Lorillard and Reynolds Sue to Halt Regulation Based on Upcoming Report on Menthol Cigarettes

Unsurprisingly, Lorillard, Inc. and Reynolds American, Inc.'s R.J. Reynolds Tobacco Company unit filed suit against FDA regarding an upcoming advisory panel board that will likely recommend a ban on menthol cigarettes.  Lorillard's top seller is the Newport brand and Reynolds sells, among other things, several mentholated versions of its Camel brand cigarettes.  FDA, of course, gained the power to regulate the tobacco industry in 2009 with the passage of the Family Smoking Prevention and Control Act.  Shortly thereafter, on September 22, 2009, FDA banned flavored cigarettes, with a particular eye towards vanilla, chocolate and clove cigarettes.  The ban of the latter raised some interesting WTO issues, but more importantly for our purposes, set the stage for the current controversy.
 
Although few know exactly what the upcoming Tobacco Products Scientific Advisory Committee (TPSAC) report on menthol cigarettes contains, many expect that the committee will call for an outright ban.  The report is due to be released on March 23, 2011, and in advance of its release, TPSAC will meet twice more in early to mid-March.  Following the report's release, FDA will consider the report and take whatever action it deems appropriate.  With a ban both legally allowable and likely imminent, manufacturers of menthol cigarettes have no choice but to take action to protect their business interests.
 
In their Complaint, filed in the United States District Court for the District of Columbia, Lorillard and Reynolds have requested the Court to enter declaratory and injunctive relief requiring the defendants to bring TPSAC and the membership of the constituents subcommittee of TPSAC into compliance with the law and to prevent FDA from taking any action based on or influenced by or from making any use of any report provided by TPSAC or the constituents subcommittee as currently constituted.  Specifically, the plaintiffs allege that three of the eight voting members of TPSAC have financial and appearance conflicts of interest and biases that are incompatible with TPSAC's roles as an impartial advisor to FDA.  Substantively, the plaintiffs allege that those three members of TPSAC cannot act objectively because they have all either appeared as paid expert witnesses in litigation against tobacco-product manufacturers or are or have been employed by members of the pharmaceutical industry engaged in the production of nicotine replacement therapy or other smoking cessation products.
 
While it remains to be seen whether this suit has any merit, at the least, it's sure to impede any further regulation of flavored cigarettes by FDA.  We'll keep our eye on this and do our best to keep you up to date.

 

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Graphic Images On Cigarette Packages? Help FDA Select Them

 You, the public, are being asked to help select the images, and/or you may post comments on the FDA’s proposal, from now until January 11, 2011. On November 10, 2010, the FDA posted on the Internet a set of 36 graphic color images showing the dangers of smoking grouped in nine categories, which are to be placed on the packages with appropriate text warnings. The public is being asked to help select from the 36 images a set of nine of them, one from each of nine categories.

Congress enacted the Family Smoking Prevention and Tobacco Control Act in 2009, requiring pointed health warnings with color graphics on all cigarette packages and advertisement after September 12, 2012.  Representing each of the nine categories, the text warnings, each to be coupled with a related image or photo, are:

v     WARNING: Cigarettes are addictive

v     WARNING: Tobacco smoke can harm your children

v     WARNING: Cigarettes cause fatal lung disease

v     WARNING: Cigarettes cause cancer

v     WARNING: Cigarettes cause strokes and heart disease

v     WARNING: Smoking during pregnancy can harm your baby

v     WARNING: Smoking can kill you

v     WARNING: Tobacco smoke causes fatal lung disease in nonsmokers

v     WARNING: Quitting smoking now greatly reduces serious risks to your health

Each of these congressionally mandated warnings will accompany a related color image, together to cover 50% of the both the front and back panels of each package, and to cover at least 20% of each advertisement. The various warnings will rotate on each package and advertisement periodically.

Some of the scenes depicted are:

o       smoke being exhaled from a tracheotomy opening of the smoker;

o       a baby and mother, with second-hand smoke from the mother engulfing the baby’s face;

o       side-by-side photographs of a healthy lung and a diseased lung;

o       an illustration of a cigarette package with an arrow pointing to a gravestone; and

o       second-hand smoke wafting from a smoker toward a non-smoker’s face during conversation.

When the public comment period ends on January 11, 2011, the FDA will use the comments and scientific research and results to pare the list of 36 images to nine. Secretary Kathleen Sebelius of U.S. Department of Health and Human Services says that she is hopeful that the tragic images will stop young people from picking up their first cigarette and also give smokers the incentive to quit. “Every day,” Secretary Sebelius says, “almost 4,000 youths try a cigarette for the first time, and 1,000 youths become regular, daily smokers.” Over 2,600 adults also try smoking for the first time every year.

The Centers for Disease Control and Prevention says tobacco use is the single biggest cause of preventable death in the United States, killing more than 443,000 users and victims of second-hand smoke every year, and causing serious illness in 8.6 million Americans. Most of smokers dying began smoking when they were under the age of eighteen.

The proposed rules were published in Federal Register, Vol. 75, No. 218, Friday, November 12, 2010.

To see the graphic color images with their text warnings, go to:

www.flickr.com/photos/fdaphotos/collections/72157625232230587/

To submit comments on the warning labels and the proposed rule, through Tuesday, January 11, 2011:

a) go to:   www.regulations.gov and insert docket number FDA-2010-N-0568-0001 into the “Search” box. (The proposed regs should be at the top of the list of Titles, and follow the prompts, clicking on the docket number in the fourth column to view the regs; to comment on the proposed regs and the color images, click on “Submit a Comment” in the right-hand column.)

b) send a fax*, with your comments, to:   301-827-6870

c) for paper submissions*, or disk* or CD-ROM* submissions, send by mail, or courier or hand delivery to :

            Division of Dockets Management (HFA-305)

            Food and Drug Administration

            5630 Fishers Lane, Room 1061

            Rockville, MD 20852

 

*NOTE: All comments should be identified by Docket ID No. FDA-2010-N-0568, and only one copy is necessary.

For the FDA’s notice, click here or go to this link

 

More information below:

As provided in the “Background” section of the proposed regulations, in 1964 the U.S. Surgeon General of the Public Health Service issued the landmark report titled “Smoking and Health,” which concluded that cigarette smoking is a health hazard of sufficient importance in the U.S. to warrant appropriate remedial action. Shortly thereafter, Congress passed the Federal Cigarette Labeling and Advertising Act of 1965, which required a printed warning to appear on cigarette packaging. Although the current text warnings on packages have been in use for twenty-five years, there is considerable evidence that the current warnings are given little consideration by viewers, and the warnings are said to have become “invisible” and fail to convey relevant information in an effective way. 

The FDA says that there is evidence of a strong worldwide consensus that effective tobacco health warnings should be large and should include a graphic image component. The World Health Organization’s (WHO) Framework Convention on Tobacco Control (FTCT) has called for such a program of graphic images, and over 30 nations or jurisdictions have implemented such a program, including Canada, India, Mexico and the United Kingdom, with efforts pending in several others. (As of August 2010, there are 168 signatories to the Convention, including the United States, although the U.S. has not ratified this Treaty.)

Results from the 2009 National Health Interview Survey (NHIS) indicate that approximately 46.6 million U.S. adults are cigarette smokers (20.6% of the adult population). During the period of 1998 to 2009, adult smokersdeclined from 24.1% to 20.6%, although from 2005 to 2009 rates showed virtually no change.

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