Enforcement Policy for Certain 
(Provisional) Tobacco Products that 
FDA Finds Not Substantially Equivalent 
 
Guidance for Industry and Tobacco Retailers 
 
Comments may be submitted at any time for Agency consideration.  Electronic comments may 
be submitted to http://www.regulations.gov.  Alternatively, submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Room 1061, Rockville, MD 20852.  All comments should be identified with Docket No. 
FDA-2013-D-1600.  
 
For questions regarding this guidance, contact the Center for Tobacco Products at (Tel) 1-877-
CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m.  4 p.m. EDT. 
 
Additional copies are available online at 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.  
You may send an e-mail request to SmallBiz.Tobacco@fda.hhs.gov to receive an electronic copy 
of this guidance. You may send a request for hard copies to U.S. Food and Drug Administration, 
Center for Tobacco Products, Attn: Office of Small Business Assistance, Document Control 
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Tobacco Products 
 
September 2015 
 
 
 
  Contains Nonbinding Recommendations 
 
Enforcement Policy for Certain (Provisional) 
Tobacco Products that FDA Finds Not 
Substantially Equivalent 
 
 
 
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Guidance for Industry and Tobacco Retailers  
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the 
title page. 
 
 
 
FDA is issuing this guidance to provide information on its enforcement policy to retailers 
regarding so called provisional tobacco products that become subject to not substantially 
equivalent orders issued under section 910(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act). The provisional tobacco products addressed by this guidance are tobacco 
products that were first introduced or delivered for introduction into interstate commerce for 
commercial distribution after February 15, 2007, and prior to March 22, 2011, and for which a 
905(j) (or substantial equivalence) report was submitted no later than March 22, 2011. Under the 
FD&C Act, tobacco products meeting these criteria were permitted to remain on the market 
pending FDAs review of such report. If FDA issues an order finding the product not 
substantially equivalent (NSE), the product is adulterated and misbranded (sections 902(6)(A) 
and 903(a)(6) of the FD&C Act; 21 U.S.C. 387b(6)(A), 387c(a)(6)).  This means that, effective 
immediately upon issuance of an NSE order, it is a prohibited act to sell or distribute the product 
in interstate commerce, to import such products into the United States, or to receive from 
interstate commerce and sell or offer to sell or otherwise deliver products.  In addition, a tobacco 
product that is the subject of an NSE order is subject to seizure at any time.   
 
Because the FD&C Act permitted this specific group of products to remain on the market 
pending FDAs review of the report, there will very likely be products at retail locations within 
the United States when FDA issues an order finding a tobacco product NSE.  FDA does not 
intend to take enforcement action for at least 30 calendar days from the date the NSE order 
issues for those products that are in the retailers current inventory at a specific retail location on 
                                                
1 This guidance was prepared by the Office of Compliance and Enforcement and Office of Regulations in the Center 
for Tobacco Products at FDA. 
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  Contains Nonbinding Recommendations 
 
the date FDA issues the NSE order. This policy extends only to tobacco products that are already 
in a retail store that offers the products for sale directly to consumers. FDA encourages retailers 
to contact their supplier or manufacturer to discuss possible options for the misbranded and 
adulterated product that they may have in their current inventory.   
 
FDAs guidance documents do not establish legally enforceable responsibilities.  Instead, 
guidances describe the Agencys current thinking on a topic and should be viewed only as 
recommendations, unless specific regulatory or statutory requirements are cited.  The use of the 
word should in Agency guidances means that something is suggested or recommended, but not 
required. 
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