Premarket tobacco application

A premarket tobacco application (PMTA) is an application that must be reviewed and approved by the Food and Drug Administration before a new tobacco product can be legally marketed in the United States.[1] To legally market a new tobacco product in the United States, a company must receive a written marketing order from FDA. Following a review of a PMTA under section 910 of the Federal Food, Drug, and Cosmetic Act a marketing order may be issued.[2] The first PMTA was approved by US FDA on November 10, 2015, when the FDA authorized the marketing of eight Swedish Match North America Inc. snus smokeless tobacco products (to be marketed under the brand name "General").[3][4]

In October 2021, FDA issued a final rule setting forth requirements for PMTAs and requiring tobacco product manufacturers to maintain records establishing that their tobacco products are legally marketed.[5] The rule became effective November 4, 2021.[6]

The final rule states it 'requires manufacturers to maintain records establishing that their tobacco products are legally marketed' and 'creates postmarket reporting requirements' for applicants that receive marketing granted orders.[7]

New tobacco product

A new tobacco product is either a product commercially marketed in the United States after February 15, 2007,[8] or any modification to a tobacco product commercially marketed after February 15, 2007. If a predicate product existed prior to February 15, 2007, applicants can apply via the Substantial Equivalence (SE) regulatory pathway.[9]

An FDA guidance for industry on PMTAs for ENDS was published in the Federal Register on October 5, 2021 (86 FR 55300) and became effective November 4, 2021.[10][11]

FDA deeming regulation

On May 10, 2016, the US FDA finalized its "deeming" rule, subjecting additional products to scrutiny under the Federal Food, Drug and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act.[12] The rule gives the US FDA authority to regulate e-cigarettes, cigars, and vape pens.[13][14] The rule also authorizes FDA to take enforcement action against manufacturers who sell and distribute products with unsubstantiated modified risk tobacco product (MRTP) claims.[15][16] The FDA deeming-rule became effective on 8 August 2016.[17]

Compliance periods

FDA is establishing staggered initial compliance periods based on the expected complexity of the applications to be submitted, followed by continued 12-month compliance periods of FDA review.[18] Substantial Equivalence exemptions have a total compliance period of 24 months and an enforcement deadline of August 8, 2017. Substantial Equivalence applications have a total compliance period of 30 months and an enforcement deadline of February 8, 2018. Premarket tobacco applications have a total compliance period of 36 months and an enforcement deadline of August 8, 2018.

In August 2017, FDA announced availability of guidance extending certain compliance deadlines related to the final deeming rule.[19] After the 2016 FDA ‘deeming’ rule placed additional products, like e-cigarettes (ENDS), under FDA tobacco authorities, a federal court order required PMTA’s for many deemed products already on the market to be submitted by 9 September 2020.[20]

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.[21][22]

Product Pathway Initial Compliance Period Continued Compliance Period Total Compliance Period FDA Enforcement Deadline
Substantial Equivalence Exemption Request 12 months 12 months 24 months August 8 2017
Substantial Equivalence Application 18 months 12 months 30 months February 8, 2018
Premarket Tobacco Application 24 months 12 months 36 months August 8, 2018

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.[23][24]

See also

References

  1. ^ "Premarket Tobacco Applications". Food and Drug Administration. Archived from the original on October 31, 2015. Retrieved 1 June 2016.
  2. ^ Products, Center for Tobacco (2025-12-19). "Tobacco Products Marketing Orders". FDA.
  3. ^ "Premarket Tobacco Application (PMTA)". GlobalSubmit. Retrieved 1 June 2016.
  4. ^ FDA issues first product marketing orders through premarket tobacco application pathway, Food and Drug Administration (November 10, 2015).
  5. ^ "21 CFR Part 1114 -- Premarket Tobacco Product Applications". www.ecfr.gov. Retrieved 2026-03-03.
  6. ^ "Premarket Tobacco Product Applications and Recordkeeping Requirements". Federal Register. 2021-10-05. Retrieved 2026-03-03.
  7. ^ Commissioner, Office of the (2021-10-05). "Premarket Tobacco Product Applications and Recordkeeping Requirements (Final Rule) Regulatory Impact Analysis". FDA.
  8. ^ "21 U.S. Code § 387j - Application for review of certain tobacco products". LII / Legal Information Institute. Retrieved 2026-02-03.
  9. ^ Products, Center for Tobacco (2026-01-09). "Substantial Equivalence". FDA. Retrieved 2026-02-03.
  10. ^ "Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)". www.fda.gov. 2025-02-11. Retrieved 2026-02-26.
  11. ^ "Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations" (PDF). Retrieved 2026-02-26.
  12. ^ "Guidance Document - Deeming Tobacco Products To Be Subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products" (PDF). Food and Drug Administration. Retrieved 1 June 2016.
  13. ^ Products, Center for Tobacco (2026-01-16). "FDA's Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products". FDA.
  14. ^ Products, Center for Tobacco (2025-07-18). "E-Cigarettes, Vapes, and other Electronic Nicotine Delivery Systems (ENDS)". FDA.
  15. ^ "Modified Risk Tobacco Product Applications". Retrieved 2026-02-03.
  16. ^ "U.S. Government Accountability Office" (PDF). Retrieved 2026-03-02.
  17. ^ "Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products". Federal Register. 2016-05-10. Retrieved 2026-03-02.
  18. ^ "TIMING AND TIPS– NEWLY DEEMED TOBACCO PRODUCT APPLICATIONS" (PDF). Retrieved 2026-02-03.
  19. ^ "Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule; Guidance for Industry; Availability". Federal Register. 2017-08-10. Retrieved 2026-03-06.
  20. ^ Products, Center for Tobacco (2025-09-19). "Perspective: FDA's Progress on Review of Tobacco Product Applications Submitted by the Sept. 9, 2020 Deadline". FDA.
  21. ^ "The Food and Drug Administration Needs To Improve the Premarket Tobacco Application Review Process for Electronic Nicotine Delivery Systems To Protect Public Health". Office of Inspector General | Government Oversight | U.S. Department of Health and Human Services. 2023-11-08. Retrieved 2026-03-06.
  22. ^ "THE FOOD AND DRUG ADMINISTRATION NEEDS TO IMPROVE THE PREMARKET TOBACCO APPLICATION REVIEW PROCESS FOR ELECTRONIC NICOTINE DELIVERY SYSTEMS TO PROTECT PUBLIC HEALTH" (PDF). Retrieved 2026-03-06.
  23. ^ "Supreme Court upholds FDA's rejection of fruit-flavored vape liquids". The Washington Post. 2025-04-02. Archived from the original on 2025-07-24. Retrieved 2026-03-06.
  24. ^ "OCTOBER TERM, 2024" (PDF). Retrieved 2026-03-06.
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