Product Regulation

Until the summer of 2009, tobacco was the single most dangerous legal product in the U.S. that was not federally regulated.  For decades, the tobacco industry fought ferociously against all attempts at regulation, despite mountains of evidence that its products cause lung cancer, coronary heart disease, respiratory disease, cancers of the bladder, oral cavity, pharynx, larynx, esophagus, cervix, kidney, lung, pancreas, and stomach, acute myeloid leukemia, and a host of other diseases.  Tobacco products remained largely exempt from regulation under the nation’s federal health and safety laws, including the Food, Drug, and Cosmetic Act.

One of the first formal tobacco regulations was the Federal Trade Commission’s requirement in 1965 that all cigarettes and tobacco advertisements carry warning labels. The FTC proposed these labels after the release of the landmark Surgeon General’s Report on the hazards of smoking.  Shortly thereafter, Congress passed the Federal Cigarette Labeling and Advertising Act of 1965, which required warning labels on cigarette packs but not on ads, and preempted the earlier rule. Over the years, the FTC passed other regulations requiring the disclosure of tobacco ingredients and stronger health warnings on cigarettes, cigars, and smokeless tobacco products.  These regulations were mainly to disclose information about the tobacco product – not regulate the product in any significant way. At the same time, the industry began to manufacture and market inviting new tobacco products, such as flavored cigarettes, light/low yield cigarettes, and smokeless tobacco – and ancient practices, such as smoking tobacco water pipes (hookahs) became trendy among the young.  The time was ripe for regulation.

On June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act, giving the U.S. Food and Drug Administration (FDA) comprehensive authority to regulate the manufacturing, marketing, and sale of tobacco products.  This new law represents the most sweeping action taken to date to reduce what remains the leading preventable cause of death in the United States.  

This section contains information on the new federal tobacco regulation and on several tobacco products that are candidates for regulation.

Check out our Product Regulation resources!

For Other Related Topics:

Featured Publications

  What is a Deeming Regulation and How Does It Work? (2014)

Short video clip that explains how under federal law the U.S. Food and Drug Administration can “deem” that a product made or derived from tobacco and intended for human consumption is, for regulatory purposes, a “tobacco product.”

  We’ve Got a Deeming Regulation! . . . . Now What? (2014)

Short video clip that explains what happens once the U.S. Food and Drug Administration “deems” that a product is a “tobacco product” for regulatory purposes.

  (Don't) See More Butts: Preemption and Local Regulation of Cigarette Litter (2014)

Article by Tobacco Control Legal Consortium attorney Michael Freiberg that examines several state and local policy options to address cigarette butt litter, and their susceptibility to federal preemption. 37 Hamline Law Review 1, 205 (2014)

  Point-of-Sale Strategies: A Tobacco Control Guide (2014)

A 52-page guide with a wealth of practical information on selecting and implementing strategies to limit the sale, display, and advertising of tobacco products in the retail environment.  (Center for Public Health Systems Science at Washington University in St. Louis and Tobacco Control Legal Consortium) 

  Regulating Electronic Cigarettes and Similar Devices (2013)

Updated policy guide with options and pointers for communities and policymakers to consider when drafting or implementing laws or policies that regulate e-cigarettes and similar devices.

  Kill the Butts: Policy Options for Reducting Cigarette and Other Tobacco Product Waste (2014)

Date: 
Thu, 03/27/2014
Time: 
12:00PM

Cigarette butts on public streets, sidewalks and other outdoor areas are toxic and unsightly and result in high litter management and collection costs for communities. Programs that effectively minimize tobacco product waste can save municipalities money, substantially benefit the environment, enhance our quality of life, and lower the risk of cigarette-caused fires.

  Pricing Strategies - Tobacco Control Guide (2014)

A 32-page guide on how to implement policies that effectively raise the cost of tobacco products, such as excise tax increases, as well as other price-related policies and enforcement measures.  (Center for Public Health Systems Science at Washington University in St. Louis and Tobacco Control Legal Consortium)

  Policy Strategies - Tobacco Control Guide (2014)

A 32-page guide on how to work with the media, coalitions, decision makers, business owners, and communities to create smoke-free environments, increase the cost of tobacco products, and restrict access to tobacco products.  (Center for Public Health Systems Science at Washington University in St. Louis and Tobacco Control Legal Consortium)

  The Land of 10000 Tobacco Products: How Minnesota Led the Way in Regulating Tobacco Products - AJPH (2013)

Overview of how Minnesota’s 2010 enactment of the Tobacco Modernization and Compliance Act addressed regulatory gaps in the state's tobacco control laws and identified ways in which future laws could be strengthened. Michael Freiberg et al., Am. J Public Health (Dec. 12, 2013).

  Racketeers at the Table: How the Tobacco Industry is Subverting the Public Health Purpose of Tobacco Regulation (2013)

Law synopsis describing the tobacco industry’s long history of misleading the public about the dangers of its products and explaining how the industry’s interest and behavior prevent meaningful participation in the regulation of its products.

  Federal Approaches to the Regulation of Noncigarette Tobacco Products - AJPM (2012)

Journal article by Michael Freiberg highlighting several federal policy interventions that would address gaps in the regulation of other tobacco products.  American Journal of Preventive Medicine 43(5S3):S249-S254) (2012); ClearWay Minnesota-funded research.

  State Electronic Smoking Device Legislation (Sept. 2013)

Table of state electronic smoking device legislation, including status of and links to legislation, prepared by University of Maryland School of Law’s Public Health Law and Policy Legal Resource Center

  FDA Citizen Petition – Asking FDA to Regulate all Tobacco Products (2013)

Citizen Petition to Food & Drug Administration on behalf of the Tobacco Control Legal Consortium and a coalition of state and local public health organizations and their national membership organizations asking the FDA to regulate e-cigarettes, cigars, “little cigars,” hookah and other tobacco products currently free of federal regulation.

  Highlights of Citizen Petition to FDA on Regulating all Tobacco Products (2013)

Highlights of Citizen Petition on behalf of a coalition of state and local public health organizations and their national membership organizations asking the FDA to assert jurisdiction over and regulate all tobacco products.

  New Tobacco Products: An Overview

Date: 
Fri, 04/05/2013
Time: 
1:00PM

As U.S. smoking rates have declined over the last decade, novel non-cigarette tobacco products, often called “other tobacco products” or OTPs have been introduced into the retail marketplace.  This webinar provides an overview of these new tobacco products, what they are, and how they are marketed. The presenters summarize some of the available research on these products and their impact on public health.

  Regulatory Options for Hookahs and Water Pipes (2013)

Fact sheet providing an overview of health risks associated with hookah use, gaps in their regulation, and policy options for state and local governments to regulate hookah smoking and the use and marketing of hookah tobacco.

  Regulatory Options for Little Cigars (2013)

Fact sheet providing a brief overview of little cigars, their health risks, gaps in their regulation, and policy approaches that state and local governments might consider to regulate their usage, pricing, and marketing.

  Regulatory Options for Snus (2013)

Fact sheet providing a brief overview of snus, its health risks, gaps in its regulation, and some approaches that state and local governments might consider to regulate its use, pricing, sale, and marketing.

  Regulatory Options for Dissolvable Tobacco Products (2013)

Fact sheet providing a brief overview of dissolvable tobacco products, their health risks, regulatory gaps, and some approaches that state and local governments might consider to restrict their usage, pricing, and marketing.

  Regulatory Options for Electronic Cigarettes (2013)

Fact sheet providing a brief overview of e-cigarettes, their potential health risks, gaps in current federal and state regulation, and some approaches that state and local governments might consider to regulate their use, pricing, sale, and marketing.

  Other Tobacco Products: A Select Bibliography of Recent Studies (2012)

Select listing of recent studies of five non-cigarette tobacco products:  dissolvables, electronic cigarettes, little cigars, snus and water pipes (hookahs).

  Options for State and Local Governments to Regulate Non-Cigarette Tobacco Products - Freiberg reprint (2012)

Annals of Health Law article that examines deficiencies in the federal, state and local regulation of non-cigarette tobacco products and proposes policy options.

  The Effect of the 2012 Federal Transportation Reauthorization Bill on State and Local Regulation of Roll Your Own Tobacco Retailers (2012)

Fact sheet describing implications of 2012 federal policy that classifies as tobacco manufacturers retailers who make RYO tobacco machines available to consumers.

  Options for State and Local Governments to Regulate Non-Cigarette Tobacco Products (2012)

This article examines deficiencies in many federal, state, and local tobacco control laws relating to OTPs, using five products as case studies. The article focuses on areas which are ripe for regulation at the state and local level. The tobacco control laws in Minnesota, which offer a unique perspective on the regulation of OTPs, are highlighted in this discussion.

Michael Freiberg, J.D.
Annals of Public Health

  Sample Language to Restrict the Sale of Flavored Non-Cigarette Tobacco Products -- Tips & Tools (2012)

Sample language that a local government can adapt in restricting the sale of flavored non-cigarette tobacco products, along with detailed commentary on the concepts addressed.

  Regulating Tobacco Products Based on Pack Size - Tips & Tools (2012)

Basic information for state and local policymakers and others on regulating tobacco products based on pack size; includes policy benefits, options, elements, legal considerations, select legislation and policies, and resources.

  Telling the Public Health Story to the FDA: How the FDA Regulates Tobacco through the Rulemaking Process (2012)

Overview of the rulemaking process under the FDA's Family Smoking Prevention and Tobacco Control Act.

  Federal Regulation of Tobacco and Its Impact on the Retail Environment (2012)

Overview of the federal tobacco restrictions that impact the retail environment, with a focus on provisions in the Family Smoking Prevention and Tobacco Control Act and related regulations. This fact sheet also includes policy options that states and many local governments can consider to further restrict tobacco in retail settings.

  Sunshine Laws: Requiring Reporting of Tobacco Industry Price Discounting & Promotional Allowance Payments to Retailers and Wholesalers - Tips and Tools (2012)

Basic information for state and local policymakers, advocates, and others who are considering requiring disclosure or reporting of industry price discounting and promotional allowance payments (i.e. "sunshine laws") as a tobacco control strategy.

  Roll Your Own Tobacco Machines: An Overview (2012)

Basic information regulating "roll your own" tobacco machines, its impact on public health, and some of the options communities might consider in regulating these products.

  Regulating Roll Your Own Tobacco Machines - Tips & Tools (2012)

Basic information for state and local policymakers, advocates, and others on regulating "roll your own" tobacco machines; includes policy benefits, policy options, legal challenges, select legislation and policies and resources.

  Regulating Non-Cigarette Tobacco Products More Effectively

Date: 
Wed, 11/02/2011
Time: 
12:00PM

Cigarette manufacturers and others are moving aggressively to develop, test, and market many non-cigarette commercial tobacco products, also called “other tobacco products” (OTPs).  This webinar provides a description of OTPs, including gaps in regulation, and emphasizes the important role state and local health departments can play in regulating these products. 

  Citizen Petition to FDA Regarding Review & Regulation of NRT Products

Petition to FDA re. tobacco cessation products (2010)

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