FDA Seeks Comments in Changes to Smokeless Health Warnings

Published in Tobacco E-News

By
Thomas A. Briant, Executive Director

The U.S. Food and Drug Administration has issued a notice requesting public comments about "what changes to the current smokeless tobacco product warnings, if any, would promote greater public understanding of the risks associated with the use of smokeless tobacco products." According to the FDA's notice, comments need to be supported by "scientific evidence" and 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." A copy of the official FDA notice accompanies this NATO News bulletin.

Under current federal law known as the Comprehensive Smokeless Tobacco Health Education Act, one of the following four warning statements must appear pursuant to a required rotating basis on each of the two principal display panels of a smokeless tobacco product and comprise at least 30% of each display panel:

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.

Besides being printed on smokeless tobacco product packages, one of these same warning labels must also be printed in an advertisement of smokeless tobacco products by a manufacturer, packager, importer, distributor, or retailer. For newspaper and poster type advertisements, each warning must comprise at least 20% of the area of the advertisement and the text needs to in black on a white background, or white on a black background, according to a rotational plan submitted to the Secretary of Health and Human Services.

The notice published by the FDA goes onto state that agency has 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% 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 and Cosmetic Act" through a rulemaking procedure if the FDA "finds that such a change would promote greater public understanding of the risks associated with the use of smokeless tobacco products."

The public comments must be filed by April 1, 2013 in electronic format at http://www.regulations.gov or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The comments must contain a reference to Docket No. FDA-2012-N-1032.

Keywords: 
moist smokeless