This afternoon, Americans for Tax Reform provided input to the Reagan-Udall Foundation as the Foundation undergoes an external review of the operations of FDA’s Tobacco Program. ATR’s submission highlights how FDA has significantly and substantially failed to fulfill their congressional mandate to act on behalf of the protection of public health.

“For far too long, FDA’s Tobacco Program has failed to act with transparency and predictability as it relates to vaping products,” said Tim Andrews, ATR’s Director of Consumer Issues. “We are grateful to the Reagan-Udall Foundation for conducting this external review and feel hopeful that the recommendations made by the Foundation will help to fix the broken system.”

“FDA’s Premarket Tobacco Product Application (PMTA) process has created impossible administrative burdens on applicants. 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,” said Andrews, “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.”

ATR offered the following seven reforms to the Reagan-Udall Foundation:

  1. 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.
  2. FDA must provide an easy, streamlined, PMTA pathway, as initially promised.
  3. FDA’s PMTA process should focus on product safety and individual risk, not behavioral and population assessments that are better gathered by a singular post-market surveillance team.
  4. FDA should be in regular, proactive contact with all PMTA applicants, as opposed to merely issuing MDO’s after year long periods of silence.
  5. 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.
  6. FDA must urgently act to combat significant public misinformation that it admits exists in the community and is a barrier to smoking cessation.
  7. 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.

ATR’s submission can be read in its entirety here.