Chemicals in Cigarettes: From Plant to Product to Puff

You probably know that cigarettes can kill you—in fact, smoking kills half of those who don't quit¹—but do you really have the full story? Do you know how many harmful chemicals are in cigarettes or how they get into the product?

FDA created these videos and interactive tools to lay the foundation for an important public health goal: we aim to publish a list of the levels of harmful and potentially harmful chemicals in tobacco, in a way that is easy for the public to understand. As an important step toward that goal, we invite you to explore the chemicals in tobacco in three stages of cigarettes, from plant to product to puff, in the videos below.

Chemicals in Every Tobacco Plant

It is a fact that cigarettes contain dangerous chemicals.² But how do these chemicals get into cigarettes? Are most of the harmful chemicals added during the manufacturing process?

Fact: Some of the toxic chemicals in tobacco are present in the plant itself.³ Watch the tobacco growth video to uncover more.

Chemicals in Every Cigarette Product

Ok, so harmful chemicals are in the tobacco plant. What happens during manufacturing? Is that when more dangerous chemicals are added?

Fact: Not all of the harmful chemicals created during cigarette manufacturing are man-made. Some of the carcinogens occur naturally as tobacco is cured.³ Watch the video about cigarette manufacturing.

Chemicals in Every Puff of Cigarette Smoke

How many harmful and potentially harmful chemicals are in a cigarette? Is there more than nicotine and tar?

Fact: There are more than 7,000 chemicals in cigarette smoke.² More than 70 of those chemicals are linked to cancer.^4,5,6,7 Watch the video on cigarette smoke to learn more about what happens when you light up.

Think You Know All the Chemicals Found in Cigarettes?

Here are some of the 93 known harmful and potentially harmful chemicals in cigarettes:

 

 

 

Downloads

Download and share with people in your life these images about the health effects of dangerous chemicals in cigarettes. To download:

1. Click on the image below that you would like to download and share to open up a larger version.
2. On the large version, right-click to Save As and save the image to your computer.

 

 

 

 

 

References

1. Doll R, Peto R, Wheatley K, Gray R, Sutherland I. Mortality in relation to smoking: 40 years observations on male British doctors. British Medical Journal 1994; 309:901-911.
2. U.S. Department of Health and Human Services (USDHHS). A Report of the Surgeon General: How Tobacco Smoke Causes Disease: What It Means to You (Consumer Booklet). Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2010.
3. U.S. Department of Health and Human Services (USDHHS). How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2010.
4. Hecht SS. Research opportunities related to establishing standards for tobacco products under the Family Smoking Prevention and Tobacco Control Act. Nicotine & Tobacco Research. 2012; 14(1):18-28.
5. Hoffmann D, Hoffmann I, El Bayoumy K. The less harmful cigarette: a controversial issue. A tribute to Ernst L. Wynder. Chemical Research in Toxicology. 2001; 14:767-790.
6. International Agency for Research on Cancer (IARC). Some non-heterocyclic polycyclic aromatic hydrocarbons and some related exposures. In: IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Vol. 92. Lyon, France: International Agency for Research on Cancer; 2010.
7. International Agency for Research on Cancer (IARC). Tobacco smoke and involuntary smoking. In: IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Vol. 83. Lyon, France: International Agency for Research on Cancer; 2004.

Submit Comments on Tobacco Products

Make your voice heard and be part of our ongoing effort to improve public health in the United States.

We solicit information and comments, announced in the Federal Register and posted in dockets on Regulations.gov, from concerned citizens, industry, and organizations on a wide range of issues related to implementation of the Tobacco Control Act.

Submit Comments

Flavor Developer and Manufacturer Site Tours Program
Docket No: FDA-2017-N-3998
Date: Submit comments by November 20, 2017
Summary: The FDA Center for Tobacco Products is announcing an invitation for participation in its voluntary Flavor Developer and Manufacturer Site Tours Program. This program is intended to give CTP staff an opportunity to visit companies that develop and/or manufacture flavors (including flavor mixtures) that are sold to tobacco product manufacturers in order to gain a better understanding of the development, testing, and production of flavors and flavor mixtures used in the manufacturing of tobacco products. The site tours in this program are not intended as regulatory inspections. The purpose of this notice is to invite parties interested in participating in the Flavor Developer and Manufacturer Site Tours Program to submit requests to CTP.

Modified Risk Tobacco Product Applications: Applications for IQOS System with Marlboro Heatsticks, IQOS System with Marlboro Smooth Menthol Heatsticks, and IQOS System with Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A.; Availability
Docket No: FDA-2017-D-3001
Date: Submit comments by December 12, 2017
Summary: The FDA is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) for IQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks submitted by Philip Morris Products S.A. Due to the large size of these applications, FDA will post the application documents in batches on a rolling basis as they are redacted in accordance with applicable laws.

What makes an effective and useful comment?

Our decisions are based on science and law. We look for logic, good science, and other evidence in the comments we evaluate.

• Provide a clear statement of whether you support or oppose the proposed rule or guidance.
• Include any of the following that support your position:
  • data
  • research
  • analysis
• Read more tips for submitting effective comments on the regulations.gov website.

Your role in shaping tobacco regulation

Our regulatory process generally follows these steps:

1. Rule/ Regulation Proposed
   We publish a proposed rule in the Federal Register.
2. Public Comments Considered
   Our proposals generally have a 60-90 day review period.
3. Final Rule Issued
   After considering all comments, we issue a final rule.
4. Compliance with New Rule Enforced
   We must ensure that retailers and businesses comply with the regulation.

Population Assessment of Tobacco and Health: An FDA and NIH Study

The Population Assessment of Tobacco and Health (PATH) Study is a uniquely large, long-term study of tobacco use and health in the United States. A collaboration between the U.S. Food and Drug Administration (FDA) Center for Tobacco Products and the National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA), the study was launched in 2011, started the first wave of data collection in 2013, and is currently in its fourth wave.

By following study participants over time, the PATH Study helps scientists learn how and why people start using tobacco, quit using it, and start using it again after they’ve quit, as well as how different tobacco products affect health (such as cardiovascular and respiratory health) over time. Findings from the study may also inform FDA’s actions related to tobacco products, thereby helping to achieve the goals of the Family Smoking Prevention and Tobacco Control Act.

The PATH Study is conducted via a contract awarded to Westat and involves researchers from:

• Center for Tobacco Products, FDA
• National Institute on Drug Abuse, NIH
• Centers for Disease Control and Prevention
• Roswell Park Cancer Institute
• Dartmouth College
• Truth Initiative (formerly Legacy)
• The Medical University of South Carolina
• The University of California, San Diego
• The University of Waterloo
• The University of Minnesota

Research Goals for the PATH Study

By monitoring and assessing behaviors, attitudes, biomarkers, and health outcomes associated with tobacco use in the United States, the PATH Study helps enhance the evidence base available to inform FDA’s regulatory activities related to tobacco. Specifically, the study aims to:

• Examine what makes people susceptible to using a tobacco product
• Evaluate initiation and use patterns, including the:
  • use of newer products, such as  e-cigarettes or ENDS (electronic nicotine delivery systems)
  • use of multiple products
  • switching from one product to another
• Study patterns of tobacco product use, cessation, and relapse
• Track potential behavioral and health impacts, including biomarkers of exposure and harm
• Assess differences in tobacco-related attitudes, behaviors, and health conditions among racial/ethnic, gender, and age subgroups

Findings from the PATH Study

About 46,000 people aged 12 years and older, including tobacco users and non-users, are included in the first wave of the PATH Study.

Initial data on adult and youth tobacco use, published January 2017 in the New England Journal of Medicine, showed that more than 25 percent of American adults were current users of tobacco in 2013-14 and roughly 9 percent of youth reported using tobacco in the past 30 days. Multiple product use was common among tobacco users, accounting for roughly 40 percent of adult and youth tobacco users, with cigarettes and e-cigarettes being the most common combination among both age groups.

Among tobacco users who reported using more than one product:

• 23 percent of adults and 15 percent of youth used cigarettes and e-cigarettes
• 6 percent of adults and 4 percent of youth used cigarettes and hookah
• 2 percent of adults and 5 percent of youth used e-cigarettes and hookah
• 5 percent of adults and 10 percent of youth used cigarettes and cigarillos

The study reports prevalence for more product combinations used by study participants.

Data Access and Availability

Data and documentation (questionnaires, codebooks) related to the PATH Study are available on the National Addiction & HIV Data Archive Program (NAHDAP) website , including:

• Public-use files (PUFs)   from Waves 1 (Sep 2013–Dec 2014) and 2 (Oct 2014–2015) of data collection.
• Restricted-use files (RUFs)  from Waves 1 (Sep 2013–Dec 2014) and 2 (Oct 2014–Oct 2015). Qualified researchers are encouraged to apply for access through the NAHDAP website.
• Biomarker Restricted-use files (BRUFs)   from Wave 1 (Sep 2013 – Dec 2014).
• Biospecimen Access Program (BAP)  which provides the research community with access to urine, serum, and plasma collected from adult PATH Study participants during Wave 1.

PATH Study Publications

Listed below is a selection of peer-reviewed journal articles from the PATH Study. See the NAHDAP website  or search PubMed.gov  for a complete list of publications.

Note: The following publications are highlighted for illustrative purposes only. The information in these highlighted publications is not a formal dissemination of information by FDA and does not represent agency position or policy. The contents of the publications are the responsibility of the authors alone.

• Villanti AC, Johnson AL, Ambrose BK, et al. Flavored tobacco product use in youth and adults: findings from the first wave of the PATH Study (2013–2014) [published online March 13, 2017]. Am J Prev Med. doi:10.1016/j.amepre.2017.01.026
• Kasza KA, Ambrose BK, Conway KP, et al. Tobacco-product use by adults and youths in the United States in 2013 and 2014. N Engl J Med. 2017;376(4):342-353.
• Hyland A, Ambrose BK, Conway KP, et al. Design and methods of the Population Assessment of Tobacco and Health (PATH) Study [published online August 8, 2016]. Tob Control. doi:10.1136/tobaccocontrol-2016-052934.
• Ambrose BK, Day HR, Rostron B, et al. Flavored tobacco product use among US youth aged 12-17 years, 2013-2014. JAMA. 2015;314(17):1871-1873.

FDA's New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products

Tobacco use is the single largest preventable cause of disease and death in the United States.¹ Since 2009, FDA has regulated cigarettes, smokeless, and roll-your-own tobacco. FDA finalized a rule, effective August 8, 2016, to regulate all tobacco products. For background information on this milestone in consumer protection, see The Facts on the FDA's New Tobacco Rule.

Read the FDA Voice blog post by Center Director Mitch Zeller on Protecting the Public and Especially Kids from Tobacco Products, Including E-Cigarettes, Cigars and Hookah Tobacco.

How Do the New Regulations Affect You?

Questions & Answers

1. What are the costs associated with submitting an application?
2. I am a vape shop with hundreds of different e-liquids. Do I need to submit an application for each flavor/ingredient variant or nicotine strength?
3. How does a manufacturer know if they need to conduct clinical trials?
4. What is the grandfather date?
5. Are there any e-cigarettes that are grandfathered and could be used as a predicate for a Substantial Equivalence application?

Read more commonly asked questions and answers.

Webinars

Documents and Additional Resources

Final Rule and Accompanying Documents

• Final Rule: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products

• Regulatory Impact Analysis (RIA): Tobacco Products Deemed To Be Subject to the Food, Drug and Cosmetic Act

• Final Rule: Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco

_{1. U.S. Department of Health and Human Services (USDHHS). The Health Consequences of Smoking— 50 Years of Progress: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014.}

Harmful and Potentially Harmful Constituents (HPHCs)

The Food, Drug and Cosmetic Act (FD&C Act) requires tobacco manufacturers and importers to report the levels of harmful and potentially harmful constituents (HPHCs) found in their tobacco products and tobacco smoke. HPHCs are chemicals or chemical compounds in tobacco products or tobacco smoke that cause or could cause harm to smokers or nonsmokers. 

FDA must publish HPHC quantities in each brand and subbrand of tobacco product, in a way that people find understandable and not misleading. There are several efforts under way at FDA to make progress toward that goal.

 

Chemicals in Cigarettes: From Plant to Product to Puff

Do you know how many harmful chemicals are in cigarettes or how they get into the product? Watch three videos to learn more about the stages of cigarettes, from plant to product to puff.

 

 

Preliminary HPHC List

FDA published a preliminary list of 93 HPHCs in March 2012. This HPHC list focuses on chemicals that are linked to the five most serious health effects of tobacco use (cancer, cardiovascular disease, respiratory effects, reproductive problems, and addiction.)  

Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke: Established List

Tobacco Industry Reporting Requirements

FDA issued draft guidance in 2012 that identified a subset of 20 HPHCs for which manufacturers and importers are to test and report to FDA. FDA chose these 20 because testing methods were well established and widely available. FDA is now evaluating the quality and reliability of the data submitted by manufacturers.  

Communicating to the Public

Making sure the public can clearly understand the real and potential risks of tobacco use is an important goal. Presently, FDA is conducting research about how best to ensure that the public is made aware of the dangers of the chemicals and chemical compounds in tobacco products and smoke and to communicate the levels of HPHCs in each brand and subbrand of tobacco product. In the meantime, FDA is including messages about HPHCs in its ongoing public health campaigns. FDA has also created three videos and interactive tools to lay the foundation for an important public health goal: we aim to publish a list of the levels of harmful and potentially harmful chemicals in tobacco, in a way that is easy for the public to understand. As an important step toward that goal, we invite you to explore the chemicals in tobacco in three stages of cigarettes, from plant to product to puff.

Light, Low, Mild or Similar Descriptors

Tobacco products that are labeled or advertised with the terms "light," "low," or "mild" or similar descriptors mislead the public into thinking that these products cause fewer health problems than other cigarettes. However, they still pose a heavy health risk. Research shows that:

• Smokers who use light cigarettes do not reduce their risk for developing smoking-related cancers and other diseases.¹
• Switching to light cigarettes does not help smokers quit, and may actually decrease the motivation to quit.^2,3

In order to better protect the public from misleading claims, the Family Smoking Prevention and Tobacco Control Act prohibits manufacturers from producing and distributing for sale any tobacco products labeled or advertised as "light," "low," or "mild" without a Modified Risk Tobacco Product order from the FDA. Manufacturers must meet rigorous criteria before we can issue an order authorizing the marketing of a modified risk tobacco product. If products are marketed as "light," "low," or "mild" without an MRTP order, FDA considers these claims to be health fraud.

Sources

1. National Cancer Institute (NCI). "Light" Cigarettes and Cancer Risk. Rockville, MD: U.S. Department of Health and Human Services, National Institute of Health, National Cancer Institute. Updated October 28, 2010. http://www.cancer.gov/about-cancer/causes-prevention/risk/tobacco/light-cigarettes-fact-sheet#q2. Accessed August 25, 2015.
2. Tindle H, Shiffman S, Hartman A, Bost J. Switching to "lighter" cigarettes and quitting smoking. Tobacco Control. 2009;18(6):485-490.
3. Center for Disease Control and Prevention (CDC). Tobacco Control Act: Resources and FDA Regulations. Atlanta, GA: U.S. Department of Health and Human Services, Center for Disease Control and Prevention. Updated July 20, 2015. http://www.cdc.gov/tobacco/stateandcommunity/fda/fda_regs/index.htm. Accessed August 25, 2015.
    

Men's Health and Smoking

Smoking continues to have a profound impact on the health and well-being of men and their families in the United States.

• About 1 in 6 men smoke cigarettes.¹
• Each day in the United States, more than 1,100 boys under 18 years of age smoke their first cigarette.²
• 1 in 10 high school aged boys smoke cigarettes.³

Impacts of Men Smoking

There is abundant research about the many harms of smoking—whether it's the dangerous chemicals, the addictive properties, or the damage smoking causes to the lungs, the heart, and nearly every organ in the body.⁴ For men who smoke, these effects can have a profound impact on your body and your life, including diminished overall heath, increased absenteeism from work, and increased health care needs and costs.⁵ Smoking also exposes your family to the harmful effects of secondhand smoke. Here are some facts about smoking's effects to you and those around you.

For Men

• Smoking causes heart disease, cancer, and stroke—the first, second, and fifth leading causes of death among men in the United States.^6,7
• Smoking cigarettes causes chronic obstructive pulmonary disease (COPD). People with COPD have trouble breathing and slowly start to die from lack of air.⁴ Approximately 80% of COPD deaths are caused by smoking. Smokers are 12 to 13 times more likely to die from COPD than nonsmokers.⁶
• Smokers are up to 20 times more likely to develop lung cancer than nonsmokers.⁵
• Life expectancy for smokers is at least a decade less than for nonsmokers.⁸
• Smokers with prostate cancer may be more likely to die from the disease than nonsmokers.⁹

For Families

• Secondhand smoke causes disease and premature death in nonsmoking adults and children.^9,10
• The U.S. Surgeon General estimates that living with a smoker increases a nonsmoker's risk of developing lung cancer by 20-30%.^9,10
• Exposure to secondhand smoke increases school children's risk for ear infections, lower respiratory illnesses, more frequent and more severe asthma attacks, and slowed lung growth, and can cause coughing, wheezing, phlegm, and breathlessness.^10,11
• Teens are more likely to smoke if they have friends or family who smoke.¹²

Next Steps

The good news is that you can do something about it now—smoking truly is what the CDC terms a "modifiable" risk factor.

Encourage the men in your life—the fathers, sons, brothers, and friends—to take a moment to care for themselves and put their own health first by finding a quit method that works for them.

CTP Newsroom

News & Events

Recent news, press releases, meetings, workshops, newsletters, and other announcements are listed below.

2017

• October 2017: FDA Actions Regarding Tobacco Manufacturers/Importers Affected by Recent Natural Disasters
• September 2017: Newsletter - CTPConnect
• September 2017: FDA Announces Flavor Developer and Manufacturer Site Tours Program
• August 2017: Newsletter - Spotlight on Science
• July 2017: FDA’s New Plan for Tobacco and Nicotine Regulation
• June 2017: Newsletter - CTPConnect
• June 2017: Statement from FDA Commissioner Scott Gottlieb, M.D. on the 2016 National Youth Tobacco Survey Results
• June 2017: CDC Press Release - Youth Tobacco Product Use, Including E-Cigarettes, Drops During 2015-2016
• May 2017: Web Statement
• April 2017: Newsletter - Spotlight on Science
• April 2017: Public Workshop - Battery Safety Concerns in Electronic Nicotine Delivery Systems (ENDS) Public Workshop
• March 2017: Newsletter - CTPConnect
• February 2017: Web Feature - Dip, Chew, Snuff, Snus: "Smokeless" Doesn’t Mean "Safe"
• January 2017: Web Statement - FDA Offers Compliance Policy for Certain Vape Shop Activities in New Draft Guidance

2016

• December 2016: Press Release - FDA takes action on applications seeking to market modified risk tobacco products
• December 2016: Web Feature - Lessons Learned from the First Review of Modified Risk Tobacco Product (MRTP) Applications
• November 2016: Public Workshop - Risk Assessment
• November 2016: Web Feature - How Cigarettes Are Made and How You Can Make a Plan to Quit
• October 2016: Public Workshop - The Premarket Tobacco Product Application for Electronic Nicotine Delivery Systems (ENDS)
• September 2016: Press Release - FDA protects kids from illegal sales of e-cigarettes, e-liquids and cigars
• May 2016: Press Release - FDA takes significant steps to protect Americans from dangers of tobacco through new regulation
• May 2016: Press Release - FDA launches public education campaign to prevent and reduce tobacco use among LGBT young adults
• April 2016: Press Release - FDA launches first ad campaign focused on dangers of smokeless tobacco among rural teens
• April 2016: Public Workshop - Biomarkers of Potential Harm
• March 2016: Web Feature - Diabetes and Tobacco Use
• March 2016: Meeting - Society For Research On Nicotine and Tobacco
• March 2016: Public Workshop - Waterpipes

Archived Content

Search for past news and events in the FDA.gov web archive.

• Press release archive
• Email newsletters & web statements archive
• Features archive
• Public meeting and workshop archive

Report Potential Tobacco Product Violation

The minimum legal age to purchase tobacco is 18 – and yet, 87 percent of adult daily smokers begin smoking before age 18.¹ Together, we can change that.

The Tobacco Control Act and related regulations give FDA tools to help keep tobacco out of the hands of America’s youth. But you also have an opportunity to play a key role. The public is crucial in helping FDA enforce tobacco regulations to protect America’s youth. 

What Is a Potential Tobacco Product Violation?

Potential tobacco product violations include (but are not limited to):

• Sales to minors
• Flavored cigarette sales
• Illegal marketing and advertising – The Tobacco Control Act gives the FDA the ability to regulate certain marketing and advertising activities by the tobacco industry, including:
  • Describing tobacco products as “light,” “mild,” or “low” – or claiming a product is safer or less harmful without an FDA order
  • Distributing t-shirts or other promotional or novelty items with brand names of cigarette or smokeless tobacco products 
  • Sponsoring events using the brand name of a tobacco product
• Distribution of free samples of tobacco products except in limited circumstances
• Placement of cigarette or smokeless tobacco product vending machines in prohibited areas (or providing access to self-service or direct access of tobacco products in prohibited areas)
• Sale of cigarettes in packages of less than 20

How Can I Report a Potential Tobacco Violation?

If you see what you believe to be a violation of the Tobacco Control Act or other related regulations, you can:

• Submit online: Online Form
• Call the Tobacco Call Center using CTP's toll-free number: 1.877.CTP.1373
• Send an email: CTPCompliance@FDA.hhs.gov
• Print and mail: Paper form (PDF) to
  Potential Tobacco Products Violation Report
  Food and Drug Administration
  Center for Tobacco Products
  Office of Compliance and Enforcement
  Document Control Center
  Building 71, Room G335
  10903 New Hampshire Avenue
  Silver Spring, MD 20993

What Happens When I Submit a Potential Violation?

FDA will evaluate any report submitted to determine if the activity is a violation of the Tobacco Control Act or related regulations. Before deciding what follow-up action, if any, is necessary, we will check to see if the product named in the complaint is regulated by FDA. If the product is regulated by a different federal or state agency, or different part of FDA, we will forward the complaint to the applicable entity for review.

FDA does not rely solely on what was submitted to take enforcement action. After reviewing a complaint, our investigation may include:

• performing an inspection of a tobacco product manufacturer, distributor, or importer;
• conducting a compliance check inspection of a tobacco retailer; or
• initiating monitoring and surveillance of a tobacco product manufacturer’s or retailer’s website.

FDA may determine that there is no evidence of a violation, or we may find evidence of the reported violation or of other potential violations that requires additional surveillance, monitoring, and/or inspections.

Privacy and Anonymity

All reports to FDA remain private to the extent allowed by law as explained in FDA’s Privacy Policy. Reports can be submitted anonymously; however, reports accompanied by names and contact information are helpful if FDA regulators need to follow-up for more information.

Children's Privacy: FDA will not collect or store information from children under 13. If a child sends us an email inquiry or comment, we will answer it and then delete the email from our files.

Tobacco Control Act

To protect the public and create a healthier future for all Americans, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), signed into law on June 22, 2009, gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products.

The Tobacco Control Act:

• Restricts Tobacco Marketing and Sales to Youth
• Requires Smokeless Tobacco Product Warning Labels
• Ensures “Modified Risk” Claims are Supported by Scientific Evidence
• Requires Disclosure of Ingredients in Tobacco Products
• Preserves State, Local, and Tribal Authority

Restricts Tobacco Marketing and Sales to Youth

The Tobacco Control Act puts in place specific restrictions on marketing tobacco products to children and gives FDA authority to take further action in the future to protect public health. These provisions ban:

• sales to minors
• vending machine sales*
• the sale of packages of fewer than 20 cigarettes
• tobacco-brand sponsorships of sports and entertainment events or other social or cultural events
• free giveaways of sample cigarettes and brand-name non-tobacco promotional items

*except in adult-only facilities

Requires Smokeless Tobacco Product Warning Labels

The Tobacco Control Act requires that smokeless tobacco packages and advertisements have larger and more visible warnings. Smokeless tobacco includes tobacco products such as moist snuff, chewing tobacco, and snus. Every smokeless tobacco package and advertisement will include one of the following warning label statements:

For smokeless tobacco packaging, the warning label statement must be located on the two principal sides of the package and cover at least 30% of each side.

For advertisements, the warning label statements must cover at least 20% of the area of the ad.

These changes aim to increase awareness of the health risks associated with smokeless tobacco use and improve the public health.

Ensures "Modified Risk" Claims are Supported by Scientific Evidence

The landmark law prohibits tobacco companies from making reduced harm claims like “light,” “low,” or “mild,” without filing an application for a modified risk tobacco product and obtaining an order to market as such.

Requires Disclosure of Ingredients in Tobacco Products

Tobacco companies must provide FDA with detailed information about the ingredients in their products.

Preserves State, Local, and Tribal Authority

The Tobacco Control Act preserves the authority of state, local, and tribal governments to regulate tobacco products in specific respects.

Additional Authorities

The Tobacco Control Act gives FDA authority to help protect the public and create a healthier future for all Americans. For example, the Tobacco Control Act:

• Requires tobacco company owners and operators to register annually and open their manufacturing and processing facilities to be subject to inspection by FDA every two years.
• Allows FDA to implement standards for tobacco products to protect public health. For example, FDA has the authority to regulate nicotine and ingredient levels.
• Bans cigarettes with characterizing flavors, except menthol and tobacco.
• Funds FDA regulation of tobacco products through a user fee on the manufacturers of certain tobacco products sold in the United States, based on their U.S. market share.

The Tobacco Control Act does not:

The law makes clear that FDA's role is to regulate and protect the public health, but it places a few restrictions on FDA's powers. FDA cannot:

• Require prescriptions to purchase tobacco products.
• Require the reduction of nicotine yields to zero.
• Ban face-to-face sales in a particular category of retail outlets.
• Ban certain classes of tobacco products.

Search the Act

• Sections of the Tobacco Control Act

NOTE: This overview highlights some of the provisions of the Tobacco Control Act and is not intended to be a comprehensive guide or to reflect FDA's interpretation of the Tobacco Control Act.  For complete information, you must read the entire law.

Health Fraud

What is Tobacco-Related Health Fraud?

False or misleading claims in the promotion, advertising, distribution or sale of tobacco products, including suggestions that a tobacco product is safer, less harmful, contains a reduced level or is free of a harmful substance, or presents a lower risk of tobacco-related disease compared to other tobacco products.

Sections 902, 903 and 911 of the Family Smoking Prevention and Tobacco Control Act provide more information.

 

Health Fraud Example 2: The fictional ABC Cigarette promotion describes their product as "light," and claims that the filter "removes seven times more tar and nicotine." These claims may be misleading, suggesting a reduced harm.  Both of these claims require scientific evidence and an order from FDA before they can be used.

Tobacco-Related Health Fraud

All tobacco products are harmful to your health, despite what they taste, smell, or look like.¹  Claiming less harm or reduced risk of disease from using tobacco products misleads consumers to think that these products are safe to use.  FDA considers these kinds of claims to be health fraud. These kinds of claims can only be made after scientific evidence to support them has been submitted to FDA, and FDA has issued an order permitting their marketing use. To date, no tobacco products have met the requirements that would permit them to make claims of reduced risk or harm to users and nonusers of their regulated tobacco products. These requirements were put in place so that American tobacco consumers are not misled about the harms of tobacco products.

Examples of Tobacco-Related Health Fraud

Recently, FDA issued a number of warning letters to tobacco internet retailers for illegally marketing tobacco products and using claims or descriptions that may mislead consumers by suggesting reduced harm or risk in using a tobacco product.  The letters cited several, specific examples of tobacco-related health fraud including:

• Marketing, advertising or promotional claims that suggest the product is safer, healthier or less risky to use, like: 
  • “Safe Smoke Filter”
  • “Less Toxic”
• Labels, internet sites, or other promotions that describe a tobacco product as “Light,” “Low,” or “Mild”

Health Fraud Example 1: While the fictional XYZ brand of smokeless tobacco displays the required warning statement, the label also states that XYZ brand is a "less toxic product."  This is an example of health fraud unless this claim was submitted to FDA with supporting scientific evidence and FDA issued an order.

Vapes, E-Cigs, Hookah Pens, and other Electronic Nicotine Delivery Systems (ENDS)

Vapes, vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigarettes or ecigs), and e-pipes are some of the many terms used to describe electronic nicotine delivery systems (ENDS).

These products use a liquid “e-liquid” that may contain nicotine, as well as varying compositions of flavorings, propylene glycol, vegetable glycerin, and other ingredients. The liquid is heated into an aerosol that the user inhales.

ENDS may be manufactured to look like conventional cigarettes, cigars, or pipes. Some resemble pens or other everyday items. Larger devices, such as tank systems or mods, bear little or no resemblance to cigarettes.

Statistics about Electronic Nicotine Delivery System Use

• More than 2 million middle and high school students were current users of e-cigarettes in 2016.^{1, 2}
• 11% of high school and 4.3% of middle school students were current users of e-cigarettes in 2016.¹
• E-cigarette use rose from 1.5% to 16.0% among high school students and from 0.6% to 5.3% among middle school students from 2011 to 2015.¹
• In 2013-2014, 81% of current youth e-cigarette users cited the availability of appealing flavors as the primary reason for use.³

FDA Regulation of Electronic Nicotine Delivery System

In 2016, FDA finalized a rule extending CTP's regulatory authority to cover all tobacco products, including electronic nicotine delivery systems (ENDS) that meet the definition of a tobacco product. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS, including components and parts of ENDS but excluding accessories. Examples of components and parts of ENDS include:

• E-liquids
• A glass or plastic vial container of e-liquid
• Cartridges
• Atomizers
• Certain batteries
• Cartomizers and clearomizers
• Digital display or lights to adjust settings
• Tank systems
• Drip tips
• Flavorings for ENDS
• Programmable software

However, products marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by the FDA through the Center for Drug Evaluation and Research (CDER). FDA published a rule clarifying the jurisdiction over tobacco products, drugs, and devices.

Manufacturing Electronic Nicotine Delivery Systems and E-Liquids

If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import ENDS, you must comply with these requirements for manufacturers.

CTP's Office of Small Business Assistance can answer specific questions about requirements of small businesses and how to comply with the law. This office also provides online educational resources to help regulated industry understand FDA regulations and policies.

Required Nicotine Addictiveness Warning on Packages and Advertisements

Beginning in 2018, all newly-regulated "covered" tobacco products* must bear the required nicotine addictiveness warning statement on product packages and advertisements. *Note: Cigars also have additional required warning statements.

Retail Sales of Electronic Nicotine Delivery Systems and, E-Liquids

Order FDA Rules for ENDS Sales Flyer

If you sell ENDS, e-liquids, or their components or parts made or derived from tobacco, please read this summary of federal rules that retailers must follow.

You may also order flyers with rules for electronic nicotine delivery system sales or download a PDF to print yourself.

You can find a list of retailer responsibilities for ENDS in the final rule Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act. In addition, our website offers more information on regulations, guidance, and webinars for retailers.

Vape Shops That Mix E-Liquids or Modify Products

If you operate a vape shop that mixes or prepares liquid nicotine or nicotine-containing e-liquids, or creates or modifies any type of ENDS, you may be considered a manufacturer. As a result, some vape shops may have legal responsibilities as both manufacturers and retailers of tobacco products. Please also see the Draft Guidance: Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops.

Importing Electronic Nicotine Delivery Systems and E-Liquids

Tobacco products imported or offered for import into the United States must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

You can also learn more about the importation process in the FDA Regulatory Procedures Manual, Chapter 9, Import Operations and Actions.

If you have questions about importing a specific tobacco product, please contact the FDA district into which your product will be imported (PDF - 406 KB).

Report a Problem with a Tobacco Product or Potential Tobacco Product Violations

If you have experienced an unexpected health or safety issue with a specific tobacco product, you can report a problem with any tobacco product, including vapes, to the FDA. Knowledge about adverse experiences can help the FDA identify health or safety issues beyond those normally associated with product use.

If you believe these products are being sold to minors, or you see another potential violation of the FD&C Act or FDA’s tobacco regulations, report the potential violation.

You can read the adverse experience reports for tobacco products to FDA in the FOIA Electronic Reading Room.

Video: Tobacco Researcher Interview—Impact of Tobacco on Oral Health and the Oral Microbiome, Christian Abnet, PhD

Impact of Tobacco on Oral Health and the Oral Microbiome

Christian Abnet, Ph.D., M.P.H

At the National Cancer Institute, Dr. Abnet and his team are experts in the oral microbiome—the bacteria that commonly exist in the mouth. The team hopes to better understand how tobacco use alters the oral microbiome and how those changes might lead to mouth damage for users of tobacco products.

The opinions in these videos reflect the views of individual researchers, and not necessarily the official position of the FDA’s Center for Tobacco Products. These videos represent accurate information about the design of these CTP supported studies at the time the interviews were conducted (Spring 2014).

Read the abstract: Impact of Tobacco Oral Health and the Oral Microbiome

View more Tobacco Regulatory Science In Action videos

Video: Tobacco Researcher Interview—Baseline Biomarkers of HPHCs in Tobacco Smoke and Smokeless Tobacco, Ben Blount, Ph.D.

Establishing Baseline Levels of Biomarkers of HPHCs in Tobacco Smoke and Smokeless Tobacco Products

Ben Blount, Ph.D.

Dr. Blount and his team at the Centers for Disease Control and Prevention are focused on applying “gold standard” analytical methods to characterizing tobacco products, including research on tobacco smoke and aerosol emitted from products, including cigars, pipes, smokeless tobacco, and e-cigarettes to understand how people are actually using these products.

The opinions in these videos reflect the views of individual researchers, and not necessarily the official position of the FDA’s Center for Tobacco Products. These videos represent accurate information about the design of these CTP supported studies at the time the interviews were conducted (Spring 2014).

Read the abstract: Population Assessment of Tobacco and Health: Measurement of Tobacco-Related Biomarkers

View more Tobacco Regulatory Science In Action videos

Video: Tobacco Researcher Interview—Evaluating New Nicotine Standards for Cigarettes, Eric Donny, Ph.D.

Evaluating New Nicotine Standards for Cigarettes

Eric Donny, Ph.D.

Dr. Donny’s NIH research project at the University of Pittsburgh will measure how a marked reduction in the nicotine content of cigarettes impacts the use and effects of tobacco in current smokers.

The opinions in these videos reflect the views of individual researchers, and not necessarily the official position of the FDA’s Center for Tobacco Products. These videos represent accurate information about the design of these CTP supported studies at the time the interviews were conducted (Spring 2014).

Read the abstract: Evaluating New Nicotine Standards for Cigarettes

View more Tobacco Regulatory Science In Action videos

Video: Tobacco Researcher Interview—Impacts of Nicotine Reduction in Cigarettes for Vulnerable Populations, Stephen Higgins, Ph.D.

Vermont Center on Tobacco Regulatory Science (TCORS)

Stephen Higgins, Ph.D.

Dr. Higgins and his team at the University of Vermont's Tobacco Center of Regulatory Science study how reducing the nicotine levels in cigarettes may change smoking behavior in vulnerable populations, including women of childbearing age/pregnant women, individuals with substance use disorders, and individuals with serious mental illness.

Read the abstract: Vermont Center on Tobacco Regulatory Science

View more Tobacco Regulatory Science In Action videos

Video: Tobacco Researcher Interview —Population Assessment of Tobacco and Health (PATH), Andrew Hyland, Ph.D.

Population Assessment of Tobacco and Health (PATH) Study

Andrew Hyland, Ph.D.

Dr. Hyland, Roswell Park Cancer Institute, is the scientific lead investigator for the landmark Population Assessment of Tobacco and Health (PATH) Study, a joint FDA/NIH research project which is supported by CTP through a National Institute on Drug Abuse research contract. The study will help scientists learn how and why people start using tobacco, switch from one tobacco product to another, quit using it, and start using it again after they’ve quit.

The opinions in these videos reflect the views of individual researchers, and not necessarily the official position of the FDA’s Center for Tobacco Products. These videos represent accurate information about the design of these CTP supported studies at the time the interviews were conducted (Spring 2014).

Read the abstract of the PATH Study.

View more Tobacco Regulatory Science In Action videos

Video: Tobacco Researcher Interview —Impact of Flavors on Initiation, Preference, and Development of Addiction to Tobacco Products, Suchitra Krishnan-Sarin, Ph.D.

Yale Tobacco Center of Regulatory Science (TCORS)

Suchitra Krishnan-Sarin, Ph.D.

Researchers at the Yale University Tobacco Center of Regulatory Science study the impact that flavors have on the initiation, preference, and development of addiction to tobacco products, especially among children and adolescents.

Read the abstract: Yale University Tobacco Center of Regulatory Science

View more Tobacco Regulatory Science In Action videos

Video: Tobacco Researcher Interview —Tobacco Product Messaging in a Complex Communication Environment, Caryn Lerman, Ph.D.

Tobacco Product Messaging in a Complex Communication Environment (TCORS)

Caryn Lerman, Ph.D.

Through the University of Pennsylvania Tobacco Center of Regulatory Science, Dr. Lerman leads studies related to understanding tobacco-related messaging, information, and misinformation received through mass media, social media, user commentary, and cigarette packaging.

The opinions in these videos reflect the views of individual researchers, and not necessarily the official position of the FDA’s Center for Tobacco Products. These videos represent accurate information about the design of these CTP supported studies at the time the interviews were conducted (Spring 2014).

Read the abstract: UPENN TCORS: Tobacco Product Messaging in a Complex Communication Environment

View more Tobacco Regulatory Science In Action videos

Video: Tobacco Researcher Interview —Effective Communication on Tobacco Product Risk and FDA Authority, Kurt Ribisl, Ph.D.

Effective Communication on Tobacco Product Risk and FDA Authority (TCORS)

Kurt Ribisl, Ph.D.

Dr. Ribisl and his research team with the University of North Carolina Tobacco Center of Regulatory Science (TCORS) work to improve messages about the content of cigarette smoke, emerging tobacco products, and the FDA's regulatory authority over tobacco products. This work includes assessing the public’s understanding of harmful and potentially harmful constituents (HPHCs).

The opinions in these videos reflect the views of individual researchers, and not necessarily the official position of the FDA’s Center for Tobacco Products. These videos represent accurate information about the design of these CTP supported studies at the time the interviews were conducted (Spring 2014).

Read the abstract: Effective Communication on Tobacco Product Risk and FDA Authority (TCORS)

View more Tobacco Regulatory Science In Action videos

Video: Tobacco Researcher Interview —Risk Perceptions of Flavored Small Cigars/Cigarillos Among Young Adults, Kymberle Sterling, Dr.P.H.

Assessing Risk Perceptions of Flavored Small Cigars/Cigarillos Among Young Adults

Kymberle Sterling, Dr.P.H.

Dr. Sterling’s NIH research project at Georgia State University seeks to understand why young people ages 18-34, particularly minority populations in this age group, seem to believe that smoking little cigars and cigarillos^* is safer than smoking cigarettes.

The opinions in these videos reflect the views of individual researchers, and not necessarily the official position of the FDA’s Center for Tobacco Products. These videos represent accurate information about the design of these CTP supported studies at the time the interviews were conducted (Spring 2014).

Read the abstract: Assessing Risk Perceptions of Flavored Small Cigars/Cigarillos Among Young Adults

View more Tobacco Regulatory Science In Action videos

_{^*Cigars and cigarillos are not currently regulated by the FDA. However, we recently proposed extending regulatory authority to all tobacco products.}

Video: Tobacco Researcher Interview—Tobacco Product Use Among Youth and Adult Populations, Mary Ellen Wewers, Ph.D.

OSU Center of Excellence in Regulatory Tobacco Science (OSU-CERTS) (TCORS)

Mary Ellen Wewers, Ph.D.

The Ohio State University Center of Excellence in Tobacco Regulatory Science program studies why youth and adults decide to start using, or continue to use, tobacco products. This research includes comparisons of populations based on the type of tobacco product, particularly smokers versus smokeless tobacco users, and an assessment of whether regional differences play a role in the use of these products.

The opinions in these videos reflect the views of individual researchers, and not necessarily the official position of the FDA’s Center for Tobacco Products. These videos represent accurate information about the design of these CTP supported studies at the time the interviews were conducted (Spring 2014).

Read the abstract: Ohio State University Center of Excellence in Tobacco Regulatory Science (OSU-CERTS) (TCORS)

View more Tobacco Regulatory Science In Action videos

Women's Health and Smoking

Smoking continues to have a profound impact on the health and well-being of women and their families in the United States.

• About 13.6% of all women smoke cigarettes.¹
• Every day, nearly 1,400 girls under 18 years of age smoke their first cigarette.²
• Nearly 7 percent of all high school aged girls smoke cigarettes.³

Impacts of Smoking on Women and Their Families

There's abundant research about the many harms of smoking—whether it's the dangerous chemicals, the addictive properties, or the damage smoking causes to the body, these effects can have a profound impact on not only your own body, but also those around you. Here are some facts about smoking's effects on women, families, babies, and pregnant moms.

For Women

• Smoking causes coronary heart disease, cancer, and stroke—the first, second, and fourth leading causes of death for women in the United States.⁴
• Smoking cigarettes causes chronic obstructive pulmonary disease (COPD). People with COPD have trouble breathing and slowly start to die from lack of air. Women who smoke cigarettes are up to 40 times more likely to develop COPD than female nonsmokers.⁵
• Life expectancy for smokers—both male and female—is at least 10 years less than for nonsmokers.⁶

For Families

• Secondhand smoke causes disease and premature death in nonsmoking adults and children.⁷
• The U.S. Surgeon General estimates that living with a smoker increases a nonsmoker's chances of developing lung cancer by 20-30%.⁷
• Exposure to secondhand smoke increases children's risk for ear infections, lower respiratory illnesses, more frequent and more severe asthma attacks, and slowed lung growth, and can cause coughing, wheezing, phlegm, and breathlessness.^7,8
• Teens are more likely to smoke if they have friends or family who smoke.⁹

For Babies and Pregnant Moms

• Smoking  during pregnancy can affect the baby's health.¹⁰
• Infants born to mothers who smoked during pregnancy are at a higher risk of low birth weight, birth defects like cleft palate, lungs that don't develop in a normal way, and sudden infant death syndrome.^4,8

Next Steps

The good news is that you can do something about it now—smoking truly is what the CDC terms a "modifiable" risk factor.

Encourage the women in your life—the mothers, daughters, sisters, and friends—to put their own health first by finding a quit method that works for them.

Youth and Tobacco

Almost 90 percent of adult daily smokers started smoking by the age of 18,¹ and nearly 2,500 youth under 18 smoke their first cigarette every day in the U.S.² In fact, use of tobacco products, no matter what type, is almost always started and established during adolescence when the developing brain is most vulnerable to nicotine addiction.^3,4 If the current trajectory of smoking rates continues, 5.6 million children in the U.S. alive today will die prematurely as a result of smoking.⁵ 

These facts highlight a critical need for stronger, more targeted youth tobacco prevention efforts grounded in regulatory actions designed to protect America’s kids.

FDA's Plan for Tobacco and Nicotine Regulation

On July 28, 2017, the FDA announced a comprehensive plan for tobacco and nicotine regulation that places nicotine, and the issue of addiction, at the center of the agency's tobacco regulation efforts. This plan will serve as a multiyear roadmap to better protect kids and significantly reduce tobacco-related disease and death in the U.S. One of the key efforts announced includes starting a national public dialogue about lowering nicotine levels in cigarettes to non-addictive levels to decrease the likelihood that future generations become addicted to cigarettes. 

Understanding Youth Tobacco Use in the U.S.

The FDA is committed to a science-based approach that addresses public health issues associated with tobacco use. That's why we collaborate with the Centers for Disease Control and Prevention's Office on Smoking and Health on the only nationally-representative survey of middle and high school students that focuses exclusively on tobacco use—the National Youth Tobacco Survey. Results from this survey provide the FDA with some key national indicators of the effectiveness of comprehensive tobacco prevention and control programs.

Public Health Education to Reduce Youth Tobacco Use

After decades of steadily declining rates, youth tobacco use has largely plateaued since 2011. While cigarette and cigar use have generally declined, sharp increases in e-cigarette and hookah tobacco use among teens in previous years have offset progress overall.⁶ 

Further, youth who use tobacco today do so despite the efforts that led so many of their peers to remain tobacco-free in the past, making them a harder audience to reach and motivate with tobacco prevention messages.⁷  

With these challenges in mind, the FDA developed and launched several award-winning youth tobacco prevention campaigns to educate at-risk teens about the harmful effects of tobacco use. Campaign advertising airing between 2014 and 2017 focused on communicating the dangers of combustible cigarettes and smokeless tobacco use. In fall 2017, the FDA launched new advertising as part of its “The Real Cost” campaign to educate teens about the dangers of using electronic nicotine delivery systems, like e-cigarettes. Many e-cigarettes contain nicotine, the same highly addictive chemical in other tobacco products, which can disrupt adolescent brain development. 

Flavored Tobacco

In 2017, the FDA intends to issue an Advance Notice of Proposed Rulemaking to seek public comment on the role that flavors in tobacco products—including menthol—play in attracting youth. The agency already banned certain characterizing flavors in cigarettes in 2009, including fruit and clove , because of their appeal to youth. The agency's national effort to enforce this provision of the Tobacco Control Act and to advise parents about the dangers of flavored tobacco products was one of its important first steps toward responsible tobacco regulation to protect youth.

Regulations Restricting the Sale and Distribution of Tobacco Products to Protect Children and Adolescents

Since 2009, the FDA has regulated cigarettes, smokeless, and roll-your-own tobacco. In 2016, the FDA finalized a rule to regulate all tobacco products, including:

• E-cigarettes/electronic cigarettes/vaporizers
• Cigars
• Hookah (waterpipe tobacco)
• Pipe tobacco
• Nicotine gels
• Dissolvables

These rules protect children and adolescents by restricting youth access to all tobacco products by:

• Not allowing products to be sold to anyone younger than 18 and requiring age verification via photo ID
• Not allowing tobacco products to be sold in vending machines (unless in an adult-only facility)
• Not allowing the distribution of free samples of tobacco products

Youth Tobacco Use: Results from the 2016 National Youth Tobacco Survey

We are committed to a science-based approach that addresses the public health issues associated with tobacco use. That's why we collaborate with CDC on the only nationally representative survey of middle and high school students that focuses exclusively on tobacco use—the National Youth Tobacco Survey (NYTS). NYTS was designed to provide national data on long-term, intermediate, and short-term indicators key to the design, implementation, and evaluation of comprehensive tobacco prevention and control programs.

 Download Infographic (PDF)