Language has been removed that would have yanked flavored e-cigarettes from the market until they had been authorized by the Food and Drug Administration.
June 2, 2016
WASHINGTON – Reuters reports that the White House Office of Management and Budget (OMB) has deleted language in the Food and Drug Administration’s tobacco regulation that would have removed flavored e-cigarettes from the market until they had been authorized by the Food & Drug Administration (FDA).
On May 5, the FDA issued its deeming tobacco rules to bring electronic cigarettes, cigars, pipe tobacco and other products under its regulatory authority. Since the rules were first proposed in 2014, the tobacco and e-cigarette industries had been awaiting the final rules, and more specifically, what those rules could mean for the profusion of e-vapor products on c-store and other retailer’s shelves. The final regulations require any nicotine delivery devices that hit stores after Feb. 15, 2007 (the predicate date), to apply retroactively for approval, a costly and lengthy Premarket Tobacco Application (PMTA) process. E-cigarettes were not on the market prior to Feb. 15, 2007.
According to Reuters, the FDA provided pages of data and scientific studies in support of its plan to ban flavored tobacco products, noting “a dramatic rise in youth and young adult use of typically flavored tobacco products, like e-cigarettes and waterpipe tobacco, and continued youth and young adult use of cigars.” The news source says that the OMB deleted both the FDA’s planned policy and the rationale.
In its original rule submitted to the OMB, the FDA said it recognized that numerous flavored products would come off the market within 180 days of the rule’s publication “and that this will significantly impact the availability of flavored tobacco products at least in the short term,” reports Reuters.
Emily Cain, a White House spokesperson, told Reuters that the OMB “does not comment on changes made during the interagency review process.” FDA spokesperson Michael Felberbaum said the FDA also does not comment during the process.