Wondering About Warnings?

FDA Center for Tobacco Products preps retailers for 2012 warnings rule

ROCKVILLE, Md. -- The U.S. Food & Drug Administration's "Required Warnings for Cigarette Packages & Advertisements" ruling does not go into effect for more than a year. But the agency held a webinar Tuesday so that retailers "can prepare and be ready" when they do take effect on September 22, 2012.

The warnings that are currently displayed on cigarette packaging "are difficult to see, they're smaller and they often go unnoticed," said Ele Ibarra-Pratt, group leader of promotion, advertising and labeling group at the office of compliance and enforcement at the [image-nocss] FDA Center for Tobacco Products (CTP).

In June, the FDA published the final rule, which included nine new graphic health warnings.

Click here to view the labels.

(Click here for previous CSP Daily News coverage of the labels. Andclick here for previous coverage of the FDA and tobacco regulation.)

Warnings on cigarette packaging and advertising must include textual warning statements, corresponding color graphics and the smoking cessation resource reference: 1-800-QUIT-NOW.

Other requirements include:

Advertising. Advertisements must require warnings that are accurately reproduced from FDA's electronic files, with the warning's text in English (unless they are in a publication or ad is predominantly in another language). The warnings much also occupy 20% or more of the top area of the advertisement and be permanently printed or affixed. The nine warnings must also be rotated quarterly for each brand of cigarettes, in accordance with an FDA-approved warnings plan.

For smaller advertisements of less than 12 square inches, an exclamation point graphic, downloadable from the CTP website, must be displayed with one of the textual warning statements.

Retailers are not in violation of the advertising rule if the ad contains a health warning, was not created by or on behalf of the retailer, and wasn't altered by the retailer so that it does not comply with requirements.

Packaging. While most packaging is likely to come from manufacturers, retailers should ensure that warnings are accurately reproduced from FDA's electronic files and are displayed in English and in the same orientation as other information on the panel of the package.

Warnings should be placed directly on the package and be clearly visible under any cellophane or other clear wrapping, and be irremovable or permanently affixed. They should also display at the top 50% of front and rear panels for cigarette packages or on the left 50% of front and rear panels for cigarette cartons.

The nine warnings must be randomly displayed in each 12-meonth period, in as equal a number of times as possible on each brand of the product, and be randomly distributed throughout the United States, in accordance with an FDA-approved warning plan.

Retailers are not in violation of this rule if the cigarette contains a health warning, is supplied to a retailer by a license- or permit-holding tobacco product manufacturer, distributor or importer and is not altered by the retailer to violate the rule.

Manufacturers have until September 12, 2012, to stop making cigarette packaging that does not comply with the rule, although they may continue to distribute the packages for an additional 30 days.

Retailers can sell through or sell off any existing inventory manufactured prior to the September date.

In order to ensure compliance with this new regulation, CTP plans to use a multifaceted approach--including surveillance, inspections, enforcement actions and compliance training.

Violations could receive warning letters or civil penalties. "FDA's current policy is to try and achieve voluntary compliance," said Emile Wang, senior regulatory counsel at the office of compliance and enforcement at CTP. "So FDA's policy is to issue warning letter for a first violation to provide an opportunity for a regulated entities to bring, in this case, cigarette packaging and advertising into compliance with this new regulation."

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