FDA to Rule on Cigars and E-Cigarettes

The long-awaited Food and Drug Administration’s rule to regulate cigar and e-cigarettes is believed to be coming later this month.

April 12, 2016

WASHINGTON – The Hill reports that the Food and Drug Administration could be ready to release its long-awaited final rule to regulate cigars and electronic cigarettes this month.

FDA spokesman Michael Felberbaum told the news source that he did not have a timeline for the rule’s release, while Matthew Myers, president of the Campaign for Tobacco-Free Kids, believes a final rule is imminent. "I do believe they will come out this month," he said. “[The FDA is] facing a serious deadline given the end of the presidential year. Having said that, the proposed rule came out in April 2014 and last spring they said they would be done by summer. Then last June they said they'd be done by the end of the summer. I guess they never said which year."

Delaying the rule has led to speculation as to what’s holding up the FDA.

Ray Story, CEO of the Tobacco Vapor Electronic Cigarette Association (TVECA), told The Hill that he believes the FDA is hung up on one provision: a mandate that requires any nicotine delivery devices that hit stores after Feb. 15, 2007, to apply retroactively for approval. This regulation, according to Story, would “wipe out” the e-cigarette industry. "Even though [the] FDA sees it as a serious issue, it cannot change it," he said. "It requires a change of the law."

However, the FDA has indicated that it does not have the authority to change the Feb. 15, 2007, date because it was signed into law in 2009 as part of the Family Smoking Prevention and Tobacco Control Act. Story told the Hill that U.S. Rep. Duncan Hunter (R-CA) is working on legislation to change the date and ensure e-cigarettes are not regulated as traditional tobacco products.

"Vaping is not the same as smoking traditional tobacco and it shouldn't be treated that way," Joe Kasper, Duncan's chief of staff, told The Hill. "Vaping is really a proxy war for anti-tobacco forces and there's nothing they want more than to continue associating vaping with regular tobacco."

Kasper also dismissed the FDA's claims that the agency's hands are tied by the statute: "If [the FDA] signaled support, this would be done by now and so many small businesses nationwide wouldn't have the anxiety that they do."

Meanwhile, Story believes a legal challenge to the FDA’s rule will be necessary should the agency act before Congress does. "If they push a rule forward, litigation will follow and stop [the] FDA dead in their tracks, and at that time they will have egg on their face," he told The Hill.