Act
18
Federal Trade Commission. Cigarette Report for 2021
19
Public Health Law Center. The FTC and Tobacco