What Is PMTA?

70 points

Who has to file a premarket tobacco application, and how does it impact c-stores?

By Anne Baye Ericksen |

The premarket tobacco application (PMTA) is the process by which tobacco-product manufacturers seek marketing authorization from the Food and Drug Administration (FDA). It’s also a topic that’s generated confusion within the convenience store industry in recent years.

To fully understand the PMTA process, one must go back to Feb. 15, 2007. According to the government, any tobacco-related product not already sold in the U.S. by this date is required to undergo the PMTA review. Products sold preceding that deadline received a grandfathered exemption.

For years, this directive was aimed at cigarettes and chewing tobacco that experienced changes in design, components or contents, or delivery of/form of nicotine. Then in May 2016, the FDA deemed e-cigarettes, vaping devices, e-liquids and nicotine salts — along with cigars, pipe tobacco, hookah tobacco, heated tobacco products and alternative nicotine products — as tobacco products comparable to combustible cigarettes, thereby subjecting them to FDA regulation, starting with PMTAs.

Because they did not exist prior to Feb. 15, 2007, all e-cigarette and vaping products on store shelves as of Aug. 8, 2016 — the date the deeming rule took effect — needed to have a PMTA to remain on the market. After several delays, lawsuits and court decisions, the submission deadline was set for Sept. 9, 2020. (Manufacturers of cigars [premium cigars are exempt], pipe tobacco and hookah tobacco introduced after Feb. 15, 2007, could file a Substantially Equivalent [SE] application because these items could be compared with predicate tobacco products.)

PMTA submissions must include documentation of ingredients and scientific studies regarding how products could qualify as being “appropriate for the protection of the public health,” according to FDA guidelines. They each undergo a five-step process:

  1. The FDA issues a letter of application acceptance.
  2. The FDA files applications that are complete with required data, evidence and scientific studies.
  3. A substantive review is conducted, which could take up to 12 months.
  4. An application is approved/denied.
  5. The FDA publicizes its approval/non-approval of PMTAs.

Products available before Aug. 8, 2016, that have had PMTAs accepted and are progressing through the process are permitted to remain for sale in the interim. Producers that did not choose to seek marketing authorization were ordered to remove all product from store shelves by Sept. 9, 2020. The FDA regards these “misbranded and adulterated,” and illegal. Authorities advise retailers to check with distributors or manufacturers to confirm PMTA/SE status. Products that ultimately receive approval can continue to be sold; conversely any product that does not receive approval at the end of the PMTA process must be pulled from planograms at that time.

The PMTA requirement also applies to any new tobacco-related product manufacturers wish to introduce to U.S. markets.

While c-stores haven’t shouldered the financial and manhour burden of compiling the necessary data and documentation, they have been operating under the confusion surrounding the issue. By fall 2021, however, the FDA should begin publicizing its final decisions, which should give category managers a clear directive.

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