Tobacco Products

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?


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.


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.


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.

Contact FDA

(9am EST-4pm EST)

For General Inquiries:

Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center

Building 71, Room G335
Silver Spring, MD 20993-002

Courier Deliveries

Page Last Updated: 08/17/2017
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