Federal Court Postpones FDA Graphic Cigarette Warnings

March 10, 2021

A federal court in the state of Texas delayed the FDA’s regulation mandating graphic cigarette warnings.

The U.S. District Court for the Eastern District of Texas issued an order on March 2, officially postponing the effective date of the Food and Drug Administration’s graphic cigarette health warning rule by another 90 days.

Based on the FDA’s draft order, the delay of the order extends from Jan. 14, 2022, to April 14, 2022. In addition to the delay, the court orders that “any obligation to comply with a deadline tied to the effective date of the rule” is also postponed.

CStore Decisions reports that the National Association of Tobacco Outlets has asked the Food and Drug Administration for further guidance on whether the agency will also postpone for 90 days the “preferred filing deadline” of March 16, 2021.

This specific deadline, notes the association, applies to manufacturers, wholesalers, and retailers to submit mandated cigarette health warning rotational plans.

The FDA announced new graphic warnings regulations to apply to the top 50 percent of the front and rear panels of cigarette packages and at least 20 percent of the top of ads.

The new set of 11 graphic images demonstrate health concerns tied to smoking like diseased lungs, erectile dysfunction in men, surgical stitches from heart or lung surgery, and a child with an oxygen mask. The agency notes that the images “depict some of the lesser-known, but serious health risks of cigarette smoking.” These risks also include potential blindness, lower blood flow to the extremities, and Type II diabetes disposition.

“These expenditures of resources for the purpose of meeting the rule’s requirements constitute irreparable harm because plaintiffs cannot recover money damages should the rule and/or the graphic-warning requirement in the Tobacco Control Act be invalidated,” argues the suing classing of tobacco companies in a legal filing.

The Winston-Salem Journal also reported that the tobacco manufacturers claim that they would experience some sort of “irreparable harm because none of them will be compensable by money damages should the rule and/or graphic warnings requirement in the Tobacco Control Act be invalidated.”

This regulatory mandate will be immediate and could promote smoking cessation in some, but not all, smokers who are willing to be more open to smoking’s health impacts.

Considering the 11 finalized cigarette health warnings, notes FDA Center for Tobacco Products director Mitch Zeller, “represent the most significant change to cigarette labels in more than 35 years.”

As mentioned, the new warnings must be randomly and equally displayed on cigarette packaging and cigarette ads. These ads also have to be circulated quarterly by the retailers and other sales outlets.

From a public health standpoint, graphic warning labels on cigarettes are long overdue in the United States. While some graphics could be stigmatizing, the graphics reviewed by Vaping Post are quite neutral and are merely illustrations instead of gruesome depictions of people’s smoking-related injuries and illnesses.

The illustrations should serve as a standard and should quell any other criticism against the FDA from a coalition of tobacco control organizations that alleged in October of 2016 that these graphics were “unlawfully withheld” or “unreasonably delayed” due to the agency’s delay in issuing its final rule.