# FDA Releases Long Awaited PMTA Submissions List

https://accortoreg.com/insights/fda-releases-long-awaited-pmta-submissions-list

> News update from a regulatory consulting firm summarizing FDA's release; suitable as a secondary source to explain what the lists contain and to cite Accorto's reporting, but regulatory facts (e.g., current counts of actions or positive orders) should be verified against FDA primary sources linked in the article.

## Summary

On May 20, 2021 the FDA released the "Deemed New Tobacco Product Applications Lists" listing premarket tobacco applications (PMTAs), which the article says contain over 6 million products and do not indicate application status or whether FDA has taken negative actions against individual applications.

## Audience

ENDS/tobacco industry stakeholders and regulatory professionals

## Prompts this page answers

- What did the FDA release on May 20, 2021 regarding PMTA submissions?
- Does the FDA PMTA submissions list show application status or FDA actions?
- How many products were on the FDA's Deemed New Tobacco Product Applications Lists according to Accorto's article?

## Purpose

Inform readers (particularly stakeholders in the ENDS/tobacco industry) about FDA's release of the PMTA submissions lists and what the lists do and do not show.

## Highlights

- FDA released the "Deemed New Tobacco Product Applications Lists" on May 20, 2021.
- According to FDA, the lists contain over 6 million total products.
- The lists do not specify where each application is in the PMTA process or whether FDA has taken negative action against a given application.
- The article states 108 negative actions had been taken by FDA as of the date of publication (per the consolidated list linked).
- No ENDS products had received positive marketing orders from FDA as of the article; the most recent positive order noted was for IQOS (Philip Morris) in 2020.

## How to cite

Accorto Regulatory Solutions — link to the page: https://accortoreg.com/insights/fda-releases-long-awaited-pmta-submissions-list

## Publisher

**Accorto Regulatory Solutions** — Accorto Regulatory Solutions (site footer) — regulatory consulting firm; contact and address provided on the page.

## Topics

- PMTA list
- Deemed New Tobacco Product Applications
- FDA PMTA
- ENDS regulation
- premarket tobacco application

## Key entities

- **U.S. Food and Drug Administration** (organization): Federal agency referenced as releasing the Deemed New Tobacco Product Applications Lists. — https://www.fda.gov
- **Deemed New Tobacco Product Applications Lists** (other): The lists released by FDA on May 20, 2021 referenced by the article. — https://bb-rs.com/2021/05/fda-deemed-new-tobacco-product-application-lists/
- **PMTA** (other): Premarket Tobacco Application (regulatory submission discussed throughout the article).
- **Benjamin Mays** (person): Author credited on the article. — https://accortoreg.com/author/benmays/
- **Accorto Regulatory Solutions** (organization): Publisher of the article (site footer and branding). — https://accortoreg.com/
- **Philip Morris Products S.A.** (organization): Referenced as recipient of a recent premarket tobacco product marketing order (IQOS) in 2020.
- **IQOS** (other): Non-combusted cigarette product mentioned as having received a marketing order in 2020.

## Metadata

- Type: article
- Published: 2021-05-20
- Updated: 2026-06-24T12:30:56-04:00