U.S. Judge Overturns F.D.A. Regulation on Premium Cigars

Despite the recent ruling, public health organizations such as the American Lung Association, American Heart Association, American Academy of Pediatrics, and the American Cancer Society expressed their disappointment. These groups filed briefs urging the judge to maintain the regulations for cigar products.

Thomas Carr, the national director of policy for the American Lung Association, described the ruling as deeply disappointing. He emphasized that all cigars, including premium ones, can be detrimental to health and cause death. He compared the need for cigar regulation to the safety measures implemented in luxury cars, stating that even premium cigars should not be exempt from regulations.

Mr. Carr also referenced the National Cancer Institute’s findings, which concluded that cigar smoking can lead to cancer in various parts of the body.

The public health groups expressed concern that exempting premium cigars from regulations would mislead consumers into believing that these products are safer. They emphasized the importance of maintaining regulations to protect public health.

The FDA’s attempt to regulate cigars stems from the Tobacco Control Act of 2009, which granted the agency authority over cigarettes and smokeless tobacco. The act also allowed the FDA to determine other products that should fall under its jurisdiction. Consequently, in 2014, the FDA initiated the process of regulating cigars.

During this process, the FDA sought public input on whether premium cigars should be subject to less rigorous regulation. Cigar Rights of America, an advocacy group and plaintiff in the case, argued for lighter regulation, stating that premium cigar smoking is an occasional pastime and many users do not inhale the smoke.

The group further contended that most users of premium cigars are responsible adults who do not fall within the demographic requiring protections defined by Congress in passing the law.

In response, the FDA required premium cigar manufacturers to conduct comprehensive studies on their products, disclose ingredients, and register annually. The agency determined that the evidence presented by the cigar industry regarding health effects and youth usage did not warrant an exemption. The FDA concluded that equal regulation for all cigars would better safeguard public health.

In turn, groups supporting the cigar industry filed lawsuits.

The FDA continues to face challenges while enforcing various provisions of the landmark 2009 law. Legal disputes are frequent, especially as the agency strives to remove thousands of e-cigarette products from the market.

Michael Edney, a partner at Hunton Andrews Kurth LLP who represented the cigar plaintiffs, believes that the court’s decision has broader implications for tobacco regulation. He asserts that the FDA must thoroughly analyze evidence presented by industry and retail groups when deciding how to regulate certain tobacco products, rather than simply imposing final decisions without consideration.

The American Lung Association is currently discussing the decision internally with other public health groups. The FDA declined to comment on the litigation.

It remains uncertain whether the agency will appeal the ruling.

Reference

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