Tobacco Products

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. 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 will be regulated as both a retailer and a manufacturer.

 What if I am both a manufacturer and a retailer?

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

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

 

Contact FDA

1-877-287-1373
(9am EST-4pm EST)
Tobacco

For General Inquiries:
AskCTP@fda.hhs.gov


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

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


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Page Last Updated: 11/07/2016
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