FDA Eyes New Warning Labels for Smokeless Tobacco

Four labels already are required that warn of oral cancer and addiction, but the agency has established a public docket to accept comments on how to increase public understanding of the risks.

The U.S. Food and Drug Administration soon may require stronger warnings on smokeless tobacco products. The agency has established a public docket to accept comments on how to increase public understanding of the risks.

Comments may be submitted via http://www.regulations.gov (Docket No. FDA-2012-N-1032) for the next 60 days.

The Family Smoking Prevention and Tobacco Control Act signed into law in early 2009 gave FDA the authority to regulate tobacco products' manufacture, marketing, and distribution. The law includes the Smokeless Tobacco Act, which specifies that smokeless tobacco product packages and advertising must bear one of these four required warning statements:

  • "WARNING: This product can cause mouth cancer."
  • "WARNING: This product can cause gum disease and tooth loss."
  • "WARNING: This product is not a safe alternative to cigarettes."
  • "WARNING: Smokeless tobacco is addictive."

FDA's notice says the agency is interested in "comments, supported by scientific evidence, regarding what changes, if any, to the smokeless tobacco product warnings would promote greater public understanding of the risks associated with the use of smokeless tobacco products. The 'public' includes both tobacco users and nonusers (i.e., never users and former users). Comments and supporting evidence should address how any changes in the warnings would affect both users' and nonusers' understanding of the risks associated with the use of smokeless tobacco products."

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