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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
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 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:
- It was commercially marketed after February 15, 2007 but before March 22, 2011; and
- 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||2013 Total|
|Refuse to Accept (RTA) letters for SE||0||0||0||0||0||0||0||0||0|
|SE Final Actions||Jan||Feb||Mar||Apr||May||Jun||Jul||Aug||Sep||Oct||Nov||Dec||2014 Total|
|Refuse to Accept (RTA) letters for SE||0||0||0||0||10||6||0||0||0||0||0||0||16|
|SE Final Actions||Jan||Feb||Mar||Apr||May||June||2015 Total|
|Refuse to Accept (RTA) letters for SE||0||4||0||0||1||1||6|
Substantial Equivalence Marketing Orders
- Access 2013 Substantial Equivalence Marketing Orders listed by FDA order letter, date, FDA decision summary and health summary.
- Access 2014 Substantial Equivalence Marketing Orders listed by FDA order letter, date, FDA decision summary and health summary.
- Access 2015 Substantial Equivalence Marketing Orders listed by FDA order letter, date, FDA decision summary and health summary.
|FDA Order Letter||Date||FDA Decision Summary|
|SE0003441||February 2014||Decision Summary SE0003441|
|SE0003442||February 2014||Decision Summary SE0003442|
|SE0003443||February 2014||Decision Summary SE0003443|
|SE0003444||February 2014||Decision Summary SE0003444|
|SE0000282||August 2014||Decision Summary SE0000282|
|SE0000283||August 2014||Decision Summary SE0000283|
|SE0000284||August 2014||Decision Summary SE0000284|
|SE0000285||August 2014||Decision Summary SE0000285|
|SE0000286||August 2014||Decision Summary SE0000286|
|SE0000287||August 2014||Decision Summary SE0000287|
|SE0000288||August 2014||Decision Summary SE0000288|
|SE0001079||May 2015||Decision Summary SE0001079|
|SE0003613||May 2015||Decision Summary SE0003613|
|SE0003614||May 2015||Decision Summary SE0003614|
|SE0003615||May 2015||Decision Summary SE0003615|
|SE0003616||May 2015||Decision Summary SE0003616|
|SE0003617||May 2015||Decision Summary SE0003617|
|SE0003618||May 2015||Decision Summary SE0003618|
|SE0003619||May 2015||Decision Summary SE0003619|
|SE0003620||May 2015||Decision Summary SE0003620|
|SE0003621||May 2015||Decision Summary SE0003621|
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.
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||Total|
|Refusal to Accept (RTA) letters for Exemption Requests||20||2||0||0||0||0||0||22|
|SE Exemption Final Actions||Jan||Feb||Mar||Apr||May||Jun||Jul||Aug||Sep||Oct||Nov||Dec||Total|
|Refusal to Accept (RTA) letters for Exemption Requests||13||1||0||0||0||0||0||0||0||0||0||0||14|
|Exemption from SE Final Actions||Jan||Feb||Mar||Apr||Total|
|Exemption from SE Orders||0||0||0||1||1|
Exemption from Substantial Equivalence Marketing Orders
- Access 2015 Exemption from Substantial Equivalence Marketing Orders listed by FDA order letter, date, FDA decision summary and health summary.
Tobacco Product Review Resources
- “Substantial Equivalence - An Update” - 4/10/13
- Common Issues Identified During FDA’s Scientific Evaluation of Substantial Equivalence Reports” - 8/21/12
- April Reports on Substantial Equivalence:(One Year Later)- 4/24/12
- Applications for Premarket Review of New Tobacco Products - 09/27/2011
- Substantial Equivalence Issue Snapshot (PDF - 1MB)
- Reports: Demonstrating Substantial Equivalence for Tobacco Products - 1/5/11
- Exemptions From Substantial Equivalence Requirements - 7/5/11
- QandA: Substantial Equivalence Tobacco Products
Questions and Answers