Federal Court Limits FDA Authority Over Cigarette Warnings and PMTA Denials

The U.S. Fifth Circuit Court of Appeals has curtailed the Food and Drug Administration’s authority to regulate tobacco and vapor product marketing. In two consecutive rulings, the federal appellate court blocked the agency’s proposed graphic health warnings on cigarette packages and rejected its internal review standards for new vapor product applications.

Blocking Expanded Cigarette Warning Labels

The first ruling addressed a lawsuit brought by a coalition of tobacco manufacturers, including R.J. Reynolds, Santa Fe Natural Tobacco Company, and ITG Brands. The companies challenged an FDA rule that required eleven rotating health warnings paired with graphic images on cigarette packaging and advertising.

The plaintiffs argued that the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 established a precise statutory framework permitting only nine specific warnings. U.S. District Judge J. Campbell Barker previously issued an injunction halting the rule, finding the FDA likely exceeded its authority.

A three-judge panel of the Fifth Circuit—consisting of Judges James Ho, Leslie Southwick, and Don Willett—affirmed the district court’s injunction. Writing for the panel, Judge Willett emphasized that federal agencies must adhere strictly to statutory boundaries set by Congress.

“At this preliminary stage, the statutory text points one way: the FDA may require the nine warnings Congress prescribed—no more,” wrote Judge Willett. “Congress legislated with precision, and an agency treated that precision as optional.”

Striking Down Internal PMTA Review Standards

The following day, a separate Fifth Circuit panel ruled against the FDA regarding its process for evaluating Premarket Tobacco Product Applications (PMTAs). Under the TCA, new vapor and tobacco products must receive agency authorization by proving they are “appropriate for the protection of the public health.”

Multiple manufacturers—including NicQuid, Breeze Smoke, Baton Vapor, and American Vapor Company—challenged the denial of their marketing applications. The petitioners revealed that the FDA had applied a “comparative efficacy standard” outlined in internal memoranda, which systematically rejected products that lacked comparative efficacy studies against other active alternatives.

The companies argued that this internal requirement functioned as a binding rule enacted without fair notice or the required public participation process.

The panel, comprised of Judges Patrick Higginbotham, Jerry Smith, and Andrew Oldham, agreed that the agency violated the Administrative Procedure Act (APA). Judge Smith explained that the standard imposed new obligations without regulatory warning.

“The comparative efficacy standard is a substantive rule that needed to be adopted under the APA’s notice-and-comment requirements so as not to imperil the due-process-protected interests of bound parties,” Judge Smith wrote.

The court remanded the cases back to the FDA, instructing the agency to reconsider the applications or properly adopt the standard through public notice-and-comment rulemaking.

Regulatory Limits Established by the Decisions

Together, the Fifth Circuit’s rulings set legal boundaries for federal tobacco oversight:

Statutory Caps: The FDA cannot add mandatory graphic warnings beyond the specific list approved by Congress in the TCA.
Procedural Compliance: The agency cannot enforce new evidentiary hurdles for PMTAs through internal memos without formal rulemaking.
Due Process Protections: Tobacco and vape manufacturers are legally entitled to clear regulatory notice before their products are barred from the market.

Source: Federal Court Blocks FDA From Imposing Tobacco Marketing Regulations

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Matthew Ma

Marketing at Ecigator

With over a decade of experience in the e-cigarette industry, Matthew Ma is a seasoned expert in both the manufacturing and usage aspects of vaping products. His extensive background has provided him with a deep understanding of the intricacies and evolving dynamics of e-cigarettes.