FDA graphic warnings on cigarettes could be introduced

On Thursday, the FDA released preliminary guidance that includes plans for enforcement policy.

RJ Reynolds Tobacco Co. and ITG Brands filed a petition with the Supreme Court in August seeking to challenge First Amendment claims challenging FDA regulations regarding graphic warnings on labels and in marketing materials.

The appeal was to be expected, given that FDA regulations would have required 11 photos, including diseased lungs, a man with stitches following heart or lung surgery, a child with an oxygen mask and warnings about erectile dysfunction.

The current series is significantly reduced from the FDA’s first sample from 2012, which featured images of smoke rising from a tracheal opening, a dead body and a terminally ill man.

The FDA plans to begin enforcing the labeling requirement on products manufactured on or after December 12, 2025. For products manufactured before that date, enforcement will begin in January 2026.

“FDA has selected 15 months to provide an orderly transition period; this is consistent with the 15-month compliance period originally provided for in the (federal) Family Smoking Prevention and Tobacco Control Act before that timeline was disrupted by litigation,” the FDA said in a statement.

The final rule also requires manufacturers to submit a plan and obtain FDA approval “for the random and even placement and distribution of required warnings on cigarette packages, and for the quarterly rotation of required warnings in cigarette advertisements.”

Manufacturers that do not yet have approved plans for health warnings on cigarettes are asked to submit them by February 10.

A coalition of anti-smoking and public health organizations sued the FDA in October 2016, claiming it “unlawfully withheld” or “unreasonably delayed” the issuance of a final rule on the graphic warnings.

The coalition includes the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Respiratory Association, the Campaign for Tobacco-Free Kids, and the Truth Initiative.

The FDA originally set a June 18, 2021 deadline for labels to cover the top 50% of the front and back of packages, as well as at least the top 20% of advertisements.

Manufacturers and other plaintiffs, including tobacco retailers, managed to convince a federal judge in Texas to delay implementation of the law ten times.

In March, the U.S. Court of Appeals for the Fifth Circuit issued a ruling against the manufacturers.

Both Reynolds and ITG typically do not comment on pending litigation. The manufacturers said in their appeal that the Fifth Circuit ruled in error, finding that the warning images and labels “are unquestionably factual” and “are no different from those a medical student would see in a textbook.”

The manufacturers say the warnings are “large, provocative and misleading” to consumers.