Searchable Tobacco Products Database Additional Information

On this page, you will find helpful information about the Searchable Tobacco Products Database, including key terminology, additional context, and answers to anticipated questions.

The content on this page is intended to provide brief and plain language explanations of the terms and entries in the database. This information is not intended to be a comprehensive guide to all legal and regulatory requirements to market, sell, or distribute a tobacco product.

Database Terminology

Company	Based on FDA’s records, this is the company, firm, manufacturer, LLC, or other entity associated with a specific tobacco product provided to FDA in regulatory submissions. Typically, this is the company submitting the documents to FDA or manufacturing the product. Sometimes, the company listed in the database may not match with the name a user may expect.  For more info, see “Why can’t I find the company I’m searching for?”
Product Name	This is the product name, including the brand and sub-brand, provided to FDA at the time of marketing authorization or when it was established as a pre-existing tobacco product. Over time, the name of a product may change.  For questions about a product name change, please contact the manufacturer.
Category	For application review purposes, FDA considers tobacco products to fall under one of nine types of categories (with “Other” being an option). These categories are in line with the options available to an applicant when submitting an application to market a new tobacco product. E-Cigarette - The term “Electronic Nicotine Delivery Systems, or ENDS,  includes products commonly known as e-cigarettes, e-cigs, vapes, vaporizers, pens, tanks, and other names. These products are one of the nine distinct categories of tobacco products in the database. However, for the purposes of presenting these products in the database, FDA is simply displaying all of these products as “E-Cigarettes.”  For a more detailed description of the category and sub-category of any ENDS product in the database, see the accompanying Order Letter or Decision Summary for the product.
Sub-Category	For application review purposes, FDA considers tobacco products to fall under one of nine types of categories. Each Category has its own set of sub-categories. FDA strives to include Sub-Category information for all products listed in the database, however, in order to use its resources most efficiently, it is not always possible to provide this information, particularly for products with older Dates of Action.
Submission Type – Marketing Authority	This column provides the type of submission made by a company (e.g., a PMTA or a PTP Determination Request) and the respective marketing authority by which the product is allowed to be legally marketed (e.g., a marketed granted order or as an established pre-existing tobacco product).  Learn more: Market and Distribute a Tobacco Product | FDA
EXREQ – Found Exempt Order	Exemption from Substantial Equivalence (EX REQ) is one of three pathways to market a new tobacco product. A new tobacco product receives a “Found Exempt Order” when FDA determines that the product meets the legal requirements under the exemption from substantial equivalence pathway. There are several requirements for exemption, but in general, the pathway is for new tobacco products with minor modifications (adding, deleting, increasing, or decreasing an additive) from a tobacco product that is already legally marketed.
PMTA – Marketing Granted Order	A premarket tobacco product application (PMTA) is one of three pathways to market a new tobacco product. A tobacco product issued a marketing granted order (MGO) under the PMTA pathway has been found by the FDA to be appropriate for the protection of the public health and – in accordance with all applicable laws, regulations, and requirements of its Order Letter – can be legally marketed in the United States.  Learn more: Market and Distribute a Tobacco Product | FDA
PTP Determination Req. – Established Pre-Existing Tobacco Product	A pre-existing tobacco product (PTP) is any tobacco product (including those products in test markets) that was commercially marketed in the United States on, or as of, February 15, 2007. PTPs are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and do not require premarket authorization to be legally marketed. A PTP Determination Request is a voluntary submission by a company asking FDA to determine if a tobacco product is a PTP. The products listed in the database under this column have been issued a letter determining them to be PTPs. PTPs that did not go through the voluntary determination process are not listed in the database – but may be legally marketed.
SE – Removed From Review	New tobacco products commercially marketed after Feb. 15, 2007 but before March 22, 2011 with a substantial equivalence (SE) Report submitted by March 22, 2011 are known as provisional SE tobacco products. These products may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent. “SE – Removed from Review" describes provisional SE tobacco products that FDA does not intend to conduct further review on because they were determined to have a lower potential to raise different questions of public health. Provisional SE tobacco products—both those that have been removed from review (included in this database) and those whose SE Reports will be reviewed by FDA (not included in this database)—may be legally marketed. However, provisional SE tobacco products removed from review will be returned to the review queue only if certain criteria are met.  Learn more: FDA Update on Provisional SE Review Process (April 2018)
SE – Substantially Equivalent Order	Substantial equivalence (SE) is one of three pathways to market a new tobacco product. SE involves comparing the new tobacco product to a legally marketed predicate product. A product that has received an SE Order has been found by FDA to have either the same characteristics as a predicate product or has different characteristics than the predicate tobacco product but the new product does not raise different questions of public health, and – in accordance with all applicable laws, regulations, and requirements of its Order Letter – can be legally marketed in the United States.  Learn more: Market and Distribute a Tobacco Product | FDA
Date of Action	This is the date FDA issued the marketing authorization, a pre-existing tobacco product status determination letter, or a communication about removal of a product from the provisional substantial equivalence review queue.
Order Letter	This is FDA’s official notice to an applicant of the final decision on their application to market a new tobacco product. Some information in these documents may be redacted by FDA to protect confidential commercial information (CCI).
Decision Summary	Also known as a “Technical Project Lead (TPL) Review.” This document is prepared by FDA to describe the comprehensive scientific review of an application to market a new tobacco product and explain FDA’s decision. In general, these Decision Summaries cover findings from a wide range of scientific disciplines. Before making this information available to the public, some information in these documents may be redacted by FDA to protect confidential commercial information (CCI).
Environmental Assessment (EA)	Under the FDA’s regulation(s) implementing the National Environmental Policy Act (NEPA), applicants for new tobacco products are required to either 1) submit a document explaining the environmental impact if FDA were to authorize their new tobacco product or 2) a claim for why their new tobacco product should be categorically exempted from submitting such a document. In accordance with 40 CFR 1506.6, FDA makes the appropriate EA document publicly available. Some information in these documents may be redacted by FDA to protect confidential commercial information (CCI).
Finding of No Significant Impact (FONSI)	This column is where FDA posts a document describing the significant environmental impact of authorizing a new tobacco product – either a Finding of No Significant Impact (FONSI) document or an Environmental Impact Statement (EIS). To date, all entries in this column for authorized tobacco products are FONSI documents. Some information in these documents may be redacted by FDA to protect confidential commercial information (CCI).
STN	A submission tracking number (STN) is a unique identifier assigned by FDA to a specific tobacco product.
Associated MRTP	For some products in the database, a company has also submitted a modified risk tobacco product (MRTP) application to market the product with specific reduced risk or reduced exposure claims. If a product has been issued a modified risk granted order, or has an MRTP application pending with the FDA, that information is noted in this column.

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 Questions & Answers

1. Why can’t I find the company I’m searching for? Why is a different company listed in the database from what is on the product package?
   For the “Company” column, FDA lists the official company, firm, manufacturer, or entity associated with the premarket application or voluntary PTP Determination Request. In some cases, a parent company, consulting/legal firm, company sub-division, or official business name that submits information to FDA differs from the company name commonly associated with a product or on its package. In other cases, the current company name may differ from the company name at the time the product was authorized for marketing or determined to be a product that does not require authorization (PTP or provisional SE product) (e.g., due to a business rebrand, merger, or other corporate change). Additionally, different divisions or sectors of the same company may submit documents to the FDA about tobacco products.
   
   Search Tip: Try using fewer words or being less specific to broaden your results. Searching for “John Smith Tobacco Products” may not return results attributed to the company’s sub-division, so try searching for just “John Smith.”
    
2.  Are there any tobacco products that may be marketed but are not in this database?
   Yes, but in very limited circumstances. 
   
   Because pre-existing tobacco products (PTP) do not require premarket authorization to be legally marketed – and the PTP Determination Request program is purely voluntary – there are likely some additional PTPs that are not listed in the database. 
   
   There are also provisional tobacco products whose SE Reports are pending FDA review that may continue to be marketed unless FDA issues an order saying otherwise. To make the best use of its resources, FDA is not listing these products at this time in the database. Any of these products that are issued SE Orders in the future will be added to the database.
    
3. Why is a column displaying “N/A,” a dash (–), or blank?
   For some tobacco products, certain types of information do not exist – these are designated as “Not Applicable (N/A).” For example, there is no Decision Summary created when a product is determined to be a pre-existing tobacco product (PTP), so that column displays as “N/A” for all PTP products.  
   
   For some tobacco products, the information exists, but it is not yet available in the database – these are designated with a dash ( – ). For example, because Order Letters and Decision Summaries require additional time and resources to ensure they are meeting certain requirements for posting – such as redacting confidential commercial information (CCI) and trade secrets and making them 508-complaint for the web – they are typically not posted until a later date. 
   
   For recent PMTA authorizations, to share as much information as possible at the time of order issuance, the agency provides redacted versions of the order letter and the “Executive Summary” section of the decision summary to broadly explain the public health rationale for authorization of these products.
   
   Other columns may be blank for a number of reasons, such as a data issue or information that FDA is unable to provide at this time. Information in the database will be updated as available.
    
4. Why aren’t tobacco products with pending applications listed?
   The purpose of the Searchable Tobacco Products Database is to provide the public with a simple list of tobacco products that can be legally marketed. If a product subject to a pending application for a new tobacco product is ultimately issued a marketing authorization, it will be added to the database. 
   
   Provisional SE tobacco products may continue to be lawfully marketed unless FDA issues an order that the new product is not substantially equivalent. Otherwise, a pending application does not create a safe harbor to sell that product. In general, FDA is unable to provide information on pending applications in order to protect confidential commercial information (CCI).
    
5. If a tobacco product is listed in the database, are there any other requirements that need to be met in order to sell the product?
   Yes. The listing of a product in the database simply means that the product has either been issued a marketing authorization order by the FDA, that FDA has determined it to be a pre-existing tobacco product, or that it is a provisional SE product that has been removed from review. To legally sell tobacco products, all other applicable federal, state, and local laws and regulations must be met.
    
6. Why is a product I see in stores not listed in the database?
   This database is not an exhaustive list of all tobacco products that can be legally marketed (see Q.2 “Are there any tobacco products that may be marketed but are not in this database?”). Additionally, some products you may see in a store are listed here by the product name at the time of an FDA decision or action, and the name may have since changed.
   
   FDA has not adopted a broad policy of enforcement discretion regarding tobacco products without marketing authorization. There have been a few tobacco products that received marketing denial orders (MDOs) that subsequently underwent further agency review. For these products, FDA has stated that it does not intend to pursue enforcement action during the pendency of agency review. In addition, in a very limited number of instances, some courts have granted stays of MDOs pending judicial review in order to maintain the status quo, or FDA has administratively stayed MDOs. In those particular instances, FDA does not intend to take enforcement action.
   
   A sizeable portion of the e-cigarettes in stores that are not listed in the database may be being sold illegally (an unauthorized new tobacco product). The public and interested stakeholders can report possible tobacco product violations of the FD&C Act by submitting information on Form FDA 3779 online, via email or postal mail, or by calling FDA's Tobacco Call Center.
    
7. Are the products listed in this database approved by FDA? 
   There is no safe tobacco product, and FDA does not approve tobacco products. FDA’s Center for Tobacco Products (CTP) is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which Congress passed in 2009. This law gives FDA broad authority to regulate the manufacturing, distribution, and marketing of tobacco products. As part of those authorities, FDA is responsible for authorizing tobacco products that meet legal requirements.
    
8. Are the e-cigarettes listed in the database the only ones that can be legally marketed? What happens if I sell an e-cigarette not listed here?
   The e-cigarettes listed in this database are the only ones to have received a marketing granted order from the FDA. Due to high interest, FDA also maintains a printable one-page flyer of e-cigarettes authorized by FDA.
   
   When e-cigarettes lack a marketing authorization order from the FDA, selling or distributing them to consumers in the U.S. is prohibited under the FD&C Act. The FDA will continue to take compliance and enforcement action – as appropriate – against those making, distributing, importing, or selling unauthorized e-cigarette products. Learn more: Advisory and Enforcement Actions Against Industry for Unauthorized Tobacco Products.

For questions or issues related to the Searchable Tobacco Products Database, email SearchTobacco@fda.hhs.gov. Please include a submission tracking number (STN) in the subject line if you are inquiring about a specific entry.