FDA announces decisions on over 99% of PMTAs

On March 15, the US Food and Drug Administration (FDA) announced that it has made decisions on almost 26 million pre-market tobacco product applications (PMTAs), which account for over 99% of tobacco products. The agency had previously stated that review of some of the most popular electronic cigarette products may not be completed until the end of the year.

On February 21st, the FDA issued a Refuse to Accept (RTA) letter to an applicant notifying them that their PMTA, which included approximately 17 million tobacco products, did not meet FDA regulations. The FDA stated that the applicant's submission was not in compliance with their guidelines.

These applications are for group submissions of electronic liquids with different sizes, nicotine strengths, and flavor combinations. According to the current pre-market review process, each application is considered a separate product application," wrote the FDA in a statement.

The general decision of the organization involves authorizing 23 new electronic cigarette products and devices, as well as issuing "refuse to accept" (RTA) letters, refusal to submit letters, or marketing refusal orders to millions of products.

These figures include the approval of nearly 6.7 million product applications received prior to September 9, 2020, over 18 million product applications received after September 9, 2020, and almost one million applications for non-tobacco nicotine products submitted before May 14, 2022, in accordance with a new federal law passed in April 2022.

As per a federal court order, manufacturers of identified new tobacco products that were already on the market as of the effective date of the regulations (August 8, 2016) are required to submit premarket review applications by September 9, 2020.

The following is the original text from the FDA:

The FDA has made a decision on over 99% of the 26 million tobacco products submitted for application by March 15, 2023.

So far, the FDA has made decisions on over 26 million applications submitted for products, with over 99% receiving a decision. This includes authorizing 23 new electronic cigarette products and devices, as well as issuing Refuse to Accept (RTA) letters, Refuse to File letters, and millions of marketing denial orders. This includes nearly 6.7 million product applications received before the September 9, 2020 deadline, over 18 million applications received after the deadline, and nearly one million applications for non-tobacco nicotine products to be submitted by May 14, 2022, under new federal law passed in April 2022. Manufacturers of new tobacco products launched on the market before the effective date of the deeming rule (August 8, 2016) were required by a federal court order to submit premarket review applications by September 9, 2020.

On February 21, 2023, the FDA issued an RTA letter to an applicant, notifying a company that its pre-market tobacco product application (PMTA) for approximately 17 million tobacco products associated with it did not meet the acceptance criteria outlined in FDA regulations. These applications were grouped submissions for electronic-cigarette liquid with varying sizes, nicotine strengths, and flavor combinations, and under the existing pre-market review process, each is treated as a separate product application.

During the acceptance phase of the review process, the FDA examines applications to ensure they meet the minimum acceptable scientific standards for review. If an application is missing required information, the FDA will not accept it. In this case, the company received a Refuse-to-Accept (RTA) letter because their application for these products lacked necessary environmental assessments. The company may submit new applications at any time, but the products cannot be sold unless the FDA reviews the application and determines that marketing them will protect public health.

We remain committed to reviewing applications as efficiently as possible, in accordance with regulations and laws, and with strong reliance on scientific evidence. For the latest updates on actions taken regarding these applications, please visit the Tobacco Product Marketing Orders page.

Reference:

The United States Food and Drug Administration (FDA) has made rulings on more than 99% of premarket tobacco product applications (PMTAs).

The FDA has evaluated over 99% of the 26 million tobacco products that have had applications submitted for them.