A measure to change the grandfather date of the U.S. Food & Drug Administration’s (FDA) deeming regulations from Feb. 15, 2007 to Aug. 8, 2016 has advanced in the House of Representatives Appropriations Agriculture Subcommittee.
That move came via voice vote, where there were no objections to advancing the FY18 Agriculture Appropriations bill, which included the language. The bill now moves to the full House Appropriations Committee, where the Cigar Association of America expects the measure to be taken up in mid-July. From there, the bill would still need to pass a vote in the full House of Representatives and have similar language pass the Senate before it would head to President Donald Trump to be signed into law.
The Agriculture Appropriations bill is what gives FDA funding, which is why the language was included in this particular bill.
Earlier this year, Rep. Tom Cole, R-Okla., and Sanford Bishop, D-Ga., introduced standalone legislation that would do the same thing. Including the language within the Agriculture Appropriations bill, which is a vital funding bill, is seen as a more effective way to getting a change because ultimately, Congress must eventually pass funding bills in some form or fashion.
As explained earlier, if passed, the language would be a massive change to how FDA regulations apply to cigars and other tobacco products, particularly e-cigarettes and vapor products:
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.
Also included was language that would exempt premium cigars from FDA regulation.
Including language in the Agriculture Appropriations bill has been a popular method for trying to counteract FDA regulations. However, the language has been ineffective because Congress has failed to pass a standalone Agriculture Appropriations bill.
Over the last few years, Congress has been forced to pass omnibus bills, a combination of various crucial bills passed late in the year. Because of the size and urgency of the omnibus, special interest language like those pertaining to FDA regulation were stripped of the bills in order to ensure the larger omnibus would pass.