FDA

US Court of Appeals Unanimously Strikes Down Warning Labels

US Court of Appeals Unanimously Strikes Down Warning Labels

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Washington, DC, July 7, 2020 —The Premium Cigar Association (PCA) and Cigar Rights of America (CRA) are pleased that a unanimous panel of the United States Court of Appeals for the District of Columbia Circuit found flaws in the FDA’s Deeming Rule regulating cigars and held that the Food & Drug Administration (FDA) did not do necessary work to show an effect of large cigar warning labels on reducing smoking rates.

Judge Gregory G. Katsas notes in the opinion, “The Tobacco Control Act permits the Food and Drug Administration to regulate tobacco products for the public health, but only after considering whether the regulation would likely increase or decrease the number of smokers. Under this authority, the FDA promulgated regulations requiring extensive health warnings on packaging and in advertising for cigars and pipe tobacco. The FDA concluded that these warnings would help communicate the health risks of smoking, but it failed to consider how the warnings would likely affect the number of smokers. We hold that this failure violated the Tobacco Control Act and the Administrative Procedure Act.”

On February 3, U.S. Federal District Court Judge Amit Mehta issued a ruling overturning the FDA regulation that required six new health warning statements for premium cigars to be printed on premium cigar packaging/cigar boxes and premium cigar advertisements. The court found that “the FDA’s subjecting of premium cigars to warnings requirements to be arbitrary and capricious in violation of the Administrative Procedures Act (APA), insofar as the agency failed to provide a reasoned explanation for this action.”

Both of these decisions further affirm the message of the PCA and CRA: That the FDA’s regulation of premium cigars is flawed and exceeds its statutory authority without justification. PCA Executive Director Scott Pearce notes, “We commend the work of our legal team on this case and providing a win for the industry. We believe that similar flaws infect the substantial equivalence requirements, which we continue to fight in the courts and with the administration”. Glynn Loope, executive director at Cigar Rights of America, stated upon the release of the court's decision, "This pronouncement by the court ratifies what the courts and members of congress have been saying for years: A reflexive, unstudied, “one-size-fits-all“ approach to regulation simply doesn’t work. For all too long, that h as been the approach of the agency, and the courts continuously tell them they’re wrong. It’s time for court decisions like today, and messages from hundreds of members of congress from both sides of the aisle to be heard: Exempt premium cigars from the most onerous elements of these regulations, and reform the most economically threatening rules that have already been implemented.”

Read the full opinion here.

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