Rep. Tom Cole, R-Okla., and Sanford Bishop, D-Ga., have introduced the FDA Deeming Authority Clarification Act in the 115th congress.
The bill is actually a bit different than H.R.2058—a bill Cole introduced in the last congress which had the same name.
Its biggest function remains the same: change the grandfather date for the U.S. Food & Drug Administration’s (FDA) deeming regulations from Feb. 15, 2007 to the date the rules were enacted, Aug. 8, 2016.
If passed, the bill would have massive implications. Any new product introduced prior to Aug. 8, 2016 would no now longer be subject to the costly and burdensome process of substantial equivalence. For smaller and newer manufacturers it would also give them ways to stay on the market with very little compliance costs. In addition, it would give all manufacturers a far greater amount of predicate product to argue for substantial equivalence for later on.
Substantial equivalence is a process where a manufacturer argues that its cigars are substantially equivalent in terms of their public health harm compared to an approved or grandfathered product. It is the method by which most cigars currently sold are expected to apply for FDA approval.
For the vapor and e-cigarette category, it would have even greater implications. The category was either extremely small or non-existent as of Feb. 15, 2007.[ref]FDA and the vapor industry disagree about how many, if any, vapor products were on the market prior to Feb. 15, 2007.[/ref] Rapid technological evolutions have taken place since then, so even if there were vapor products on the market as of the current grandfather date, it’s unlikely that any of the existing products sold today would be able to argue they are substantially equivalent.
As such, FDA expects that most, if not all, vapor and e-cigarette products would have to apply for approval via premarket tobacco product application, a multi-million dollar approval process that is in many ways similar to a clinical trial. This process, which no cigar manufacturer is expected to be subject to, is immensely more challenging and costly than substantial equivalence.
Because of this, it’s likely this bill will garner substantial opposition from both big tobacco and anti-tobacco advocates.
H.R. 2058 garnered just 77 sponsors in its time.
The new bill also has provisions that would prohibit advertising of any vapor product in any publication that is not considered an “adult publication” and would create standardization for batteries within the vapor industry.
This bill is different from H.R.564 and S.441, which would exempt premium cigars from FDA control. That bill only deals with premium cigars, whereas this bill would affect cigars, vapor and e-cigarette products, hookah products and pipe tobacco.
Furthermore, this bill would not exempt any products from FDA control. Cigars would still be subject to the regulations on free samples, the requirement for warning labels and some of the other basic pillars of the regulations. Most importantly, even if this new bill is passed any product introduced after Aug. 8, 2016 would need FDA approval before it was allowed to be sold.
Members of the cigar industry were lobbying on the hill earlier this week.
For more information about FDA’s regulation of cigars, click here.