The U.S. Food and Drug Administration is obliged to protect the public health. The Family Smoking Prevention and Tobacco Control Act of 2009 extended its purview to tobacco products.
In 2019, scientists at its Center for Tobacco Products were directed to "eyeball" data. The agency retaliated when they objected. In 2022, the U.S. Office of Special Counsel disclosed that wrongdoing. The agency was supposed to self-correct but didn't. In 2025, the first U.S. sale of oral pouch products containing nicotine extracted from tobacco was authorized. That determination was flawed and the agency promised a correction, but it hasn't. Instead, it continued unscientific, ignorant, and misleading arguments in its role to regulate tobacco products.
The FDA is granted a broad authority to choose how it enforces the law, exercising enforcement discretion to exclude itself from its own policies that govern scientific integrity. That unchecked freedom, under conflicting agendas and performative oversight, has allowed the agency to stray from its mission, with leadership that enforce an unwritten current thinking to support predetermined decisions to deny or allow the sale of tobacco products in the United States.
Despite profits made from addicting Americans to nicotine, this isn't a rebuke of Big Tobacco or the tobacco industry. It is a reprimand of wrongdoing by Big Government that persists despite the products, politics, or mechanisms in place to ensure objectivity. We fail to fix problems when we don't understand what they are. The focus becomes the size of government instead of how it works, where wrongdoing continues via each choice by each individual about their own behavior, and problems persist regardless of the people in power.
This is the story of a regulatory agency misaligned with its mission, mandates, and messaging, where superficial oversight has created a U.S. tobacco market that is effectively unregulated.
Leppanen, Christy: - Christy Leppanen, Ph.D., is an environmental scientist with experience where statutes governing biological, physical, and chemical contaminants are applied. From 2021 to 2025, she was the first microplastic pollution subject matter expert at the FDA Center for Tobacco Products. She was hired to support the agency's compliance with the National Environmental Policy Act, the Family Smoking Prevention and Tobacco Control Act of 2009, and the Federal Food, Drug, and Cosmetic Act.Dr. Leppanen earned a B.S. in Biology and Chemistry from the University of Memphis, an M.S. in Biology from the University of Memphis, and a Ph.D. in Biological Sciences from the University of Maine. She has worked with NGOs, with state, territorial, and federal governments, with international efforts, and taught and published in environmental toxicology, entomology, invasion biology, and conservation science. Dr. Leppanen was an Associate Editor of the journal Biological Invasions, and her work has been supported by the National Science Foundation, the National Fish and Wildlife Foundation, the National Geographic Society, and the University of Washington's Helen R. Whiteley Center. She also wrote the 2014 Foreword INDIES Bronze Winner for Horror, Bulletin of ZOMBIE Research: Volume 1, that was awarded the Kirkus Star.
