FDA's Crackdown on Flavored Vapor Products Survives Supreme Court Challenge
WASHINGTON, D.C. — The U.S. Supreme Court (SCOTUS) ruled unanimously in favor of the Food and Drug Administration's (FDA) pushback on flavored e-cigarette products on April 2.
In the case of FDA v. Wages and White Lion, SCOTUS found that the FDA did not violate federal law when it denied pre-market tobacco applications (PMTAs) during the Biden Administration.
The decision threw out a ruling from the U.S. Court of Appeals for the Fifth Circuit which found that the FDA's denial of PMTAs for sweet-flavored liquids used in e-cigarettes used arbitrary and unfair standards requiring the companies, without warning, to present studies showing that flavored products would help with smoking cessation.
In its opinion, the court stated the FDA did not act arbitrarily and capriciously because the marketing denial orders were sufficiently consistent with the agency's previous guidance regarding scientific evidence necessary for authorization.
[Read more: FDA's Center for Tobacco Products Sees Staff Cuts]
The court's ruling also noted the FDA had stated the marketing plan from Wages and White Lion Investments dba Triton Distribution would be an important factor in evaluating its application, but did not ultimately consider the marketing plan. It sent the case back to the Fifth Circuit to reevaluate under the correct standard whether the agency's failure to review marketing plans in the PMTA was a harmless error. Its ruling could still lead to an eventual decision in favor of Triton.
Triton plans to continue litigation, according to report from The Associated Press. Triton attorney Eric Heyer expressed disappointment with the ruling but stated that Triton believes in "the great harm reduction potential" of its products.
Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids, hailed the decision as "a major victory for the health of America's kids and efforts to protect them from the flavored e-cigarettes that have fueled a youth nicotine addiction crisis."
However, the decision could ultimately become moot, as President Donald Trump has reportedly promised to "save" vaping, according to the news outlet.
To date, the FDA has rejected more than 1 million nicotine products formulated to taste like fruit, candy or other sweet flavors because their manufacturers did not meet the legal requirement of demonstrating that their flavored vapes had a net public benefit.