Smoking can lead to many kinds of cancer in the body.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2909.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 17:29:00.0
Image of a vape charging overnight with the text overlay - Don't charge your vape overnight. Find more tips on avoiding vape battery explosions at www.fda.gov/tobacco.
Syndicated Content Details:
Source URL: https://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm553160.jpg
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2017-10-12 02:30:00.0
Image of a vape device charging with text overlay - Don't charge your vape with a phone or tablet charger. Find more tips on avoiding vape battery explosions at www.fda.gov/tobacco.
Syndicated Content Details:
Source URL: https://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm553158.jpg
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2017-10-12 02:17:00.0
Each Puff Poster 1. It hit me. Like a toxic mosh pit...
Syndicated Content Details:
Source URL: http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm528509.jpg
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2016-09-15 17:39:00.0
Poster - Each Puff 2: Suddenly it struck. The toxic beast...
Syndicated Content Details:
Source URL: http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm528510.jpg
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2016-11-08 21:37:00.0

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

PATH Study’s Wave 1 Biospecimens Now Available

For access, submit your concept statement by Nov. 30, 2017, and applications by March 28, 2018.

PATH - Population Assessment of Tobacco and Health - A collaboration between the NIH and FDA

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.

Dr. Andrew Hyland

Dr. Andrew Hyland, Roswell Park Cancer Institute, Scientific Director of the PATH Study

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 disclaimer icon, including:

PATH Study Publications

Listed below is a selection of peer-reviewed journal articles from the PATH Study. See the NAHDAP website disclaimer icon 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.

 

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm337005
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2014-12-11 14:51:00.0
You get all your smokes for free. Or do you?
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2921.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 17:46:00.0
Formaldehyde. A compound used for preserving dead bodies and found in cigarette smoke.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2913.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 17:36:00.0
Think of what you could lose if you put cigarettes first. #TheRealCost
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2911.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 17:33:00.0
Cigarette butts are the #1 littered item on U.S. roads.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2910.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 17:30:00.0
3 out of 4 teen smokers who think they will stop smoking in a few years don't.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2859.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 15:39:00.0
Some teens can have cravings after just a few cigarettes.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2860.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 15:41:00.0
Nicotine reaches your brain within 10 seconds.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2861.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 15:46:00.0
Research shows menthols may be even more addictive than other cigarettes.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2863.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 15:50:00.0
Nearly 9 out of 10 adult smokers started before they were 18.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2862.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 15:47:00.0
9 out of 10 high school students don't smoke.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2864.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 15:56:00.0
A menthol cigarette is still a cigarette, complete with all the toxic chemicals.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2873.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:04:00.0
As many as 30 chemicals in smokeless tobacco are linked to cancer.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2879.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:09:00.0
Nicotine, the addictive chemical, occurs naturally in the tobacco plant.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2880.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:10:00.0
More than 70 chemicals in cigarette smoke can cause cancer
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2874.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:05:00.0
Cadmium: Found in batteries and cigarette smoke.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2877.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:07:00.0
Carbon monoxide: Found in car exhaust and cigarette smoke.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2875.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:06:00.0
Formaldehyde: Used to preserve dead bodies and found in cigarette smoke.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2878.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:08:00.0
More than 7,000 chemicals are found in a single puff of cigarette smoke.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2872.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:03:00.0
Lead: Once used in paint and found in cigarette smoke.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2876.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:06:00.0
Smoking accelerates skin aging which could lead to premature wrinkles.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2866.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 15:58:00.0
Smoking causes gum disease, which could cost you teeth.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2867.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 15:59:00.0
Don't smile, smoking can stain your teeth.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2869.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:00:00.0
No surprise, smoking makes your breath smell like an ashtray.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2868.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:00:00.0
Smoking as a teen can stunt lung growth.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2865.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 15:57:00.0
On average, every cigarette takes eleven minutes off your life.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2881.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:10:00.0
Smokeless tobacco causes cancer of the mouth, pancreas, and esophagus.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2870.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:01:00.0
Smoking causes cancer, heart attacks and serious lung disease.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2871.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:02:00.0
Nearly 1 out of 5 deaths in the U.S. is caused by smoking.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2885.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:13:00.0
In the U.S., more than 1,300 people die each day due to smoking.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2883.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:12:00.0
On average, smokers die at least 10 years younger than non-smokers.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2882.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:11:00.0
Cigarette smoking causes about 480,000 deaths in the U.S. per year.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2884.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 16:13:00.0
A third of all teens who persist in smoking as adults will die about 13 years earlier than non-smoking peers.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2919.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 17:43:00.0

CTP Newsroom

From press releases to public meetings to email newsletters, stay up to date on the latest news and events from the FDA Center for Tobacco Products.

Sign up to receive email updates from CTP

News & Events

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

2017

2016

Archived Content

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

 

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm2019061
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2015-12-07 17:29:00.0
Photo of a vape device on the dashboard of a car with the text overlay - Protect your vape from extreme temperatures. Find more tips on avoiding vape battery explosions at www.fda.gov/tobacco.
Syndicated Content Details:
Source URL: https://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm553162.jpg
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2017-10-12 02:33:00.0
Photo of a wet vaping device with the text overlay - Replace the batteries in your vape if they get damaged or wet. Find more tips on avoiding vape battery explosions at www.fda.gov/tobacco.
Syndicated Content Details:
Source URL: https://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm553159.jpg
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2017-10-12 02:27:00.0

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.

Young men sitting with basketball

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.

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.

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm330160
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2014-12-11 15:27:00.0
Smokers' lungs don't work as well as those of nonsmokers.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2904.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 17:01:00.0
Tobacco is robbing you in more ways than you know.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2914.jpg
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 17:37:00.0
There's no better time to quit tobacco than today.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2916.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 17:40:00.0
El cerebro del adolescente aun esta en desarrollo
Syndicated Content Details:
Source URL: https://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm576108.gif
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2017-10-12 02:36:00.0
Smoking can damage your DNA.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2906.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 17:23:00.0

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

8 different electronic nicotine delivery systems

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:

components of electronic nicotine delivery systems

  • 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

FDA Rules for Electronic Nicotine Delivery System Sales

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.

Tips to Help Avoid Vape Battery Explosions Infographic

1. Centers for Disease Control and Prevention (CDC). Tobacco use among middle and high school students – United States, 2011-2016. Morbidity and Mortality Weekly Report. 2017; 66(23):597-603.
2. Centers for Disease Control and Prevention (CDC). Tobacco use among middle and high school students – United States, 2011-2016. Morbidity and Mortality Weekly Report. 2017; 66(23):597-603.
3. Villanti AC, Johnson AL, Ambrose BK, et al. Use of flavored tobacco products among U.S. youth and adults; findings from the first wave of the PATH Study (2013-2014).

 

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm456610
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2014-12-11 04:29:00.0

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

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm436618.htm
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2015-04-13 13:34:00.0

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

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm446707.htm
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2015-06-02 14:20:00.0

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

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm442633.htm
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2015-05-06 15:42:00.0

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

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm446726
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2015-08-17 14:58:00.0

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

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm436676.htm
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2015-04-13 13:38:00.0

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

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm446720
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2015-08-17 14:53:00.0

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

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm442628.htm
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2015-05-06 15:36:00.0

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

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm442639.htm
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2015-05-06 15:44:00.0

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.

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm436663.htm
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2015-04-13 13:36:00.0

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

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm446713.htm
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2015-06-02 14:20:00.0
Even when you bum a smoke, you're still paying.
Syndicated Content Details:
Source URL: http://syndication-files.s3-website-us-east-1.amazonaws.com/2918.png
Source Agency: U S Food and Drug Administration (FDA)
Captured Date: 2014-12-11 17:42:00.0

Youth and Tobacco

teenage boys

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

1. U.S. Department of Health and Human Services. 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.
2. Substance Abuse and Mental Health Services Administration. Results from the 2015 National Survey on Drug Use and Health: Detailed Tables. Rockville, MD: U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality; 2016. http://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2015/NSDUH-DetTabs-2015/NSDUH-DetTabs-2015.pdf. Accessed September 9, 2016.
3. U.S. Department of Health and Human Services. 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.
4. U.S. Department of Health and Human Services (USDHHS). A Report of the Surgeon General: Preventing Tobacco Use among Youth and Young Adults. We Can Make the Next Generation Tobacco-Free (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; 2012.
5. 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.
6. Centers for Disease Control and Prevention. Tobacco use among middle and high school students – United States, 2011-2016. Morbidity and Mortality Weekly Report. 2017; 66(23):597-603.
7. Centers for Disease Control and Prevention. Association Between The Real Cost Media Campaign and Smoking Initiation Among Youths — United States, 2014–2016. Morbidity and Mortality Weekly Report. 2017; 66(02);47–50.

 

-

Resources for Parents

-
-

Resources for Industry

-
Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm2022527
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2015-08-07 18:19:00.0

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 Download Infographic (PDF)
Youth Tobacco Use: Results from the 2016 National Youth Tobacco Survey Thumbnail

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm405173
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2015-04-22 14:58:00.0
Consumo de tabaco entre los jóvenes: Resultados de la Encuesta nacional de jóvenes y tabaco 2016
Syndicated Content Details:
Source URL: https://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm577539.jpg
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2017-09-26 18:27:00.0

 

 

 

 
Terms of Use | Privacy Policy
©2017 ARCHES Technology. All Rights Reserved.