WASHINGTON -- The U.S. Food & Drug Administration (FDA) is establishing a public docket to obtain comments, supported by scientific evidence, regarding what changes to smokeless tobacco product warnings, if any, "would promote greater public understanding of the risks associated with the use of smokeless tobacco products," the agency said in a notice published in The Federal Register on Jan. 29, 2013.
The deadline for submitting electronic or written comments to www.regulations.gov is April 1, 2013 (Docket No. FDA–2012–N–1032).
On June 22, 2009, President Barack Obama signed the Family Smoking Prevention & Tobacco Control Act into law. The Tobacco Control Act grants the FDA authority to regulate the manufacture, marketing, and distribution of tobacco generally and to reduce tobacco use by minors. The Tobacco Control Act amended the Comprehensive Smokeless Tobacco Health Education Act to prescribe new requirements for health warnings that must appear on smokeless tobacco product packages and advertising.
The Smokeless Tobacco Act requires that smokeless tobacco product packages and advertising must bear one of 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."
One of these four statements must be located on each of the two principal display panels of the package and comprise at least 30% of each such display panel.
The Smokeless Tobacco Act also sets forth requirements for the placement, type, size, and color of warnings on packaging and advertisements, respectively.
The Tobacco Control Act further amended the Smokeless Tobacco Act to give the FDA the authority to "adjust the format, type size and text of any of the label requirements, require color graphics to accompany the text, increase the required label area from 30% up to 50% percent of the front and rear panels of the package, or establish the format, type size and text of any other disclosures required under the federal Food, Drug & Cosmetic Act" through rulemaking conducted under the Administrative Procedures Act if FDA "finds that such a change would promote greater public understanding of the risks associated with the use of smokeless tobacco products."
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, the FDA said.
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