Frequently Asked Questions on the Passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) Updated October, 2010

HEALTH

What are the health effects of smoking?

According to the Centers For Disease Control and Prevention (CDC), smoking causes chronic and often fatal diseases, such as lung cancer and other forms of cancer; heart disease; and respiratory diseases, including emphysema, chronic bronchitis, and pneumonia. Each year in the United States, over 440,000 people die as a result of cigarette smoking. This represents one in every five deaths in adults.

What are the health benefits of quitting smoking/tobacco use?

According to the CDC, quitting smoking and quitting tobacco has immediate and substantial health benefits. These can include a decreased risk of many cancers including cancers of the mouth, throat, esophagus, larynx, and lungs and reducing the risk of coronary heart disease and stroke.

IMPLEMENTATION and REGULATION:

How is FDA implementing the Family Smoking Prevention and Tobacco Control Act?

By regulating tobacco products in the United States, the Food and Drug Administration has taken several important steps in a larger public health effort aimed toward preventing our children from becoming the next generation of Americans to die prematurely from tobacco use and ultimately reducing death and disease associated with tobacco use.

The past sixteen months,has seen the initiation of the scientific and regulatory foundation for the regulation of tobacco products. FDA will continue to work deliberately toward our goals for a healthier America.

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

As set forth in the Tobacco Control Act, funding for the Center and other activities related to the regulation of tobacco will come from user fees paid by manufacturers and importers of tobacco products.

Does FDA now have the authority to regulate tobacco products?

Yes. On June 22, 2009, President Barack Obama signed into law the Tobacco Control Act.

What specifically has FDA been charged with under this new legislation?

This historic legislation grants authority the U.S. Food and Drug Administration to regulate tobacco products. Among other things, the FSPTCA provides FDA with regulatory authority to regulate marketing and promotion of tobacco products and to set performance standards for tobacco products to protect the public health.

What is the main goal in regulating tobacco products?

The main goal is to use 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.

What products are considered to be tobacco products as defined by the Tobacco Control Act?

The term “tobacco product” means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product. This includes, among other products, cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

What products are not considered to be tobacco products as defined by the Tobacco Control Act?

The term “tobacco product” does not apply to raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product. Nor does it mean something that is defined as a drug, device, or combination product under the Federal Food, Drug, and Cosmetic Act.

SPECIFIC PRODUCTS

Does FDA have the authority to ban cigarettes?

No. The Tobacco Control Act specifically states that FDA cannot ban all cigarettes, smokeless tobacco products, cigars, pipe tobacco or roll-your-own tobacco products.

Will FDA take action to reduce nicotine levels in products?

FDA has not yet evaluated this issue. The Tobacco Control Act allows FDA to establish tobacco product standards that can include provisions for nicotine yields if such provisions are appropriate for the protection of the public health. However, The Tobacco Control Act specifically states that FDA is prohibited from requiring the reduction of the nicotine yields of a tobacco product to zero.

Are Cigars impacted by the passage of the Act?

Cigars are considered tobacco products under the Tobacco Control Act. However, the Act does not automatically apply to cigars. FDA must issue a regulation deeming cigars to be subject to the law.

Does the legislation impact tobacco products for pipe smoking?

Pipe tobacco is considered a tobacco product under the Tobacco Control Act. However, the Act does not automatically apply to pipe tobacco. FDA must issue a regulation deeming pipe tobacco to be subject to the law.

APPROVAL PROCESS

Will the current tobacco products on the market be removed?

Tobacco products that were commercially marketed in the United States as of February 15, 2007 may continue to be marketed, but must comply with all provisions of the Tobacco Control Act.

Will new tobacco products now be subject to FDA approval?

The Agency will need to conduct a premarket review of applications for tobacco products not commercially marketed in the United States as of February 15, 2007, unless those products are exempt for certain reasons outlined in the FSPTCA. For those products requiring premarket review, FDA will review, among other things, information submitted regarding the health risks of the tobacco product, ingredients, methods used for manufacture, and labeling.

How do these products differ from those approved by other FDA Centers, such as those approved under the Center for Drug Evaluation and Research (CDER)?

The products which go through the CDER review process are ones which meet the definition for drugs under the Federal Food, Drugs and Cosmetic Act and are not defined as a tobacco product. In addition, CDER primarily approves nicotine replacement products to reduce withdrawal symptoms associated with quitting smoking.

TOBACCO & YOUTH

Will FDA raise the minimum age to purchase tobacco products?

As required by the Tobacco Control Act, an expert panel will be convened to conduct a study on the public health implications of raising the minimum age to purchase tobacco products. The results of this study are to be submitted to Congress.

What will FDA do to curb tobacco use among children and adolescents?

FDA will employ many effective public health strategies to reduce the burden of illness and death caused by tobacco products. One of the first items aimed at reducing tobacco use among children and adolescents was to reissue the 1996 regulation aimed at reducing young people’s access to tobacco products and curbing the appeal of tobacco to the young. A number of measures took effect, including:

• Tobacco manufacturers may no longer sponsor athletic, and entertainment events using tobacco product brand names and logos; 
• Tobacco manufacturers may no longer sell or give away clothing or other items which bear the brand name or logo of a tobacco product; and 
• Tobacco manufacturers will no longer be able to distribute free samples of cigarettes, and free samples of smokeless tobacco will be allowed only in adult-only facilities.

LABELING AND ADVERTISING

Will FDA issue regulations on graphics for labels on tobacco products?

Yes, FDA will issue regulations requiring health warnings (graphics) on labels depicting the negative health consequences of smoking. Once established, FDA will communicate with industry and the public about implementation.

When will FDA make public the information it collects about ingredients in tobacco products?

Each tobacco product manufacturer or importer is required to submit a listing of all ingredients to FDA within 6 months of the signing of the Tobacco Control Act, and a list of all constituents identified by FDA as harmful or potentially harmful to health within 3 years of the signing of the Tobacco Control Act. Within 4 years of the signing of the Tobacco Control Act, FDA will publish a list of harmful and potentially harmful constituents in each tobacco product by brand and by quantity.