Regulatory and Legal Implications of the Surgeon General’s Call For Cancer Warning On Alcohol Labels

On January 3, 2025, outgoing US Surgeon General Dr. Vivek Murthy released a new advisory outlining the alleged causal link between alcohol consumption and cancer, claiming “numerous high-quality observational studies and meta-analytic reviews have assessed and observed a significant relationship between alcohol consumption and increased cancer risk.” The advisory points to scientific evidence finding that alcohol consumption is the third leading preventable cause of cancer in the United States (after tobacco and obesity) and links consumption to at least seven types of cancer, including breast and throat cancers. Additionally, the advisory underscores that the amount of evidence supporting this connection has increased over the past four decades and seeks to legitimatize the science by drawing parallels with the efforts taken to conclude that cigarette smoking causes lung cancer. The Surgeon General makes a series of recommendations to increase public awareness of this risk, such as development of a stronger and more detailed health warning statement on alcoholic beverages.

Although the intent of the Surgeon General’s advisory was to raise public awareness to help minimize alcohol-related cancer cases and deaths in the United States, it also presents significant regulatory challenges and legal concerns for the industry.

Preemption Under the Alcoholic Beverage Labeling Act

In 1988, Congress passed the Alcoholic Beverage Labeling Act (ABLA) (27 U.S.C. § 215), which, in part, requires placement of the following warning on all containers of alcoholic beverages:

Despite continued pressure from both consumer and health advocacy groups over the last three-plus decades, this language has remained unchanged since 1988.

The power to change the current warning that accompanies alcoholic beverages rests squarely with Congress. For example, the ABLA states: “No statement relating to alcoholic beverages and health, other than the statement required by section 215 of this title, shall be required under State law. . . ” (27 U.S.C. § 216). And at least one court has explicitly interpreted the phrase “statement relating to alcoholic beverages and health” to include statements regarding a “heightened risk of certain forms of cancer.” The Surgeon General’s recent advisory also reinforces Congress’s exclusive jurisdiction, writing that “[t]he power to change the label statement lies with Congress.” And regulatory guidance similarly provides that the ABLA “specifies how the label should appear and the exact words to use.”

Thus, absent Congressional statute, it appears that federal agencies and state and local governments are preempted from unilaterally requiring changes to this warning. Nonetheless, members of the Pennsylvania House of Representatives have already introduced a bill requiring all alcoholic beverages sold in Pennsylvania to be labeled with a warning about the risk of cancer associated with consumption. Other states, such as Alaska, have previously tried to circumvent preemption arguments by passing laws that require alcohol sellers to post warning signs about alcohol-related cancer risks in their places of business.¹

As for Congressional action, it remains unclear whether the current administration will push to prioritize revisions to the current warning.

Overlapping Agency Jurisdiction

Even with Congress’s blessing, implementing and enforcing a revised warning across all alcoholic beverages may prove challenging, given the uneven regulatory landscape.

Alcohol labeling in the United States is variously governed by the Federal Alcohol Administration (FAA) Act, Internal Revenue Code (IRC), and the Federal Food, Drug, and Cosmetic Act (FDCA). Both the IRC and FAA Act give the Alcohol and Tobacco Tax and Trade Bureau (TTB) authority to regulate alcohol labeling for “distilled spirits, wines, or malt beverage products,”² while the FDCA gives the Food and Drug Administration (FDA) authority to regulate certain beers, hard ciders, hard seltzers, Kombucha teas, and alcohol-infused foods that do not meet the definitions of “distilled spirits, wines, and malt beverage products” under the FAA Act. The FDA also has the authority to regulate menu labeling requirements in certain chain restaurants, including for alcoholic beverages.

One implication of this jurisdictional divide is that TTB-regulated alcoholic beverages are subject to certain pre-market requirements, while FDA-regulated alcoholic beverages are not. For example, TTB-regulated beverages must submit an image of the label as it will appear on the container to the TTB and obtain a Certification of Label Approval (COLA) before that product can be brought to market. ³ Therefore, if any revision to the health warning statement is mandated, the TTB would be able to ensure compliance with new labeling laws. FDA-regulated beverages, by contrast, are not subject to any pre-market approval scheme and may be shipped out to consumers without the FDA ever verifying whether a revised label was implemented. Although it would be in the best interests of all alcoholic beverage manufacturers to ensure their products retain revised labeling under the law, in practice, the FDA would not be able to ensure compliance for the alcoholic beverages it regulates.

Regulatory Reluctance and Industry Pushback

Although Congress is the only entity allowed to amend the warning, the TTB may, “in consultation with the Surgeon General,” notify Congress of the need to update the warning if “available scientific information would justify a change in, addition to, or deletion of the statement.”⁴ Despite this carveout—and despite the allegations highlighted by the Surgeon General of increasing scientific evidence showing a causal link between alcohol consumption and increased cancer risk over the last 40 years—the TTB has never approached Congress with a request to amend the health warning language. In fact, the only significant effort to do so occurred in 2020 when eight consumer and public health groups petitioned the TTB calling for the following cancer warning to be added to alcoholic beverage labels: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.” To date, the TTB has yet to act on this petition.

This is unsurprising, given the TTB’s historic reluctance to act on revising other aspects of alcohol labeling. For example, unlike the health warning statement, the TTB is unilaterally authorized to revise labeling regulations to provide “adequate information” regarding the identity, quality, and alcohol content of alcoholic beverages to prevent such labels from being false or misleading.⁵ Pursuant to that authority, in the early 2000s, 69 organizations and eight individuals filed a petition to compel the TTB to require basic nutrition and allergen information on the alcoholic beverages it regulates (information that was already similarly required by the FDA for the beverages it regulates). In late 2022—almost two decades later—the groups had to file suit to force the agency’s hand.⁶ Shortly thereafter, the TTB agreed to issue proposed rules requiring standardized alcohol content, calorie, and allergen labeling on the beverages it regulates.

Here, even if the TTB were to act in short order, any call to Congress to revise the health warning statement would be met with significant public and industry backlash. It is no secret that alcohol companies and trade groups spend millions of dollars each year lobbying against mandatory and burdensome labeling requirements that pose a risk to their commercial speech rights. Should the Surgeon General’s recommendations gain tangible momentum with the government, we may expect these same entities to take this fight to the courts on the basis of freedom of speech. But these arguments may prove difficult to make in light of the Supreme Court’s 2020 refusal to review a tobacco industry challenge to graphic health warnings on cigarette packs and advertisements required under an FDA rule, in turn solidifying the Fifth Circuit’s ruling that such warnings do not violate the First Amendment as they are “factual,” “uncontroversial,” and scientifically sound.⁷

Plaintiff Mobilization and Anticipated Targets

Although the federal government has yet to take any concrete steps to address the latest advisory, the Surgeon General’s statements have already opened the door for plaintiffs’ law firms across the country to recruit plaintiffs for personal injury and class action lawsuits. Indeed, plaintiff firms are seeking to hold alcohol manufacturers and other industry parties “responsible” under a number of legal theories, including failure to warn and other product liability claims. It is unclear whether such claims would be held preempted by the ABLA, but if these suits garner traction and suggest industry misconduct, we can expect federal agencies and other government actors to quickly follow suit under theories widely employed in the tobacco, asbestos, and opioid litigations.

Given the scale and overlapping workstreams in the industry, we may see the following actors become targets of civil lawsuits and government investigations: manufacturers; distributors; wholesalers; retailers; marketing consultants; celebrity and influencer marketers; hospitality and entertainment conglomerates; restaurant chains; hotel chains; and casinos.

Although any risk mitigation and litigation defense will be product- or company-specific, we can anticipate successful strategies may hinge on each entity’s involvement in and marketing of the underlying product, each entity’s knowledge of the science underlying the alleged injuries, and a court’s or agency’s appetite to assign risk to the public.

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Mayer Brown specializes in areas and industries that may be affected by the Surgeon General’s advisory, including product liability and mass torts, consumer litigation and class actions, and food and beverage law. Should you have any questions or require legal guidance regarding alcohol labeling or related issues, Mayer Brown’s experienced team can help clients take proactive steps to address the latest advisory, including the identification of litigation risks, regulatory evaluation and risk assessment, government action and involvement, commercial engagement, evaluation of alternative options in the industry, and reputational and governance advisement.

¹ See H.B. 298, 2024 Sess. (Alaska Mar. 25, 2024).

² See 27 U.S.C. §§ 205(e), 211(a)(5–7); 26 U.S.C. §§ 5301, 5368, 5412.

³ 27 C.F.R. pts. 4-5, 7, 13, and 16.

⁴ 27 U.S.C. § 217 (2012).

⁵ 27 U.S.C. §§ 205(e)(2); 205(e)(4).

⁶ See Center for Science in the Public Interest et al v. U.S. Department of Treasury et al, Case No. 1:22-cv-02975 (D.D.C.).

⁷ R J Reynolds Tobacco Co. v. Food & Drug Admin., 96 F.4th 863, 875-87 (5th Cir. 2024), cert. denied, Reynolds Tobacco v. FDA, No. 24-189, 2024 WL 4874678 (Nov. 25, 2024).