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U.S. Department of Health and Human Services

Tobacco Products

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Tobacco Product Marketing Orders

 

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Tobacco products are a unique addition to FDA’s regulatory authorities because they are: 

  • Harmful yet widely used consumer products; and
  • Responsible for severe health problems in both users and non-users, including cancer, lung disease, and heart disease, which often lead to death.     


FDA’s traditional “safe and effective” standard for evaluating medical products does not apply to tobacco. Instead, FDA regulates tobacco products based on a public health standard intended to reduce the toll that tobacco use causes. To legally market a new tobacco product in the United States, a manufacturer must receive a written order from FDA permitting the marketing of the new tobacco product under one of three pathways. These three pathways are as follows:

  • Premarket Tobacco Applications
  • Substantial Equivalence
  • Exemption from Substantial Equivalence  

  

 


Premarket Tobacco Application

Marketing orders are given to Premarket Tobacco Applications that have demonstrated that the new tobacco product is appropriate for the protection of the public health, which is determined with respect to the risks and benefits to the population as a whole, including users and non-users of tobacco products, and taking into account the following: 

  • The increased or decreased likelihood that existing users of tobacco products will stop using such products; and
  • The increased or decreased likelihood that those who do not use tobacco products will start using such products.

 

Summary of Premarket Tobacco Application Final Actions

 PMTA Final Actions February 2014 Total to Date
 Refuse to File (RTF) submissions for PMTAs 4  4

 

Explanation of Selected PMTA Decisions

Included in the summary below are some of the reasons why the FDA may refuse to file a new tobacco product application (PMTA).

 

 


Substantial Equivalence

Substantial equivalence is a second pathway manufacturers can use to market a new tobacco product in certain circumstances.

New tobacco products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. However, if a new tobacco product meets the following criteria:

  1. It was commercially marketed after February 15, 2007 but before March 22, 2011; and
  2. A Substantial Equivalence Report was submitted by March 22, 2011,

then this new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to a valid predicate product.  

Marketing orders for substantially equivalent tobacco products can be issued for new products that have the same characteristics as valid predicate tobacco products, or have different characteristics but the new products do not raise different questions of public health.   

 

Summary of Substantial Equivalence Final Actions

SE Final Actions Pre-June 2013 Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Total to Date
 SE Orders 0  2  0  0  4 3 8 0 0 0 0 17
 NSE Orders 0  4  0  4  0 5 0 0 0 4 0 17
 Report Withdrawals 132  7  6  10  13 31 7 1 26 75 27 335

 

Substantial Equivalence Marketing Orders

FDA Order Letter Date FDA Decision Summary Health Summary
SE0003730 June Decision Summary SE0003730 Available from manufacturer
SE0003731 June Decision Summary SE0003731 Available from manufacturer
       
SE0001697 September Decision Summary SE0001697 Available from manufacturer
SE0001698 September Decision Summary SE0001698 Available from manufacturer
SE0003199 September Decision Summary SE0003199 Available from manufacturer
SE0003200 September Decision Summary SE0003200 Available from manufacturer
       
SE0003297 October

Decision Summary SE0003297

Decision Summary SE0003297 Addendum

Available from manufacturer
SE0003298 October Decision Summary SE0003298 Available from manufacturer
SE0003299 October Decision Summary SE0003299 Available from manufacturer
       
SE0001762 November Decision Summary SE0001762 Available from manufacturer 
SE0003525 November Decision Summary SE0003525 Available from manufacturer 
SE0003526 November Decision Summary SE0003526 Available from manufacturer 
SE0003528 November Decision Summary SE0003528 Available from manufacturer 
SE0003529 November Decision Summary SE0003529 Available from manufacturer 
SE0004386 November Decision Summary SE0004386 Available from manufacturer 
SE0004387 November Decision Summary SE0004387 Available from manufacturer 
SE0004388 November Decision Summary SE0004388 Available from manufacturer 

 

Provisional Not Substantially Equivalent Orders

FDA Order Letter Date FDA Decision Summary
SE0003441 February Decision Summary SE0003441
SE0003442 February Decision Summary SE0003442
SE0003443 February Decision Summary SE0003443
SE0003444 February Decision Summary SE0003444

 

Explanation of Selected Not Substantially Equivalent Orders

Included in the summary below are some of the reasons why the FDA concluded that products were Not Substantially Equivalent (NSE) to the predicate products identified in the submissions.


 

 


Exemption from Substantial Equivalence

A tobacco product that is modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, may be considered for exemption from demonstrating substantial equivalence if:

  • The product is a modification of another tobacco product and the modification is minor;
  • The modifications are to a tobacco product that may be legally marketed under the FD&C Act;
  • A Substantial Equivalence Report is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for the protection of public health;
  • The modified tobacco product is marketed by the same organization as the original product; and 
  • An exemption is otherwise appropriate.

Before legally marketing your product, you must obtain written notification that FDA has granted the product an exemption from demonstrating substantial equivalence. In addition, at least 90 days before commercially marketing the product, you must submit a report notifying FDA of your intention to do so and establishing that your product is covered by a granted exemption. (See 21 CFR 1107.1 and Section 905(j) of the FD&C Act.)

 

Exemption from Substantial Equivalence Final Actions

SE Exemption Final Actions Jun Jul Aug Sep Oct Nov Dec Jan Feb Total to Date
Refusal to Accept (RTA) letters for Exemption Requests 20 2 0 0 0 0 13 - 35

 

 

Tobacco Product Review Resources