FDA Creates List of Harmful Elements in Tobacco Smoke, Products

Required by the same law that gave FDA authority to regulate tobacco products, it is a long list of potentially harmful constituents, including benzene, lead, mercury, and toluene.

Beginning June 22, 2012, manufacturers of tobacco products and importers of such products or their agents must submit a list of the potentially harmful constituents in those products and in the smoke they produce -– and report it by the quantity found in each brand. This is required by the 2009 law that gave the U.S. Food and Drug Administration authority to regulate tobacco products, and now FDA has created the list of harmful and potentially harmful constituents plus draft guidance to help those who must report.

FDA said its list may not include every potentially harmful constituent, partly because it focused on only five disease outcomes: cancer, cardiovascular disease, respiratory effects, developmental or reproductive effects, and addiction. FDA will continue to review scientific information, and it may add or remove constituents in the future.

HHS Secretary Kathleen Sebelius issued a statement March 30 saying the list is an important tool. "Tobacco use continues to be the leading cause of preventable death in our country and today's action by the FDA is a significant step toward providing Americans with the facts about the dangers of tobacco," she said. "Tobacco companies will be required to report the amount of harmful and potentially harmful chemicals in tobacco products and their smoke. The chemicals that will be reported cause or could cause serious health problems including cancer, lung disease, and addiction. Today's action will ultimately provide important new information about the risks associated with tobacco products. In addition, the Family Smoking Prevention and Tobacco Control Act requires that tobacco products marketed to reduce risk are promoted truthfully and are backed by sound science. After the 1964 Surgeon General's report linked smoking to cancer, industry changed the design of cigarettes and used the adjectives such as 'light,' 'mild,' or 'low' to imply that these brands were less harmful. But experts found that they were no safer than regular cigarettes. The law now prohibits the use of such descriptors unless tobacco companies can prove their products are actually less dangerous. These requirements prevent misleading advertising from an industry that spends more than $10 billion a year -– $1 million an hour –- to market their deadly products.

"We are committed to protect public health and to make tobacco related disease and death part of America's past and not its future," Sebelius said. "We will continue to do everything we can to help smokers quit and prevent kids from starting this deadly addiction."

The guidance and list are published in the April 3 Federal Register. The list includes 93 constituents, including arsenic, benzene, chromium, lead, mercury, and toluene.

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