Public Health Groups Urge Supreme Court Reversal of Ruling that Effectively Nullifies Tobacco Control Act’s Venue Restrictions & “Cripples” Efforts to Protect Kids from E-Cigarettes

William B. Schultz_listing
William B. Schultz
Man
Andrew N. Goldfarb
Trillium Chang_Listing
Trillium E. Chang

On behalf of the Campaign for Tobacco-Free Kids, and ten other prominent public health, medical, and community organizations, Zuckerman Spaeder LLP has filed an amicus brief supporting the Food and Drug Administration (FDA) in urging the U.S. Supreme Court to overturn a Fifth Circuit Court of Appeals ruling that effectively nullifies the venue restrictions in the Family Smoking Prevention and Tobacco Control Act. The amici say that the decision “cripples FDA’s ability to protect children from e-cigarettes.” 

In the case, R.J. Reynolds sued FDA over a marketing denial order (MDO) denying the company’s application to market its Vuse product – a flavored e-cigarette. As amici explain, e-cigarettes pose unique and dangerous health risks to youth and flavors are critical to tobacco companies’ ability to market to young people. FDA’s denial of marketing applications for flavored e-cigarette products in recent years has led to a decline in youth e-cigarette use. 

If a company seeks to challenge a MDO, the Tobacco Control Act limits the possible venues to the D.C. Circuit or the circuit where the petitioner resides or has its principal place of business. However, amici argue that when the Fifth Circuit stayed the Reynolds’ MDO it “held that a manufacturer located outside the circuit may obtain review there, as long as its petition is joined by a retail seller of the manufacturer’s product that is located within the circuit.” 

This is highly significant because the Fifth is an “outlier” in how it has decided MDO challenges and has “vacated at least seven companies’ MDOs, on grounds identical to those rejected by these other circuit courts.” 

In the brief, amici explain the consequences of allowing this ruling to stand: “By enabling out-of-circuit e-cigarette manufacturers to improperly steer their MDO challenges to the Fifth Circuit, which has repeatedly stayed the challenged MDOs, [the venue decision] allows Reynolds’ Vuse products and other youth-appealing, addictive, and harmful flavored e-cigarettes to remain on the market despite a finding by FDA that such products do not meet the statutory public health standard for marketing authorization. Such a result does grievous harm to public health, particularly to the health of young people.”

The amicus brief cites research showing the high prevalence and dangers of e-cigarette use by young people, noting that over 1.6 million youth, including nearly 10 percent of high schoolers, reported current e-cigarette use in 2024, and nearly 30 percent of high school users reported daily use. Importantly, amici point out that nearly 90% of middle and high school users of e-cigarettes use flavored products, like Reynolds’ Vuse product.

The brief was submitted by the following organizations:

  •       American Academy of Family Physicians
  •       American Academy of Pediatrics
  •       American Cancer Society Cancer Action Network
  •       American Heart Association
  •       American Lung Association
  •       American Medical Association
  •       American Thoracic Society
  •       Campaign for Tobacco-Free Kids
  •       Louisiana State Medical Society
  •       Parents Against Vaping E-cigarettes
  •       Truth Initiative

The amicus brief was prepared by Zuckerman Spaeder partners William B. Schultz, who previously served as General Counsel at the U.S. Department of Health and Human Services and Deputy Commissioner for Policy at FDA, and Andrew N. Goldfarb, along with associate Trillium E. Chang.

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Kalie Hardos
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