Spending bill threatens new rules for e-cigarettes, cigars

Language in a proposed House Agriculture Committee spending bill is threatening to derail new rules out Thursday that give the Food and Drug Administration (FDA) the ability to regulate cigars and electronic cigarettes, or e-cigarettes.

{mosads}If Congress keeps the amendment the House Appropriations Committee passed last month exempting all e-cigarettes and cigars currently on the market from FDA review, Mitch Zeller, director of the agency’s Center for Tobacco Products, said it would have an “enormous adverse impact on FDA’s ability to do its job.”

The rule now requires any product that hit store shelves after Feb. 15, 2007, to go through a new product-approval process. The bipartisan amendment from Reps. Tom Cole (R-Okla.) and Sanford Bishop (D-Ga.), however, changes that date, subjecting only those products hitting the market after the rule takes effect in 90 days to FDA review.

“If the grandfather date changes and becomes the effective date of the final rule, that will exempt all these products from any premarket review … and worse, they can use these as predicates for new products coming down the road,” Zeller said.

Health officials have raised concerns about the safety of chemicals and batteries used in e-cigarettes. A 17-year-old in upstate N.Y. was reportedly hospitalized earlier this week after an e-cigarette battery exploded and blew a hole in the back of his throat. If the amendment is left intact, the FDA argues it won’t be able to evaluate these kinds of product failures.

Cole, however, is standing by his rider.

“This regulation takes an overly-broad approach to regulating these products,” he said in a statement. “While we can all agree that tobacco products should not be marketed to children, I still believe that my bipartisan amendment, recently approved by the Appropriations Committee in the Agriculture Appropriations bill, provides the same framework for new tobacco products without needlessly subjecting small businesses to unnecessary regulations and without treating law abiding adults like naive children.”

If the rider is approved, manufactures will still be prohibited from selling these products to anyone under the age of 18 or in vending machines. Retailers will still be required to check photo IDs when they make a sale and manufacturers will still be required to put warning labels on product labels and in advertisements.