FDA Wins Control Over Tobacco

With President Obama’s June 22 signing of the Family Smoking Prevention and Tobacco Control Act of 2009 (http://frwebgate.access.gpo.gov/cgibin/ getdoc.cgi?dbname=111_cong_ bills&docid=f:h1256enr.txt.pdf), the Food and Drug Administration (FDA) was given what it and other organizations described as “historic” authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by minors. The Act also established the Center for Tobacco Products within the FDA to administer these regulations.

Now, the FDA is seeking feedback from the public on the approaches and actions the agency should take to reduce the incidence and prevalence of tobacco use and protect public health. “We’re interested in receiving input from across the country as the FDA begins to implement this important new authority intended to reduce the enormous toll of suffering and death caused by tobacco products in the United States,” explained FDA commissioner Margaret A. Hamburg, MD, in a statement announcing the public comment period.

The call for comments was published in the Federal Register on July 1; interested parties have until September 29 to share their views. Comments can be submitted electronically to www. regulations.gov; more information is available in the Federal Register notice, which can be viewed at http:// edocket.access.gpo.gov/2009/pdf/E9- 15549.pdf.

According to the FDA, tobacco products are responsible for more than 430 000 deaths per year, and the Centers for Disease Control and Prevention estimates that 60 million adults in this country alone smoke cigarettes. The FDA now can set national standards to control the manufacture of tobacco products, which the law defines as any product made or derived from tobacco that is intended for human consumption.

The Act doesn’t allow the FDA to ban the sale of cigarettes, smokeless tobacco products, cigars, little cigars, pipe tobacco, or roll-your-own tobacco products, nor can the agency require manufacturers to reduce the nicotine yield of a tobacco product to zero. However, the FDA can otherwise reduce the amount of nicotine, reduce or eliminate other harmful components in these products, test these products, and issue recalls, among other powers.

Among other requirements set forth by the new legislation:

• Any new tobacco product—that is, a product not substantially equivalent to an existing tobacco product—that came on the market after February 15, 2007, must go through the application process for premarket approval, as must all such products introduced going forward.

• Labeling must include certain health information, and manufacturers can no longer use the terms “light,” “mild,” or “low” in their marketing or otherwise market the product in a way that makes the user believe it is less harmful than other such products.

• Cigarettes cannot contain any flavor other than tobacco or menthol, including strawberry, grape, orange, clove, cinnamon, and vanilla.

• Manufacturers must alert the FDA if they make any changes to their product.

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