Bill Amendment To Change FDA Predicate Date es
The fight to protect cigars from being overly regulated by the U.S. Food and Drug istration received a big boost today as lawmakers ed a new cigar-friendly provision and sustained another.
The U.S. House Committee on Appropriations, which establishes the FDA's yearly budget, ed its House Appropriations bill earlier today that includes language to change the predicate date from February 15, 2007, to the effective date of the FDA's new deeming regulation on cigars. The cigar-friendly amendment was added by Rep. Tom Cole (R-OK), and the bill was ed by a vote of 31 to 19.
This change will allow cigarmakers to avoid the costly applications processes established in the Tobacco Control Act. Without this amendment, cigarmakers would be required to file new product applications with the FDA and undergo an arduous, expensive approval process for any product that wasn't on the market prior to February 15, 2007 (the FDA's initial predicate date).
"This is something that everyone in the industry needs, from the manufacturer to the consumer," said Craig Williamson, president of the Cigar Association of America. "[The predicate date] was the most important issue for the CAA and everyone involved in the tobacco industry."
Additionally, the committee struck down an amendment proposed by Rep. Rosa DeLauro (D-CT) to remove cigar-friendly language ed last week by the U.S. House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies that protects cigars from FDA regulation.
That provision added by Congressman Robert Aderholt (R-AL), chairman of the Agriculture Subcommittee, states that "None of the funds made available in this Act may be used to finalize, implement, ister, or enforce the [Deeming Rule introduced in April 2014 that subjects cigars to FDA regulation] if such rule would apply to traditional large and cigars." In other words, the FDA would receive no funding to regulate cigars until September 30, 2017, the day the fiscal year ends.
DeLauro's amendment, however, was defeated by a vote of 34 to 14, and the cigar-friendly provision remains.
Cigarmakers and tobacconists as well as cigar lobbying groups Cigar Rights of America and the International Cigar & Pipe Retailers association ed the Appropriations Committee's actions.
"The International Cigars and Pipe Retailers organization is encouraged that the full Appropriations Committee moved forward with language to exempt cigars from onerous FDA regulation and took action to update the predicate date for newly regulated tobacco products," said Kip Talley, senior director of federal legislative affairs for the IPR.
"The action taken today by the House Committee on Appropriations is yet another clear indication that Congress never intended to treat cigars like other tobacco products," said J. Glynn Loope, executive director of the Cigar Rights of America. "This language is a symbol that Congress recognizes the unique differences of cigars, and that any effort by the FDA to regulate them would run contrary to Congressional intent of the 2009 Tobacco Control Act."
The bill now has to be sent to the House of Representatives for a floor vote. The bill must then go through the same process in the Senate before it's ed on to the president for his signature.
"I am encouraged to see the predicate date change language at the committee level," said Hans-Kristian Hoejsgaard, CEO of Oettinger Davidoff AG. "While this would be welcome and helpful news for our industry, we also recognize there remains important work to be done for this common-sense language to both houses."
[Update: April 20 for clarification]
