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FDA Urged Reformation of PMTA Process

Regulations by 2FIRSTS.ai
Dec.18.2023
FDA Urged Reformation of PMTA Process
US senators urge the FDA's Center for Tobacco Products to reform the pre-market tobacco product application process.

According to a report from Vaporvoice, United States Senators Joe Manchin, Rand Paul, and Ted Budd have jointly written a letter to the Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA), urging it to reform the pre-market tobacco product application (PMTA) process. Additionally, they have requested the center to provide information regarding policies and actions taken to ensure that its actions are grounded in science and evidence and conducted in an effective manner.

 

A report highlights that "smoking is a leading cause of preventable diseases and deaths in the United States, with approximately 31 million Americans being smokers," wrote the senators in their letter. "In order to achieve the Food and Drug Administration's goal of reducing harm, an effective authorization process must be in place.

 

Since 2009, more than 26 million PMTA applications for new products have been submitted in the United States. However, the Center for Tobacco Products (CTP) has only approved less than 50 of these applications. Senators argue that availability of scientifically backed and authorized PMTA or MRTP could potentially improve the health conditions of current smokers using risky tobacco products.

 

Senators mentioned that in order to achieve the goal of preventing harm to public health, the FDA must have an effective authorization process. Additionally, they also stated that the FDA's authorization speed is far from acknowledging the risk levels of tobacco products.

 

Senators wrote in a letter, "Previously, CTP attributed its backlog of work to staff shortage, but over the past decade, the number of employees at CTP has grown from 426 in 2013 to over 1,100 now.

 

According to them, since 2009, the FDA has had the authority to assess and collect user fees from tobacco manufacturers and importers, with these fees reaching $712 million per year since 2019. "With such substantial resources, there should be no reason for the CTP to be incapable of complying with the requirements of the Food, Drug, and Cosmetic Act.

 

References:
[1] U.S. Senators Demand FDA to Reform PMTA Process
Also Read:
[1] FDA and CBP Seize 1.4 Million Unauthorized E-Cigarette Products
[2] US Congress Demand Action from Department of Justice and FDA to Stop Child-Friendly E-Cigs
[3] FDA Takes Civil Penalty Lawsuits Against 25 US Retailers for Illegally Selling Unapproved Vapes
[4] FDA Files Lawsuit Against Vape Junkie Ejuice for Unauthorized E-cigarette Sales
#North America#United States#Traditional tobacco#Legislation#FDA

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