History of Premarket tobacco application in Timeline

A Premarket Tobacco Application (PMTA) is a requirement for new tobacco products seeking legal marketing approval in the United States from the FDA. Companies must submit a PMTA and receive a written marketing order from the FDA after a thorough review process as per section 910 of the Federal Food, Drug, and Cosmetic Act. The first PMTA approval occurred on November 10, 2015, when the FDA authorized eight snus smokeless tobacco products from Swedish Match North America Inc.

February 15, 2007: Definition of new tobacco product

As of February 15, 2007, a new tobacco product is defined as either a product commercially marketed in the United States after this date, or any modification to a tobacco product commercially marketed after this date.

November 10, 2015: First PMTA approved

On November 10, 2015, the US FDA approved the first Premarket Tobacco Application (PMTA), authorizing the marketing of eight Swedish Match North America Inc. snus smokeless tobacco products under the brand name "General".

May 10, 2016: FDA finalizes deeming rule

On May 10, 2016, the US FDA finalized its "deeming" rule, subjecting additional products to scrutiny under the Federal Food, Drug and Cosmetic Act. The rule gives the US FDA authority to regulate e-cigarettes, cigars, and vape pens.

2016: FDA ‘deeming’ rule

In 2016, the FDA ‘deeming’ rule placed additional products, like e-cigarettes (ENDS), under FDA tobacco authorities.

August 8, 2017: Substantial Equivalence exemption enforcement deadline

August 8, 2017, marked the enforcement deadline for Substantial Equivalence exemptions, with a total compliance period of 24 months.

August 2017: FDA extends compliance deadlines

In August 2017, the FDA announced the availability of guidance extending certain compliance deadlines related to the final deeming rule.

February 8, 2018: Substantial Equivalence applications enforcement deadline

February 8, 2018, marked the enforcement deadline for Substantial Equivalence applications, with a total compliance period of 30 months.

August 8, 2018: Premarket tobacco applications enforcement deadline

August 8, 2018, marked the enforcement deadline for Premarket tobacco applications, with a total compliance period of 36 months.

September 2020: PMTA submission deadline

After the 2016 FDA ‘deeming’ rule placed additional products, like e-cigarettes (ENDS), under FDA tobacco authorities, a federal court order required PMTAs for many deemed products already on the market to be submitted by September 9, 2020.

September 2020: FDA receives PMTAs for ENDS products

By the September 9, 2020 deadline, FDA’s Center for Tobacco Products received PMTAs for more than 6 million ENDS products.

October 5, 2021: FDA guidance for PMTAs for ENDS published

On October 5, 2021, the FDA guidance for industry on PMTAs for ENDS was published in the Federal Register and became effective November 4, 2021.

October 2021: FDA issues final PMTA rule

In October 2021, the FDA issued a final rule outlining the requirements for Premarket Tobacco Applications (PMTAs) and mandating that tobacco product manufacturers maintain records verifying the legal marketing of their tobacco products.

November 4, 2021: PMTA rule effective

On November 4, 2021, the FDA's final rule setting forth requirements for PMTAs and requiring tobacco product manufacturers to maintain records establishing that their tobacco products are legally marketed became effective.

2023: HHS audit reports on PMTA review process

A 2023 Health and Human Services Office of Inspector General audit reported that by the 9 September 2020 deadline, FDA’s Center for Tobacco Products received PMTAs for more than 6 million ENDS products and recommended improvements to the ENDS PMTA review process.

2025: U.S. Supreme Court decides FDA v. Wages and White Lion Investments

In 2025, the U.S. Supreme Court decided in the FDA v. Wages and White Lion Investments case that the FDA had lawfully denied authorization to market certain flavored ENDS products.