The best hope for a reversal in the regulatory path is through Congress.
Currently, Congress is considering two separate changes to the rules passed by FDA. Both changes are included as part of the FY2017 Appropriations Bill on Agriculture, which is where FDA’s budget comes from.
1. Exempt Premium Cigars from FDA Regulation
This would exempt almost all traditional, large cigars so long as they weigh at least 6 pounds per 1,000. This would include cigars regardless of price and whether they were flavored or traditional. In addition, some domestic-made cigars would qualify. This would allow for manufactures like J.C. Newman to continue to make cigars domestically, something that would be quite prohibitive if the regulations go into effect.
2. Change the Predicate Date
This measure would change the grandfather date from Feb. 15, 2007 to the date the rules go into effect, i.e., Aug. 8, 2016. This would mean that any cigar released after Feb. 15, 2007 but before Aug. 8, 2016 would be able to apply as a grandfathered product, which would allow thousands of cigars to remain on the market.
Changing the predicate date would also affect other tobacco products, most notably e-cigarettes and vaping products. Because very few—if any—vapor products were on the market as of Feb. 15, 2007, this would allow for the vaping industry to not only have grandfathered products, but also access to substantial equivalence, something that seems relatively unlikely with the current predicate date, though FDA says it is looking into the possibility that a handful of products might have been on the market prior to Feb. 15, 2007. (Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act…, 20-21)
This makes the predicate date change much more controversial.
Both provisions are included in the current draft of the FY2017 Appropriations Bill on Agriculture, which has passed the committee on appropriations. It will now move to a full vote in the House, a separate bill in the Senate and ultimately the two chambers conferencing over a finalized bill before it can go before a final vote.
The bill could realistically hit the House floor as early as June, and depending on how quickly Congress can vote and pass other appropriations bills, namely ones dealing with energy and defense, a vote could come before the November election. What seems more likely is that Congress will pass a continuing resolution after summer and ultimately deal with the appropriations bill after the election.
If so, it will be part of what’s called an Omnibus, a collection of various essential bills needed to keep government funded and running.
- What can we do now to help cigars get the exemption/grandfather date changed?
Contacting your U.S. Senators is most important. You will want to contact both about the standalone bill, but most importantly including the exemption in the Senate's version of the Agriculture Appropriations bill.
- What happens if Congress doesn’t pass the bill?
- What cigars are included under the exemption?
- I heard the exemption is only good for one year?
- Didn’t we have an Omnibus last year? Didn’t the exemption fail?
- Why will this year’s Omnibus be different?
- What about the petitions to the White House?