Elsevier

The Lancet

Volume 381, Issue 9877, 4–10 May 2013, Pages 1570-1580
The Lancet

Series
Understanding the Tobacco Control Act: efforts by the US Food and Drug Administration to make tobacco-related morbidity and mortality part of the USA's past, not its future

https://doi.org/10.1016/S0140-6736(13)60735-7Get rights and content

Summary

The USA has a rich history of public health efforts to reduce morbidity and mortality from tobacco use. Comprehensive tobacco-prevention programmes, when robustly implemented, reduce the prevalence of youth and adult smoking, decrease cigarette consumption, accelerate declines in tobacco-related deaths, and diminish health-care costs from tobacco-related diseases. Effective public health interventions include raising the price of tobacco products, smoke-free policies, counter-marketing campaigns, advertising restrictions, augmenting access to treatment for tobacco use through insurance coverage and telephone help lines, and comprehensive approaches to prevent children and adolescents from accessing tobacco products. The US Food and Drug Administration (FDA) has six major areas of regulatory authority: regulation of tobacco products; regulation of the advertising, marketing, and promotion of tobacco products; regulation of the distribution and sales of tobacco products; enforcement of the provisions of the Tobacco Control Act and tobacco regulations; regulatory science to support FDA authorities and activities; and public education about the harms of tobacco products and to support FDA regulatory actions. With passing of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) in June, 2009, important new regulatory approaches were added to the tobacco prevention and control arsenal.

Introduction

The USA has made great efforts to reduce morbidity and mortality from tobacco use, but progress in decreasing the prevalence of tobacco use has slowed. Comprehensive tobacco-prevention programmes, when implemented robustly, diminish the prevalence of youth1, 2 and adult3 smoking, decrease cigarette consumption,4 accelerate declines in tobacco-related deaths,5, 6, 7 and reduce health-care costs from tobacco-related diseases.8, 9, 10 However, funding for such programmes has been cut sharply,11 which has resulted in reduced implementation of the public health interventions that have proven effective. Such interventions include increasing the price of tobacco products, smoke-free policies, counter-marketing campaigns, advertising restrictions, increasing access to treatment for tobacco use through insurance coverage and telephone help lines, and comprehensive approaches to minimise access to tobacco products for children and adolescents.12, 13 Although not expensive interventions per se, implementation of effective policy interventions can be challenging; for example, in the USA in 2012, only Illinois increased significantly its excise tax on cigarettes and only North Dakota passed a comprehensive smoke-free air law. No US states equalised their taxes on other tobacco products with those on cigarettes, and states only increased efforts minimally to help smokers quit, despite opportunities to do more through implementation of the Affordable Care Act.14

With the exception of Federal Trade Commission requirements on marketing and labelling of tobacco products, tobacco products have been largely exempted from other public health regulatory requirements, including consumer product safety regulation. For example, the Consumer Product Safety Commission regulates cigarette lighters but not cigarettes or other forms of tobacco.15 With the passing of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) in June, 2009, important new regulatory approaches were added to the US tobacco prevention and control arsenal. Much like other areas of tobacco prevention and control, the actions taken by one country can provide a model for other countries to emulate and expand on. Thus, some statutory requirements model accomplishments in other countries (eg, graphic health warnings, flavour ban), whereas others create new authorities that other countries have not implemented (eg, premarket review of new tobacco products).

Here, we explain the regulatory authorities of the US Food and Drug Administration (FDA) and describe actions the FDA has taken to date to support these. We summarise the FDA's statutory authorities within a framework of six major activities and review regulations and guidance issued to date for these same six areas.

Section snippets

The Tobacco Control Act

The Federal Food, Drug, and Cosmetic Act (FD&C Act) is the primary federal law that governs the FDA's work.16 The Tobacco Control Act became law on June 22, 2009,17 and it amended the FD&C Act to give the FDA authority to regulate the manufacture, distribution, and marketing of tobacco products to protect the public's health. All operations and expenses of the FDA's Center for Tobacco Products, which implements the law, are paid for by user fees imposed on particular tobacco manufacturers and

Scope of the FDA's authorities under the Tobacco Control Act

The FDA's authorities and activities cover six major areas: regulation of tobacco products; regulation of the advertising, marketing, and promotion of tobacco products; regulation of the distribution and sales of tobacco products; enforcement of tobacco regulations; regulatory science research; and public education about the harms of tobacco products and to support the FDA's regulatory actions. The FDA's authority over tobacco products is quite broad but has several limitations. For example,

Tobacco product regulation by the FDA and the role of public input

The FDA's authority is derived from a set of laws, including the FD&C Act, the Administrative Procedures Act,61 and the FDA's Good guidance practices.62 The FDA issues regulations and guidance documents routinely to explain and enforce those laws. Regulations have the force of law and explain what the regulated industry must do to comply with the law, whereas guidance documents describe the agency's current thinking on a regulatory issue. Guidance is a generally recommended approach to meet a

Opportunities and challenges

Implementation of the Tobacco Control Act presents great opportunities for substantial public health improvement via the new provisions of the FD&C Act, which combines regulation of the manufacture, marketing, and distribution of tobacco products in the USA under one agency of the US Government—the FDA. The authorities for tobacco product regulation represent a public health regulatory framework for decreasing morbidity and mortality caused by tobacco use in the USA. These authorities are new

Conclusions

The Tobacco Control Act provides a new public health approach to reduce deaths and disease caused by tobacco use in the USA. Just as the FDA has learnt (and continues to learn) from other countries that have implemented regulatory actions, our hope is that the regulatory frame the FDA is putting in place can provide a model for other countries as they seek to strengthen their regulatory approach to tobacco prevention and control. The FDA has been moving forward to implement and enforce its

References (72)

  • M Farrelly et al.

    The impact of tobacco control program expenditures on aggregate cigarette sales: 1981–2000

    J Health Economics

    (2003)
  • JA Tauras et al.

    State tobacco control spending and youth smoking

    Am J Public Health

    (2005)
  • MC Farrelly et al.

    A comprehensive examination of the influence of state tobacco control programs and policies on youth smoking

    Am J Public Health

    (2013)
  • MC Farrelly et al.

    The impact of tobacco control programs on adult smoking

    Am J Public Health

    (2008)
  • Declines in lung cancer rates: California, 1988–1997

    MMWR Morb Mortal Wkly Rep

    (2000)
  • CM Fichtenberg et al.

    Association of the California tobacco control program with declines in cigarette consumption and mortality from heart disease

    N Engl J Med

    (2000)
  • California tobacco control update 2006: the social norm change approach

  • JM Lightwood et al.

    Short-term economic and health benefits of smoking cessation: myocardial infarction and stroke

    Circulation

    (1997)
  • J Lightwood et al.

    Short term health and economic benefits of smoking cessation: low birth weight

    Pediatrics

    (1999)
  • J Harris

    Status report on the Massachusetts tobacco control campaign, with a preliminary calculation of the impact of the campaign on total health care spending in Massachusetts

    (2000)
  • Broken promises to our children: the 1998 state tobacco settlement 14 years later

  • Reducing tobacco use: a report of the Surgeon General

  • Best practices for comprehensive tobacco prevention and control programs, 2007

    (2007)
  • State of tobacco control 2013 report

    (2013)
  • Regulations, mandatory standards and bans

  • Regulatory information: Federal Food, Drug, and Cosmetic Act (FD&C Act)

  • Family Smoking Prevention and Tobacco Control and Federal Retirement Reform

  • Section 101 of the Tobacco Control Act: amendment of Federal Food, Drug, and Cosmetic Act (FDCA)

  • Section 901 of the Federal Food, Drug, and Cosmetic Act: FDA authority over tobacco products

  • Federal register: part VIII—semiannual regulatory agenda

  • Regulation of e-cigarettes and other tobacco products

  • Sottera vs Food and Drug Administration: case 627 F.3d 891 (2010)

  • Family Smoking Prevention and Tobacco Control Act: section 2, finding 36

  • Section 907 of the Federal Food, Drug, and Cosmetic Act: tobacco product standards

  • Section 906 of the Federal Food, Drug, and Cosmetic Act: general provisions respecting control of tobacco products

  • Section 905 of the Federal Food, Drug, and Cosmetic Act: annual registration

  • Guidance for industry: registration and product listing for owners and operators of domestic tobacco product establishment

  • Section 904 of the Federal Food, Drug, and Cosmetic Act: submission of health information to the Secretary

  • Guidance for industry: listing of ingredients in tobacco products

  • Harmful and potentially harmful constituents in tobacco products and tobacco smoke: established list

  • Reporting harmful and potentially harmful constituents in tobacco products and tobacco smoke under section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act: draft guidance for industry

  • Letter to tobacco product registered establishments

  • Guidance for industry and FDA staff: general questions and answers on the ban of cigarettes that contain characterizing flavors

  • Section 910 of the Federal Food, Drug, and Cosmetic Act: application for review of certain tobacco products

  • Establishing that a tobacco product was commercially marketed in the United States as of February 15, 2007

  • Guidance for industry and Food and Drug Administration staff: section 905(j) reports—demonstrating substantial equivalence for tobacco products

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