Appellate Court Rules FDA Cannot Regulate Tobacco Products

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 7 No 9
Volume 7
Issue 9

WASHINGTON--A Federal appeals court has ruled that regulation of tobacco rests with Congress, not the FDA. In a 2-to-1 vote, a panel of the Fourth Circuit Court of Appeals, Richmond, Va, overturned a lower court ruling that had upheld FDA’s right to regulate tobacco.

WASHINGTON--A Federal appeals court has ruled that regulation of tobacco rests with Congress, not the FDA. In a 2-to-1 vote, a panel of the Fourth Circuit Court of Appeals, Richmond, Va, overturned a lower court ruling that had upheld FDA’s right to regulate tobacco.

The judges wrote, in the majority opinion: "We do not dispute in this case that Congress has charged the FDA with protecting the public health and that tobacco products present serious health risks for the public."

However, the judges went on to say, there is "strong evidence that Congress has reserved for itself the regulation of tobacco products rather than delegating that regulation to the FDA. . . . Based on our review of the record, the FDA lacks jurisdiction to regulate tobacco products, and all of the FDA’s regulations of tobacco products are invalid."

The proposed comprehensive tobacco bill, defeated in the Senate in June, would have explicitly granted FDA the right to regulate nicotine as a drug and cigarettes as a drug-delivery system.

The appellate court ruling overturns the FDA’s program to restrict teenage tobacco use that included requiring persons under age 27 to present photo ID when purchasing cigarettes and prohibiting the sale of tobacco products to persons under the age of 18.

Justice Department officials plan to appeal the ruling to the full Fourth Circuit appellate court. If the full court does not overturn the ruling of the three-judge panel, the government could then take its appeal to the US Supreme Court. The FDA’s antitobacco regulations will remain in effect during the appeals.

Newsletter

Stay up to date on recent advances in the multidisciplinary approach to cancer.

Recent Videos
1 expert is featured in this series.
2 experts are featured in this series.
2 experts are featured in this series.
5 experts are featured in this series
5 experts are featured in this series
2 experts in this video
“If you have a [patient in the] fourth or fifth line, [JNJ-5322] could be a valid drug of choice,” said Rakesh Popat, BSc, MBBS, MRCP, FRCPath, PhD.
2 experts in this video
Earlier treatment with daratumumab may be better tolerated for patients with pretreated MRD-negative multiple myeloma.
The trispecific antibody JNJ-5322 demonstrated superior efficacy vs approved agents in multiple myeloma in results shared at the 2025 EHA Congress.
Related Content