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Public Health Advocacy Institute

at Northeastern University School of Law

360 Huntington Avenue, 117CU

Boston, MA 02115


You are here: Home > About Us > Newsletters > October 2011 Newsletter

October 2011 Newsletter

FDA Releases Proposed Graphic Warnings for Cigarettes
New Law Restricts Sale of Hookah and Other Smoking Paraphernalia
New York City Sees Significant Decline in Smoking Prevalence
Tobacco Companies Still Focused on Price Promotion
New York Tenant’s Guide to Smoke-Free Housing Now Available

FDA Releases Proposed Graphic Warnings for Cigarettes

For the first time in 25 years, cigarette warning labels will be changed in an effort to provide more specific and more noticeable warnings about the risks associated with smoking. Starting in September 2012, the Food and Drug Administration (FDA) will require that all cigarette packages manufactured and sold in the United States contain graphic warning labels accompanied by text warnings about the health effects of cigarette use. Additionally, the labels will provide a smoking cessation number, 1-800-QUIT-NOW. The FDA approved nine different graphic and text labels after a survey of their impact on nearly 18,000 individuals. Warning labels are required to cover the top half of the front and back of cigarette packages, and cover at least 20 percent of each advertisement. FDA officials hope that these warnings will educate the public on the risks of smoking and dissuade youth from using tobacco.

The graphic warnings range from a man smoking through a tracheotomy hole with the message, “Cigarettes are addictive,” to a mouth filled with rotting teeth and a cancerous sore accompanied by the words, “Cigarettes cause cancer.” (Older warning labels communicate similar risks in text only.) The graphic images on newer labels are expected to help people to understand the seriousness of the accompanied text. Studies have affirmed the effectiveness of graphic health warning labels at changing social perceptions of smoking and communicating the risks associated with tobacco consumption.

On August 16, 2011, the major tobacco companies (with the exception of Philip Morris) filed a lawsuit in the U.S. District Court for the District of Columbia claiming that the rule issued by the FDA violates their First Amendment rights. While these companies filed a suit previously inCommonwealth Brands (now on appeal under the name Discount Tobacco v. United States) claiming that the law requiring the new warning labels was unconstitutional, the argument in the new lawsuit is that that specific rule issued by the FDA is invalid. The plaintiffs are seeking an order from the court that the FDA cannot enforce its rule and must issue a new one.

The tobacco companies do not dispute that “the Government may require them to provide purely factual and uncontroversial information” about the dangers of tobacco products. They claim, however, that the images required by the FDA are “controversial and non-factual” and that they “exaggerate the potential effects of smoking.” They also claim that the FDA violated the Administrative Procedures Act by failing to provide enough evidence to support its rule.

Although framed as a challenge to the rule, the lawsuit repeats many of the same argument raised and rejected in Commonwealth Brands. In his opinion upholding the new warnings required by Congress, Federal District Court Judge Joseph H. McKinley, Jr. wrote in Commonwealth Brandsthat “the government’s goal is not to stigmatize the use of tobacco products on the industry’s dime; it is to ensure that the health risk message is actually seen by consumers in the first instance.” Judge McKinley cited the Surgeon General’s assertion that current cigarette warnings are practically “invisible” to consumers. Judge McKinley also referenced a report issued by the Institute of Medicine in 2007 stating that US warnings are “unnoticed and stale, and fail to convey relevant information in an effective way.” Finally, he held “the government’s message is objective and has not been controversial for many decades.”

To view a copy of the Complaint filed against the FDA in connection with the proposed warnings, click here.

More information about the FDA’s graphic warnings may be found here.

New Law Restricts Sale of Hookah and Other Smoking Paraphernalia in New York

In July, Governor Cuomo approved a new law amending the New York Adolescent Tobacco Use Prevention Act (ATUPA). ATUPA prohibits the sale of tobacco products to persons under the age of 18. The new provision expands that restriction and prohibits the sale of shisha and smoking paraphernalia (e.g., hookahs and rolling paper) to minors. A hookah is a water pipe used to smoke tobacco. Hookah tobacco, sometimes known as shisha, is very moist and usually sweetened with either molasses or fruit. The tobacco does not remain lit independently, so a piece of lit charcoal is placed on top of the tobacco within the hookah.

There exists a common misconception that hookah smoking is safer and less addictive than cigarette smoking. Some people believe that the water in the pipe somehow “filters” the toxins out of the smoke.  In fact, hookah smokers inhale high levels of nicotine, carbon monoxide, tar and other hazardous substances, including charcoal combustion products. Hookahs require smokers to inhale more deeply than do cigarettes, so smokers may inhale, in one session with a hookah, the equivalent of 100 or more cigarettes.

Hookahs have become popular with teenagers in New York as an available alternative to cigarettes. The new law is designed to close a loophole that allowed minors access to smoking products and to protect youth from the harmful effects of smoking and nicotine addiction.

New York City Sees Significant Decline in Smoking Prevalence

In 2010, New York City saw a decline in the number of current smokers to 14 percent of adults. This figure marks the lowest level reported since the city began tracking the smoking rate two decades ago and is lower than the national average (which stands at 19.3 percent). The results come from a periodic community health survey conducted by the New York City Health Department of 10,000 people over the age of 18.

The results reveal that from 2009 to 2010 the number of people who smoke in New York City decreased by 11 percent, or 100,000 people. This is the largest decline in smoking since immediately after the passage of Smoke Free Air Act of 2002 (which saw a decrease from 22 to 19 percent). Moreover, the survey results show that the largest decline in smoking occurred in young adults (18-24 year olds), falling from 23.8 percent to 13.6 percent.

Perhaps most importantly, the smoking rate among high school students has dropped from 18 percent in the beginning of the decade to 7 percent in 2010. This decline may be attributed in part to the Youth Tobacco Enforcement and Prevention Program run by the Department of Consumer Affairs. The program uses undercover minors and inspectors to inspect tobacco retailers in the city on a yearly basis. In 2011 the program made 9,659 inspections. This program, carried out in cooperation with the city’s Health Department, has increased the number of compliant retailers from 52 percent in 1998 to 90 percent in 2011.

City officials attribute the decline in smoking to the aggressive tobacco control measures that have been implemented in recent years. In 2002, with the Smoke Free Air Act, New York City reduced the exposure of persons to secondhand smoke by prohibiting smoking in bars, restaurants, public transportation platforms, hospital entrances, and most workplaces. Recently, the law was extended to public parks and beaches, though the effects of that extension are not reflected in the report. The number of people smoking in New York City has fallen 35 percent since the passage of the Smoke Free Air act in 2002 and officials say that these measures could potentially prevent 50,000 premature deaths by 2052.

Another successful measure taken to reduce smoking has been an increase in the cigarette tax. Studies show that raising the cost of cigarettes has been proven to have a deterrent effect on smoking. In 2010 the taxes (federal, state and city) on cigarettes were increased to $6.86 per pack (well above the tax of $1.58 per pack imposed in 2000), which brings the average cost for a pack of cigarettes in New York City to $11.20.

Tobacco Companies Still Focused on Price Promotion

The Federal Trade Commission recently released its latest reports on tobacco industry marketing expenditures. The new reports analyze tobacco industry spending in 2007 and 2008. The five major manufacturers (the only manufacturers submitting data to the FTC for this report) spent a total of $10.5 billion on the advertising and promotion of their products in the United States. (According to the Campaign for Tobacco-Free Kids, $360.3 million of that was spent in the state of New York.) The vast majority of these expenditures (72% for cigarettes and 59% for smokeless tobacco products) were focused on price promotions, designed to reduce the price of tobacco products for consumers. While the amount spent on price promotions for cigarettes has remained relatively steady, the amount spent to reduce the price of smokeless tobacco has more than tripled since 2005.

Studies have consistently shown that the price of tobacco products, especially cigarettes, affects the prevalence of tobacco use.  Simply put, people smoke more cigarettes when prices are lower, and the tobacco companies are well aware of this relationship. This behavior explains the investment made by the companies in promotions that reduce the price consumers actually pay for tobacco products.

The Center recently published its latest technical report, Tobacco Price Promotion:  Policy Responses to Industry Price Manipulation. The report provides an overview of the relationship between price and tobacco use, the methods employed by tobacco companies to manipulate the prices of their products, and potential policy options to keep the price of tobacco products high.  To view the report, click here.

To review the FTC Cigarette Report click here.

To review the FTC Smokeless Tobacco Report, click here.

New York Tenant’s Guide to Smoke-Free Housing Now Available

The Center recently worked with Smoke Free Housing New York to develop the New York Tenants’ Guide to Smoke-Free Housing. The guide provides information for tenants wishing to avoid exposure to secondhand smoke in multi-unit buildings, including guidance for working with landlords and other tenants to implement a smoke-free policy throughout the building. The Guide may be found on the Center’s website and will be available soon on www.smokefreehousingny.org. Coming soon are guides to assist condominium associations and housing cooperative corporations (co-ops) in drafting and implementing smoke-free policies.


The Food and Drug Administration (FDA) has issued a notice that it is preparing to draft rules concerning the non-face-to-face sale and distribution of tobacco products (e.g., internet sales), and the advertising, promotion and marketing of those products.

The Family Smoking Prevention and Tobacco Control (FDA) Act requires the FDA to issue regulations regarding remote sales of tobacco products and the promotion and marketing of tobacco products available for sale remotely, specifically to ensure that minors do not have access to such sales. Since the enactment of the FDA Act, the Prevent All Cigarette Trafficking (PACT) Act has become law as well. While this law is currently being challenged in the courts, it prohibits cigarettes and smokeless tobacco from being sent through the U.S. Postal Service (with some exceptions), and requires Internet and other remote sellers to verify the age of their customers both at the time of sale and at the time of delivery. In this context, the FDA is seeking information and comments from the public related to the remote sales of tobacco products and its effect on minors’ access to tobacco products.

Anyone may submit comments or provide information relevant to this issue by submitting them in writing by December 8, 2011. Any comments should reference Docket No. FDA-2011-N-0467 and/or RIN number 0910-AG43 and may be sent electronically through the Federal eRulemaking Portal at http:/www.regulations.gov. Alternatively, comments may be faxed to 301-827-6870 or mailed to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852 

For additional instructions, see http://www.gpo.gov/fdsys/pkg/FR-2011-09-09/html/2011-23096.htm.

For more information about the rulemaking process, see Getting Your Voice Heard:  Commenting on Federal Regulations.

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