The US Food and Drug Administration (FDA) has published final guidance regarding Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS), detailing how they intend to prioritize...
FDA extends PMTA review deadline
Nicotine
Jan 30, 2024 | Published by Paul Hardman
Nicotine
The US Food and Drug Administration (FDA) has just announced an extension of its review of Premarket Tobacco Product Applications (PMTAs), as reported by CSP Daily News. The Agency now expects to act on 94 percent of covered applications by March 31, but it will not complete the review process until June 30. Here, Paul Hardman, Managing Consultant of Chemistry at Broughton, explains the reason for the extension.
Covered applications apply to new tobacco products that were on retailers’ shelves as of August 8, 2016, with a PMTA filed by September 9, 2020, and which reach two percent or more of the total retail sales volumes as per NielsenIQ reports.
The latest announcement is not the first extension announced by the FDA. In prior court-ordered status reports, the Agency had indicated that it expected to have taken action on all covered applications by June 30, 2023, and its fourth report then moved this back to December 31, 2023.
Why the latest extension?
As of December 31, 2023, the FDA reported that it had reviewed 72 percent of covered applications, but that regulatory and legislative issues were causing delays to its review of the remaining submissions. In its latest status report, the FDA stated that the continued review process is necessary in light of recent judicial decisions and amendments made by manufacturers.
“Many of these amendments contain substantial data and scientific explanation,” the FDA stated in its report. “The amendments range from a few pages to hundreds of pages and were received on a rolling basis, with the most recent 2023 amendment being filed in December 2023.”
Interestingly, the Agency has said that it now expects to act on 94 percent of covered applications by March 31, but it could miss this target if it finds itself dealing with another influx of PMTA applications and amendments.
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