FDA Tobacco Regulation in the United States: Origins and Responses

Historically, several events led to the passage of the Tobacco Control Act in 2009, which gave the FDA authority to regulate tobacco products. This project documents that history and how organizations and individuals have responded to FDA tobacco regulatory actions since then.

There are two series in this project:

• Part One: From Pesticide to NRT: A Regulatory History of Nicotine

  • Chapter One: Tobacco & Nicotine History That Contributes to the Regulatory Landscape

  • Chapter Two: Federal Tobacco Taxation: Revenue, Regulation, and Public Health

  • Chapter Three: Indigenous Peoples, Tobacco, and Federal Authority

  • Chapter Four: From Tobacco Water to Nicotine Pesticide: Discovery, Commercialization & Federal Regulation

  • Chapter Five: Beyond FDA: Federal Tobacco Policy & Regulation Across the Federal Government

  • Chapter Six: Federal Tobacco Enforcement: Agencies, Authorities, and Enforcement Mechanisms

  • Chapter Seven: When Does Tobacco Become a Drug? Federal Drug Law and the Therapeutic-Claims Boundary

  • Chapter Eight: Nicotine Becomes Medicine: The Development and Regulation of NRT

• Part Two: Litigation: Foundations of FDA Tobacco Jurisdiction, 1974–2011

• Part Three: History of the Family Smoking Prevention and Tobacco Control Act

• Part Four: After the TCA (Title name to be determined later)

  • Deeming Rule

  • Poor Man’s PMTA

  • Other topics to be determined as project progresses

• Organization and Individual Response Collection

  • Litigation

  • Policy, Rules, Guidance, and Oversight

  • Marketing Orders - PMTA & MRTP

• Product and Action Specific Response Collections

Entries may be updated as new FDA actions and responses occur.

Scope: This project documents the development and exercise of FDA authority over tobacco products in the United States. The historical series traces important developments in nicotine regulation, efforts to establish FDA jurisdiction over tobacco products, and the events, debates, and advocacy surrounding passage of the Family Smoking Prevention and Tobacco Control Act in 2009.

The response series documents how organizations and individuals have responded to FDA tobacco regulatory actions since that authority was established. It primarily focuses on noncombustible tobacco and nicotine products, including e-cigarettes, nicotine pouches, heated tobacco products, snus, and other smokeless products, while also including selected combustible cigarette policies when they are especially relevant to nicotine regulation or to reducing smoking-related harm. Related litigation, policy, oversight, and product-marketing decisions are included when relevant.

The project is not intended to document every event in the history of nicotine and tobacco regulation, every FDA tobacco action, or every lawsuit involving FDA’s Center for Tobacco Products.

Project goal: To document both how FDA came to regulate tobacco products and what happened after it did. The project brings together historical evidence, regulatory actions, and responses from organizations and individuals so readers can follow how positions, alliances, disagreements, and regulatory philosophies developed over time.

Particular attention is given to preserving diverse perspectives, including those of public health organizations and advocates, researchers, government officials, industry participants, legal organizations, and others—rather than presenting the history or subsequent regulatory debates from a single viewpoint.

• Coming Soon: From Pesticide to NRT: A Regulatory History of Nicotine

• Coming Soon: Litigation: Foundations of FDA Tobacco Jurisdiction, 1974–2011

• Coming Soon: History of the Family Smoking Prevention and Tobacco Control Act

• Coming Soon (Organization)

  • Marketing Orders — PMTA & MRTP

  • Policy, Rules, Guidance, & Oversight

  • Litigation

• Coming Soon (Organization)

  • Marketing Orders — PMTA & MRTP

  • Policy, Rules, Guidance, & Oversight

  • Litigation

• US FDA CTP - Jan. 2025 Reactions Part 1.

• US FDA CTP & WHO - Jan. 2025 Reactions Part 2.

• Reactions Part 3 - US FDA JUUL MGO.

• Glas - Reactions to FDA Authorization.

• Responses to ZYN MRTP Announcement.

Note: Any statements by someone representing an organization will be included in the post about the organization.

• on!

• AACR - American Association for Cancer Research

• AAP - American Academy of Pediatrics

• AARC - American Association for Respiratory Care

• Achieve Life Sciences

• ACC - American College of Cardiology

• ACCP - American College of Chest Physicians

• ACS CAN - American Cancer Society Cancer Action Network

• AHA - American Heart Association

• ALA - American Lung Association

• AMA - American Medical Association

• ASH (US) - Action on Smoking & Health

• Tammy Baldwin, U.S. Senator

• Baltimore Sun Editorial Board

• Big Cities Health Coalition

• Michael Bloomberg and Bloomberg Philanthropies

• Blue Cross Blue Shield

• Richard Blumenthal, U.S. Senator

• CASAA

• Cory Booker, U.S. Senator

• Danielle Carnival, Spokesperson, Cancer Moonshot

• CTFK - Campaign for Tobacco-Free Kids

• Dallas Morning News Editorial Board

• Doctors for America

• Wanda de Kanter, MD

• Mark DeSaulnier, U.S. Congressman

• Tammy Duckworth, U.S. Senator

• Dick Durbin, U.S. Senator

• Essentia Health

• Allen Frances, MD, Chair, DSM-IV Task Force and Former Chair, Duke Dept of Psychiatry

• Stanton Glantz, et al.

• Brian Grady, Urologist with Sutter Health. Vice Chair, California Medical Association.

• Mazie Hirono, U.S. Senator

• Casey Husser, MD

• Kaiser Permanente

• Robin Kelly, U.S. Congresswoman

• Dr. Rudy Kink

• Jessica Knurick, PhD, RD

• Gary L. Kreps, PhD

• Raja Krishnamoorthi, U.S. Congressman

• Pamela Martinez, PhD

• Ed Markey, U.S. Senator

• Jeff Merkley, U.S. Senator

• Alexandre Mihaila, Pharmacist

• Gavin Newsom, Governor of California

• Michael O’Brien, MD

• Frank Pallone, Jr., U.S. Congressman

• PAVe - Parents Against Vaping e-cigarettes

• Prevent Cancer Foundation

• Protect Our Care

• Jack Reed, U.S. Senator

• Reid Health

• Resolve to Save Lives & Dr. Tom Frieden

• Robert Wood Johnson Foundation

• Bernie Sanders, U.S. Senator

• Charles Schumer, U.S. Senator

• TI - Truth Initiative (formerly American Legacy Foundation)

• Tobacco Control Legal Consortium

• U.S. PIRG Education Fund

• Elizabeth Warren, U.S. Senator

• James Wigmore

• Ron Wyden, U.S. Senator

Until next time…

Notes:

• I create these newsletters as a personal project. They are not affiliated with any current or past employers or groups with which I volunteer. I receive no financial compensation for my efforts to create these newsletters. I use AI to help with spelling, punctuation, grammar, and editing some of my work.