SILVER SPRING, Md. — A court order required tobacco manufacturers to submit tobacco products subject to the premarket tobacco application (PMTA) process by today. So what do convenience-store retailers need to know following this deadline?
The U.S. Food and Drug Administration (FDA) said on Sept. 4 that companies have already asked for an extension; however, it has not granted the requests from individual manufacturers and importers.
Here are four things retailers should know about the process moving forward …
FDA will make PMTA list public
Although some e-cigarette companies like Juul Labs, San Francisco, and E-Alternative Solutions, Jacksonville, Fla., made public which products they submitted for PMTA review, not all companies have done so.
The FDA said it will make public a list of the tobacco products subject to the PMTA deadline of Sept. 9, but has also said doing so will take time.
While the FDA does not know how many applications will be submitted by Sept. 9, there are more than 400 million deemed products listed with the FDA, that is, products for which the FDA has regulatory oversight.
Manufacturers of cigars, pipe tobacco, electronic cigarettes, vapor products, hookahs, alternative nicotine products and heated tobacco products introduced between Feb. 15, 2007, and Aug. 8, 2016, were required to file substantial equivalence (SE) or PMTA marketing authorization requests by Sept. 9. The deadline was originally May 12, 2020, but the FDA provided more time due to the COVID-19 pandemic.
So far, the FDA has received applications for about 2,000 deemed products, of which about 40% have been resolved.
FDA is not granting extensions
Since the PMTA deadline was extended due to COVID-19, the FDA has received multiple requests for an additional extension of the Sept. 9 deadline from individual manufacturers and importers, as well as from certain industry groups, citing the pandemic, recent natural disasters and other circumstances.
These extensions have not been granted, the FDA said on Sept. 4, but the agency intends to take each firm’s individual circumstances into account as it considers PMTAs that are submitted by the deadline. The FDA encouraged each firm to identify any content that may be missing from their application and clearly explain how COVID-19 or another circumstance has prevented them from providing such information. They should also provide a time frame by when they will submit the missing information to the FDA.
The FDA said it would take into account relevant considerations in deciding whether to initiate enforcement action against a particular product as the one-year period for review comes to an end in September 2021.
Premium cigars are an exception
In accordance with a court order, the FDA will not enforce the premarket review requirements against manufacturers of premium cigars that do not submit premarket applications for these products by Sept. 9. A premium cigar is defined as one that meets the following criteria, the FDA said, which includes:
- Is wrapped in whole tobacco leaf
- Contains a 100% leaf tobacco binder
- Contains at least 50% (of the filler by weight) long filler tobacco
- Is handmade or hand rolled
- Has no filter, nontobacco tip or nontobacco mouthpiece
- Does not have a characterizing flavor other than tobacco
- Contains only tobacco, water and vegetable gum with no other ingredients or additives
- Weighs more than 6 pounds per 1,000 units
Enforcement for products
For products with timely applications, the FDA may continue to defer enforcement of the premarket requirements for up to one year through Sept. 9, 2021, unless a negative action is issued by the FDA on an application during that time.
However, deemed products not submitted by the deadline must be pulled form shelves, or retailers and suppliers could face enforcement actions.
The FDA asked for patience as it works through making a list of the companies that have submitted PMTAs on time, and suggested, in the meantime, retailers refer to public statements made by the companies or to contact the companies directly to get information about applications they may have submitted.