Proposed Tobacco Regulations and Guidance Documents
The FDA has the authority to propose new tobacco-related regulations and issue Guidance documents. A Guidance document is an explanation of the FDA’s current thinking on how a regulation will be administered and enforced. Below are summaries of pending FDA proposed regulations and Guidance documents.
- Menthol: Prohibiting the use of menthol in cigarettes, heated tobacco products and roll-your-own cigarette tobacco.
In January 2025, the OMB's Office of Information and Regulatory Affairs published the "OIRA Conclusion of EO 12286 Regulatory Review" notices and referenced the menthol cigarette ban regulation as "Concluded Action: Withdrawn." It is important to note that an OIRA notice of a "withdrawn" proposed regulation or "withdrawn" final rule from OIRA review does not nullify a proposed rule. At the same time, it is customary for a federal agency to publish a notice in the Federal Register that a proposed regulation is withdrawn. The FDA has not yet published a notice in the Federal Register that the menthol cigarette ban regulation is withdrawn.
» Click for more information on the Proposed Menthol Cigarette Prohibition.
- Flavored Cigars: Prohibiting characterizing flavors in cigars. The FDA has not yet published a notice in the Federal Register that the flavored cigar ban regulation is withdrawn.
» Click for more information on the Proposed Flavored Cigar Prohibition.
- Nicotine Levels in Cigarettes and Other Combustible Tobacco Products: On January 16, 2025, the U.S. Food and Drug Administration published a proposed federal regulation that would set a maximum level of nicotine in cigarettes and other combustible tobacco products. The publication of the proposed regulation is Step 5 in the nine-step process that federal agencies must follow to adopt a new regulation.
Based on published proposed regulation, the regulation would cap the nicotine level at 0.7 milligrams per gram of tobacco in cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars (including little cigars, cigarillos, and most large cigars), and pipe tobacco. The proposed nicotine cap regulation would not apply to electronic cigarettes, nicotine pouches, non-combustible cigarettes (such as heat-not-burn tobacco products), waterpipe hookah tobacco, smokeless tobacco products, or premium cigars.
The proposed nicotine cap of 0.7 milligrams per gram of tobacco is significantly less than the level of nicotine per gram of tobacco currently found in the vast majority of cigarettes and other combustible tobacco products.
The FDA will accept public comments on the proposed regulation through September 15, 2025. This requirement to accept public comments is Step 6 in the regulation adoption process. The remaining Steps 7, 8 and 9 of the regulatory approval process include the FDA reviewing all the public comments and making any changes to the regulation, sending a final version of the regulation to the White House Office of Management and Budget (OMB) for approval, and then publishing the regulation with a specific effective date.
As a part of the comment process, the FDA has specifically asked for feedback from industry members about whether manufacturers will be able to comply with the lower total nicotine content levels if the regulation were to go into effect two years after the regulation is finalized.
On August 18, 2025, CDA submitted comments to the FDA opposing the agency’s proposed rule that would set a maximum nicotine content level of 0.70 milligrams of nicotine per gram of tobacco in cigarettes, roll-your-own cigarette tobacco, cigars (excluding premium cigars), and pipe tobacco.
This proposed nicotine cap means an average reduction of 92% to 95% in the nicotine levels of cigarettes currently on the market and similar percentage reductions in nicotine in RYO tobacco, machine-made cigars, and pipe tobacco.
The practical impact of the proposed rule would be to ban the sale of 99.99% of all conventional cigarettes on the marketplace today and prohibit the marketing of current roll-your-own tobacco, non-premium cigars, and pipe tobacco products.
CDA’s comments can be read here.
To read more, click here. To read the published version of the proposed regulation, click here.
- Submission Tracking Numbers: Requiring an importer to submit an FDA-issued Submission Tracking Number (STN) into the Automated Commercial Environment (ACE) data interchange system operated by Customs and Border Protection for electronic cigarette products being imported into the United States. The submission of the STN would occur at the time the electronic cigarette products are entering a U.S. port. Currently, the submission of a STN for electronic cigarette products being imported is optional. This proposed regulation only applies to electronic cigarettes.
» Click for more information on the Proposed Submission Tracking Number Regulation.
- Guidance Document on Enforcement of Cigarette Graphic Health Warnings: The FDA’s Center for Tobacco Products issued a Guidance document on September 12, 2024, explaining how the agency plans to enforce a regulation requiring graphic picture health warnings to be printed on cigarette packages and cigarette advertisements.
The Guidance states that FDA intends to exercise enforcement discretion and not enforce requirements in the graphic health warnings regulation until December 12, 2025, plus refrain from enforcement activities for an additional 30 days until January 12, 2026 regarding cigarettes manufactured before December 12, 2025. However, the Guidance does not contain any language allowing an unlimited sell-through period for distributors and retailers to sell cigarette inventory that was manufactured up to December 12, 2025 without graphic health warnings printed on the cigarette packages.
CDA has submitted a comment letter to the FDA asking the agency to clarify that the Guidance document should allow an unlimited sell-through period for cigarettes manufactured without graphic picture health warnings so that distributors and retailers do not lose their financial investment in the products.
» Click for more information on the proposed Guidance Document.
- Litigation Updates: On November 25, 2024, the U.S. Supreme Court declined to hear an appeal filed by R.J. Reynolds Tobacco Company and other companies of a decision issued by the Fifth Circuit Court of Appeals in the case titled R.J. Reynolds Tobacco v. FDA, 24-189. The Supreme Court justices did not issue any explanation with their decision to decline the appeal filed by R.J. Reynolds.
The decision by the Fifth Circuit Court of Appeals upheld the FDA's regulation requiring new graphic and text cigarette health warnings on cigarette packages and cigarette advertisements but also remanded the case back to the federal district court in Texas to determine whether the FDA violated the Administrative Procedures Act when it compiled and drafted the cigarette graphic health warning regulation.
The Texas federal judge then blocked the FDA from enforcing a looming requirement that cigarette packages and advertisements contain graphic warnings illustrating the health risks of smoking. On January 13, 2025, U.S. District Judge J. Campbell Barker in Tyler, Texas ruled in favor of R.J. Reynolds and other tobacco companies in finding the FDA went beyond its authority by requiring packaging and advertising to contain 11 specific warnings because the FDA regulation requiring 11 warnings goes above and beyond the nine warnings that Congress specified when in 2009 it passed the Tobacco Control Act, which gave the FDA the authority to regulate tobacco products and mandated adoption of the graphic warnings. Moreover, Judge Barker found that the FDA only used the exact text of two of the original nine warnings as passed by Congress.
The order by Judge Barker included a preliminary injunction postponing the effective date of the graphic cigarette health warning regulation until the court rules on whether the FDA violated the provisions of the Administrative Procedures Act. The FDA had intended to begin enforcing the graphic cigarette health warnings in December 2025. The court also found that a preliminary injunction is necessary due to the FDA’s rewriting of some of the health warnings. Subsequently, the FDA appealed the ruling of Judge Barker to the U.S. Circuit Court of Appeals, where the case remains pending. On February 3, 2026, the U.S. Circuit Court of Appeals held an oral argument on the case and a decision by the court is pending.
Read more here. View the January 13, 2025, Court Decision here.
Subsequent to the U.S. Supreme Court’s decision on November 25, 2024 to decline to hear an appeal in the R.J. Reynolds Tobacco Company lawsuit referenced above, a new lawsuit was filed on December 13, 2024, in the United States Federal District Court for the Southern District of Georgia naming the U.S. Food and Drug Administration (FDA) as the primary defendant and seeking to overturn the agency’s graphic cigarette health warning regulation, which was scheduled to go into effect in December 2025. The lawsuit was filed by four plaintiffs, including Philip Morris USA Inc., Dhaliwal & Associates, Inc. (which operates three convenience stores in Georgia), Stewart Candy Company d/b/a Stewart Distribution (headquartered in Blackshear, Georgia), and the Georgia Association of Convenience Stores, Inc.
The lawsuit includes two key claims against the FDA’s graphic cigarette health warnings. First, the plaintiffs allege that the FDA violated the Administrative Procedures Act (APA), which is a federal law that governs the process by which federal agencies develop and issue new regulations.
The second important claim made by the plaintiffs is that the graphic cigarette health warnings violate the First Amendment to the U.S. Constitution. The First Amendment protects free speech, and the U.S. Supreme Court has ruled that free speech includes “commercial speech,” which is advertising. With the graphic cigarette health warning regulation requiring the new warnings to cover the top 50% of the front and back of each cigarette package and the top 20% of all cigarette advertisements, the plaintiffs argue that the size of the warnings “drown[s] out the manufacturers’, distributors’, and retailers’ ability to speak their own message.”
The new lawsuit requested that the U.S. District Court issue an order for the following relief:
1. Vacate the graphic cigarette health warning regulation and send the issue back to the FDA for further review.
2. Declare that the graphic cigarette health warning regulation violates the First Amendment and is, therefore, unconstitutional.
3. Postpone the effective date of the regulation until 15 months after the U.S. District Court issues a final decision on the lawsuit’s claims.
On August 29, 2025, the federal district court in Georgia issued a ruling vacating the FDA’s graphic cigarette health warning regulation.
This decision strikes down the FDA’s regulation that requires cigarette manufacturers to display graphic cigarette health warnings on cigarette packs and cigarette advertisements. In the decision, the federal judge determined that the FDA failed to disclose the raw data of the studies that the agency relied on during the regulatory rulemaking process, which prejudiced Philip Morris USA and the other plaintiffs during the process that the public is allowed to submit comments to a proposed regulation.
Specifically, the judge’s rule states, “Accordingly, because Defendant [the FDA] failed to disclose the raw data for its studies on which the FDA relied during rulemaking, Plaintiffs were prejudiced during the rulemaking process, and the proper course is vacatur.”
On October 27, 2025, the FDA filed a Notice of Appeal with the U.S. Court of Appeals for the Eleventh Circuit to appeal the August 29, 2025 federal district court decision vacating the graphic cigarette health warning regulation.
To read the full complaint in the new graphic cigarette health warnings lawsuit, click here.
To view the court order issued on August 29, 2025, click here.
To view the Notice of Appeal filed by the FDA on October 27, 2025, click here.
On June 20, 2025, the U.S. Supreme Court issued a decision that allows manufacturers and other businesses adversely affected by an FDA denial of a pre-market tobacco product application to file a lawsuit challenging the denial in any jurisdiction where the manufacturer or other businesses operate.
This decision was issued in response to a petition brought by the U.S. Food and Drug Administration (FDA) against R.J. Reynolds Vapor Company, the Mississippi Petroleum Marketers and Convenience Store Association, and Avail Vapor, LLC. In the petition, the FDA claimed that only the manufacturer has the right to petition the courts when a marketing denial order is issued and that retail trade organizations and retailers are not adversely affected by such a denial order.
Originally, R.J. Reynolds Vapor Company, the Mississippi Petroleum Marketers and Convenience Store Association, and Avail Vapor, LLC filed a lawsuit petition in a Texas federal district court seeking to overturn the FDA’s marketing denial order of pre-market tobacco applications for Vuse Alto electronic cigarette products. The Texas federal court venue was selected since Avail Vapor, LLC operates a retail store in Houston. Both Mississippi and Texas are located within the Fifth Circuit Court of Appeals.
The Family Smoking Prevention and Tobacco Control Act (TCA) authorizes “any person adversely affected” by an FDA marketing denial order to file a lawsuit for judicial review with a federal court in either the District of Columbia Circuit or “the circuit in which such person resides or has their principal place of business.”
In its decision, the Supreme Court held that: (1) the retailers also have the right to petition for review under the TCA “because Avail Vapor and the trade association have their principal places of business in Texas and Mississippi,” and (2) the retailers are adversely affected because “[i]f the FDA denies an application, the retailers lose the opportunity to profit from the sale of the new tobacco product—or, if they sell the product anyway, risk imprisonment and other sanctions.”
A full copy of the U.S. Supreme Court decision can be read here.
Questions? Contact Tom Briant (tomb@cdaweb.net; (703) 208-1641),
Kathee Facchiano (kfacchiano@capitoldecisions.com; (202) 638-1950)
or Sarah Herbert (sherbert@capitoldecisions.com; (202) 638-0326).