R.J. Reynolds wins at Supreme Court on how to challenge FDA vape rulings

Washington Post

20-06-2025

The Supreme Court on Friday rejected government effort to narrow options for challenging Food and Drug Administration denials of applications to market e-cigarettes, including flavored products that health officials say have led to a youth vaping epidemic.
In a case that centered on questions of venue-shopping, the justices ruled 7-2 that tobacco giant R.J. Reynolds was allowed to ask a conservative appeals court far from its North Carolina home to examine an FDA rejection of its bid to market menthol cigarettes.
The FDA told the justices that R.J. Reynolds and other e-cigarette manufacturers were gaming court system rules by filing the vast majority of product-denial appeals in the U.S. Court of Appeals for the 5th Circuit, based in New Orleans, which is widely seen as more sympathetic to their arguments.
The FDA said the tactic was hindering the agency's ability to regulate vapes that are used by hundreds of thousands of teenagers. In the case before the justices, the 5th Circuit overturned the FDA's denial of an R.J. Reynolds application.
'In 2024, by our count … about 75 percent of e-cigarette cases were filed … in the 5th Circuit, all of them by out-of-circuit applicants trying to use the tactic,' Vivek Suri, an assistant to the solicitor general who is representing the FDA, said at oral arguments in January.
Under the 2009 Family Smoking Prevention and Tobacco Control Act, manufacturers must get FDA approval to sell some existing products, as well as new products, that are marketed in more than one state. The Vuse line of menthol vapes are the ones in question in the R.J. Reynolds case.
Ryan J. Watson, who is representing R.J. Reynolds, told the justices at oral arguments that the company was permitted to file a challenge in the 5th Circuit because the act allows 'any person adversely affected' by a denial to file a challenge in the District of Columbia Circuit or the 'circuit in which such person resides or has their principal place of business.'
R.J. Reynolds partnered with a Texas vape store and the Mississippi Petroleum Marketers and Convenience Stores Association to bring the challenge to the FDA ruling. The 5th Circuit covers Texas and Mississippi, while R.J. Reynolds is in the 4th Circuit.
Suri, arguing on behalf of the government, said Congress never meant for retailers to be parties to such litigation when it passed the act. He pointed out that retailers aren't notified when the FDA rejects manufacturers' applications to market vaping products and said the tactic defeats the venue restrictions laid out in the law.
In a separate case decided in April, the high court ruled unanimously that the FDA properly rejected applications to market fruit- and dessert-flavored liquids for electronic cigarettes that the agency says are popular with young people and risk them getting hooked on nicotine. The products had names such as 'Jimmy the Juice Man Peachy Strawberry,' 'Suicide Bunny Mother's Milk and Cookies,' 'Iced Lemonade' and 'Killer Kustard Blueberry.'
An e-cigarette or vape is a battery-powered device that heats a nicotine-infused liquid, turning it into a vapor that is inhaled. E-cigarettes are generally considered less harmful than traditional cigarettes but still carry health risks.
The FDA has moved aggressively to regulate flavored vapes in recent years because of their popularity with young people.
A 2024 Centers for Disease Control and Prevention survey found that e-cigarettes were the most common tobacco product used by middle-schoolers and high-schoolers. About 1.6 million students use e-cigarettes, according to the survey, which amounts to about 6 percent of the middle and high school population. Nearly 90 percent of those who vape prefer the flavored liquids, according to the survey. Overall, youth vaping has declined significantly after reaching a peak in 2019.
This is a developing story. It will be updated.