Health Labels Planned for October 2021

Image: FDA

The U.S. Food and Drug Administration (FDA) has set Oct. 16, 2021, as the new effective date for graphic health warning labels for combustible cigarettes.

The FDA signed off March 18 on a new set of 11 graphic warning labels for traditional cigarettes that are toned down considerably from its first attempt in 2012, which was abandoned after an industry legal challenge.

The new set of warnings contains images of diseased lungs, a man experiencing erectile dysfunction, a man with surgical stitches from heart or lung surgery and a child with an oxygen mask. But there is no smoke coming out of a tracheal hole, no cadaver and no photo of a man who appears deathly ill, as the FDA proposed.

The labels must cover the top 50 percent of the front and rear panels of packages, as well as at least 20 percent of the top of advertisements. The messages must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements.

The warnings were mandated by a federal judge for cigarette packaging and marketing. The ruling does not affect other tobacco products, such as electronic cigarettes.

Initially, the agency set a deadline for June 18, 2021. However, on April 3, Philip Morris USA, R.J. Reynolds Tobacco Co., ITG Brands and Liggett Group filed a joint motion requesting a preliminary injunction on implementing the labels and a ruling to prohibit enforcement. The manufacturers insist that the labels violate the First Amendment of the U.S. Constitution, which guarantees free speech.

On May 8, the FDA and the manufacturers filed a joint motion to extend the deadline by 120 days. The manufacturers said the pandemic has complicated their ability to meet the June 18, 2021, deadline.

Despite the postponement of the deadline, the FDA urged manufacturers to submit plans for compliance as soon as possible.

“Early submission will facilitate timely FDA review of plans prior to the effective date of the required warnings, encourage dialogue with entities regarding any implementation concerns, and provide time to consider proposals by entities in a timely manner,” the FDA said.