D.C. Circuit’s Upholding of FDA Cigar Regulations and User Fees is a Win for Public Health

WASHINGTON, D.C. – The D.C. Court of Appeals’ unanimous decision upholding the premarket review provisions of the FDA’s Deeming Rule for cigars will finally force cigar makers to show that their products are substantially equivalent to products that were already on the market before the passage of the landmark Tobacco Control Act. This decision will ensure that FDA retains the tools it needs to protect kids from flavored cigars and remove from the market the flavored cigars introduced since the passage of the Tobacco Control Act and marketed to attract kids.

This decision also makes clear that despite years of effort by the cigar industry to make themselves exempt from FDA review, they will now be subject to the 2016 Deeming Rule that subjected cigars, e-cigarettes and a range of other tobacco products to the FDA’s regulatory authority under the Tobacco Control Act. Cigarettes have been subject to FDA regulation since the enactment of the Tobacco Control Act in 2009, but cigar makers were entirely unregulated for seven years until the Deeming Rule subjected them to minimal regulations. Not unexpectedly, the cigar industry took full advantage of this period to market a new generation of flavored cigars, following the ban on most cigarette flavors in the Tobacco Control Act. Cigar makers quickly redesigned cigars to be cheap, small and kid friendly and began introducing mass-produced, cigarette-like products with sugary flavors designed to appeal to youth and with names like ‘Sweet Dreams’ and “Da Bomb Blueberry’.

The Campaign for Tobacco-Free Kids filed a “friend of the court” brief in the case, joined by the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, and Truth Initiative. The groups argued, and today’s decision confirms, that applying the Tobacco Control Act’s requirements to cigars is essential to protect the public health. Cigar manufacturers targeting young people with cheap, flavored products resulted in their use by hundreds of thousands of adolescents. Because the D.C. Circuit decision enables the FDA to enforce the premarket review requirements of the Tobacco Control Act, against cigars, FDA has ample authority to remove from the market the kid-friendly cigars that have become the most popular tobacco product among Black high school students and the second most popular tobacco product, after e-cigarettes, among all high school students.

Today’s decision is a win for kids, their families and the public health.