The Food and Drug Administration (FDA) said today that it has made decisions on more than 99 percent of the nearly 26 million tobacco products considered tobacco products submitted for Premarket Tobacco product applications (PMtas). The agency has previously said its review of some of the most popular vaping products could take until the end of the year.
The FDA also announced that it sent a denial of Acceptance (RTA) letter to an applicant on February 21, notifying a company that their PMtas, associated with approximately 17 million tobacco products, did not comply with FDA regulations.
The FDA wrote in a statement: These applications are group submissions for different sizes, nicotine strength, and flavor combinations of e-vape, and each is considered a separate product application under the existing premarket review process.
The agency’s overall decision included authorizing 23 new vaping products and devices, as well as issuing denial of Acceptance (RTA) letters, denial of submission letters or marketing denial orders for millions of products.
The data includes decisions on nearly 6.7 million product applications received by the September 9, 2020 deadline, more than 18 million product applications received after the September 9, 2020 deadline, And nearly 1 million applications for non-tobacco nicotine products filed as of May 14, 2022, under a new federal law passed in April 2022.
According to a federal court order, manufacturers of identified new tobacco products marketed as of the effective date of the designation rule (August 8, 2016) must submit applications for premarket review by September 9, 2020.
The following is the full text of the official announcement:
The FDA has made decisions on more than 99 percent of the nearly 26 million deemed products submitted to date, including authorizing 23 new vape products and devices and issuing Denial of Acceptance (RTA) letters, Denial of filing letters, or marketing rejection orders for millions of products. This includes the identification of nearly 6.7 million product applications received before the September 9, 2020 deadline, more than 18 million product applications received after the September 9, 2020 deadline, and nearly 1 million applications for non-tobacco nicotine products.
Submitted by May 14, 2022, in accordance with the new federal law passed in April 2022. Under the Federal Court order, manufacturers of constructive new tobacco products placed on the market as of the effective date of the Constructive rule (August 8, 2016) are required to file applications for premarket review by September 9, 2020.
On February 21, 2023, FDA sent an RTA letter to an applicant informing a company that its Premarket Tobacco product Application (PMTA) related to approximately 17 million tobacco products did not meet the acceptance requirements outlined in FDA regulations. The applications are grouped submissions for different sizes, nicotine strength, and flavor combinations of e-vape, and each is considered a separate product application under existing premarket review processes.
During the acceptance phase of application review, FDA reviews applications to ensure that they meet the minimum threshold of acceptability for FDA scientific review. If it lacks the required contents for acceptance, FDA will not accept it. The company received the RTA letter because the company’s application for these products lacked the required environmental assessment. The Company may submit new applications for these products at any time; However, the products may not be marketed unless FDA reviews the application and determines that marketing of the products is appropriate to protect public health.
We remain committed to reviewing applications as efficiently as possible in accordance with regulations and laws and driven by strong science. For the latest updates on actions taken against these apps, visit the Tobacco Products Marketing Order page.
