Tag: Americans for Tax Reform

  • Advocacy Group Suggests FDA Reforms

    Advocacy Group Suggests FDA Reforms

    Photo: Araki Illustrations

    The U.S. Food and Drug Administration has “significantly and substantially failed” to fulfill its congressional mandate to protect the public health, Americans for Tax Reform (ATR) told the Reagan-Udall Foundation in a letter.

    The Reagan-Udall Foundation is reviewing the FDA Center Tobacco Products’ (CTP’s) policies and procedures following months of criticism over its handling of e-cigarette reviews. As part of its assessment, the foundation offered stakeholders an opportunity to share their input.

    In its comment, the ATR suggested seven reforms to improve the agency’s performance:

    • FDA should introduce cross-disciplinary expert analysis factoring input from fields like psychology and behavioral economics to increase public awareness and engagement in the decision-making process.
    • FDA must provide an easy, streamlined PMTA pathway as initially promised.
    • FDA’s PMTA process should focus on product safety and individual risk, not behavioral and population assessments that are better gathered by a singular postmarket surveillance team.
    • FDA should be in regular, proactive contact with all PMTA applicants as opposed to merely issuing marketing denial orders after year-long periods of silence.
    • FDA should consider implementing product standards to assist in the streamlining process and look also to countries such as the United Kingdom as a model for a regulatory system that works.
    • FDA must urgently act to combat significant public misinformation that it admits exists in the community and is a barrier to smoking cessation.
    • FDA must reform its approach to youth risk behavior. FDA should accept that youth can benefit from harm reduction and properly evaluate the consequences of reduced vape access for both adults and youth.

    Tim Andrews, ATR’s director of consumer issues, wrote that the Reagan-Udall Foundation’s review could help the agency better the PMTA review process.

    “[The PMTA] process has created impossible administrative burdens on applicants,” he said. “When processes and requirements were changed, FDA failed to notify applicants and is alleged to have applied a new and different standard to certain applicants. FDA’s failures are structural. Our submission is cognizant of that and emphasizes that these issues can’t be solved with increased funding, especially not through user fees on small vape manufacturers.”

  • Survey Reveals Political Strength of Vapers

    Survey Reveals Political Strength of Vapers

    A survey released by Americans for Tax Reform (ATR) demonstrates the influence of the “vape vote,” referencing the millions of Americans who use vapor products to stay away from cigarettes, to impact the 2022 U.S. midterm elections.   

    “This data conclusively proves how the vaping vote can influence elections,” said Tim Andrews, ATR’s director of consumer issues. “Vapers are very active in political issues. Almost four in five voters who vape said they are likely to speak out on vaping issues. 

    “Supporting consumers’ right to quit smoking through vaping isn’t only the morally right thing to do—it’s the politically smart thing to do. Our exclusive polling data shows that vapers are significantly more likely to vote for a candidate who opposes tax increases or flavor bans on vaping products.” 

    According to Andrews, there are 20 million adult vapers in the United States. That equates to at least 45,000 in each Congressional district, he says—enough to make the difference in a close election. ATR’s survey found that two in three vapers are likely to vote for a candidate aligned with them on vaping policy.

    In 2016, Senator Ron Johnson credited his come-from-behind victory in Wisconsin’s U.S. Senate election to the “vape vote.” Survey data found that vapers lean Democratic but are willing to switch their vote for a pro-vaping candidate. There is clearly potential for vaping voters to change close races. 

    “Vaping is shown to be 95 percent less harmful than cigarettes and has the potential to save 6.6 million American lives over the next 10 years,” said Andrews. “Supporting the right of Americans to access lifesaving vaping products should be a no-brainer for all candidates in this year’s midterms. Vaping not only saves lives—it can also save an election campaign.” 

  • FDA Urged to Extend Enforcement Deadline

    FDA Urged to Extend Enforcement Deadline

    Photo: Oleksandr Moroz

    A coalition of 23 organizations has asked the U.S. Food and Drug Administration to follow the recommendations of the Small Business Administration (SBA). Earlier this year, the SBA urged the FDA to allow nicotine products to remain on the market for another year after the current Sept. 9, 2021, deadline while their premarket reviews are in progress.

    Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications—the FDA will unlikely be able to process all submissions before manufacturers are required to pull their products off the market, according to the SBA.

    In a letter to the FDA prepared by the Americans for Tax Reform (ATR), the 23 organizations say that the FDA’s promise to exercise discretion in its enforcement provides insufficient certainty for businesses who have complied with all relevant regulations and have not received authorization due to processing delays by the FDA.

    If an extension is not granted, the letter cautions, there could be devastating consequences for businesses, particularly small businesses. Furthermore, any potential reduction in the supply of safe alternatives to tobacco could have a negative impact on public health across the United States and lead to an increase in tobacco-related mortality, according to the authors.

    The letter also argues that “millions of consumers who depend on ENDS products for their health and thousands of businesses who depend on these products for their livelihood are threatened by this needless bureaucratic uncertainty.” The only way to avert such an adverse outcome for businesses and consumers is for the FDA to obtain a court order allowing it to extend the existing moratorium on enforcement by another year, according to the letter writers.

    “The vaping industry, unlike many others, was created by small businesses, and these same small businesses continue to drive innovation in the market,” the coalition letter states. “Without these entrepreneurs, the vape industry will be consolidated into a few large corporations, causing prices to rise and consumer choice to decrease.”