James Comer, chairman of the U.S. House Oversight and Accountability Committee, is providing oversight of the Food and Drug Administration's (FDA) regulation of tobacco and nicotine products through his Center on Tobacco Products (CTP).

He said CTP failed to effectively define and manage its tobacco and nicotine regulatory programs, leading to industry uncertainty and unsafe products entering the market. In a letter to FDA Commissioner Robert Califf, Chairman Comer requested documents, communications, and staff briefings related to CTP's activities to ensure it performs its regulatory functions as intended.

“The Oversight and Accountability Board, through its Center for Tobacco Products (CTP), is providing oversight of the Food and Drug Administration’s (FDA’s) regulation of tobacco and nicotine products. A recent review of CTP by the Reagan-Udall Foundation (RUF) found that, CTP does not clearly lay out the most basic elements of its tobacco and nicotine regulatory program. This leads to confusion, inefficiency, litigation and suspicion of political interference. CTP contributes to market uncertainty and allows unsafe and unregulated products proliferating. Therefore, we seek documentation and information on CTP activities to enable transparency and ensure that CTPs perform their required functions," Chairman Comer wrote.

The Reagan-Udall Foundation (RUF) evaluation of CTPs indicates that CTPs are failing in their essential function of ensuring Americans have access to products that have the potential to reduce smoking-related disease and mortality. In the absence of policy clarity, stakeholders even reported having to guess what the CTP's provisions might be. Congressional oversight is needed to increase transparency of CTP's lack of clear policies that lead to market uncertainty, unregulated products, and enforcement failures.

“We are deeply concerned that CTP’s decision was influenced by political concerns rather than scientific evidence. Comments by FDA staff on RUF reflect this concern, but are no longer available on its website. For example, a Where the review is complete and a scientific decision is made, they are also overruled by the political agenda and forced to change the decision, commenters said. Another said that scientific disagreement would be opposed, if not completely suppressed, And one-third said leadership does not support the reviewer's basic responsibility to provide an unbiased review using the best available science. FDA must clearly identify and publish what scientific standards are required for products, including electronic delivery systems (ENDS) products and smoke-free products,” continued Chairman Comer.

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