Following a review authorized by Commissioner Robert M. Califf, the Reagan-Udall Foundation found that More effort is needed to get rid of the millions of illegal vaping products in the market. The independent review showed that the FDA regulators were overwhelmed and fatigued by the high workload that comes from handling issues related to e-cigarettes. There is therefore a need for a major effort by the FDA to remove illegal vaping products from the market.
The Review report also revealed that the FDA’s Center for Tobacco Products has fallen behind in setting clear priorities for the sector. This is in part due to the many lawsuits brought against the agency by both tobacco companies and public health advocacy groups. As a result, the agency has not been efficient in carrying out its mandate as spelt out in the 2009 law that created it.
This has resulted in the vaping market being flooded by millions of illegal e-cigarettes. Many of these products are being sold by companies that had their authorization rejected and those that did not bother to make formal authorization applications to the FDA. While the report blamed the presence of millions of these illegal products on the American market for the enforcement shortfalls by the FDA, it acknowledges that the agency does not have the authority to remove those products. The removal of illegal products is the work of the Justice Department.
The Reagan-Udall Foundation review group was led by Lauren Silvis who was the Chief of staff for Scott Gottlieb when he was the FDA commissioner. The group argued the Biden administration to look into setting up an interagency task force to address the issue of illegal vaping products in the market and to coordinate the enforcement of the existing tobacco laws.
The reports also want the FDA to set out a road map that will guide the implementation of its core mandate. This includes the authorization of vaping products and setting standards for emerging products.
Robert M. Califf, the FDA Commissioner says that the agency will review the report and develop necessary steps to address the issues raised going forward. According to him, the agency will provide more information on this by February 2023. The commissioner says that the FDA has made a lot of progress since the review began but he believes that more work needs to be done and the report will help in putting in place measures to make the agency even more effective in its mandate.
The report has been praised by both the supporters and critics of the FDA on its handling of the vaping challenges in the country. Many anti-tobacco groups have raised their support for the improved enforcement and compliance measures that the report is asking for. The pro-vaping groups, on the other hand, have praised the calls for a government-wide agency to deal with emerging challenges that relate to vaping products. They feel that the FDA has been slow in approving products and enforcing laws. With the review reports now available, many expect the FDA to implement its recommendations and thus become more effective in handling issues related to vaping.
