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 In this section:

                Market and Distribute a Tobacco Product

Market and Distribute a Tobacco Product

                        Questions & Answers
          Tobacco Products Marketing Orders
          Deemed New Tobacco Product Applications Lists
          Reviewer Guides and Scientific Policy Memoranda about FDA Review of Tobacco Product Applications
          Supervisory Review/Appeal Process for Tobacco Product Decisions


                        Substantial Equivalence
          Exemption from Substantial Equivalence
          Premarket Tobacco Product Applications Home
          Tobacco Products
          Products, Guidance & Regulations
          Market and Distribute a Tobacco Product
          Tobacco Products Marketing OrdersMarket and Distribute a Tobacco Product Tobacco Products Marketing Orders
  
  	
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Marketing a New Tobacco Product
	Premarket Tobacco Product Applications (PMTA)
	Marketing Granted Orders (MGO)
		Marketing Denial Orders (MDO)
	Substantial Equivalence (SE) Reports
	Marketing Orders
		Provisional Not Substantially Equivalent (NSE) Orders
		Provisional SE Products Removed from Review
	Exemption from Substantial Equivalence Requests (EX REQ)
	Marketing Orders
	Pre-Existing Tobacco ProductsFDA works expeditiously to post all relevant documents for marketing orders. Please note that before these documents are posted, they are 1) redacted in accordance with applicable statutes and regulations and 2) reviewed to ensure compliance with Section 508, which requires that all website content be accessible to people with disabilities. Because of these requirements, relevant documents for marketing orders are usually posted several weeks after they are issued.

FDA regularly provides aggregate numbers and data on the progress of tobacco product applications that have been submitted on Metrics & Reporting.

****Marketing a New Tobacco Product

To legally market a new tobacco product in the United States, a company must receive a written marketing order from FDA. 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 product use takes on public health. Companies may receive marketing authorization through one of the three pathways:

Premarket Tobacco Product Applications (PMTA)
	Substantial Equivalence (SE) Reports
	Exemption from Substantial Equivalence Requests (EX REQ)Note: If you were marketing a deemed tobacco product that is new and that was on the market as of Aug. 8, 2016, you were required to submit a marketing application by Sept. 9, 2020 as required by the Court, and as set forth in CTP’s compliance policy (see exception for premium cigars). In addition, any tobacco product (including those products in test markets) that was commercially marketed in the United States as of February 15, 2007, is considered a pre-existing tobacco product. Pre-existing tobacco products are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and do not require premarket authorization to be legally marketed.

****Premarket Tobacco Product Applications (PMTA)

A PMTA may be submitted to seek marketing authorization for any new tobacco product. PMTAs are evaluated based on several factors, including whether permitting the marketing of a new tobacco product would be appropriate for the protection of the public health, which is determined with respect to the risks and benefits of the product to the population as a whole, including users and non-users.

**FDA’s announcements on the latest marketing decisions:**

January 22, 2024: Marketing Denial Order Bidi Vapor LLC (Bidi Stick—Classic)
	January 19, 2024: Marketing Denial Orders Shenzhen Youme Information Technology Co. Ltd. (Suorin) and Fontem US, LLC (blu PLUS+)
	January 16, 2024: Marketing Denial Orders Shenzhen IVPS Technology Co., Ltd (SMOK)
	October 12, 2023: Marketing Denial Order R.J. Reynolds Vapor Company (Vuse Alto menthol-flavored and mixed berry-flavored products)
	July 10, 2023: Marketing Denial Order Fontem, US, LLC (myblu Menthol 2.4%)
	May 18, 2023: Marketing Denial Orders Mothers Milk WTA (Mothers Milk)
	May 12, 2023: Marketing Denial Orders for 10 Companies
	March 17, 2023: Marketing Denial Orders R.J. Reynolds Vapor Company (Vuse Solo Menthol Products)
	January 24, 2023: Marketing Denial Orders R.J. Reynolds Vapor Company (Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%)
	October 26, 2022: Marketing Denial Orders Logic, LLC (Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package)
	October 6, 2022: Marketing Denial Orders Magellan Technology Inc. (Hyde)
	June 23, 2022: Marketing Denial Orders JUUL Labs Inc (JUUL System)
	June 10, 2022: Marketing Granted and Denial Orders NJOY LLC (NJOY Daily)
	May 12, 2022: Marketing Granted and Denial Orders R.J. Reynolds Vapor Company (Vuse Vibe and Vuse Ciro)
	April 26, 2022: Marketing Granted and Denial Orders NJOY LLC (NJOY Ace)
	April 8, 2022: Marketing Denial Orders Fontem, US, LLC (myblu)
	March 24, 2022: Marketing Granted and Denial Orders Logic, LLC (Logic Vapeleaf, Logic Pro, Logic Power)
	October 19, 2021: Marketing Granted Orders U.S. Smokeless Tobacco Company LLC (VERVE®)
	October 12, 2021: Marketing Granted and Denial Orders R.J. Reynolds Vapor Company (Vuse Solo)****Marketing Granted Orders (MGO)

View all marketing granted order letters, and other related documents.****Marketing Denial Orders (MDO)

FDA has publicly named only products that FDA or the manufacturer has confirmed to be currently marketed, due to potential confidential commercial information (CCI) issues. Similarly, company names are included in the MDO list below only if products from that company are currently marketed.

View information on companies that have been issued a marketing denial order (CSV – Last updated 1/22/24)
	View a Sample Decision Summary Document. This sample does not reflect the decision rationale for each MDO action taken by FDA.Tobacco products covered under an MDO cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In addition to ensuring that the manufacturer complies with the MDO, as with unauthorized products generally, FDA intends to ensure compliance by distributors and retailers.

Substantial Equivalence (SE) Reports

A SE Report can be submitted by any manufacturer for any new tobacco product seeking an FDA substantially equivalent order.

A new tobacco product may be found “substantially equivalent” to a valid predicate product where it has the same characteristics as that predicate product, or if the product has different characteristics, it does not raise different questions of public health than the predicate product.

SE Orders

View all SE order letters, decision summaries, and other related documentsProvisional Not Substantially Equivalent (NSE) Orders

View all provisional tobacco products issued NSE ordersProvisional SE Products Removed from Review

View the list of provisional products that have been removed from review (CSV)Exemption from Substantial Equivalence Requests (EX REQ)

An EX REQ can be submitted by the original manufacturer for any new tobacco product seeking an FDA exemption order. A tobacco product that is modified by adding or deleting a tobacco additive, or by increasing or decreasing the quantity of an existing tobacco additive may be considered for an exemption from demonstrating SE.

Found Exempt Orders

View all Found Exempt order letters and decision summariesPre-Existing Tobacco Products

A pre-existing tobacco product is any tobacco product (including those products in test markets) that was commercially marketed in the United States as of February 15, 2007. FDA interprets “as of” to mean “on” or before that date. Pre-existing tobacco products are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and do not require premarket authorization to be legally marketed.  A voluntary request may be submitted to FDA to determine a tobacco product’s preexisting status.

A pre-existing tobacco product that has been modified in any way is considered a new tobacco product according to Section 910(a)(1)(B) and must apply for an FDA marketing order via one of the three pathways for new tobacco products.

View all standalone pre-existing tobacco product submissionsNote: This database contains pre-existing tobacco product determination information from voluntarily-submitted requests for a pre-existing status determination of a tobacco product. This database does not list all pre-existing tobacco products. It is updated periodically and contains original submission information that is typically released in response to a FOIA request.

                                                                                  Content current as of:
      01/22/2024
              
              
Regulated Product(s)
		 TobaccoMarket and Distribute a Tobacco Product

          
                        Questions & Answers
          Tobacco Products Marketing Orders
          Deemed New Tobacco Product Applications Lists
          Reviewer Guides and Scientific Policy Memoranda about FDA Review of Tobacco Product Applications
          Supervisory Review/Appeal Process for Tobacco Product Decisions


                        Substantial Equivalence
          Exemption from Substantial Equivalence
          Premarket Tobacco Product Applications
 
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