The Center for Tobacco Products (CTP) at the U.S. Food and Drug Administration (FDA) underwent an independent review in late 2022 by the Reagan Udall Foundation (RU).
This review happened as the center continues to flounder in regulating novel tobacco products such as e-cigarettes.
RU was tasked by FDA Commissioner Robert Califf to examine the ways in which the center could improve its regulatory practices. The review was published on December 19, which was the same day that FDA employees met with long-standing e-cigarette opponents to discuss the review.
It is now becoming overwhelmingly apparent that the agency tasked with regulating the products that could help the 34 million American adults quit smoking is not going to follow the science, or the RU recommendations. And unfortunately, it appears that even an independent review cannot change this.
RU was not tasked with overhauling the entire regulatory processes at CTP, but rather, examining how these processes could be improved. Key recommendations included: urging the agency to “pivot from a reactive mode to a proactive mode,” becoming more efficient and transparent, and that CTP should “address the policy and scientific questions that underpin its regulatory framework.”
On the day the review was published, FDA employees met with Matthew Myers, president of the Campaign for Tobacco-Free Kids (CTFK) and Harold Wimmer, the president and CEO of the American Lung Association (ALA). Doubling down later in the week, FDA employees then went on to meet with Karen Collishaw, the executive director of the American Thoracic Society and Nancy Brown, the CEO of the American Heart Association (AHA).
Some of these organizations (including the CTFK, ALA, and AHA), already sued the FDA after the agency delayed the deadline for submitting applications for e-cigarette products as it was overwhelmed by the number of applications. This hinderance on the FDA was noted by the RU panel. Nonetheless, a judge did side with the e-cigarette opponent groups and the FDA was forced to move the deadline for e-cigarette applications up.
Even more perniciously, all these groups have received substantial financial assistance from billionaire Michael Bloomberg to conflate the data and push for even more restrictions on alternatives to smoking.
In 2019, Bloomberg launched a $160 million campaign to “fight flavored e-cigarettes,” partnering with the CTFK, the ALA, the AHA, and others. Announcing the initiative, CTFK’s Myers was “deeply honored to partner with Bloomberg,” while Wimmer at the ALA went on to “applaud Bloomberg” and the AHA’s Brown thanked “Mayor Bloomberg for his unprecedented leadership and unwavering commitment.”
The initiative calls for the removal of all flavored e-cigarette products from the U.S. marketplace, despite the evidence that adults rely on these to remain smoke-free, and youth are not overwhelmingly citing flavors as a reason for e-cigarette use.
A 2019 study in the Annals of the American Thoracic Society found that adults preferred fruity and sweet flavors, with one author noting that many participants had reported using e-cigarettes to quit smoking and “these flavors may be part of the reason why they end up using e-cigarettes in the long-term.” Further, a 2018 survey of nearly 70,000 American adult vapors found that 83.2 percent and 72.3 percent reported vaping fruit and dessert flavors, respectively.
Data on youth who use e-cigarettes also indicates that kids are not using e-cigarettes because of flavors. According to the 2021 National Youth Tobacco Survey, among middle and high school students that have ever tried e-cigarettes, 57.8 percent reported trying them because a friend used them, 47.6 percent cited curiosity, 25.1 percent reported trying them because they were “feeling anxious, stressed, or depressed,” and only 13.5 percent of American youth that had tried an e-cigarette reported trying them because they were available in flavors.
The organizations that the FDA recently met with did not relay this data out. What is more disturbing is that the organizations are actively conflating numbers to continue with a fake youth vaping epidemic. For example, in December, the CTFK announced the results of the national Monitoring the Future Survey which found a decline in youth vaping in its survey results, even among daily e-cigarette users. Yet, when announcing the MTF results, Myers at CTFK stoked more alarmism by pointing to another youth survey and comparing those figures to 2018 figures, instead of 2019, when youth vaping peaked in America.
It is overwhelmingly apparent this independent review of the CTP at the FDA was not independent. These meetings to discuss the panel’s findings are a damning testament that the FDA will continue to be blinded by billionaire-funded organizations that apparently do not want to see the end of combustible cigarettes.
Lindsey Stroud – The Center Square – 2023-01-12.
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