CTP Responds to the Reagan-Udall Foundation Evaluation Report

CTP Connect

Latest News

CTP Responds to the Reagan-Udall Foundation Evaluation Report

On Feb. 24, CTP Director Dr. Brian King published a statement summarizing the center’s plans to address the Reagan-Udall Foundation evaluation recommendations, including CTP’s approach, responses to the recommendations, and next steps.

A more detailed description of CTP’s plan for addressing the recommendations may be accessed on our new webpage, Actions to Address Recommendations from the Reagan-Udall Evaluation of CTP.

The actions outlined are a blueprint for action, and there is still much work to be done. CTP is committed to incorporating the activities into the center’s everyday workflow as expeditiously as possible. As always, CTP will be driven by strong science, health equity, stakeholder engagement, and transparency.

Read Dr. King’s Statement

FDA Proposes New Requirements for Tobacco Product Manufacturing Practices, Registration Open Now for Public Hearing

On March 8, FDA proposed new requirements for tobacco product manufacturers regarding the manufacture, design, packing, and storage of their products. These proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency.

Registration is open for FDA’s upcoming public oral hearing on April 12, 2023, from 9:30 a.m. to 5:00 p.m. ET. The hearing is an opportunity for the public to verbally comment on the agency’s proposed rule “Requirements for Tobacco Product Manufacturing Practice.” Registration to provide oral comments will close on March 31, 2023.

FDA will also hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18 to seek recommendations from the agency’s outside panel of experts on the requirements laid out in the proposed rule. 

Read More About the Proposed Rule

FDA Makes Determinations On More Than 99% of the 26 Million Tobacco Products For Which Premarket Tobacco Product Applications (PMTAs) Were Submitted

FDA has made determinations on more than 99% of the nearly 26 million deemed products for which PMTAs were submitted, including authorizing 23 new e-cigarette products and devices, and issuing refuse to accept (RTA) letters, refuse to file letters, or marketing denial orders for millions of products.

This includes determination on applications for nearly 6.7 million products received by the Sept. 9, 2020, deadline, more than 18 million products received after the Sept. 9 deadline, and applications for nearly 1 million non-tobacco nicotine products submitted by May 14, 2022, in accordance with the new federal law passed in April 2022.

We remain committed to reviewing applications as efficiently as possible, in accordance with regulations and the law and driven by strong science.

Read More About Tobacco Products Marketing Orders

FDA Files Civil Money Penalty Complaints Against Four E-Cigarette Product Manufacturers

On Feb. 22, FDA announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization. This is the first time FDA has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.

It is illegal to manufacture, sell, or distribute e-liquids that FDA has not authorized. FDA previously warned each of the companies that, by making and selling their e-liquids without marketing authorization from FDA, they were in violation of FDA’s premarket requirements for tobacco products and that failure to correct these violations could lead to an enforcement action, such as a CMP. Despite the agency’s warning, these companies continue to make and sell their unauthorized e-liquids to consumers.

Read More

In Case You Missed It: Recent CTP News

This newsletter serves as a digest of the latest announcements and stories out of CTP. It is a complement to our Spotlight on Science newsletter and CTP News e-blasts.