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The FDA is at a crossroads for reducing tobacco-related disease and death

Thought Leader: Anand Shah
August 25, 2022
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By Michael B. Farber and WWSG Exclusive Speaker, Anand Shah

The U.S. is at a crossroads for tobacco use, the country’s leading cause of preventable death, at nearly half a million deaths a year.

Since the onset of Covid-19, which has been universally labeled as a pandemic, more Americans have died from tobacco use than from Covid.

Although cigarette smoking has steadily declined over the past several decades, thanks to a more educated and health-conscious society, new and existing combustible and noncombustible tobacco products continue to pose public health challenges.

In a watershed moment in the battle to better control the ongoing tobacco epidemic, the Food and Drug Administration recently took actions to reduce tobacco use. From eliminating menthol flavoring to capping nicotine levels, the FDA has made a deliberate effort to capitalize on the existing and new authorities granted by Congress.

But in the aftermath of the Supreme Court’s recent decision in West Virginia v. EPA, in which the court narrowed the regulatory power of executive agencies, the FDA must now tread lightly when taking significant actions not explicitly authorized by Congress, a development that could hamstring the agency’s efforts in this arena.

Starting in April with the proposal to eliminate menthol from cigarettes and all non-tobacco flavors from cigars, the FDA signaled a redoubled commitment to the Cancer Moonshot — a White House effort launched in 2016 to reduce deaths from cancer by at least 50% over the following 25 years. The FDA proposal has been a long-awaited step following the passage of the 2009 Family Smoking Prevention and Tobacco Control Act, which gave the FDA statutory authority to regulate tobacco.

The agency’s next action was even bolder, as it announced plans to cap nicotine levels in cigarettes and other combustible tobacco products. While not targeting tobacco itself, the FDA pointed to research showing that reducing nicotine to minimally or non-addictive levels can lead to millions fewer people dying from tobacco-related illnesses.

For many decades, the oversight of tobacco — a clear public health challenge — has been calibrated by litigation and court decisions. The same will be true moving forward.

Following the West Virginia v. EPA decision, these recent efforts will likely face another tier of scrutiny under the Supreme Court’s major questions doctrine, which requires Congress to explicitly authorize agency actions with major political or economic significance. Much of the discussion around the court’s decision has focused on the impact the ruling will have on climate policy. But the deeper issue the court addressed was how much authority administrative agencies like the FDA should have.

To answer this question, the court looked to a landmark case in 2000 involving none other than the FDA. That case — FDA v. Brown & Williamson Tobacco Corporation — established that the agency did not have the statutory authority to regulate tobacco products. This meant the FDA had limited authority over cigarettes until the Tobacco Control Act passed nine years later with overwhelming bipartisan support.

Along with concrete steps like banning tobacco sales to minors, limiting promotional activities by tobacco companies, and requiring clear warning labels, the Tobacco Control Act explicitly gives the FDA authority to regulate the manufacture, distribution, and marketing of tobacco products. But the act gives the FDA authority only over tobacco, leaving it without statutory authority over many types of tobacco-free e-cigarettes — at least until Congress clarified this April that it can regulate products containing nicotine from any source, including synthetic forms not derived from tobacco.

What does the West Virginia v. EPA decision mean for the FDA and the Cancer Moonshot going forward? In the short term, it may slow those efforts. The tobacco industry has already cited this Supreme Court decision in comments to the FDA’s proposed rules on issues such as the elimination of all non-tobacco flavors from cigars. This likely portends legal challenges that the FDA is exceeding its delegated authority by taking actions with broad political and economic significance without clear approval from Congress. The practical outcome is that the FDA and Congress will need to remain in lockstep, with the latter frequently clarifying and adding to existing law, to ensure the FDA has the levers it needs to fully implement the Tobacco Control Act.

Congress must keep building upon the progress it has made to date to provide the FDA with explicit authority to regulate additional products associated with tobacco harm. If curbing tobacco-related harm and death can continue to garner the public support it has had over the past quarter century, then there is reason to believe the FDA can continue to positively affect preventable sickness and death in the United States.

Michael B. Farber is a dual degree candidate at Harvard Law School and Harvard Business School. Anand Shah is an oncologist and adjunct senior fellow at the University of Pennsylvania’s Leonard Davis Institute of Health Economics, and was the deputy commissioner for medical and scientific affairs at the Food and Drug Administration from 2020 to 2021.

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