CTP Compliance & Enforcement

To protect the health of future generations, FDA closely monitors retailer, manufacturer, importer, and distributor compliance with Federal tobacco laws and regulations and takes corrective action when violations occur.

On this page:

• Compliance Check Inspections
• Warning Letters
• Civil Money Penalty Complaints
• No-Tobacco-Sale Order (NTSO) Complaints

Compliance Check Inspections

FDA conducts inspections of tobacco product retailers to determine a retailer's compliance with federal laws and regulations, including The Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act, and our rules and regulations.

During Undercover Buy Inspections, the retailer is unaware an inspection is taking place. The minor and inspector will not identify themselves.

Results from compliance check inspections of tobacco retailers are available in a searchable retailer inspection database.

The database lists which inspected retailers received a warning letter, a civil money penalty, a no-tobacco-sale order, or were found to have no observable violations. You can search by tobacco retailer name, city, state, zip code, or decision date. You can also search using an interactive map by state or region. Those businesses where FDA has completed compliance check inspections will be displayed as pins on the map.

Note: Absence of a retail establishment from this database does not imply compliance with all applicable statutory and regulatory requirements.

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Warning Letters

We issue warning letters to traditional “brick and mortar” retail stores nationwide as well as online retailers and manufacturers the first time a tobacco compliance check inspection reveals a violation of the federal tobacco laws and regulations that FDA enforces. Failure to promptly and adequately correct all violations and ensure compliance with all applicable laws and regulations may lead to enforcement actions, including Civil Money Penalties or No-Tobacco-Sale Orders.  All warning letters issued as the result of compliance check inspections of tobacco retailers prior to October 1, 2016, have been archived via the FDA Web Archive.  Search Archived Tobacco Retailer Warning Letters.

If you have any questions about warning letters, contact the Center for Tobacco Products at 1-877-CTP-1373 or via email to the address listed in your warning letter: CTP-Compliance-WL-Correspondence@fda.hhs.gov or CTPCompliance@fda.hhs.gov.

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Civil Money Penalty Complaints

A Civil Money Penalty (CMP) Complaint is used to initiate an administrative legal action against a retailer that can result in a monetary penalty, called a Civil Money Penalty.

The Tobacco Control Act provides that the amount of a CMP for violations of the regulations in part 1140 shall not exceed certain amounts, depending on the number of previous violations, the time period in which the violations occurred, and other factors (see section 103(q)(2)(A) of the Tobacco Control Act). The current maximum amounts are:

Under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Pub. L. No. 114-74), HHS is required to adjust the amounts annually for inflation no later than January 15th each year. Read the rule, Adjustment of Civil Monetary Penalties for Inflation, for more information. See the Federal Register notice with the 2017 adjusted amounts.

FDA files Civil Money Penalty Complaints against tobacco retailers when subsequent violations of the tobacco regulations and/or other requirements relating to tobacco products in the Federal Food, Drug, and Cosmetic Act are observed during a compliance check inspection.

All Civil Money Penalty Complaints filed by the Center for Tobacco Products are listed in the searchable compliance check inspection database.

If you are a retail establishment that has received a Civil Money Penalty Complaint and wish to settle the case, you can submit the Acknowledgement Form and pay your Civil Money Penalty online.

For more information about CMPs view our guidance documents and webinars. 

No-Tobacco-Sale Orders To Retailers

Under the law, the FDA may pursue a No-Tobacco-Sale Order (NTSO) against retailers that have a total of five or more repeated violations of certain restrictions within 36 months. Retailers are prohibited from selling regulated tobacco products at the specified location during the period of the NTSO.

Retailers who receive an NTSO complaint from the FDA may either:

• enter into a settlement agreement with the agency that results in a final order issued by the Administrative Law Judge (ALJ), or
• respond to the court with an Answer and choose to go to a full hearing before an ALJ.

In determining the period of a No-Tobacco-Sale Order, the FDA considers the nature, circumstances, extent, and gravity of the violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require.

When FDA conducts unannounced compliance check inspections during the period of the NTSO, for the limited purpose of confirming the retailer’s compliance with the NTSO Order, the results are not included in the searchable inspection database.

View a list of all NTSOs imposed by an ALJ, along with the effective dates of each NTSO. 

For more information about NTSOs, view our guidance documents and webinars.

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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.

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Webinars

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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

 

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_{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.

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

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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.  

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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.

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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.
    

 

CTP Newsroom

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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

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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. 

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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

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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

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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.

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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.

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Summary of Federal Rules for Tobacco Retailers

FDA regulates all tobacco products, including e-cigarettes, hookah tobacco, and cigars. If you sell tobacco products, you must comply with all applicable federal laws and regulations for retailers.

This page offers a summary of the federal rules. You can find comprehensive federal requirements for tobacco retailers in the Federal Food, Drug, and Cosmetic Act (FD&C Act), Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco and Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act.

How Do I Comply?

These rules apply to all "covered tobacco products" beginning August 8, 2016:

• Check photo ID of everyone under age 27 who attempts to purchase any tobacco product.
• Only sell tobacco products to customers age 18 or older.²
• Do NOT sell tobacco products in a vending machine unless in an adult-only facility.³
• Do NOT give away free samples of newly-regulated tobacco products to consumers, including any of their components or parts.⁴

These rules, along with rules specific to each tobacco product, are listed below.

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“This Is Our Watch” Program

The “This Is Our Watch” program helps retailers comply with federal tobacco law and regulations and protect minors. Flyers are available for download and print, and all other materials will be distributed by mail.

Rules for Cigarettes, Cigarette Tobacco, and Roll-Your-Own Tobacco Sales

These rules have been in place since 2010:

• Check photo ID of everyone under age 27 who attempts to purchase cigarettes, cigarette tobacco, or roll-your-own tobacco.
• Only sell cigarettes, cigarette tobacco, and roll-your-own-tobacco to customers age 18 or older.²
• Do NOT sell cigarettes, cigarette tobacco, or roll-your-own tobacco in a vending machine or self-service display unless in an adult-only facility.³
• Do NOT give away free samples of cigarettes, cigarette tobacco, or roll-your-own tobacco to consumers, including any of their components or parts.⁴
• Do NOT sell cigarettes, cigarette tobacco, or roll-your-own tobacco that contain a characterizing flavor (except menthol or tobacco flavor).
• Do NOT sell cigarette packages containing fewer than 20 cigarettes, including single cigarettes, known as “loosies.”
• Do NOT break open packages of cigarettes, cigarette tobacco, or roll-your-own tobacco to sell products in smaller amounts.

Beginning August 10, 2018:

• Do NOT sell or distribute cigarette tobacco or roll-your-own tobacco products without a warning statement on the package.¹
• Do NOT display advertisements for cigarette tobacco or roll-your-own tobacco products without a warning statement.¹

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Rules for Smokeless Tobacco Sales

• Check photo ID of everyone under age 27 who attempts to purchase smokeless tobacco.
• Only sell smokeless tobacco to customers age 18 and older.²
• Do NOT sell smokeless tobacco in a vending machine or self-service display unless in an adult-only facility.
• Do NOT give away free samples of smokeless tobacco unless in a “qualified adult-only facility” and in limited quantities as specified in the law. ^3,4
• Do NOT break open smokeless tobacco packages to sell products in smaller amounts.
• Do NOT sell smokeless tobacco without a health warning statement displayed on the package.
• Do NOT display advertisements for smokeless tobacco products without a warning statement.

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Rules for Cigar Sales

• Check photo ID of everyone under age 27 who attempts to purchase cigars.
• Only sell cigars to customers age 18 and older.²
• Do NOT sell cigars in a vending machine unless in an adult-only facility.³
• Do NOT give away free samples of cigars to consumers, including any of their components or parts.⁴

Beginning August 10, 2018:

• Do NOT sell or distribute cigars without a health warning statement displayed on the package.¹
• Do NOT display advertisements for cigars without a health warning statement.¹
• If you sell cigars individually, and not in a product package, you must post a sign with six required warning statements within 3 inches of each cash register.¹

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Rules for Hookah and Pipe Tobacco Sales

• Check photo ID of everyone under age 27 who attempts to purchase hookah tobacco or pipe tobacco. 
• Only sell hookah or pipe tobacco to customers age 18 and older.²
• Do NOT sell hookah and pipe tobacco in a vending machine unless in an adult-only facility.³
• Do NOT give away free samples of hookah or pipe tobacco to consumers, including any of their components or parts.⁴

Beginning August 10, 2018:

• Do NOT sell or distribute hookah or pipe tobacco without a health warning statement displayed on the package.¹
• Do NOT display advertisements for hookah or pipe tobacco without a health warning statement.¹

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Rules for Sales of E-Cigarettes and Other Electronic Nicotine Delivery Systems (ENDS)

 Some examples of ENDS include e-cigarettes, vape pens, e-hookahs, e-cigars, personal vaporizers, and electronic pipes.

• Check photo ID of everyone under age 27 who attempts to purchase e-cigarettes or other ENDS.
• Only sell e-cigarettes and other ENDS to customers age 18 and older.²
• Do NOT sell e-cigarettes or other ENDS in a vending machine unless in an adult-only facility. ³
• Do NOT give away free samples of e-cigarettes or other ENDS to consumers, including any of their components or parts.⁴

Beginning August 10, 2018, these rules apply to all “covered tobacco products”:

• Do NOT sell or distribute e-cigarettes or other ENDS without a health warning statement on the package.¹
• Do NOT display advertisements for e-cigarettes or other ENDS without a health warning statement.¹

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Rules for Sales of Nicotine Gels

• Check photo ID of everyone under age 27 who attempts to purchase nicotine gel.
• Only sell nicotine gel to customers age 18 and older.³
• Do NOT sell nicotine gel in a vending machine unless in an adult-only facility.³
• Do NOT give away free samples of nicotine gel to consumers.⁴

Beginning August 10, 2018:

• Do NOT sell or distribute nicotine gel without a health warning statement on the package.¹
• Do NOT display advertisements for nicotine gel without a health warning statement.¹

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Rules for Sales of Dissolvables

These rules apply to dissolvable tobacco products that are not already regulated as smokeless tobacco.

• Check photo ID of everyone under age 27 who attempts to purchase dissolvable tobacco products.
• Only sell dissolvable tobacco products to customers age 18 and older.²
• Do NOT sell dissolvable tobacco products in a vending machine unless in an adult-only facility. ³
• Do NOT give away free samples of dissolvable tobacco products to consumers.⁴

Beginning August 10, 2018:

• Do NOT sell or distribute a dissolvable tobacco product without a health warning statement on the package.¹
• Do NOT display advertisements for dissolvable tobacco products without a health warning statement.¹

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This is Our Watch

To give retailers all the tools they need to comply with tobacco regulations, the FDA’s Center for Tobacco Products has developed a new education program called “This is Our Watch.” This program helps tobacco retailers better understand FDA tobacco regulations, the importance of compliance, and the greater purpose—protecting the nation’s youth from the harms of tobacco use.

“This is Our Watch” launched nationally in November 2017. A full toolkit of resources is available to retailers—including posters, stickers, age verification tools, and more—to help retailers better comply with federal tobacco regulations. 

Free Program Materials

“This is Our Watch” program materials include a mix of educational pieces for owners, managers, and clerks, as well as a variety of point-of-purchase tools to inform customers of the law and emphasize the retailer’s role.

• Poster
• Register stickers
• Regulation flyers
• Age verification calendar
• Register signage
• Instruction booklet

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Connect with Us

You can find more information by connecting with us on Twitter and by signing up for email updates.

FDA Tobacco Compliance Webinars

FDA Center for Tobacco Products (CTP) hosts a series of webinars on federal tobacco regulations. These webinars are designed to provide FDA tobacco compliance education and information to retailers and to small business manufacturers.  

Compliance Webinars for Tobacco Manufacturers and Retailers on the Final Rule Extending FDA Authority to All Tobacco Products

The FDA has finalized a rule—commonly referred to as the "deeming rule"—extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco, and pipe tobacco, among others.

The FDA's series of webinars will help tobacco retailers, importers, and manufacturers better understand the agency's regulatory authority. Participants will learn the steps they must take to comply with the rule’s requirements for the marketing and sale of all tobacco products.

Note: In May 2017, FDA announced it was providing a three-month extension of all future compliance deadlines for requirements under the final deeming rule. In August 2017, FDA published extended timelines to submit tobacco product review applications for newly-regulated tobacco products that were on the market as of August 8, 2016.

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  2017 Webinars

 

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

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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

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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.

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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.

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Requires Disclosure of Ingredients in Tobacco Products

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

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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.

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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.

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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.

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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

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.

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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.

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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

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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.

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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.

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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.

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

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.

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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.

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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).

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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.

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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

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.

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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. 

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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.

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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. 

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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.

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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

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