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• FDA Warns Companies against Marketing Illegal Flavored Cigarettes 

The U.S. Food and Drug Administration is enforcing the flavored cigarette ban provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letters to companies continuing to sell illegal flavored cigarettes to consumers in the United States through their Web sites.

The warning letters directed the companies to cease the marketing and sale of these products immediately or to take other appropriate action to bring the products into compliance with the law. Failure to do so may result in additional regulatory actions such as seizure or injunction. In addition, FDA requested a written response from each of the companies within 15 days outlining the corrective actions taken.

Enforcement of the flavored cigarette ban is FDA’s effort to remove cigarettes that contain certain candy or fruit flavors from the marketplace. Removal of these products from the market will assist in the prevention of children and adolescents from starting to smoke and in the reduction in death and disease caused by smoking.

“FDA takes the enforcement of this flavored cigarette ban seriously,” said Lawrence R. Deyton, M.S.P.H, M.D., director of FDA’s Center for Tobacco Products. These actions should send a clear message to those who continue to break the law that FDA will take necessary actions to protect our children from initiating tobacco use.” . . .

Report possible violations of the flavored cigarette ban: www.fda.gov/flavoredtobacco

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• SUMMARY REPORT GENERAL ELECTION  

SUMMARY REPORT

GENERAL ELECTION

UNOFFICIAL RESULTS . . .

ST. LOUIS COUNTY-PROPOSITION N

**PROHIBITION OF SMOKING**

(Vote for ) 1

(WITH 479 OF 480 PRECINCTS COUNTED 99.79%)

YES . . . . . . . . . . . . 89,405 65.39

NO. . . . . . . . . . . . . 47,313 34.61

KIRKWOOD-PROPOSITION 1

**PROHIBITION OF SMOKING**

(Vote for ) 1

(WITH 15 OF 15 PRECINCTS COUNTED)

YES . . . . . . . . . . . . 4,628 65.24

NO. . . . . . . . . . . . . 2,466 34.76

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• November 4 Election Results 

SUMMARY REPORT . . .

VOTES PERCENT

PRECINCTS COUNTED (OF 480). . . . . 211 43.96

REGISTERED VOTERS - TOTAL . . . . . 705,716

BALLOTS CAST - TOTAL. . . . . . . 64,021

VOTER TURNOUT - TOTAL . . . . . . 9.07

ST. LOUIS COUNTY-PROPOSITION N

**PROHIBITION OF SMOKING**

(Vote for ) 1

(WITH 211 OF 480 PRECINCTS COUNTED 43.96%)

YES . . . . . . . . . . . . 40,475 63.55

NO. . . . . . . . . . . . . 23,216 36.45

KIRKWOOD-PROPOSITION 1

**PROHIBITION OF SMOKING**

(Vote for ) 1

(WITH 0 OF 15 PRECINCTS COUNTED)

YES . . . . . . . . . . . . 244 72.84

NO. . . . . . . . . . . . . 91 27.16

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• GENERAL ELECTION FOR INFORMATIONAL USE ONLY (PDF) 

ST LOUIS COUNTY

PROPOSITION N

SIMPLE MAJORITY

REQUIRED

Shall the Revised Ordinances of St. Louis County be amended by enacting and adding thereto a prohibition of smoking in enclosed public places in St. Louis County, all as set forth in Exhibit A of Ordinance No. 24,105 on file with the St. Louis County Administrative Director and the St. Louis County Board of Election Commissioners?

YES NO

EXCERPT

CITY OF KIRKWOOD

PROPOSITION 1

SIMPLE MAJORITY

REQUIRED

Shall the city of Kirkwood prohibit smoking in enclosed places of employment and enclosed public places for the purpose of reducing workers and citizens exposure to secondhand tobacco smoke?

YES NO

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• Operation ‘Samhna’ : Potentially the largest seizure of cigarettes ever 

A multi agency operation, code named ‘Samhna’, headed up by Revenue’s Customs Service, is currently underway in Greenore Port, Co Louth, and surrounding area.

The operation, targeting the suspected criminal activities of an organised crime group operating both north and south of the border, involved the surveillance of a general cargo vessel M/V Anne Scan, which sailed from the Philippines on 15/09/2009 for Greenore Port, arriving at approximately 0600 hours on Monday, 26/10/2009, carrying a cargo declared as ‘animal feed’. Officers kept the vessel under surveillance, as they suspected that a large consignment of contraband cigarettes was concealed within the cargo.

Following the discharge of part of the cargo from the vessel earlier this morning onto awaiting trucks, which were allowed onwards to the importer’s premises, the multi agency task force, involving Officers of Revenues Customs Service and An Garda Siochana, moved in and raided several premises in the Co. Louth area, in addition to mounting an operation on the vessel itself. A large consignment of contraband cigarettes has been confirmed, estimated to be in excess of 120m cigarettes with a retail value of about €50m and a potential revenue at risk of approximately €40m. Several persons have been arrested at various locations by the Gardai for questioning.

The operation in the Republic of Ireland involved Officers of Revenue’s Customs Service, An Garda Siochana, The Criminal Assets Bureau, the Irish Naval Service and Air Corps and in Northern Ireland, Officers of HM Revenue & Customs and the PSNI. In addition the European Anti-Fraud Office (OLAF), which was also involved, will co-ordinate the international enquiries which will form part of the follow-up investigations. It is estimated that in excess of 150 Officers from the various Agencies participated in the field in today’s operation.

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• New Web Site Provides Info On Upcoming Smoking Ban  

A new government Web site has been launched to ease the transition with a new law that requires restaurants, bars and lodging establishments that serve food and drink to go smoke-free as of January 2, 2010.

The Web site, www.SmokeFree.NC.gov, provides business owners and customers information on the new law, on the health hazards of secondhand smoke and on resources to help those smokers who may want to quit smoking. There are downloadable fact sheets, no-smoking signs and other tools to help make the transition to smoke-free air an easy one.

"This change is historic for North Carolina and will have a significant positive impact on public health," said Gov. Bev Perdue. "By banning smoking in our restaurants and bars, we will greatly reduce the dangers of secondhand smoke and lower health care costs for families. Our goal is to make sure North Carolina's families and businesses have the information they need about the hazards of second-hand smoke and how to implement the new law."

The new law (G.S. 130A-497) was passed by the General Assembly and signed by Governor Bev Perdue in May, and will make virtually all indoor areas of restaurants and bars in the state smoke-free, with very few exceptions.

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• Draft Guidance: The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act 

The Center for Tobacco Products is posting a draft guidance document entitled "The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act." The availability of this draft guidance will be announced in a notice published in the Federal Register in the near future. . . .

This guidance document is being distributed for comment purposes only. . . .

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

I. Introduction

This guidance is intended for manufacturers, retailers, importers, and FDA staff. The guidance describes FDA’s current thinking regarding the scope of the provision prohibiting the marketing of a tobacco product in combination with another product regulated under the Federal Food, Drug, and Cosmetic Act (FDCA). It is not intended to be an exhaustive analysis of all activities that may or may not fall within the scope of the prohibition. . . .

A. FDA believes the following activities are included within the scope of section 201(rr)(4) of the FDCA and, therefore, are prohibited:

A tobacco product and a non-tobacco product regulated under the FDCA are physically, chemically, or otherwise combined or mixed to produce a single entity that is marketed as containing both products. For example:

*

* Mouthwash (which may be a drug or a cosmetic under the FDCA) is added to the ingredients of a cigarette and the cigarette is identified as containing mouthwash. . . .

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• Flavored Tobacco 

On September 22, 2009 a ban on cigarettes containing certain characterizing flavors went into effect. The ban, authorized by the new Family Smoking Prevention and Tobacco Control Act, is part of a national effort by FDA to reduce smoking in America.

FDA’s ban on candy and fruit-flavored cigarettes highlights the importance of reducing the number of children who start to smoke, and who become addicted to dangerous tobacco products. FDA is also examining options for regulating both menthol cigarettes and flavored tobacco products other than cigarettes.

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• FDA LETTER ON FLAVORINGS (PDF) 

The Food and Drug Administration (FDA) is providing this notice to remind regulated industry that effective September 22, 2009, cigarettes that contain certain characterizing flavors are considered adulterated under the Federal Food, Drug, and Cosmetic Act (FFDCA or the Act), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA).

Smoking is the leading preventable cause of death in the United States. An important way to reduce the death and disease caused by smoking is to prevent children and adolescents from starting to smoke. Congress has stated that flavors make cigarettes more appealing to youth and often result in exposure to additional carcinogens and other toxic constituents. The removal from the market of cigarettes that contain certain characterizing flavors is an important step in FDA’s efforts to reduce the burden of illness and death caused by tobacco products. . . .

As of the September 22, 2009, effective date, cigarettes and their component parts that fail to comply with the special rule established under section 907 are deemed adulterated under section 902 of the Act. Under the Act, adulterated products sold or held for sale in the United States may be subject to seizure under section 304 of the Act. In addition, manufacturers, distributors, and retailers may be subject to injunction actions, civil money penalties, and/or criminal prosecution for violating the requirements of the Act (FFDCA, sections 301, 302, 303). FDA intends to use the full range of enforcement tools within the Agency’s authority to ensure compliance with the new requirement.

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• Take Care New York 2012: A Policy for a Healthier New York City (PDF) 

2NYC Aims to… Be Tobacco Free . . .

DOHMH will advocate for city, state and federal tax increases on cigarettes and other tobacco products to reduce smoking among youth and adults, and support the enforcement of existing laws and the passage of new laws to minimize or eliminate the distribution of non-taxed and low-taxed cigarettes.

Advocate for the regulation of tobacco industry marketing practices.

DOHMH will advocate for the adoption of local laws and regulations to reduce the impact of tobacco advertising and other marketing practices, and introduce anti-tobacco messages in retail locations.

Reduce the availability and social acceptance of tobacco.

DOHMH will urge organizations and businesses in New York City to reject tobacco industry products, placement, funding and sponsorship.

Limit exposure to second-hand smoke.

The health department will continue to enforce New York City’s 2002 Smoke-Free Air Act and will work with the city’s Department of Parks and Recreation and other entities to expand smoke-free spaces to include city parks and public beaches.

II. Prevention, Quality and Access Expand access to, and use of, smoking cessation services.

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• FDA Moves Forward on Implementation of Tobacco Law 

The U.S. Food and Drug Administration today announced an action regarding the implementation of the Family Smoking Prevention and Tobacco Control Act. The Agency has officially established the Tobacco Products Scientific Advisory Committee (TPSAC).

The Tobacco Products Scientific Advisory Committee is tasked with providing advice, information, and recommendations to the Commissioner of Food and Drugs on health and other issues relating to tobacco products. The committee will be asked to consider a variety of topics including:

*

* identifying the effects of the alteration of the nicotine yields from tobacco products;

* reporting on the impact of the use of menthol in cigarettes on the public health; and

* advising on an application for modified risk (use of descriptors such as “light”) tobacco product.

The TPSAC will consist of 12 members . . .

The three non-voting members will be identified with industry interests. These members will include one representative of the tobacco manufacturing industry, one representative of the tobacco growers, and one representative of the small business manufacturing industry.

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• Frequently Asked Questions on the Passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) 

How will FDA begin to implement the Family Smoking Prevention and Tobacco Control Act (FSPTCA)?

FDA will begin by seeking input from the public and establishing a Center for Tobacco Products. FDA will perform its duties by using the best available science to guide the development and implementation of effective public health strategies to reduce the burden of illness and death caused by tobacco products.

Does FDA have the financial and personnel resources to fully implement the FSPTCA?

Yes. To implement this important program, FDA will start with $5 million from the fiscal year 2009 budget authority. This money will go directly to establishing the administrative functions necessary to expand upon the core group already working on implementation and will be reimbursed by user fees collected under the FSPTCA.

Where will the funding for the Center for Tobacco Products come from?

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• FDA and Public Health Experts Warn About Electronic Cigarettes 

The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.

Electronic cigarettes, also called “e-cigarettes,” are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.

These products are marketed and sold to young people and are readily available online and in shopping malls. In addition, these products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people.

Public health experts expressed concern that electronic cigarettes could increase nicotine addiction and tobacco use in young people. Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium and Jonathan Samet, M.D., director of the Institute for Global Health at the University of Southern California, joined Joshua Sharfstein, M.D., principal deputy commissioner of the FDA, and Matthew McKenna, M.D., director of the Office of Smoking and Health for the Centers for Disease Control and Prevention, to discuss the potential risks associated with the use of electronic cigarettes.

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• Remarks By The President In Announcement Of US Surgeon General 

With that, let me introduce the next Surgeon General of the United States, Dr. Regina Benjamin.

DR. BENJAMIN: Thank you, Mr. President. And thank you, Secretary Sebelius, for being here with me.

I am honored and I am humbled to be nominated to serve as United States Surgeon General. This is a physician's dream. But for me, it's more than just a job.

Public health issues are very personal to me. My father died with diabetes and hypertension. My older brother, and only sibling, died at age 44 of HIV-related illness. My mother died of lung cancer, because as a young girl, she wanted to smoke just like her twin brother could. My Uncle Buddy, my mother's twin, who's one of the few surviving black World War II prisoners of war, is at home right now, on oxygen, struggling for each breath because of the years of smoking.

My family is not here with me today, at least not in person, because of preventable diseases. While I can't -- or I cannot change my family's past, I can be a voice in the movement to improve our nation's health care and our nation's health for the future.

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My mother died of lung cancer, because as a young girl, she wanted to smoke just like her twin brother could. My Uncle Buddy, my mother's twin, who's one of the few surviving black World War II prisoners of war, is at home right now, on oxygen, struggling for each breath because of the years of smoking. My family is not here with me today, at least not in person, because of preventable diseases. While I can't -- or I cannot change my family's past, I can be a voice in the movement to improve our nation's health care and our nation's health for the future.
President Obama's nominee for Surgeon General of the United States, Dr. Regina Benjamin, in the Rose Garden.

• FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban  

The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research. “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Similar information on mental health events will be required for bupropion marketed as the antidepressant Wellbutrin and for generic versions of bupropion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.

Woodcock said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. She added that patients should immediately contact their health care professional if they experience such changes.

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