LAKEVILLE, Minn. — Sept. 9 was the FDA deadline for manufacturers to submit either a Substantial Equivalence Application (SE) or a Premarket Tobacco Application (PMTA) for “deemed” tobacco products introduced into the marketplace between Feb. 15, 2007, and Aug. 8, 2016. Tobacco products subject to the premarket application requirements include cigars (except “premium cigars” as noted below), pipe tobacco, electronic cigarettes, nicotine vapor products, hookah tobacco, alternative nicotine products and heated nicotine products.
Many brands of domestic cigars, pipe tobacco and hookah tobacco products were already on the market as of Feb. 15, 2007; therefore, they qualify for grandfather status and do not need a SE or PMTA. For those domestic cigars, pipe tobacco and hookah tobacco products which are not grandfathered, manufacturers must have filed either a SE or PMTA application with the FDA by Sept. 9.
Because there were no electronic cigarette, vapor or alternative nicotine products on the market as of Feb. 15, 2007, they will not be grandfathered, and there is generally no substantially similar product to rely on to file a SE application. For these products, manufacturers were required to file PMTAs with the FDA by Sept. 9 or their products could no longer be sold on the market.
As to “premium cigars” only, a federal court ruling issued last month deferred enforcement of the FDA’s Sept. 9 application filing deadline, preventing the FDA from enforcing the application requirement against premium cigars until the agency creates a streamlined SE application process for them. “Premium cigars” are defined as a cigar that:
- Is wrapped in whole tobacco leaf; contains a 100% leaf tobacco binder;
- Contains at least 50% (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar);
- Is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling);
- Has no filter, non-tobacco tip, or non-tobacco mouthpiece;
- Does not have a characterizing flavor other than tobacco;
- Contains only tobacco, water and vegetable gum with no other ingredients or additives; and
- Weighs more than 6 pounds per 1,000 units.
In late August, the FDA issued a statement that it plans to make publicly available a list of the deemed tobacco products that were subject to the Sept. 9 deadline, that were on the market as of Aug. 8, 2016, and for which a SE or PMTA application was submitted to the agency by Sept. 9. However, because the agency needs time to review and accept or decline SE and PMTA applications as they are filed and ensure that the SE and PMTA application information to be published complies with federal disclosure laws, that list of products for which a SE or PMTA application has been filed may not be published for some time. In the meantime, the FDA encourages retailers to contact manufacturers directly to obtain information and confirmation about whether SE or PMTA applications have been filed with the FDA.
The agency also stated it will take compliance and enforcement action against those tobacco products for which a SE or PMTA application was required to be filed by the Sept. 9 deadline, but which the manufacturer did not file. Enforcement action is allowed against those products as they would now be considered “misbranded and adulterated” by the FDA and illegally on the market.
Retailers need to ensure they are selling only legal tobacco products.
Thomas Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at firstname.lastname@example.org.