Last month, FDA issued draft guidance addressing the submission of warning plans for cigarettes and smokeless tobacco products. As we previously reported, beginning on September 22, 2012, all cigarette packages and advertisements must bear one of the nine new federally mandated textual warnings with an accompanying color graphic (subject to certain manufacturers’ constitutional challenge to this requirement). Similarly, as of June 22, 2010, all smokeless tobacco product packages and advertisements, including outdoor billboard advertisements, must bear one of four required warning statements. In connection with the roll out of these new warnings, FDA is requiring the submission of warning plans that will detail how an entity intends to comply with the specific requirements relating to the random display, random distribution, and quarterly rotation of the required warnings. Such warning plans previously were submitted to and reviewed by the Federal Trade Commission (FTC).
In its guidance, FDA answers the following questions:
Who submits a warning plan?
With respect to packages, a tobacco product manufacturer, importer, distributor, or retailer may be the appropriate person to submit a warning plan. FDA suggests that the entity that is responsible for placing or directing the placement of warnings on a brand’s packages and directing distribution of the packages should be the entity that submits the plan. For most domestic products, this entity will be the manufacturer. For products manufactured under contract, the appropriate entity may be the private label brand distributor. For imported products, FDA recommends that the importer create the warning plan.
With respect to advertisements, the relevant consideration is who creates the advertisement, causes the advertisement to be created, or is otherwise responsible for inclusion of the warning on the advertisement. FDA suggests that it is unlikely a retailer would fall into any of these categories.
What is the scope of the warning plan?
Each warning plan should address both packaging and advertising, to the extent applicable. Also, because the requirements for cigarette warning plans differ from the requirements for smokeless tobacco product warning plans, you must submit a separate warning plan for each, though you can submit the plans as a single document.
When should a warning plan be submitted?
Not surprisingly, FDA recommends that cigarette warnings plans be submitted “as soon as possible.” FDA estimates that it will take it at least six months to review a submission. As warning plans for smokeless tobacco products should have been submitted to FDA by July 22, 2010; any person who has not yet submitted a plan should do so immediately. FDA anticipates beginning enforcement of the smokeless tobacco product warning plan requirement either 6 months after the publication of final guidance on the issue or 6 months after the publication of a final regulation regarding the submission of warning plans, whichever comes first.
FDA recommends that a new plan or a supplement to an approved warning plan be submitted to FDA at least three months prior to distributing packages or displaying advertisements for the new brand or making changes to the distribution or display of warnings on packages or rotation of warnings in advertisements.
What information should be submitted as part of a warning plan?
FDA requests that a warning plan include a cover letter. The guidance sets forth the specific information that FDA requests be included in the letter. The guidance also addresses the content of the warning plans themselves, including FDA’s request that warning plans include representative samples of packages and advertisements with each of the warnings.
Click here for more detailed information regarding the submission of cigarette and smokeless tobacco product warnings plans. The guidance includes examples of warning plans FDA believes satisfy the applicable requirements.
The Troutman Sanders Tobacco practice has extensive experience in drafting warning plans. Please contact us if you need assistance in developing and submitting a warning plan.