FDA Regulation of Tobacco Products

The need for legislation to grant the U.S. Food and Drug Administration the authority to regulate tobacco products is a direct result of the Supreme Court's March 2000 decision that held that, under current law, the FDA does not have authority to regulate tobacco products. As a result of the Court's ruling, it is now up to Congress to grant the FDA the authority it needs to regulate tobacco products - just as it does with any other consumer.

The need for action is clear.

  • In the 4 years since Congress' last attempt to pass legislation granting authority to the FDA to regulate tobacco1, about 3 million children have become regular smokers, of whom about 1 million will die prematurely of tobacco-related illnesses.2
  • Every year the Federal government spends an estimated $38 billion on services attributable to tobacco-related illnesses (Medicare, Medicaid, Veterans, etc…)3. In addition, states spend an estimated $7.3 billion every year on Medicaid services for tobacco-related illnesses4.

The authority that such legislation would grant the FDA would not lead to a ban on tobacco products or even constitute special regulation of tobacco - it would simply be comparable to the FDA's existing authority over other consumer products.

Effective regulation would provide more information to consumers, protect kids and the public health and assure that decisions are based on sound science.

  • Limiting Sales of Tobacco Products to Children - Effective regulation of the tobacco industry would lower rates of tobacco use among children and adolescents by: (1) imposing limits on industry marketing, sales, and promotions, and (2) limiting where tobacco products can be sold so as to limit access by children to tobacco products.
  • FDA's Authority No Greater Than For Other Consumer Products - The FDA's authority to override ("pre-empt") State tobacco product laws would be no different than its existing authority for food, drugs, and cosmetics.
  • Disclosure of What Is In Tobacco Products - Consumers would have access to all the ingredients (as well as the naturally occurring elements in tobacco smoke known as "constituents") that tobacco manufacturers add to their products.
  • Access to Tobacco Manufacturers Research - FDA authority over tobacco products would give the FDA and the public access to all the information the tobacco industry has on the health effects of their products, on nicotine and its addictiveness, on marketing to children, along with any other information that would protect public health.
  • Protecting Public Health - In making decisions about whether or not to approve different tobacco products, the FDA would calculate whether or not the introduction of a new tobacco product would harm more people than it helps.
  • Meaningful Warning Labels - The FDA would be able to require manufacturers to place meaningful and more realistic health warnings (on their products and advertisements) about the risks of using tobacco products (including harmful ingredients and "constituents") beyond those found in the traditional Surgeon General's warnings.
  • Reducing Risks Where Technologically Feasible - The FDA would have the authority to require manufacturers to reduce or eliminate ingredients and naturally occurring "constituents" that are known to be harmful to human health either by prohibiting their use or by reducing or eliminating them with a proven technology.
  • Any Claims Must Be Based on Science - The FDA would have the authority to require tobacco manufacturers to scientifically prove any claims they make about the health risks (or alleged benefits) posed by their products (for example, statements that suggest lower risks of cancer, heart disease, etc…).
  • FDA Would Only Be Able To Regulate Manufacturers, Not Farmers - FDA authority would be limited to tobacco manufacturers and their products, not to tobacco farmers, warehouses, auction houses or other entities unrelated to manufacturing.

Related APHA Policy

The American Public Health Association supported measures to give the FDA the authority it needs to effectively regulate tobacco products. Specifically, in Policy Statement 9412, "Regulation of Tobacco Products by the Food and Drug Administration," APHA urges Congress to reaffirm that the FDA has the authority to develop an appropriate regulatory system for tobacco products and urges Congress to fund this function adequately.

Updated 10-02

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Resources

  1. On June 17, 1998 the Senate defeated the Universal Tobacco Settlement Act (S. 1415), a.k.a., the "McCain" bill.
  2. Targeting Tobacco Use: The Nation's Leading Cause of Death, www.cdc.gov/tobacco/overview/oshaag.htm.
  3. Xiulan Zhang et al, "Cost of Smoking to the Medicare Program, 1993," Health Care Financing Review 20(4); L. Miller et al, "State Estimates of Total Medical Expenditures Attributable to Cigarette Smoking, 1993" Public Health Reports 113.
  4. Ibid