Congress Introduces Bill To Change FDA Predicate Date

Congress Introduces Bill To Change FDA Predicate Date

A new piece of legislation aimed at creating a fair set of regulations for the U.S. tobacco market has been introduced. Representatives Tom Cole (R-OK) and Sanford Bishop (D-GA) filed H.R.1136 late last week, which would effectively change the predicate date of newly regulated tobacco products—including premium cigars—and provide a 21-month grace period for new products seeking FDA approval.

The bill, known as the "FDA Deeming Authority Clarification Act of 2017," would change the predicate date for premium cigars from February 15, 2007 to August 8, 2016, the day the FDA officially took over regulatory control of the cigar industry. The lawmakers have argued that makers of "newly deemed" products have been unfairly required to "look back over nine years" for grandfathered or "predicate brands" that could be used for a Substantial Equivalence application.

The bill states that the cigarette industry, which came under FDA regulation in 2009 after the passing of the Family Smoking Prevention and Tobacco Control Act, "only had to ‘look back' two-and-a-half years" in order to find grandfathered products compatible for substantial equivalence. Therefore, the bill argues that a blanket predicate date for all tobacco products would be unfair for newly deemed products like cigars.

Should the bill become law, it would also add a 21-month grace period for new tobacco products seeking a Substantial Equivalence approval. As current regulations stand, cigarmakers cannot release a new cigar onto the U.S. market unless it has first been granted substantial equivalence by the FDA. This would allow new products to debut on the marketplace and remain there for 21 months while its Substantial Equivalence application is reviewed.

The introduction of H.R.1136 comes on the heels of Senate Bill 294, which proposes exempting premium cigars from FDA regulation entirely. That bill, which serves as a companion to H.R. 564, is also a bipartisan effort put forth by Florida Sens. Bill Nelson and Marco Rubio, a Democrat and Republican, respectively.