Judge Delays Enforcement of New Cigarette Graphic Warnings
SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) will have to wait to enforce the new cigarette warnings on packaging and advertising after a federal judge pushed the pause button.
U.S. District Judge J. Campbell Barker in Tyler, Texas, on Monday sided with several tobacco companies, including Winston-Salem. N.C.-based R.J. Reynolds Tobacco Co., that have been challenging the warnings. In a ruling on Jan. 13, Barker found that the FDA went beyond its authority by requiring packaging and advertising to contain 11 specific warnings, Reuters reported.
His decision temporarily delays the effective date pending further litigation. The FDA had previously signaled it would begin enforcing the graphic warnings requirement in December 2025.
To read the ruling, click here.
Tyler said those warnings go above and beyond the nine that Congress specified when it passed the Family Smoking Prevention and Tobacco Control Act in 2009. The move gave the agency regulatory authority over tobacco products and mandated adoption of the graphic warnings.
Barker said not only did the FDA adopt two extra warnings beyond the nine the law required, but it only used the exact text Congress required for two of the remaining nine, according to Reuters.
The FDA argued the law gave it the authority to adjust the format, type and text of any of the required labels; however, Barker said that power was limited, noting that even if the agency was allowed to rewrite the nine warnings, it could not add two extra ones, the news outlet reported.
The FDA issued its final rule on the warnings, which feature a combination of text and images depicting some of the health risks of cigarette smoking, in March 2020. At the time, the agency set a June 18, 2021, implementation date.
However, implementation was hung up multiple times after several tobacco companies asked for the date to be moved back and raised First Amendment concerns.
Tobacco companies tried to bring the issue to the U.S. Supreme Court, however, in a written brief handed down in November, the high court declined to hear the case, as Convenience Store News previously reported.
The warnings are required to appear on the top 50% of the front and back of cigarette packages and at least 20% of the top of ads. In addition, the warnings must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements.
There are 11 required warnings. They are:
- WARNING: Tobacco smoke can harm your children.
- WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
- WARNING: Smoking causes head and neck cancer.
- WARNING: Smoking causes bladder cancer, which can lead to bloody urine.
- WARNING: Smoking during pregnancy stunts fetal growth.
- WARNING: Smoking can cause heart disease and strokes by clogging arteries.
- WARNING: Smoking causes COPD, a lung disease that can be fatal.
- WARNING: Smoking reduces blood flow, which can cause erectile dysfunction.
- WARNING: Smoking reduces blood flow to the limbs, which can require amputation.
- WARNING: Smoking causes type 2 diabetes, which raises blood sugar.
- WARNING: Smoking causes cataracts, which can lead to blindness.