Following the Reagan Udall Foundation release of their final report reviewing the operations of FDA's tobacco program, Vapor Technology Association Executive Director Tony Abboud released the following statement:
"The Reagan-Udall Foundation's independent review of FDA's tobacco program has uncovered systemic problems inside the Center for Tobacco Products that allowed political decisions to override the science-based recommendations of FDA professional staff concerning the authorization of vaping products that would provide safer alternatives for adult smokers looking to quit combustible cigarettes.
"The Reagan-Udall review was requested by FDA Commissioner Califf to address problems with the Center for Tobacco Products (CTP) programs for regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. Their observations included the following:
- CTP has no strategic plan and must create one that identifies the Center's strategic objectives and plots an operational roadmap to achieve them.
- CTP must resolve how to weigh the public health benefits of adults who use ENDS that will completely quit smoking combustible tobacco products against the potential public health harms to youth who use ENDS.
- CTP has not clearly articulated what is required to meet the appropriateness for the protection of public health standard.
- CTP struggles to function as a regulator due to some of its own policy choices.
- CTP faces significant challenges in clearing policies through the career and political infrastructure.
- CTP lacks consistent implementation of its own policies, particularly with respect to harm reduction.
- CTP has not been transparent regarding its failure to clear the market of illegal products.
- CTP's current goals and priorities are unclear in communication and practice.
"The Vapor Technology Association has raised concerns for years about the opaque and questionable operations of the CTP. Reagan-Udall's review highlights a shifting and arbitrary decision-making process, untethered from science due to political or external pressures, that has damaged the marketplace for safer vaping products, impaired the FDA's credibility, undermined the FDA's mission of harm reduction by denying millions of American smokers truthful information and authorized products. We are pleased to see many of the recommendations VTA provided to the Reagan-Udall Foundation reflected in the Foundation's report.
"The fact that CTP has continued to issue major decisions despite deficiencies highlighted by Reagan-Udall is highly questionable. VTA agrees that 'CTP must invest the time, now'…to create and implement a Strategic Plan' and that 'the path to resolving many of the Center's current challenges starts with establishing the scientific and policy framework to make clear and timely product decisions.' For that reason, the FDA Commissioner should instruct CTP to stand down on issuing any further denials of less harmful nicotine alternative product applications until CTP has been able to review and implement the safeguards and recommendations made by the Reagan-Udall Foundation, and VTA stands ready to assist FDA and CTP by providing the necessary stakeholder input that the Foundation also said was necessary," said Tony Abboud.
The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.
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Original Source: Vapor Technology Association Statement on Critical Reagan-Udall Foundation Final Report