U.S. House committee votes to smooth e-cigarette regulatory path

Reuters News
Posted: Apr 19, 2016 4:41 PM

By Toni Clarke

(Reuters) - A U.S. House of Representatives committee on Tuesday approved an amendment to an agricultural funding bill that would make it easier for e-cigarettes to win regulatory clearance than currently proposed.

Under a proposed Food and Drug Administration rule, almost all e-cigarette and vapor products introduced after Feb. 15, 2007, would be required to meet regulatory standards that the industry considers excessively stringent. The House Appropriations Committee voted 31-19 on Tuesday in favor of easing the process.

The 2009 Tobacco Control Act allows a new tobacco product to be authorized for sale if it can be shown to be "substantially equivalent" to a product already on the market before February 15, 2007. If no such product exists, the new product must undergo a much more stringent review under the agency's "premarket tobacco application" (PMTA) process.

A PMTA requires a company to prove, with scientific data, that the new product will not harm the population as a whole. So far only one company, Stockholm-based Swedish Match AB, has cleared that bar. Last year the FDA authorized the sale of eight of its smokeless snus products.

The vapor industry says almost all its products would be subject to PMTA review under the FDA's proposal because only one e-cigarette was on the market in the United States before the grandfather date.

Since then, some 100,000 new e-cigarette and vapor products have been introduced. Moving or invalidating the grandfather date would allow some or all of those products to act as "predicates" for future products.

"What happened today is a big boost of momentum for the industry," said Arnaud Dumas de Rauly, treasurer of the Vapor Technology Association, which represents manufacturers, wholesalers, and small businesses.

"We're happy to have bipartisan co-sponsors because up until now we only had Republican buy-in. Now we have Democratic buy-in as well," he added.

The amendment was offered by Republican Tom Cole of Oklahoma and Democrat Sanford Bishop of Georgia. A vote by the full House of Representatives on the spending bill has not yet been scheduled.

The FDA is expected soon to issue a final rule giving it authority for the first time to regulate e-cigarettes and vapor products, which generated $3.3 billion in U.S. sales last year.

The agency already has authority to regulate cigarettes, smokeless tobacco and roll-you-own tobacco. The Tobacco Act gave it the option of extending its authority over other tobacco products after issuing a rule.

(Reporting by Toni Clarke in Washington; Editing by Alan Crosby)