Commonly Asked Questions: About the Center for Tobacco Products
For General Consumers
- What is the Center for Tobacco Products (CTP)? How did it come about?
- What are the mission and goals of the Center for Tobacco Products (CTP)?
- What is the Center for Tobacco Products (CTP) authorized to do?
- What are some of the accomplishments of the Center for Tobacco Products (CTP)?
- What types of tobacco products are regulated by the Center for Tobacco Products?
- If my tobacco-related question falls outside of the jurisdiction of the Center for Tobacco Products or is about a product you do not regulate, whom can I contact? Are there other resources you can provide?
- FDA regulates safe and effective products. How does tobacco fit in?
- Is there a way to find out the harmful ingredients in different tobacco products?
- Can you provide me with a list of ingredients in a certain tobacco product?
- Which tobacco product/brand is the healthiest option?
- Are electronic cigarettes (e-cigarettes) safe to use?
- How do I report a violation of the Family Smoking Prevention and Tobacco Control Act, such as selling tobacco products to a minor?
For Tobacco Product Retailers
For Tobacco Product Manufacturers
- What documents do I need to submit to the Center for Tobacco Products?
- How can I get my new or innovative product approved by FDA?
For General Consumers
The Family Smoking Prevention and Tobacco Control Act, signed into law in June 2009, granted the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products. FDA then established CTP to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use.
Tobacco use continues to be the leading cause of preventable death and disease in the United States. To help make tobacco-related death and disease a part of America’s past, not its future, CTP is committed to educating the public about the harms of tobacco products, keeping tobacco products out of the hands of America’s youth, and dramatically reducing the appeal of these deadly products. Everything we do is designed to reduce the impact of tobacco on public health, including our three key goals:
- Prevent Americans—especially youth—from starting to use tobacco
- Encourage current users to quit
- Decrease the harms of tobacco product use
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) allowed FDA to establish CTP and granted CTP the authority to:
- Require tobacco product manufacturers register with FDA
- Establish standards for tobacco products, such as tar and nicotine levels, in an effort to reduce their toxicity and addictiveness
- Establish limits on sale and distribution of tobacco products
- Require premarket review for new and modified risk tobacco products to protect the public health
To learn more about the Tobacco Control Act, view our fact sheet.
CTP continues to make progress toward reducing the impact of tobacco use on the nation’s health. Some key accomplishments include the following:
- Restricting access and marketing of cigarettes, cigarette tobacco, and smokeless tobacco to youth
- Removing cigarettes with characterizing flavors, such as candy and fruit, from the market, making cigarettes less appealing to kids
- Enforcing the ban on brand-name tobacco sponsorship of sporting events and concerts
- Issuing and enforcing new restrictions on marketing and promotion, such as the minimum pack size of 20 cigarettes
- Proposing a rule to extend its tobacco authority to cover additional tobacco products
Providing Information to Help Educate Consumers
- Implementing provisions that require tobacco companies to report to FDA on the quantities of a list of harmful or potentially harmful constituents in tobacco products
- Launching “The Real Cost,” FDA’s first national public education campaigns designed to prevent young people from using tobacco
- Releasing a preliminary scientific evaluation addressing the association between menthol cigarettes and various outcomes, including initiation, addiction, and cessation
- Issuing an Advance Notice of Proposed Rulemaking to take public input on menthol in cigarettes
Implementing Tobacco Product Review
- Requiring cigarette, roll-your-own, and smokeless tobacco product manufacturers to seek FDA authorization before marketing a new product or making changes to existing products
- Establishing a rigorous review process for new tobacco products through three separate pathways to market: premarket tobacco product applications, substantial equivalence reports, and exemption from substantial equivalence
- Working to ensure that any new tobacco product authorized through the substantial equivalence pathway will not present more harm to public health than the predicate product with which it was compared
- Issuing the first orders to stop the continued sale and distribution of currently marketed tobacco products because the manufacturer did not meet the requirements of the Tobacco Control Act to continue selling their products
Ensuring Compliance With the Law
- Enforcing the law’s prohibition on the use of marketing terms for regulated tobacco products that imply reduced risk (such as “light,” “mild,” or “low”) without FDA authorization
- Implementing a compliance and enforcement program to ensure industry compliance with regulatory requirements
Expanding Regulatory Science
- Partnering in research with the National Institutes of Health to dramatically increase regulatory science capabilities. A few of those projects include:
- The Population Assessment of Tobacco and Health Study, the first longitudinal study of patterns of tobacco use over time
- Innovative research on the alteration of nicotine levels in tobacco products to assess how such changes could affect the way people might use tobacco products and become addicted
- Award of $53 million to establish 14 Tobacco Centers of Regulatory Science leading
- Establishing a world-class testing laboratory, in partnership with the Centers for Disease Control and Prevention, with the capacity to analyze tobacco products and increase our understanding of their health risks
FDA currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. By law, FDA has the authority to regulate “tobacco products,” which is defined in part as any product “made or derived from tobacco” that is not a “drug,” “device,” or "combination product" under the Food, Drug, and Cosmetic Act.
FDA does not currently regulate products such as cigars, hookah tobacco, or electronic cigarettes, unless their manufacturers make therapeutic claims. However, FDA recently published a proposed rule for public comment to bring more types of tobacco products under FDA’s regulatory authority. The proposed rule would include electronic cigarettes (e-cigarettes), cigars, pipe tobacco, waterpipe (hookah) tobacco, novel products like nicotine gels and dissolvables not already under FDA’s authority, as well as future products that meet the definition of a tobacco product. FDA’s proposed rule also would include tobacco product components or parts that are used in the consumption of a tobacco product, like e-cigarette cartridges. It would not include tobacco product accessories, like cigar cases.
6. If my tobacco-related question falls outside of the Center for Tobacco Products jurisdiction or is about a product you do not regulate, whom can I contact? Are there other resources you can provide?
- For more tobacco-related information, visit the U.S. Department of Health and Human Services’ BeTobaccoFree.gov website.
- For questions about nicotine replacement therapies and smoking-cessation products, contact FDA’s Center for Drug Evaluation and Research:
- For information about cessation programs and local-/state-level initiatives, contact the Centers for Disease Control and Prevention’s Office on Smoking and Health:
- Centers for Disease Control - Smoking and Tobacco Use
- Quit Now: (800) 784-8669
- General information: (800) 232-4636
- For questions about the cultivation of the tobacco plant, contact the U.S. Department of Agriculture’s Farm Service Agency:
- For questions about products that you suspect are illegal drugs, contact the U.S. Drug Enforcement Administration:
- For questions about cigarette trafficking, interstate commerce, or Internet sales, contact the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives:
- To report criminal activity: (888) 283-8477
- General questions: (800) 800-3855
- For questions about manufacturing and importing permits, general importing/exporting, and taxes, contact the U.S. Alcohol and Tobacco Tax and Trade Bureau:
- TTB.gov - Alcohol and Tobacco Tax and Trade Bureau
- General questions: (877) 882-3277
- For questions about tobacco retail licenses, state-accepted legal age to buy or sell tobacco, and other state/local laws, contact your state/local health department and ask for the tobacco division.
FDA’s traditional “safe and effective” standard for evaluating medical products does not apply to tobacco. FDA evaluates new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product on the population as a whole, including users and nonusers.
The law requires FDA to apply a public health approach when developing regulation that considers the net effect on tobacco-related behavior changes within the entire population, not just an individual user, for initiation, cessation, and re-initiation of tobacco use.
There is no known safe tobacco product. But FDA currently does not have the authority to ban any class of tobacco products, such as cigarettes. We do, however, have the authority to dramatically reduce the harm of all tobacco products, and we will use that authority to continue improving public health.
FDA is required by law to publicly display information about harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke that cause harm, or could cause harm, to users and non-users, in a way that is understandable and not misleading. The regulation includes listing the amount of each chemical present in specific brands and sub-brands of tobacco products.
FDA will make HPHC information available once the Agency is confident that the list is accurate, understandable, and not misleading to the public. FDA is still evaluating the data it has received from manufacturers, including verifying its accuracy. In addition, FDA is conducting scientific studies to assess consumer understanding of how the Agency presents information about HPHCs. For example, FDA recently elicited comments from the Risk Communication Advisory Committee, the Tobacco Products Scientific Advisory Committee and the public on the results of one of its first consumer research studies “Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents.”
Upon completion of these important activities, FDA intends to publish the HPHC information, so that consumers can make more informed decisions about tobacco products.
Section 915 of the Federal Food, Drug, and Cosmetic Act requires FDA to issue regulations requiring the testing and reporting of tobacco product constituents, ingredients, and additives that FDA determines should be tested to protect the public health. Once FDA issues a proposed rule related to Section 915, it will be available for public comment. You can track the status of the proposed rule through the Unified Agenda, which semi-annually lists all of the Agency’s projected publication dates. Additionally, for more information about the FDA rulemaking process, visit our Rules and Regulations page.
No matter what they taste, smell, or look like, all tobacco products can be harmful to your health. The Family Smoking Prevention and Tobacco Control Act grants FDA the authority, and responsibility, to reduce the harm of tobacco products. The most effective way to achieve the greatest reduction in tobacco-related death and disease is to stop using all tobacco products. However, FDA understands there is a potential market for tobacco products that could present less health risks to consumers. These items are called modified risk tobacco products (MRTPs), and they are tobacco products that are sold or distributed for use to reduce harm or risk of tobacco-related disease associated with commercially marketed tobacco products. FDA can issue an order authorizing the marketing of a product claiming reduced harm or risk, only if the evidence submitted in the application includes, among other things, data showing that the product will or is expected to benefit the health of the population as a whole. Furthermore, if a proposed MRTP is a new tobacco product (not yet on the market), a person or entity seeking to bring that MRTP to market is subject to premarket requirements (e.g., substantial equivalence, exemption from substantial equivalence, or a premarket tobacco application) in addition to MRTP requirements. To learn more, see FDA’s Modified Risk Tobacco Products webpage.
As the safety and efficacy of e-cigarettes have not been fully studied, consumers of e-cigarette products currently have no way of knowing whether e-cigarettes are safe for their intended use, how much nicotine or other potentially harmful chemicals are being inhaled during use, or if there are any benefits associated with using these products. Further research is needed to assess the potential public health benefits and risks of electronic cigarettes.
Currently, only e-cigarettes that are marketed for therapeutic purposes are regulated by the FDA's Center for Drug Evaluation and Research. For more information, please visit FDA’s Electronic Cigarettes page.
FDA recently proposed a rule to include e-cigarettes under its authority, along with cigars, pipe tobacco, waterpipe (hookah) tobacco, novel products like nicotine gels and dissolvables not already under FDA’s authority, and future products that meet the definition of a tobacco product. The proposed rule would also include tobacco product components or parts that are used in the consumption of a tobacco product, like e-cigarette cartridges. It would not include tobacco product accessories, like cigar cases.
To learn more about the proposed rule, visit our Extending Authorities to Additional Tobacco Products page.
To report a potential violation of the Family Smoking Prevention and Tobacco Control Act, you can call Center for Tobacco Products’ Call Center at (877) CTP-1373 or send an email to AskCTP@fda.hhs.gov.
In addition, you may also use the downloadable Potential Tobacco Product Violations Reporting form.
For Tobacco Product Retailers
Retailers play an important role in protecting the health of America’s youth by not selling, marketing, or advertising cigarettes or smokeless tobacco products to underage children and adolescents. FDA conducts compliance check inspections of tobacco product retailers to determine a retailer’s compliance with federal laws and regulations.
FDA generally issues Warning Letters for first-time violations and civil money penalties for violations found on subsequent inspections. Results from compliance check inspections covering cigarettes and smokeless tobacco products are available on our website.
FDA generally sends Warning Letters to retailers the first time a tobacco compliance check inspection reveals a violation of the federal tobacco laws and regulations that FDA enforces. First, review the letter carefully to see what charges are listed. You should respond in writing to the letter within 15 working days. Include the following in your response to the Warning Letter:
- An explanation of the steps you will take to correct the violation(s) and prevent future violations (e.g., retrain your employees, remove the problematic items)
- Your current contact information, including telephone number and email address
Promptly and adequately correct the violations listed and be sure that you comply with all applicable laws and regulations. The Warning Letter includes contact information, so if you have any questions, reach out to us for more information. You may also visit our Warning Letters Overview page for further resources.
For Tobacco Product Manufacturers
Tobacco product manufacturers or importers are required to submit certain information to FDA, including:
- Tobacco health documents
- Establishment registration and product listing
- Listing of ingredients in tobacco products
- Reporting of harmful and potentially harmful constituents in tobacco products and tobacco smoke
For more details about the requirements and submission process, visit our Manufacturers webpage.
FDA does not “approve” tobacco products, but the Family Smoking Prevention and Tobacco Control Act provides legal ways for new tobacco products to be marketed. If FDA determines a new tobacco product meets the relevant legal requirements, we will issue a written notification permitting the marketing of the new tobacco product. Tobacco manufacturers may use one of the three Pathways to Market to seek to legally market new tobacco products. These include:
- Premarket tobacco products—This pathway requires the applicant to demonstrate that FDA permitting the marketing of the new tobacco product would be appropriate for the protection of the public health.
- Substantial equivalence—This pathway may be appropriate for a new tobacco product that demonstrates it has the same characteristics as a predict tobacco product, or has different characteristics, but does not raise different questions of public health from a predicate product.
- Exemption from substantial equivalence—This pathway may be appropriate for new tobacco products with certain minor modifications to additives of a legally marketed tobacco product.
Learn more about these pathways by visiting our Tobacco Product Review and Evaluation webpage.