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Last week, Food and Drug Administration (FDA) Commissioner Dr. Robert Califf announced that he is ordering an external review of “key agency activities”, including the Center for Tobacco Products (CTP). This review offers the opportunity for FDA to re-examine the overarching aim of their tobacco “control” efforts and shift the focus to harm reduction, rather than harmful prohibitions.

Since April, a slew of FDA decisions has brought increased attention to the ambiguous, often disorderly operations of the agency. FDA has announced proposed rules to ban menthol cigarettes, ban flavored cigars including premium cigars, and force tobacco companies to decrease nicotine in cigarettes by 95%, essentially a total prohibition on cigarettes in the United States. Critics, including Americans for Tax Reform, have denounced these actions as detrimental for criminal justice reform efforts, harmful to national security, and unprecedented attacks on consumer freedom.

FDA has not limited their authoritative measures to traditional tobacco products. In late June, FDA ordered JUUL, one of the most popular e-cigarette brands that has helped more than a million Americans quit smoking, to stop selling and distributing their products. The order was short-lived, as the U.S. Court of Appeals issued a stay, allowing JUUL to continue operations, before FDA announced that they would be suspending the JUUL ban pending additional review, an embarrassing reversal of a highly publicized decision.

Disturbingly, JUUL alleged that FDA ignored over 6,000 pages of data showing that “chemicals are not observable in the aerosol that Juul user inhale”. It is not surprising that FDA would ignore evidence on e-cigarettes, as they have thus far refused to follow the overwhelming scientific consensus that e-cigarettes are at least 95% less harmful than smoking and an effective way to help smokers quit the deadly habit of cigarettes. In fact, more than 100 of the world’s leading public health agencies have endorsed vaping for these very reasons.

And yet, in the face of indisputable evidence, FDA has continued to take the wrong approach to e-cigarettes. This external review, which will be performed by the Reagan-Udall Foundation, is the perfect opportunity for FDA to admit past mistakes and forge a new path, one that embraces reduced-risk alternatives to smoking and helps to usher in a smoke-free generation.

FDA has taken positive steps towards this goal. In 2019, FDA authorized eight smokeless tobacco products to be marketed as “modified risk” and in 2020, the IQOS Tobacco Heating System was similarly authorized as a modified risk product. Smokeless tobacco and heat-not-burn (HNB) products both subject users to significantly less harm than traditional cigarettes. In Sweden, smokeless tobacco use has led Swedish to develop lung cancer at the lowest rate in the developed world. In Japan, HNB popularity caused cigarette sales to decrease by 43%.

The Reagan-Udall review will assess the “processes and procedures, resourcing, and organizational structure” of CTP. The impact that such a review could have on the future operations of the agency is unclear. What is clear is that CTP, in its current form, is ill-equipped to bring about a smoke-free America.

The demonstrated health benefits of smokers switching to reduced-risk products rely upon easy and legal access for adult consumers. FDA must recognize that their current path, one that embraces prohibition while rejecting popular, safer products, will lead to increased tobacco-related harm. E-cigarettes are vital for public health and can save 6.6 million American lives, according to an analysis from Georgetown University Medical Center. This is truly an issue of life or death for millions of Americans. FDA must accept the science, embrace harm reduction, and usher America into a new era of evidence-based public health policy.