Tobacco Issues Awaiting Robert Califf at the FDA

By Cathy Zhang

Yesterday, the Senate confirmed Dr. Robert Califf for his second, non-consecutive term as Commissioner of the U.S. Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions.

Prior to his first term as Commissioner during the Obama administration, Califf, a cardiologist, served as the FDA’s Deputy Commissioner for Medical Products and Tobacco.

In addition to fielding scrutiny over mifepristone access, reviewing opioid regulations, and handling COVID-19 vaccine and treatment approvals in the midst of a pandemic, Califf will be overseeing the FDA at a time when public health advocates are anticipating agency action on several tobacco issues.

Two major developments expected in this area include a menthol ban and greater regulation of e-cigarettes.

Banning Menthol Cigarettes

The FDA is scheduled to propose standards for banning menthol in cigarettes by this April, along with a ban on all flavors—including menthol—in cigars. The FDA made the commitment in April of 2021, but these actions reflect years of advocacy and legal pressure.

When Congress gave the FDA the authority to regulate tobacco in 2009, it banned cigarettes with characterizing flavors, with the exception of menthol. Congress left the question of whether to ban menthol cigarettes for the FDA to decide, according to the agency’s public health determinations. In 2013, public health advocates filed a citizen petition requesting that the FDA take action against menthol cigarettes in light of health harms and disproportionate impacts on African Americans, Native Hawaiian and Pacific Islanders, and other racial and ethnic minorities in the US.

In 2018, the FDA announced it would initiate rulemaking on the issue, but, after persistent delay, several of the same advocacy groups filed suit in 2020 to compel the FDA to act. That litigation has been put on hold until May of 2022 in light of the FDA’s anticipated proposal in April. If the FDA fails to issue a notice of proposed rulemaking by then, it may have to continue defending these delays in court.

Reviewing E-cigarettes

At the same time the agency is developing a menthol ban, it is also reviewing whether e-cigarette products can remain on the market. Stemming from a separate lawsuit by anti-tobacco groups, a federal judge previously set a deadline for the FDA to review applications for e-cigarette products by September 9, 2021. While the agency has ruled on 99% of applications, including its first e-cigarette authorizations, in October, it has yet to rule on products made by Juul, which account for 42% of the e-cigarette market. Public health groups are beginning to push for a court-ordered updated timeline for completion of these reviews.

The overlapping regulation of menthol cigarettes and menthol-flavored e-cigarettes has posed some policy challenges for the FDA in the past. Experts, including former Commissioner Scott Gottleib, have expressed concern that eliminating menthol-flavored e-cigarettes from the market before banning traditional menthol cigarettes could drive vape users to begin smoking more harmful traditional cigarettes. Califf will have to coordinate action on both these fronts in the coming months.

Other Issues

In addition to menthol and e-cigarette regulatory developments, the FDA is also considering requiring tobacco companies to limit the amount of nicotine in cigarettes to non-addictive levels. In December, the FDA authorized the marketing of two cigarette products as “modified risk tobacco products,” or low nicotine products, to help users smoke less.

The FDA may also develop legal strategies to regulate synthetic nicotine, which has become a regulatory loophole for flavored e-cigarette producers, at the urging of several members of Congress. Last month a bill was introduced in the House to clarify the FDA’s authority to regulate synthetic nicotine.

While the underlying issues in tobacco regulation have been in place long before Califf’s time as Deputy Commissioner for Medical Products and Tobacco, new legal pressure may precipitate some long-awaited action by the FDA.

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