E-Cigarette Approval Case Has Important Implications for Government Agencies 

Washington, D.C. – The government’s ability to protect kids from e-cigarettes designed to attract children to harmful tobacco products is at stake, as the United States Supreme Court heard oral arguments today in Food and Drug Administration v. Wages and White Lion Investments, LLC., DBA Triton Distribution, et al. The “White Lion” case could have serious implications that threaten to stop the FDA from fulfilling its mandate to protect our health and safety.

“A bad ruling in this case could have devastating consequences that would limit the FDA’s ability to fulfill its mandate to protect the health and safety of Americans,” said Skye Perryman, President and CEO of leading pro-democracy legal organization Democracy Forward, which submitted a friend of the court brief in the case on behalf of sixteen members of Congress. “The FDA’s rightful decision to protect kids from harmful tobacco products designed to attract and addict children was based in research and science and was firmly rooted in the authority granted to the agency by Congress. The Supreme Court should make it very clear that special interests cannot evade rules put in place to protect people.” 

On September 5, 2024, U.S. Senate Majority Whip Dick Durbin (D-IL), Chair of the Senate Judiciary Committee; U.S. Representative Frank Pallone, Jr. (D-NJ-06), Ranking Member of the House Energy and Commerce Committee; and U.S. Senator Jeff Merkley (D-OR) led a group of sixteen lawmakers represented by Democracy Forward in filing a friend of the court brief to the Supreme Court urging the Court to support the FDA authority and actions to regulate e-cigarettes. The case centers around the FDA’s appeal of a Fifth Circuit decision that the agency acted “arbitrarily and capriciously” in denying premarket tobacco product applications (PMTAs) from an e-cigarette manufacturer selling addictive, kid-friendly vaping devices with flavors including, “Peachy Strawberry” and “Mother’s Milk and Cookies.”

In the bicameral brief submitted in September, the lawmakers urged the Court to reverse the Fifth Circuit decision and reinstate the marketing denial orders. They argued that the Fifth Circuit’s decision setting aside the FDA’s marketing denial orders threatens to undermine both the past public health successes of the 2009 Family Smoking Prevention and Tobacco Control Act (“The Act”) and its future efficacy. 

Under the law, e-cigarette manufacturers must prove to the FDA, with high-quality scientific evidence, that a tobacco product is “appropriate for the protection of the public health” before the product is sold in the United States. The FDA has rejected PMTAs from hundreds of manufacturers representing millions of e-cigarette products for failing to demonstrate this public health benefit. In approximately two dozen denials, manufacturers have appealed the denials to federal courts, and the FDA has prevailed in the majority of the cases, winning on the merits in seven of the nine courts of appeals that have ruled.  

For more information, please visit www.democracyforward.org. 

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