The FDA Causes Harm
Jeffrey Miron and Jacob Winter
According to the Food and Drug Administration (FDA), its mission is partly to “[regulate] the manufacturing, marketing, and distribution of tobacco products to protect the public health.” Is it achieving that mission?
Research suggests not. A recent study (Cato Research Brief no. 427)
[evaluated] the full effect of FDA drug regulation—from initial application preparation to post-market activities—for [e‑cigarettes], which the Circuit Court for the District of Columbia unexpectedly exempted from drug regulation in December 2010.
The study found that
the exemption reduced mortality attributable to smoking by approximately 10 percent .… And survey data suggest e‑cigarettes reduced the percentage of those who smoke regularly by 4.3 percentage points.
The exemption reduced smoking because it caused
e‑cigarette innovation [to increase] dramatically .… E‑cigarette patent applications increased sharply in the United States between 2011 and 2019.
This innovation made e‑cigarettes more widely available, leading people to switch from more harmful cigarettes. This effect saved lives:
The regulation exemption enabled innovation that increased years of life among the US population by approximately 74,000 annually from 2011 to 2019.
This study underscores that the FDA’s regulations meant to save lives at least sometimes have the opposite effect.
This article appeared on Substack on April 2, 2025.
