Tobacco Cos. Seek to Block New FDA Cigarette Warnings

A pack of cigarettes

NATIONAL REPORT — Several tobacco companies are joining forces in a legal challenge against the Food and Drug Administration's (FDA) 11 cigarette health warnings.

The agency issued its final rule requiring health warnings on cigarette packages and in cigarette ads in March. The graphic warnings feature a combination of text and images depicting some of the health risks of cigarette smoking.

However, on April 3, R.J. Reynolds Tobacco Co., Santa Fe Natural Tobacco Co., ITG Brands, Liggett Group and five tobacco retailers filed a lawsuit in the Federal District Court for the Eastern District of Texas against the FDA.

According to the Convenience Distribution Association (CDA), the companies want to invalidate the health warnings and the requirement mandated under the Family Smoking Prevention and Tobacco Control Act that directs the FDA to issue the warnings.

Beginning June 18, 2021, the warnings will be required to appear on the top 50 percent of the front and back of cigarette packages and at least 20 percent 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," as Convenience Store News previously reported.

The claims in the lawsuit, according to CDA, include:

  • The new rule requiring 11 different text/graphic cigarette health warnings to appear on cigarette packages, cigarette cartons and cigarette advertisements violates the First Amendment to the U.S. Constitution.
  • The Family Smoking Prevention and Tobacco Control Act's requirement that the FDA issue a rule requiring text and graphic cigarette health warnings violates the First Amendment to the U.S. Constitution.
  • The FDA acted arbitrarily and capriciously in drafting and issuing the rule/regulation.

This is the latest legal challenge against the FDA's health warnings. In June 2011, the agency published a final rule requiring color graphics depicting the negative health consequences of smoking to accompany nine textual warning statements specified the legislation.

However, that final rule was challenged in court by several tobacco companies and was ultimately vacated in August 2012 after the U.S. Court of Appeals of the District of Columbia held that the rule violated the First Amendment. In March 2013, the federal government announced its decision not to seek further review of the court's ruling.

Following another lawsuit filed by several public health groups, a judge in the U.S. District Court for the District of Massachusetts issued an order in March directing the agency to publish the proposed rule by August 2019 and issue a final rule in March 2020.