Key Points
- On May 7 EDT, FDA CTP published a statement by Acting Director Bret Koplow on accelerating product review and improving PMTA efficiency.
- On May 12 EDT, Marty Makary resigned as FDA Commissioner, and Trump confirmed that Kyle Diamantas would serve as acting head of the agency.
- On the afternoon of May 13 EDT, CTP’s official X account and newsletter pushed the May 7 statement, later than CTP’s usual communication pattern.
- The FDA has not explained the delay. The timing does not prove a policy shift, but it changed the context in which the statement was received.
2Firsts
May 13, 2026 | Shenzhen
2Firsts has observed that a U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) statement on accelerating product review and improving PMTA efficiency was pushed through CTP’s official X account and newsletter nearly a week after it first appeared on the FDA website. The push came one day after the resignation of FDA Commissioner Marty Makary was confirmed.
According to the FDA website, CTP oversees implementation of the Family Smoking Prevention and Tobacco Control Act. Its responsibilities include reviewing premarket applications for new tobacco products and modified risk tobacco products. The FDA also lists the CTP Newsroom and CTP email newsletters as channels for the latest CTP news and actions, and identifies @FDATobacco as CTP’s X account.
May 7: CTP Issues Statement on Review Efficiency
On May 7, 2026 EDT, FDA CTP Acting Director Bret Koplow published a statement in the FDA’s CTP Newsroom titled “CTP Acting Director Statement: New Steps Forward in Accelerating Innovation and Efficiency in Product Review.”
The statement focused on product-review efficiency. CTP said it reduced the PMTA application backlog by approximately 70% in 2025 and that there is no longer a queue for PMTAs pending acceptance review. CTP also said it is improving filing and scientific review efficiency and working on a process to prioritize and efficiently review certain supplemental PMTAs, or sPMTAs.
The statement also referenced FDA’s nicotine pouch PMTA review pilot, launched in September 2025. CTP said the first decisions under the pilot came in December 2025, three months after scientific review began, with authorizations for six new nicotine pouch products. CTP said lessons from the pilot would be incorporated into all nicotine pouch PMTA reviews.
May 12: Makary’s Resignation Is Confirmed
On May 12, 2026 EDT, Marty Makary resigned as FDA Commissioner. NPR reported that Makary resigned on Tuesday, ending a 13-month tenure. Later that afternoon, Trump posted on Truth Social thanking Makary and said FDA Deputy Commissioner for Food Kyle Diamantas would temporarily take over as head of the agency.
TIME also reported that Trump confirmed Makary’s departure on Truth Social and said Diamantas would serve as the FDA’s acting head.
May 13: CTP Pushes the May 7 Statement Through X and Newsletter
On the afternoon of May 13, 2026 EDT, CTP’s official X account, @FDATobacco, pushed the May 7 statement on review efficiency. A FDA newsletter screenshot obtained by 2Firsts shows that the same statement was also distributed through CTP’s email subscription channel.
The timing is notable. Under CTP’s usual communication pattern, Newsroom items are generally shared through social media and newsletters either simultaneously or within 24 hours. In this case, however, the May 7 statement was not distributed through those channels until May 13, placing the push one day after Makary’s resignation was confirmed.
The Unusual Element Was the Timing, Not the Statement Itself
The unusual element in this case was not that CTP issued a statement on product-review efficiency. Rather, it was the gap between the statement’s publication on the FDA website and its later distribution through official communication channels.
The FDA has not publicly explained the delay. Therefore, the timing cannot be taken as evidence of a direct causal link between the push and Makary’s resignation. Still, the delayed distribution placed a May 7 review-efficiency statement back into public view one day after a major FDA leadership change.
In other words, the delay does not prove a policy shift. But it changed the timing context in which the statement was observed and interpreted.
As of publication, the FDA has not issued a public explanation for the delayed push. For industry observers tracking U.S. tobacco regulation, the question is not whether one personnel change directly affected CTP, but whether CTP will continue to give product-review efficiency greater visibility during the FDA’s leadership transition.
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(Cover Image: FDA CTP’s newsletter shared its May 7 Acting Director statement on accelerating innovation and improving efficiency in product review.)
