U.S. House Appropriations Committee Passes Predicate Date Language
Today, the U.S. House Appropriations Committee considered the FY 2016 Agriculture Appropriations Bill which passed 29-21. The legislation will now be schedule for consideration on the House Floor. Included in this bill was a provision to make a technical change to the Tobacco Control Act, affecting the regulation of premium cigars, pipe tobacco, and other tobacco products.
When the Tobacco Control Act was passed into law, an arbitrary date of February 15, 2007 was implemented to determine what is considered a new tobacco product. Anything introduced after that date would be subject to a costly pre-market review which could cost manufacturers over $400,000 per cigar blend, size, or shape. For an industry like ours, which heavily relies on seasonal releases and limited editions, the 2007 date would devastate our humidors, with an estimated 85% of products being affected and possibly removed from market.
Language has been included in the Appropriations bill to fix this problem. If signed into law, the “predicate date” would change to date of enactment for any new regulation on a tobacco product. As FDA continues to consider regulation of premium cigars and pipe tobacco, the date of implementation remains critically important. With the clarified language, any product released after this date is subject to pre-market review, but any product on the market prior, would be grandfathered in as a “substantially equivalent” product. Though a misguided amendment was offered to strip this language from the bill, it was defeated by a vote of 23-26.
IPCPR continues to urge FDA and the White House to exempt premium cigars from regulation by adopting “Option 2” in the proposed regulation. We support the Appropriations Committee effort and hope the U.S. House will pass this legislation.