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 

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? 

As set forth in the FSPTCA, after the start-up period, the 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. 

Will the new Center at the FDA replace the Office of Smoking and Health? 

No. This new tobacco center will work in close coordination with CDC’s Office of Smoking and Health.

 

REGULATION 

Does FDA now have the authority to regulate tobacco products? 

Yes. On June 22, 2009, President Barack Obama signed into law the FSPTCA. 

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. 

When will new FDA authorities to regulate tobacco products become effective? 

The legislation went into effect when the President signed the bill into law. FDA is simultaneously establishing the internal administrative processes and scientific foundations needed to meet the requirements outlined in the FSPTCA. 

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 are some of the key regulatory timelines associated with the FSPTCA? 

There are many requirements with deadlines outlined in the FSPTCA. Some highlights include: 

• By October 2009, cigarettes will be prohibited from having candy, fruit, and spice flavors as their characterizing flavors. 
• By January 2010, tobacco manufacturers and importers will submit information to FDA about ingredients and additives in tobacco products. 
• By April 2010, FDA will reissue the 1996 regulation aimed at reducing young people’s access to tobacco products and curbing the appeal of tobacco to the young. 
• By July 2010, tobacco manufacturers may no longer use the terms "light," "low," and "mild" on tobacco products without an FDA order in effect. 
• By July 2010, warning labels for smokeless tobacco products will be revised and strengthened. 
• By October 2012, warning labels for cigarettes will be revised and strengthened. 

What products are considered to be tobacco products as defined by the FSPTCA? 

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 FSPTCA? 

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. 

Is the FSPTCA related to FDA’s attempt to regulate tobacco as a drug in the mid-90s? 

The FSPTCA, passed on June 22, 2009, is a piece of legislation that is separate from the regulation that FDA issued in the mid-1990s. However, as directed by the FSPTCA, one of the first regulations FDA will issue is the reissuance of the 1996 regulation aimed at reducing tobacco access to youth.

 

SPECIFIC PRODUCTS

Does FDA have the authority to ban cigarettes?

No. The FSPTCA 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 FSPTCA 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 FSPTCA specifically states that FDA is prohibited from requiring the reduction of the nicotine yields of in tobacco product to zero. 

Are Cigars impacted by the passage of the Act? 

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

Why is the FDA banning all flavored tobacco products that adults may wish to purchase and smoke? 

The FSPTCA passed by the United States Congress and signed by the President of the United States sets forth a special rule for cigarettes prohibiting them from containing an artificial or natural flavor other than tobacco or menthol.

 

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 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 bill, 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 will be to reissue the 1996 regulation aimed at reducing young people’s access to tobacco products and curbing the appeal of tobacco to the young. When this becomes effective, a number of measures will take 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 

When will we begin to see new product labeling on tobacco products? 

By July 2010, warning labels for smokeless tobacco products will be revised and strengthened. By October 2012, warning labels for cigarettes will be revised and strengthened. Warnings for cigarettes will comprise the top 50 percent of the front and rear panels of the package. 

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

Yes, FDA will issue regulations requiring 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 bill, and a list of all constituents identified by FDA as harmful or potentially harmful to health within 3 years of the signing of the bill. Within 4 years of the signing of the bill, FDA will publish a list of harmful and potentially harmful constituents in each tobacco product by brand and by quantity. 

 

STATE and LOCAL GOVERNMENTS

Does the FSPTCA provide funds for grants to state, local or other organizations working to prevent people from smoking? 

The FSPTCA specifically does not provide for funds for state and local grants. However, as FDA works to implement the various parts of the FSPTCA, the Agency will continue to seek opportunities to provide information about ways FDA can work with state and local government’s tobacco control efforts. 

What can state, local, and tribal governments do under the FSPTCA to combat tobacco use? 

In addition to the provisions outlined in the FSPTCA, states, localities, and tribal governments can impose requirements that are in addition to or more stringent than FDA requirements. For example, states may: 

• Impose specific bans or restrictions on the time, place, and manner – but not the content – of cigarette advertising. 
• May prohibit or restrict the distribution or free samples of smokeless tobacco in any location. 
• May tax tobacco products.