Electronic cigarette companies are steeling for a legal brawl with the Obama administration over coming regulations they believe could wipe out the fast-growing industry.
The closely watched Food and Drug Administration (FDA) deeming rule, now under final review at the White House, would bring e-cigarettes as well as conventional cigars under the agency’s jurisdiction.
Though the FDA has not made the language public, sources with knowledge of the rulemaking expect major changes in the final regulations, compared with a draft version released last year.
Yet one group claiming to have obtained a leaked copy says the FDA aims to leave intact the provision of most concern to industry groups: a mandate that any nicotine delivery devices that hit stores after Feb. 15, 2007, will have to apply retroactively for approval.
“That’s a de facto ban,” said Ray Story, CEO of the Tobacco Vapor Electronic Cigarette Association (TVECA).
The FDA has said it does not believe it has the authority to alter or amend the date, because it was set by statute in the Family Smoking Prevention and Tobacco Control Act that was signed into law by President Obama in 2009.
Industry groups argue the process would cost millions of dollars, making it prohibitively expensive for companies to keep their products on store shelves.