Reagan-Udall Foundation Publishes Review of FDA’s Tobacco Regulations

The Reagan-Udall Foundation, a non-profit focused on the U.S. Food & Drug Administration (FDA), published its review of FDA’s Center for Tobacco Products (CTP). This review was one of two requested over the summer 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.

Other than to acknowledge that cigars are regulated by FDA, cigars are more or less not mentioned throughout the 39-page document. The report was not asked to review FDA’s regulatory policies, i.e. whether or not it should be regulating cigars or e-cigarettes, but rather, how FDA has gone about it and where the processes can be improved. The agency is not bound by any of the report’s recommendations, though Califf said in a statement that said that FDA would review the report and provide an update about its recommendations in February.

The authors have four key points:

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.

While the panel was given just 60 days to review CTP, it was able to come up with rather insightful takeaways. For example, the panel found that CTP was set up to use tools meant to evaluate products before they entered the market but in reality, the agency is actually regulating existing industries:

The current environment reflects an unintended shift from what was structured by law as a pre-market authorization framework to the reality of a post-market regulatory environment, which is much more difficult to deal with given that there are few incentives for industry to come into compliance and many incentives for industry to delay the process.

It also notes that both industry and anti-tobacco groups have used litigation to warp CTP’s regulations, oftentimes creating much larger challenges for the agency.

Nowhere is this clearer than a lawsuit filed by pediatricians and anti-tobacco groups in Maryland, who argued that FDA was acting too slowly. FDA lost that case and the federal judge overseeing it imposed accelerated deadlines for product reviews, which the agency was not prepared to evaluate in a timely manner. More than two years later, those evaluations are still ongoing and that’s without many applications for cigars.

It should be noted that CTP’s next major tobacco policy—a proposal to ban the sale of menthol cigarettes and flavored cigars—is something that was brought on via an accelerated  timeline due to litigation.

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While the panel was sympathetic to CTP’s staff and some of the issues created externally, it had many issues with top-level leadership.

For example:

The Panel 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. Fundamental policy and scientific issues remain unanswered that the Center must address.

It also highlighted how fluid its leadership has been. In its first 13 years, CTP has had seven different commissioners, three different administrators and three different CTP directors.

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The regulation of premium cigars is not mentioned, which makes sense for a number of reasons, not the least of which is that it’s unclear where FDA’s premium cigar regulation stands. The industry and the agency are awaiting a final ruling in a six-year-old federal lawsuit brought on by three cigar trade groups against FDA. The judge has found that FDA did not follow rules regarding the regulations of “premium cigars,” opening up the door for the deregulation of some cigars.

However, there are some parts of the report that could affect cigar regulation in the future.

A major topic of the aforementioned litigation has been about the lack of data regarding premium cigar usage. FDA has also commissioned a separate panel through the National Academy of Sciences Engineering and Medicine to evaluate the data regarding premium cigars.

The Reagan-Udall Foundation committee suggested, likely in the context of e-cigarettes and vaping products, that FDA needs to consider how to regulate short- and long-term when there are gaps in the data:

Acknowledge where gaps in the data exist in making policy judgments (such as the Center’s harm reduction posture); explain how the Agency intends to regulate products, including taking enforcement actions, in the short-term and in the long-term as more data emerges.

In addition, the report suggested that FDA should consider new pathways for product regulation beyond the existing ones—premarket tobacco product application (PMTA), substantial equivalence (SE), grandfathering—which could impact cigars. Once again, this seemed more related to vaping and e-cigarette products, though some of this might also be to make it easier for FDA to regulate products as the committee highlighted that other FDA divisions have alternative pathways.

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Finally, the report is critical of the process used by CTP to try to punish those selling illegal products.

The elephant in the room is that FDA is reliant on the Department of Justice (DOJ) to handle its litigation. There are times when FDA’s attorneys and DOJ’s attorneys are not on the same page, which means that even if FDA wants to go after a company for selling illegal products, sometimes it cannot.

For its part, the committee does not suggest trying to gain independent litigation authority, rather, it suggests finding additional partners—like states or other local authorities—beyond DOJ that would allow FDA to not only do more enforcement but also to do the enforcement quicker.

You can read the full report here.