FDA’s Center for Tobacco Products Responds to Reagan-Udall Foundation Report, Announces Plans for New Transparency & Policy Units

As promised, the U.S. Food & Drug Administration’s (FDA) Center for Tobacco Products (CTP) has published a more detailed response to last year’s Reagan-Udall Foundation report, which looked at issues within CTP. This external review—the Reagan-Udall Foundation is centered around FDA but is a separate entity—was one of two requested during 2022 by Dr. Robert Califf, FDA’s commissioner, after high-profile controversies regarding FDA’s regulation of Juul e-cigarettes and issues with the U.S. supply of baby formula, which is regulated by FDA.

When the report was announced in December 2022, Brian King, director of CTP, said that a more detailed response would come in February in regards to the four major recommendations that the report made:

1. CTP Should Be Proactive, Not Reactive — It also recommends that the agency “should take the time now to think strategically about where it is today and where it needs to go in the next several years.”
2. CTP Must Be Run Efficiently, Fairly and Transparently — For example, the report highlights how the agency appears to have shifted its position on non-tobacco-flavored vaping/e-cigarettes without notice. Transparency is a major focus of the report.
3. CTP Must Identify and Address the Key Policy and Scientific Questions — It argues that not doing this has caused some of the legal issues that have complicated CTP’s mission.
4. CTP Needs to Work With Other Agencies to Remove Illegal Tobacco Products — The report documents that FDA oftentimes needs the Department of Justice to take up enforcement actions, something that slows down and complicates enforcement. The report suggests working with local agencies more.

King and CTP have issued that response, which like the report itself, makes no mention of premium cigars. In today’s response, there are some common FDA talking points: science-based regulations, a focus on maximizing public health, listening to lower level employees and more transparency. There are also some more concrete changes plan.

Amongst those changes includes the announcement of a new policy unit that would focus on how the agency’s regulations are developed and later enforced. As part of this, the agency will be more transparent about its policy agenda; CTP says it will publish a policy agenda by the end of this year and then update it annually. It has also promised to install transparency liaisons within the various existing units at CTP. CTP said it will also begin to publish more information about what it is doing as part of a large effort to increase dialogue with stakeholders.

In addition, CTP says it will begin looking into ways to be more proactive in enforcement, specifically by finding ways to work with law enforcement agencies other than the Department of Justice, something the Reagan-Udall Foundation report said was inefficient. Perhaps most notable as part of this initiative is that CTP says that it will ask Congress to change existing laws to allow this to happen:

CTP will consider whether statutory changes are needed to assist the center in enforcing the law. If statutory changes are needed, CTP in coordination with relevant FDA and HHS offices and the administration, will seek such changes from Congress.

For the tobacco industry, this is opening a can of worms. While CTP’s intent could be simply changing how it’s able to conduct enforcement, once the door is opened on making statutory changes, the door will open to make much more substantial changes to how FDA operates.

The agency has launched a webpage dedicated to how it will address the Reagan-Udall Foundation’s recommendations.

You can read Brian King’s letter in full here.