FDA Issues Letter On Warning Labels

“At this time, FDA will not be soliciting or reviewing cigarette warning plans, the agency noted.

Due to ongoing litigation, the implementation date for the Food and Drug Administration’s (FDA) final rule entitled “Required Warnings for Cigarette Packages and Advertisements” (“June 2011 Rule”) —which requires larger, more prominent health warnings on all cigarette packaging and advertisements in the U.S. and was scheduled to become effective in September 2012—is uncertain, the FDA noted in a letter last week.

The ongoing case in question is R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration, No. 11-1482 (D.D.C.), on appeal, No. 11-5332 (D.C. Cir.).

Anyone who manufactures, packages, or imports cigarettes for sale or distribution within the U.S., and any manufacturer or importer who advertises (or causes to be advertised) cigarettes within the U.S., must continue to comply with the requirements for cigarette health warnings under the Federal Cigarette Labeling and Advertising Act (FCLAA), as in effect before amendment by the Family Smoking Prevention and Tobacco Control Act.

Pending further notice, the Federal Trade Commission (FTC) will continue to have responsibility for the review and approval of cigarette warning plans under the existing FCLAA requirements, and all questions regarding the submission, review, or approval of such plans should be addressed to FTC.

Likewise, at this time, FDA will not be soliciting or reviewing cigarette warning plans. In the future, FDA may notify the public that it is requesting and accepting the submission of cigarette warning plans in advance of the effective implementation date for the June 2011 Rule. Companies that manufacture, package, sell, offer to sell, distribute or import for sale or distribution cigarettes within the U.S. should closely follow FDA and FTC for future updates concerning the submission, review, and approval of cigarette warning plans.

In addition, because of uncertainties caused by ongoing litigation, those who manufacture, package, sell, offer to sell, distribute or import for sale or distribution cigarettes within the U.S. will not be expected to comply with Section 903(a)(2) of the Federal Food Drug and Cosmetic Act with respect to cigarette packaging and labels until further notice from FDA. This means that, until such further notice, these entities will not be expected to include the following statements on cigarette labels or packaging:

• the name and place of business of the tobacco product manufacturer, packer, or distributor (903(a)(2)(A));

• an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count (903(a)(2)(B));

• an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco (903(a)(2)(C)); and

• where applicable, the statement: “sale only allowed in the United States” (903(a)(2)(D) and 920(a)(1)).

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