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Bill Amendment To Change FDA Predicate Date Passes

Apr 19, 2016 | By Andrew Nagy
Bill Amendment To Change FDA Predicate Date Passes

The fight to protect premium cigars from being overly regulated by the U.S. Food and Drug Administration received a big boost today as lawmakers passed a new cigar-friendly provision and sustained another.

The U.S. House Committee on Appropriations, which establishes the FDA's yearly budget, passed 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 passed 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 passed last week by the U.S. House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies that protects premium 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, administer, or enforce the [Deeming Rule introduced in April 2014 that subjects premium cigars to FDA regulation] if such rule would apply to traditional large and premium cigars." In other words, the FDA would receive no funding to regulate premium 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 premium cigar lobbying groups Cigar Rights of America and the International Premium Cigar & Pipe Retailers association supported the Appropriations Committee's actions.

"The International Premium Cigars and Pipe Retailers organization is encouraged that the full Appropriations Committee moved forward with language to exempt premium 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 IPCPR.

"The action taken today by the House Committee on Appropriations is yet another clear indication that Congress never intended to treat premium 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 premium 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 passed on to the president for his signature.

"I am encouraged to see the predicate date change language pass 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 pass both houses."

[Update: April 20 for clarification]

"**** TAKE ACTION, WRITE TO YOUR CONGRESSMAN **** The House Appropriations Bill in question is H. R. 5054. (Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017). The section that would PREVENT the FDA from enforcing this is Sec. 749. Tell your representative that you SUPPORT this language. You can see the bill yourself at" —May 6, 2016 18:24 PM
"Good information but what is the Bill number? It will be H.R. xxxx since it is in the House. When you write an article about the legislative process it helps to know the exact bill number otherwise folks don't know what bill to search for nor comment on when writing to their legislator. Best" —May 4, 2016 16:15 PM
"That's a great first step. Way to rally the troops for Cigar Rights of America to get the folks in touch with their congressmen to voice our opinion." —April 27, 2016 12:50 PM

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