Amendment to change 2007 predicate date passes US House committee

The U.S. House Appropriations Committee, on April 19, approved an amendment to the Agriculture Appropriations bill offered by Rep. Tom Cole (R-OK) and Rep. Sanford Bishop (D-GA), that would modify the predicate date for vapor products.  

The vapor industry has been very concerned with one proposed U.S. Food and Drug Administration (FDA) regulation in particular – a rule that would require all e-cigarette and vapor products that came on the market since February 2007 to undergo a Pre-Market Tobacco Applications (PMTA) process that  could cost each company/manufacturer millions of dollars.

“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 and 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.”

The amendment to modify the “grandfather” date was approved 31-19.

The FDA is expected to issue a final rule (sometime this year, although there is no specific date) giving it authority for the first time to regulate e-cigarettes and vapor products (the White House has been reviewing the FDA deeming regulations for  exactly six months on April 19),which generated $3.3 billion in U.S. sales last year.

The committee’s decision doesn’t mean the amendment is law. It will now have the chance to go forward as part of an appropriations bill and be voted on in the House of Representatives. If passed, it would then move on to the U.S. Senate.

Vapor industry representatives say this legislation is a strong step forward. However, future innovations may not be able to meet the substantially equivalent standard, even with a 2016 date, due to the lack of a substantially equivalent product being on the market.