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FDA Issues Guidance on Nonenforcement of Warning Statements

Document in response to court decision that prevents agency from acting while appeal pending

LAKEVILLE, Minn. -- This week, the U.S. Food and Drug Administration (FDA) issued a guidance document, “Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco,” in response to a federal court decision enjoining the agency from enforcing the new health warning statements for cigar and pipe tobacco packaging and advertising.

The FDA issued six new warning statements for cigar packaging and advertisements and a new nicotine addictiveness warning statement for pipe tobacco. The statements were issued as part of the FDA’s deeming regulations, which extended the agency’s tobacco regulations to cigars, pipe tobacco, electronic cigarettes and hookah tobacco.

However, this injunction is part of an ongoing lawsuit brought by three plaintiffs—the Cigar Association of America, the International Premium Cigar and Pipe Retailers Association and the Cigar Rights of America—against the FDA. The lawsuit challenges certain aspects of the agency’s deeming regulations as applied to cigars and pipe tobacco. The initial federal court decision in this lawsuit upheld the FDA’s authority to regulate cigars and pipe tobacco as a part of the agency’s deeming regulations; however, these three associations then appealed the initial U.S. District Court’s decision to the U.S. Circuit Court of Appeals for the District of Columbia. 

In a July 5 court decision, a judge issued the injunction preventing the FDA from enforcing the new pipe tobacco and cigar health warning statements while the appeal is pending. The court stated that the pending appeal of the underlying court decision on the lawsuit raises “serious legal questions” on the merits of the lawsuit and the potential of irreparable harm to the cigar and pipe tobacco industries, as well as the public interest in the matter, all “strongly favor” an injunction against enforcing the cigar and pipe tobacco health warning statements.

This injunction applies to the cigar and pipe tobacco warning statements on product packages and in product advertisements that were otherwise scheduled to go into effect Aug. 10, 2018.  The injunction will continue in effect for a period of 60 days after the final disposition of the underlying litigation. This means that the FDA cannot take any action to enforce the agency’s new warning statements for cigar and pipe tobacco packaging and advertisements until the pending lawsuit and all appeals are finalized.

Photo courtesy of Shutterstock. 

 

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