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FDA Regulation of Tobacco Products

On June 22, 2009, President Barack Obama signed a bill into law that allows the Food and Drug Administration (FDA) to have broad authority over the regulation of tobacco products. The bill, called the Family Smoking Prevention and Tobacco Control Act (H.R. 1256), gives the FDA the authority to regulate the manufacturing, marketing and distribution of tobacco products in the United States. The purpose of the bill, as provided in the text, includes:

United States Congress
  1. The ability of the FDA to set national standards controlling the manufacture of tobacco products and the identity, public disclosure, and amount of ingredients used in such products

  2. New and flexible enforcement authority by the FDA to ensure effective oversight of the tobacco industry's efforts to develop, introduce, and promote less harmful tobacco products

  3. The ability of the FDA to regulate the levels of tar, nicotine and other harmful components of tobacco products

  4. The requirement of tobacco product manufacturers to disclose research which has not previously been made available, as well as research generated in the future, relating to the health and dependency effects or safety of tobacco products

  5. The development of measures to ensure that tobacco products are not sold or accessible to underage purchasers

  6. The promotion of cessation to reduce disease risk and the social costs associated with tobacco-related diseases

  7. Strengthened legislation against illicit trade in tobacco products.

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Read the entire bill at external link

While attempts to grant FDA authority to regulate tobacco go back almost 30 years, the push for this legislation dates back more recently to 1995, when Dr. David Kessler, then FDA Commissioner, proposed increased regulations on tobacco product manufacturers. Dr. Kessler tried to impose regulations on the industry but the U.S. Supreme Court overturned them in 2000.

A bill that would have placed tobacco under FDA jurisdiction was passed by the Senate in 2004 but was never approved by the House. The bill that the House approved in the spring was introduced in both chambers in 2007 and again in the House in 2008.

To date, the FDA Center for Tobacco Products has banned the use of labeling cigarettes and other tobacco products as “light;” banned the selling of flavored cigarettes (with the exception of menthol and other tobacco products); required stronger warning labels on cigarettes (though some of that has been overturned by courts); and banned the selling and distribution of some bidis tobacco products. The FDA is still expected to pass regulations on e-cigarettes and menthol cigarettes, though no timeline has been provided.

Source: United States Food and Drug Administration, Tobacco Products section, 2012 [accessed 7 April 2014].




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