FDA Misses the Point, Again: Reagan-Udall Evaluation

In 2022 FDA Commissioner Califf announced a review of its Center for Tobacco Products by the Reagan-Udall Foundation. The foundation said that the CTP “has a critical mission to protect the public health from tobacco-related disease and death and is regulating products that have no inherent benefit and huge societal costs, it is a government regulatory program with a duty to run efficiently, fairly, and transparent.” They also reported a lack of clarity and transparency, as well as internal communication issues. Moreover they found that the CTP is not equipped to face the workload that comes with the PMTA process and other regulatory oversights they have been tasked with.

“The almost 40-page report highlighted that Reagan-Udall was “unable to identify a current comprehensive plan that clearly articulates CTP’s priorities, direction for the future, and its near-term and longer-term goals and objectives.” Its sweeping suggestions included improving communications and transparency, perhaps through a potential public meeting; adopting methods to allow more stakeholder input; developing clearer frameworks for “high-quality” marketing applications for nicotine products, and increasing “use of the Tobacco Products Scientific Advisory Committee.

In typical FDA fashion the solution they came up with to fix these serious deficiencies within the CTP is to urge Congress to approve the implementation of user fees to cover the “costs of the workload caused” by the PMTA process. He said “To achieve these goals, we need to have the appropriate resources to hire and retain staff with the skills needed to effectively meet our public health mandate around tobacco.”  A few things run through my mind when I hear statements like this one, Use fees caused by “whom?” and this is a solution to above issues cited by RUF? They grab your money and then shut you down.  Seems legit! 

In another statement by Califf in this FDA press release he doubles down on misinformation by stating “Unfortunately, the tobacco industry has fought the agency on many of the science-based actions we’ve taken – putting profits over public health. For example, despite being the only country with sweeping regulatory authority over the industry, unlike many other nations, legal challenges have twice prevented us thus far from implementing congressionally mandated warnings on cigarette packs depicting the serious health risks of cigarette smoking.”

This is truly a comical statement since CTP are clearly the ones that are putting profits above public health by denying 99.99% of PMTA applications submitted, prioritizing youth use over adult lives.

While vapers are not shocked at these responses to the RUF review it still saddens me to see that even when such steps are taken with results that could (and should) be promising real change at the FDA we still end up with more of the same. 


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