FDA Issues Final Rule On Cigarette Warnings And Unveils Nine New Graphic Warning Labels

Jun 21, 2011   

On June 21, 2011, the FDA released nine new graphic warning labels that will be required to appear on every pack of cigarettes sold in the US and in every cigarette advertisement starting no later than September 2012. A copy of the Department of Health and Human Services press release can be read here.

As we previously reported, with the passage of the Family Smoking Prevention and Tobacco Control Act, (“Tobacco Act”) Congress granted the FDA the authority to regulate all tobacco products marketed within the United States. As part of this expansion of FDA jurisdiction, Congress required the FDA to establish nine new larger and more noticeable textual warning statements to appear on all cigarette packaging and in all advertisements. The act also required the FDA to develop and implement regulations requiring that graphic color images depicting the negative health consequences of smoking go together with each new warning statement. The new warning labels can be viewed on the FDAs website.

The new regulations require that by September 2012, the new cigarette warning labels and incorporated graphic images must appear on the top half of both the front and rear panels of each cigarette package to replace the current warnings which appear on cigarette packaging. Additionally, the regulations require that these warnings and images appear in the upper portion of each cigarette advertisement and occupy at least 20 percent of the total area of the advertisement. A copy of the final rules regarding cigarette warning labels can be read here.

Since its passage, the Tobacco Act has been the subject of numerous lawsuits by tobacco manufacturers challenging several of its key provisions. As we previously reported, in February of 2011, two menthol cigarette manufacturers, Lorillard and R.J. Reynolds filed suit to block the FDA from implementing the recommendations of the Tobacco Products Scientific Advisory Committee regarding the prohibition of sale of menthol cigarettes. The suit alleges that the committee cannot provide fair advice because three of its members have conflicts of interests, which are expressly prohibited under the Tobacco Act.

Additionally, prior to the adoption of final rules regarding new warnings labels, tobacco manufacturers filed suit alleging that the requirement of new warning labels, as well as the ban on color and graphics on future packaging and advertisements, violated the manufacturers right to free speech under the First Amendment. The United States District Court for the Western District of Kentucky found that the Tobacco Acts “blanket ban” on all uses of color and images in tobacco labels and advertisements was not sufficiently narrowly tailored to survive and therefore violated the First Amendment. However, the Court went on to find that the warning labels requirement is “sufficiently tailored to advance the governments substantial interest” in protecting public health and thus does not violate the First Amendment.

It is important to note that tobacco product regulation in the United States also involves the U.S. Customs and Border Protection (CBP) and the U.S. Department of the Treasury, Alcohol, Tobacco, Tax and Trade Bureau (TTB). Additionally, the Department of Justice, Office of Consumer Protection Litigation (OCPL) regulates Cigarette labeling and advertising, and the Bureau of Alcohol, Tobacco, and Firearms (ATF) investigates and enforces interstate trafficking of contraband cigarettes. State laws may also be implicated.

Experienced attorneys at FI can help establish calculation of duty including excise taxes and user fees, ensure compliance with invoice, permit, and recordkeeping requirements, ensure legal labeling and product packaging and defend against administrative actions and litigation. If you have questions pertaining to the FDCA or the Tobacco Act or how to ensure that your business maintains regulatory compliance at both the state and federal levels, contact Fuerst Ittleman PL at contact@fidjlaw.com.