Legislation

Court Strikes Down FDA’s Cigar Warning Label Plan

Jul 7, 2020 | By Andrew Nagy
Court Strikes Down FDA’s Cigar Warning Label Plan

A trio of judges on the U.S. Court of Appeals for the Washington D.C. Circuit ruled unanimously this morning to keep FDA warning labels off of cigars. The court said the FDA “acted arbitrarily and capriciously” when it established its warning label plan for cigars in 2016’s Final Deeming Rule, and its move today means cigar boxes and advertisements won’t be obscured by massive warnings, barring an appeal, which is unlikely.

The judges’ decision, the newest development in Cigar Association of America, et al. v. United States Food and Drug Administration, et al., actually reverses Judge Amit Mehta’s 2018 order that upheld, but delayed, the warning label requirements. In his decision, Judge Mehta ruled in favor of the FDA, but specifically expressed his displeasure with the FDA’s warning label plan, saying that it “smacks of basic unfairness.”

In February, Judge Mehta actually struck down the warning label plan, but only for premium cigars. Today’s decision affects all cigars (handmade as well as machine-made) and even includes pipe tobacco.

When the Final Deeming Rule was published, one of the major mandates outlined by the FDA was requiring premium cigar companies to cover at least 30 percent of the cigar box—much larger than what was previously required—with one of six specific health warnings. Additionally, the plan also laid out other strict rules, including required warning labels to cover 20 percent of every cigar advertisement.

In October 2019, the cigar industry argued in court that the FDA’s warning label plan violated the Family Smoking Prevention and Tobacco Control Act, the Administrative Procedure Act (APA) and the First Amendment.

The three judges who heard the cigar industry’s arguments agreed that the FDA did not meet the statutory requirements laid out in both the Tobacco Control Act and the APA by failing to consider how health warnings would affect the number of smokers. This alone was enough to get the warnings thrown out.

In his opinion, Judge Gregory G. Katsas wrote that the “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.”

“... Because the regulation contains no discussion tying the warnings to reduced smoking, the FDA failed to bridge the gap between effective communication and fewer smokers,” Katsas continued. “By its terms, section 906(d)(1) required the FDA to “tak[e] into account” whether the warning requirements would affect the number of smokers. Because the FDA declined even to consider that question, it violated section 906(d)(1) and acted arbitrarily and capriciously.”

Unsurprisingly, the cigar industry was very pleased with today’s decision.

“We are very pleased to see that after all our efforts, the D.C. Court of Appeals court has reversed the District Court, holding that the FDA health warnings for cigars violated the Tobacco Control Act and are therefore improper on any type of cigars,” said Javier Estades, head of premium cigar operations for Tabacalera USA and chairman of the Cigar Association of America. “This is truly a victory of the industry and proves that working together makes us stronger.”

Glynn Loope, executive director at Cigar Rights of America, says "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 has 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.”

“In light of today’s decision, we hope that the courts and FDA will reconsider the regulation of premium cigars altogether,” said Drew Newman, general counsel of J.C. Newman Cigar Co. “As an industry of small, family-owned businesses that handcraft natural products in small batches, regulating premium cigars like cigarettes simply does not make sense.”

Now while it is possible that the FDA could appeal this decision to a higher court, the chances of either court hearing the case are slim, especially because today’s decision was unanimous.

FDA

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