Earlier this week, FDA published guidance to help small businesses understand and comply with FDA’s regulations regarding the new required cigarette warnings.  These regulations take effect on September 22, 2012 and, as previously reported, require all cigarette packages and advertisements to contain one of nine new textual warning statements, a corresponding graphic image, and a specified toll free smoking cessation assistance resource phone number.  Roll-your-own and cigarette tobacco are not covered by the regulations.  Further, small advertisements of less than 12 square inches need not comply with the smoking cessation assistance resource requirement.    

Some of the subjects addressed in the guidance include:

How to access electronic files of the images of the required warnings.  These files are available on the Internet or by submitting a request to FDA.  The size of these files can be modified to fit packages and advertisements of varying sizes.

  •  To whom do the regulations apply.  For cigarette packages, the new warning requirements apply to any person who manufactures, packages, distributes, imports, sells, offers to sell, or imports for sale or distribution cigarettes within the United States.  For cigarette advertisements, the requirements apply to any manufacturer, importer, distributor, or retailer of cigarettes who advertises or causes to be advertised cigarettes within the United States.
  • The circumstances under which retailers are not subject to enforcement actions.  Such circumstances include when a cigarette package already contains a health warning, is supplied by a license- or permit-holding tobacco product manufacturer, importer, or distributor; and is not materially altered by the retailer.  Similarly, retailers are not subject to enforcement action regarding cigarette advertisements when the advertisement already contains a health warning; is not created by or on behalf of the retailer; and is not materially altered by the retailer.
  • The effect on remaining stock of cigarette packages manufactured before September 22, 2012.  Manufacturers may sell and distribute these packages for an additional 30 days after the September 22, 2012.  Importers, distributors, and retailers can sell and distribute cigarette packages after September 22, 2012 so long as the packages were manufactured before September 22, 2012.
  • How must the required warnings appear on packages.  The guidance addresses the size and location, orientation, equal display and random distribution, and permanency requirements of the new warnings.  For cigarette advertisements, the guidance also addresses the rotation requirements.

To read the guidance in its entirety click here.

Interestingly, FDA’s guidance does not address the two pending federal lawsuits challenging the constitutionality of the new warnings requirements.  Troutman Sanders previously reported on these two cases, which were filed by several large tobacco companies and are pending in U.S. District Court for the District of Columbia and the U.S. Court of Appeals for the Sixth Circuit.   A preliminary injunction hearing took place in the D.C. case on September 21.  A number of post-hearing briefs have been filed, including a motion for summary judgment filed last week by FDA.  The Sixth Circuit heard oral arguments in that warnings case on July 27, but has not yet issued an opinion.  If the plaintiffs are successful in these cases, the effective date of the new warning requirements could be delayed.  The Troutman Sanders Tobacco practice will continue to monitor and report any significant developments in these warnings cases.  In the meantime, please contact us if you have any questions regarding the new warnings requirements and/or need compliance assistance.

Contributor: Brenna Newman

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.