On Monday, a federal judge from the Eastern District of Texas, Judge J. Campbell Barker, ruled that the U.S. Food and Drug Administration (FDA) exceeded its authority under the Tobacco Control Act by requiring cigarette packaging and advertisements to include one of 11 new graphic warning labels. The ruling temporarily blocks the enforcement of the FDA’s 2020 rule until a final judgment is reached.
The Tobacco Control Act, enacted in 2009, granted the FDA extensive authority to regulate the manufacture, marketing and distribution of tobacco products. It also required cigarette packaging and advertisements to display one of nine specific health warnings outlined in the law. In an effort to modernize these warnings, the FDA issued a final rule in 2020 introducing 11 new cigarette health warnings. Each warning featured unique text paired with graphic imagery designed to illustrate the severe health risks of smoking, including bladder, head and neck cancer; fatal lung disease; stunted fetal growth during pregnancy; cataracts; and Type 2 diabetes. The FDA justified the updates as necessary to foster “greater public understanding” of the health risks associated with smoking. Despite the FDA’s efforts, the rule remains unenforced due to ongoing legal challenges from the tobacco industry.
In 2020, R.J. Reynolds, ITG Brands and Liggett Group first sued the FDA, claiming the rule violated First Amendment rights. Barker initially ruled in favor of the tobacco companies on constitutional grounds, but that decision was overturned by the Fifth Circuit Court of Appeals. The Supreme Court then declined to review the case, allowing the Fifth Circuit’s decision to stand. The current ruling shifts the focus from constitutional authority to the FDA’s statutory authority, with the cigarette makers arguing the agency acted arbitrarily, capriciously and beyond the scope of its discretion in adopting the rule.
Barker concluded that the FDA’s rule exceeded the authority granted by Congress. He stated that the Tobacco Control Act permits the FDA to modify the format, type or text of the nine specified warnings but does not give the agency authority to add new ones. The judge also highlighted that the FDA used the exact language mandated by Congress for only two of the 11 proposed warnings, further underscoring the agency’s overreach. Notably, he emphasized that agencies must adhere to the boundaries set by Congress and cannot unilaterally expand their powers.
This injunction delays the rule’s implementation, originally set for February 2026, and raises broader questions about the limits of regulatory authority. As the case continues, it highlights the ongoing tension between public health advocacy and the legal boundaries of regulatory agencies. The outcome could shape not only the future of tobacco regulation but also how courts interpret agency authority in public health policymaking.
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