FDA tobacco bill

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This article is part of the Tobacco portal on Sourcewatch funded from 2006 - 2009 by the American Legacy Foundation.

The FDA tobacco bill, also known as the "Family Smoking Prevention and Tobacco Control Act," or the "Waxman tobacco bill" is legislation designed to give the U.S. Food and Drug Administration the power to regulate tobacco products. It was first introduced in the U.S. Congress in February, 2007, and was reintroduced in 2008 and again in 2009.[1]

News reports have indicated the bill was produced through negotiations between Philip Morris and the Campaign for Tobacco-Free Kids.[2]


In 1994, David A. Kessler, then Commissioner of the U.S. Food and Drug Administration (FDA) asserted that nicotine was a drug and cigarettes were drug-delivery devices intended to affect the structure and function of the body, and as such, should be regulated by the FDA under the federal Food, Drug & Cosmetic Act. Following this assertion, FDA promulgated rules that were narrowly tailored to protect youth from nicotine addiction, like the use of "tombstone" advertising (black and white text only), and restrictions on point of sale advertising. In 1995, Philip Morris, R.J. Reynolds, Brown & Williamson, Lorillard Tobacco Company and Liggett Tobacco Company challenged FDA's jurisdiction over nicotine in court [3] and ultimately, in 2000, the Supreme Court ruled on a split decision (5 to 4) that only Congress has the ability to direct FDA to regulate cigarettes.[4]


With the exception of menthol, the proposed bill would eliminate the use artificial flavorings in tobacco; require the disclosure of ingredients; allow FDA to require manufacturers recall "defective" cigarette products (that is, cigarettes that, according to the bill, contain "a manufacturing or other defect not ordinarily contained in tobacco products on the market that would cause serious, adverse health consequences or death"); require cigarettes not be "adulterated or misbranded"; require specifically worded warning labels with colors and graphics that take up 30 to 50 percent of the front and back of the pack; prevent the givaway of free samples; regulate advertising and promotion, and other measures. [5]

Criticism and opposition

Critics of the FDA tobacco bill include the American Association of Public Health Physicians and FDA chief Dr. Andrew C. von Eschenbach, who maintains that FDA's role is to regulate products that are beneficial to public health, and that the agency should be asked to regulate products that are harmful. Bringing tobacco under the jurisdiction of FDA could also mislead consumers into believing that tobacco products are safe or even good for their health. Opponents also argue that FDA agency does not have the financial or staff resources available to allow it to regulate the tobacco industry.[6]

Other criticisms include that the bill:

  • Precludes FDA’s authority to ban any class of tobacco product.
  • Precludes FDA’s authority to eliminate nicotine, the addictive element, from tobacco products.
  • Precludes FDA’s authority to remove additives that are nontoxic but contribute to the lure of the product.

Critics argue that the FDA should have full authority to remove all additives used in tobacco products regardless of their toxicity, since many non-toxic additives, like menthol or smootheners, contribute to the product's appeal and thus reinforce exposure to other toxins found in tobacco.

Critics oppose a provision in the bill that mandates that the tobacco industry have representation on the oversight committee created by the bill. They argue that tobacco manufacturers should not be given special access or authority to influence rules the government makes about the labeling, health and safety regulations of tobacco products. They also claim that this provision would also make the United States noncompliant with one of the key articles in the World Health Organization's Framework Convention on Tobacco Control.

The bill would also preempt state and local regulation of tobacco products. Critics argue that the FDA should set minimum standards for regulation and that local and state health authorities should have the ability to implement stronger regulations if such regulations are deemed necessary to protect public health.[7]

Related SourceWatch resources

External resources


  1. Library of Congress, Thomas Family Smoking Prevention and Tobacco Control Act, Henry A. Waxman. Accessed March 5, 2009
  2. Brody Mullins Philip Morris, Tobacco Foes Tied the Knot Roll Call, October 5, 2004
  3. J.L. Furr, M.L. Holton III, et al Coyne Beahn, Inc., Plaintiffs V. United States Food and Drug Administration and David A. Kessler, M.S., Commissioner of Food and Drugs, Defendants. First Amended Complaint for Declaratory and Injunctive Relief Civil Action, File Number 2 95CV00591 Court pleading. 39 pp. September 7, 1995. Bates No. 89278409/8447
  4. Linda Greenhouse, New York Times High court holds FDA can't impose rules on tobacco March 22, 2000
  5. GovTrack.us Text of H.R. 1256: Family Smoking Prevention and Tobacco Control Act, accessed March 5, 2009
  6. David Gutierrez, NaturalNews.com Why Philip Morris Supports FDA Regulation of Tobacco April 1, 2008. Accessed March 5, 2009
  7. Joel Nitzkin, David Cundiff, American Association of Public Health Physicians AAPHP Full Analysis of Proposed FDA Tobacco Legislation, July 12, 2007.33 pp. Accessed March 5, 2009