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This year, for the first time, tobacco companies will be required to report to the Food and Drug Administration (FDA) a list of chemicals—and how much of them—are in currently regulated tobacco products and tobacco smoke.
These are chemicals or chemical compounds—that FDA calls Harmful and Potentially Harmful Constituents (HPHCs)—that cause, or could cause, harm to tobacco users or non-users. They have been found in cigarette smoke, cigarette filler, roll-your-own tobacco and smokeless tobacco. Different tobacco products may contain different HPHCs, and some HPHCs are created when the chemicals are burned.
Health and Human Services Secretary Kathleen Sebelius called the upcoming requirements a "critical step forward in providing Americans with the facts about the dangers of tobacco use."
FDA's Center for Tobacco Products (CTP) has established an initial list of 93 HPHCs, and has identified a shortened list of 20 chemicals from that list that tobacco companies must report on first, by the end of 2012. This action is required by the Family Smoking Prevention and Tobacco Control Act that was passed by Congress and signed by President Obama in 2009.
"The law requires tobacco companies to report this information to FDA, and FDA is required to inform the public about the quantity of chemicals that may cause disease in specific tobacco products, and that is what we are doing," said former CTP director Lawrence Deyton, M.S.P.H., M.D.
There are more than 7,000 chemicals in tobacco and tobacco smoke, according to scientific studies.
Of those chemicals, FDA has published an initial list of 93 and may revise the list periodically. All HPHCs included on the list have been identified as causes or possible causes of cancer, cardiovascular disease, respiratory effects, developmental or reproductive effects, and addiction to tobacco products.
FDA will initially require reporting on 20 of the 93 chemicals. These 20 chemicals were selected to be reported first because their quantities can be verified using well-established laboratory testing methods and because they are a representative sample of the types of chemicals on the full list of 93, says Deyton. Over time, FDA will broaden this enforcement requirement to include other HPHCs.
"This will be important new information for American consumers, who—for the first time—will know which harmful and potentially harmful chemicals are in tobacco products," says FDA Commissioner Margaret Hamburg, M.D. "And, as industry discloses information about harmful and potentially harmful chemicals in its products to FDA, we are building knowledge about tobacco products to help us to make science-based regulatory decisions that improve the public health."
FDA plans to share this new information about individual tobacco products and their smoke with the public by April 2013 in a consumer-friendly format.
"We will continue to do everything we can to help smokers quit and prevent kids from starting this deadly addiction," says Sebelius.
There is no safe tobacco product. If you do not use tobacco products, avoid exposure to second-hand smoke. If you use tobacco products, quit. If you need help to quit smoking, free help is available at 1-800-QUIT NOW and www.smokefree.gov.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
March 30, 2012
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