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Predicate date may be changed

Legislation Introduced to recognize a more fair “predicate date.”

February 16th, 2017

Representatives Tom Cole (R-OK) and Sanford Bishop (D-GA) have together filed “FDA Deeming Authority Clarification Act of 2017,” new legislation that aims to amend some of the FDA’s harsh cigar regulations with fairer rules. Also known as H.R.1136, the bipartisan bill would change the predicate date for premium cigars to August 8, 2016 – the day the FDA officially seized power over the whole U.S. tobacco industry.

In the current Final Deeming Rule, previously enacted by FDA in 2016, the agency decided that cigars available on the market as of February 15, 2007 would be “grandfathered.”

The two lawmakers argue that subjecting newly-deemed products (in this case, premium cigars) to the same predicate date as other tobacco products that have already been under FDA authority is unfair, especially when finding cigars to test against for Substantial Equivalence (SE). The congressmen are also looking to institute 21-month grace period for testing new tobacco products – meaning cigar makers could make new cigars available to the market for 21 months while the FDA application is considered.