Representative Tom Cole (R-Oklahoma) and Representative Sanford Bishop (D-Georgia) have introduced H.R. 1136, the FDA Deeming Authority Clarification Act of 2017. This is proposed legislation that would move the U.S. Food and Drug Administration (FDA)’s predicate date for deemed tobacco products from February 15, 2017 to 21 months after the act’s date of enactment. For premium cigars, this proposed legislation would essentially change the grandfather date for exempted product from regulation from February 15, 2007 to a much later date.
The FDA has be on the record stating that any change to the predicate date requires an Act of Congress (i.e. a legislative change). The February 15, 2007 date was selected somewhat arbitrarily. It was the date the Family Smoking Prevention and Tobacco Control Act was first introduced to Congress. It was this legislation that was passed into law and gave the FDA power over all tobacco products.
H.R. 1136 also includes proposal to establish common-sense licensing and advertising guidelines for vapor products as well direct the FDA to establish product standards for vapor product batteries.
“While there is disagreement about whether certain tobacco products should be regulated or not, there should be agreement that new regulations should apply to products moving forward, and not retroactively,” said Representative Cole in a press release. “Inconsistent authority like this will be detrimental and unfair to many manufacturers and businesses. This legislation preserves the FDA’s ability to regulate these products on part with cigarettes, grandfathers currently available products and then requires the FDA’s approval before any new product is introduced.”
Legislation like this was proposed back in 2015 in the 114th Congress with H.R. 2058. The new H.R. 1136 bill is a replacement bill to keep that previously proposed legislation alive in the new Congress.
While the exemption bills such as the recently introduced HR 564 and S.294 have had most of the attention by the premium cigar industry, The previously proposed H.R. 2058 was a much quieter effort. Efforts to advance the bill to change the grandfather date have been pushed more by the vape and electronic cigarette industry and resulted in a total of 78 sponsors. Given there are specifics to these vapes and electronic cigarettes, it is not expected the premium cigar industry will push H.R. 1136 legislation as heavily as the exemption bills.
At the same time, the change in the predicate date under the proposed legislation would exempt products released since 2007 and allow them to stay on the market. While the current February 15, 2007 is devastating to the premium cigar industry, it is even worse for the vape and electronic cigarette industry as it is a newer industry with the majority of its products hitting the market after that 2007 date.