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

?August 2017 Update: Extended timelines to submit tobacco product review applications for newly-regulated tobacco products that were on the market as of August 8, 2016.

July 2017 Update: FDA’s New Plan for Tobacco and Nicotine Regulation

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?

Manufacturer?

Do you ...

  • mix e-liquids?
  • make or modify any type of vaping device?
  • mix loose tobacco for people to smoke in a pipe?
  • roll or blend tobacco for cigars?
  • manufacture loose tobacco for consumers to roll their own cigarettes?
  • import tobacco products?
  • manufacture any tobacco product?

If you answered yes to any of these questions, you may be a manufacturer.

Retailer?

Do you ...

  • sell cigars?
  • sell hookah tobacco?
  • sell e-cigarettes or e-liquids?
  • sell any tobacco product?

If you answered yes to any of these questions, you are a retailer.

If you mix e-liquids, make or modify vaporizers, or mix loose tobacco, and you also sell these products, you may be regulated as both a retailer and a manufacturer.

 

Questions & Answers

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

Read more commonly asked questions and answers.

Webinars

Documents and Additional Resources

Final Rule and Accompanying Documents

 

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/ucm394909
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2016-08-09 18:52:00.0

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

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?

Download the "FDA Age Calculator" a voluntary smartphone application to help retailers comply with federal age restrictions for selling tobacco products.

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.

“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.

Do you mix e-liquids, make or modify vaporizers, or mix loose tobacco, and you also sell these products? If so, you may be regulated as both a retailer and a tobacco product manufacturer.

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

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
Rules for Smokeless Tobacco Sales

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.

Rules for Cigar Sales

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

Rules for Hookah and Pipe Tobacco Sales

Note: If you mix loose tobacco, and you also sell these products, you will be regulated as both a retailer and a tobacco product manufacturer.

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

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.

Note: If you mix e-liquids or make or modify vaporizers, and you also sell these products, you will be regulated as both a retailer and a tobacco product manufacturer.

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

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

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

Why Are These Laws Important?

These laws are designed to make regulated tobacco products less accessible and less attractive to youth. Every day, nearly 2,500 kids smoke their first cigarette and more than 400 kids become cigarette daily smokers.5 Additionally, the CDC and FDA found that during 2011-2015, e-cigarette use rose from 1.5% to 16.0% among high school students.6 Many of these children will become addicted before they are old enough to understand the risks. As a retailer, you play an important role in protecting children and adolescents by complying with the law and regulations.

1. A retailer of any cigarette tobacco, roll-your-own tobacco or "covered tobacco products" will not be in violation of this section for packaging that: (i) Contains a health warning; (ii) Is supplied to the retailer by the tobacco product manufacturer, importer, or distributor who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable, and (iii) Is not altered by the retailer in a way that is material to the requirements of this section.
For important details about required warning statements, please see the small entity compliance guide.
2. Retailers must also follow state and local tobacco laws, even if they are more restrictive. For example, in some states the minimum age is 19.
3. An adult-only facility is one in which minors are neither present nor permitted to enter at any time.
4. FDA finalized the Guidance on Prohibition of Distributing Free Samples of Tobacco Products in January 2017.
5. Substance Abuse and Mental Health Services Administration (SAMHSA). Results from the 2015 National Survey on Drug Use and Health: Detailed Tables. Rockville, MD: U.S. Department of Health and Human Services, SAMHSA, 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.
6. Centers for Disease Control and Prevention. Tobacco Use Among Middle and High School Students - United States, 2011 -2015. Morbidity and Mortality Weekly Report 2016; 65(14): 361-367.

 

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm205021
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2014-12-11 04:45:00.0

This is Our Watch

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

Download the “FDA Age Calculator” a voluntary smartphone application to help retailers comply with federal age restrictions for selling tobacco products.

Connect with Us

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

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Source URL: http://www.fda.gov/syn/html/ucm237741
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2014-12-11 14:21:00.0

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.  

Sign up to receive email updates about this webinar series.

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.

 2017 Webinars

 

 2016 Webinars

A table of contents is provided for select webinars to give an overview of the webinar content. For context, the FDA recommends you watch the entire webinar first, then use the chapter links to jump to a specific section.

FDA Import Operations
FDA's Import Operations: How FDA Regulates Imported Products disclaimer icon (32:18) Download Slides

Internet and Publication Surveillance YouTube thumbnail
Internet and Publication Surveillance disclaimer icon (30:55)


Cigar Warnings and Warning Plan Requirements Youtube thumbnail
Cigar Warnings and Warning Plan Requirements disclaimer icon (34:23) 
 

  1. FDA Authority
  2. Definition of Tobacco Product
  3. FDA-Regulated Tobacco Products
  4. Requirements for Newly Deemed Products
  5. Addictiveness Warning Requirement
  6. Cigar Warning Requirements
  7. Effective Dates for Cigar Warnings and Warning Plans
  8. Required Cigar Warning Statements
  9. Warning Statement Requirements for Cigar Packages
  10. Warning Statement Requirements for Cigar Products Sold Without Packaging
  11. Retailer Exception for Warning Statement Requirements on Cigar Packages
  12. Warning Statement Requirements for Cigar Advertisements
  13. Retailer Exception – Warning Statement Requirements for Cigar Advertisements
  14. Marketing Requirements for Cigar Packages and Advertisements
  15. Cigar Warning Plans
  16. Who Submits Cigar Warning Plans?
  17. What to Submit With a Cigar Warning Plan
  18. Cigar Warning Plans for Packages
  19. Example Cigar Packages – Equal/Random Display
  20. Example Cigar Packages – Random Display/Distribution
  21. Cigar Warning Plans for Advertisements
  22. Example of a Quarterly Rotation Schedule for Cigar Advertisements 
  23. What to Submit With a Cigar Warning Plan
  24. When to Submit Cigar Warning Plans
  25. Where to Submit Cigar Warning Plans
  26. Effective Dates for Cigars

Premarket Tobacco Product Applications (PMTA) for Electronic Nicotine Delivery System (ENDS) - Draft Guidance
Premarket Tobacco Product Applications (PMTA) for Electronic Nicotine Delivery System (ENDS) - Draft Guidance disclaimer icon (50:18) Download Slides

New Regulatory Requirements for Tobacco Manufacturers and Importers Ele Ibarra-Pratt.
New Regulatory Requirements for Tobacco Manufacturers and Importers disclaimer icon (37:28) Download Slides

  1. FDA’s Authority to Regulate Tobacco Products (The Deeming Rule)
  2. The Deeming Rule— Automatic Provisions
  3. What are “Finished Tobacco Products”?
  4. What are “Covered Tobacco Products”?
  5. What products are currently regulated by the FDA?
  6. Newly Regulated Tobacco Products
  7. Examples of Components/Parts of Newly Regulated Tobacco Products
  8. Electronic Nicotine Delivery Systems (ENDS)
  9. What is the Definition of a Tobacco Product Manufacturer?
  10. Vape Shops: An Overview
  11. Vape Shops: Reporting Requirements
  12. What Requirements Apply to Tobacco Product Importers?
  13. Addictiveness Warning Statement Requirements—Cigarette Tobacco, Roll-Your-Own Tobacco, and Covered Tobacco Products Other than Cigars
  14. Addictiveness Warning Statement Requirements—Cigars
  15. What is a Covered Tobacco Product?
  16. Modified Risk Tobacco Product Requirements for Newly Deemed Products
  17. User Fees
  18. Premarket Requirements for Newly Regulated Tobacco Products
  19. More Information and Additional Resources

Archived Webinars

Watch previously-recorded webinars:

Participate by Live Webcast / Phone

You do not need to register for these events. However, web connections are limited and available on a first-come basis. We recommend that you test your computer and network connections prior to the webinar.

Ask Questions
  • Submit questions during the webinar using the “Q&A box” on your screen.
  • If you have questions after the webinar, please contact us.
Share your Ideas

We request your valued input for future webinar topics. Send your ideas to AskCTP@fda.hhs.gov.

 

Syndicated Content Details:
Source URL: http://www.fda.gov/syn/html/ucm220111
Source Agency: Food and Drug Administration Center for Tobacco Products (FDA/CTP)
Captured Date: 2014-12-11 15:30:00.0

 

 

 

 
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