More - U.S. FDA - unveils proposed warning labels for cigarette packs and smokeless tobacco - First Amendment Challenge possible..

One of 36 proposed
new warning labels..
November 11, 2010 - Yesterday, November 10th U.S. Department of Health & Human Services (HHS) said will help tobacco users quit and prevent minors from starting, the agency has unveiled a new comprehensive tobacco control strategy that includes proposed new "bolder" health warnings on cigarette packages and advertisements.

Previous news brief: U.S.. FDA - unveils proposed warning labels for cigarette packs and smokeless tobacco..

The strategy includes a proposal issued by the U.S. Food & Drug Administration (FDA) titled "Required Warnings for Cigarette Packages & Advertisements." Specifically, the proposed rule details a requirement of the Family Smoking Prevention & Tobacco Control Act that nine new larger and more noticeable textual warning statements and color graphic images depicting the negative health consequences of smoking appear on cigarette packages and in cigarette advertisements.

Required Warnings for Cigarette Packages and Advertisements AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule.

Critical Dates:

June 22, 2009 - President Obama signed into law historic legislation granting the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products to protect the public health.

January 9, 2011 - The public has an opportunity to comment on 36 proposed images through January 9, 2011.

June 22, 2011 - By June 22, 2011, FDA will select the final nine graphic and textual warning statements after a comprehensive review of the relevant scientific literature, the public comments and results from an 18,000-person study.

September 22, 2012 - Implementation of the final rule on September 22, 2012, will ultimately prohibit companies from manufacturing cigarettes without new graphic health warnings on their packages for sale or distribution in the United States. In addition, manufacturers, importers, distributors and retailers will no longer be allowed to advertise cigarettes without the new graphic health warnings in the United States.

October 22, 2012 - By October 22, 2012, manufacturers can no longer distribute cigarettes for sale in the United States that do not display the new graphic health warnings.

"When the rule takes effect, the health consequences of smoking will be obvious every time someone picks up a pack of cigarettes," said FDA commissioner Margaret A. Hamburg. "This is a concrete example of how FDA's new responsibilities for tobacco product regulation can benefit the public's health."

David Howard, spokesperson for R.J. Reynolds Tobacco Co., told CSP Daily News, "We are currently reviewing the 140-page notice (The Proposed Rule) issued today. It is important to note that the legality of requiring larger and graphic warnings is part of our lawsuit that is currently pending in the 6th Circuit Court of Appeals. A hearing on the matter is expected to occur sometime next year." (Tobacco Firms Sue to Block Marketing Law by
DUFF WILSON, The New York Times, 8/31/2009; More - Judge McKinley's ruling turns down request to immediately halt enforcement of new tobacco federal regulations..)

Winston-Salem, N.C.-based Reynolds American Inc., parent company of R.J. Reynolds, is part of the suit with Greensboro, N.C.-based Lorillard Inc. and others. According to an Associated Press report, they have argued that the warnings would relegate the companies' brands to the bottom half of the cigarette packaging, making them "difficult, if not impossible, to see."

FDA Proposes Graphic Cigarette Warning Labels by Ricardo Carvajal, 11/10/2010

The graphic artists working on behalf of FDA have been busy, busy, busy! The agency posted 36 proposed graphic health warnings that would accompany the new health warning statements required under section 201 of the Family Smoking Prevention and Tobacco Control Act. FDA’s proposed rule to implement the new warning requirements is due to publish in an upcoming issue of the Federal Register.

If a picture is worth 1,000 words, the pictures proposed by FDA obviate the need for words altogether. The proposed rule provides a rationale for compelling industry to use the proposed graphic health warnings that is clearly intended to head off a First Amendment challenge. Nonetheless, such a challenge is almost certain to be raised as FDA’s rulemaking goes forward.

In addition to the announcements made yesterday, other recent tobacco control and prevention efforts include:
* The Affordable Care Act is giving Americans in private and public health plans access to recommended preventive care, such as tobacco use cessation, at no additional cost.
* The American Recovery & Reinvestment Act (ARRA) invested $225 million to support local, state and national efforts to promote comprehensive tobacco control and expand tobacco quitlines.
* The Prevent All Cigarette Trafficking Act (PACT) aims to stop the illegal sale of tobacco products over the Internet and through mail order, including the illegal sale to youth.
* The Family Smoking Prevention & Tobacco Control Act (FSPTCA) gives FDA the authority to regulate the manufacture, marketing and distribution of tobacco products. It has restricted the use of the terms "light," "low" and "mild"; banned characterizing fruit, candy and spice, flavors from cigarettes; and put in place restrictions on the sale and distribution of cigarettes and smokeless tobacco products to youth.
* The Children's Health Insurance Program Reauthorization Act (CHIPRA) raised the federal cigarette tax by 62 cents per pack.

Richmond, Va.-based Philip Morris USA said in a statement that it "supported several of the initiatives cited [by HHS] regarding tobacco issues. The company supported legislation to give the [FDA] regulatory authority over tobacco products, the [PACT] Act and has encouraged states to spend tobacco settlement funds on health-related initiatives and underage tobacco use prevention. Philip Morris USA has actively participated in the FDA's rulemaking and public comment processes and plans to do the same on this proposal."

TOBACCO EPIDEMIC A Tobacco Control Strategic Action Plan for the U.S. Department of Health and Human Services

Proposed Cigarette Product Warning Labels

Reference: A Look at Warning Labels FDA, HHS propose extremely graphic images for cigarette packaging, CSP (Convenience Stores /Petroleum) Daily News, 11/11/2010.