Biomarkers Health Effects of Menthol vs. Nonmenthol Cigarettes (Executive Summary) by Food and Drug Administration

A biomarker is defined as “objective indications of medical state observed from outside the patient – which can be measured accurately and reproducibly.”

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September 26th, 2013

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More than 400,000 deaths per year in the United States are caused by tobacco use. Health Effects of Menthol vs. Nonmenthol Cigarettes (Executive Summary) by Food and Drug Administration

According to the Centers for Disease Control & Prevention:

Worldwide, tobacco use causes more than 5 million deaths per year, and current trends show that tobacco use will cause more than 8 million deaths annually by 2030.

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Approximately one-fourth of all cigarettes sold in the United States are menthol Health Effects of Menthol vs. Nonmenthol Cigarettes (Executive Summary) by Food and Drug Administration

Low-income smokers in NY are also spending one-fourth of their income on cigarettes.

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Long been used in cigarettes Health Effects of Menthol vs. Nonmenthol Cigarettes (Executive Summary) by Food and Drug Administration

Menthol was first added to cigarettes during the 1920s. Spud was the first cigarette brand to add menthol.

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Flavor-characterizing additive Health Effects of Menthol vs. Nonmenthol Cigarettes (Executive Summary) by Food and Drug Administration

Though perhaps the term “flavor” is used loosely, as in 2008 all cigarettes with flavor additives were banned except menthol.

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Menthol Health Effects of Menthol vs. Nonmenthol Cigarettes (Executive Summary) by Food and Drug Administration

The definition of menthol:

Menthol is an organic compound made synthetically or obtained from cornmint, peppermint or other mint oils. In addition to its use in cigarettes, menthol has local anesthetic and counterirritant qualities, and it is widely used to relieve minor throat irritation.

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The Federal Food, Drug, and Cosmetic Act (FD&C Act) Health Effects of Menthol vs. Nonmenthol Cigarettes (Executive Summary) by Food and Drug Administration

The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.

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Youth and young adulthood appear to be a critical age-span for initiation of cigarette smoking, Health Effects of Menthol vs. Nonmenthol Cigarettes (Executive Summary) by Food and Drug Administration

A nationally-representative study of 16 to 24 year-olds found that, over the course of two years, 15.0% of menthol cigarette users switched to non-mentholated brands, while only 6.9% of non-menthol users switched to menthol brands. This supports the conclusion that menthol is a starter product for youth.

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May have an impact on initiation rates that differ from nonmenthol cigarettes. Health Effects of Menthol vs. Nonmenthol Cigarettes (Executive Summary) by Food and Drug Administration

An NCBI study indicated that Menthol use is more common among Americans who have recently started smoking than among long-term smokers.

Furthermore, a 2011 report by the NSDUH showed that over half (51.7%) of Americans who began smoking within the past year smoke menthol cigarettes, compared to 33.7% of those who have been smoking for longer than one year.

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There are no product standards for menthol when used in cigarettes. Health Effects of Menthol vs. Nonmenthol Cigarettes (Executive Summary) by Food and Drug Administration

However, Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, stated in a press announcement on July 23, 2013:

“FDA’s actions today on menthol reflect our commitment to explore all potential options, including the establishment of product standards. In the meantime, we will conduct new research to further inform our decision making.”

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