Enforcement Policy for Certain  Marketed  
Tobacco Products*   
 
Guidance for  Industry  
  
DRAFT GUIDANCE  
 
This guidance document  is being distributed for  comment purposes only.  Comments  regarding 
this draft guidance may be submitted  within  60 days of publication in the  Federal Register  of the  
notice announcing the  availability  of the draft  guidance. Electronic comments may be submitted  
to http://www.regulations.gov. Alternatively,  submit  written comments to  the  Dockets  
Management  Staff (HFA-305), Food and Drug Administration, 5630 Fishers  Lane, Room 1061, 
Rockville, MD 20852.   All comments  should be identified with  Docket No.  FDA-2018-D-3244.  
 
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/Labeling/RulesRegulationsGuidance/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  
 
February 2019  
 
 
 
 
*When final, this guidance will supersede  the guidance, Enforcement Policy for Certain  
(Provisional) Tobacco Products that FDA  Finds Not Substantially Equivalent, issued September  
2015.  
 
  Contains Nonbinding Recommendations  
Draft    Not for Implementation  
 
Enforcement Policy for Certain  Marketed  Tobacco 
1 
Products   
 
 
 
2 
Guidance for  Industry  
 
 
This  draft  guidance, when finalized,  will represent the  current thinking of the Food and Drug  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 regarding  FDAs enforcement policy for  
certain  marketed tobacco products  that become the subject  of  a  not substantially equivalent  
(NSE)  order. This policy  primarily involves  the  so-called provisional3  tobacco products that  
become subject to  NSE  orders issued under section 910(a)(2)(B) of the  Federal Food, Drug, and 
Cosmetic Act (FD&C Act).  This policy  also  extends to  new  tobacco products  created by  
modifying the quantity of a provisional tobacco product in a  pending substantial equivalence  
(SE) Report4  that become  subject to NSE orders.  The guidance  also provides information on 
FDAs  enforcement policy  for when  FDA  receives from  the applicant  a request for supervisory  
review under 21 CFR 10.75 within 30  calendar days  of the issue date of the NSE order.   FDA 
intends to offer copies of those final scientific reviews that supported the basis of the Agencys  
decision to the applicant  concurrent with the NSE order  for provisional tobacco products.   
 
                                                 
1  When final, this  guidance will supersede the guidance,  Enforcement Policy for Certain (Provisional) Tobacco  
Products that  FDA Finds Not  Substantially Equivalent, issued September 2015 (2015 guidance)  
(https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM386629.pdf). Here, as  
with the 2015 guidance, FDA  indicates that it does not intend to take enforcement action against a retailer for  certain  
marketed  tobacco  products for  a certain period of time (see page 2 of this guidance for  more information).   
2  This guidance was prepared by the Office of  Compliance and Enforcement, Office of Science, and Office of  
Regulations in the Center for Tobacco  Products at FDA. 
3  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.  
4  As described in Question and Response 8 of the guidance document,  Demonstrating the Substantial Equivalence of  
a New  Tobacco Product:  Responses to Frequently Asked Questions (Edition 3)*  (FAQs Guidance), 
http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM436468.pdf.  
1  
  Contains Nonbinding Recommendations  
Draft    Not for Implementation  
 
Upon issuance by  FDA of  an order finding the product 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, upon issuance of an NSE  order, it is a prohibited act to introduce  
or deliver  the product  for introduction into  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 adulterated and misbranded  is subject to seizure at 
any time.   
 
However, because  the  FD&C Act permits a  provisional  tobacco  product  to remain on the market  
pending  FDAs review of  the SE Report  for that product, the  product  is likely  to be  available to  
consumers  at retail locations within the United States when FDA issues an  NSE  order,  rendering  
the  tobacco product  adulterated and misbranded.  Likewise, because  FDA has previously stated 
that it does not intend to enforce the premarket requirements under sections 910 and 905(j) of the  
FD&C Act for those new tobacco products  created by modifying the quantity  of  a provisional  
tobacco product  subject to a pending SE Report, these products  are  also likely to be  available to 
consumers at retail locations within  the United States when FDA issues an order finding the  
tobacco product NSE. To  provide time  for sell-off of the products described in this paragraph 
that are  in distribution, FDA does not intend to take enforcement  action against a manufacturer, 
importer, or distributor  of the product  for at least  30 calendar days from the date of the NSE  
order.    
 
In addition, should FDA  receive  a request for supervisory  review  of an NSE order  from  the 
applicant  under 21 CFR 10.75 (appeal)  within 30  calendar days from the  issue date of the NSE  
order (i.e., date on the order  letter), FDA does not intend to take enforcement action against  the 
manufacturer, importer, or distributor  based on the order  until FDA makes  a decision on that  
request. If the appeal results in a finding that the  product is substantially equivalent, then 
commercial marketing of the product  may continue. If the  appeal  results in  FDA  affirming  the 
NSE order, then FDA does not intend to take enforcement action against a  manufacturer, 
importer, or distributor  for at least 30 calendar days from the date of  FDAs decision  on that  
appeal  (i.e., date on the appeal denial letter).  
 
FDA also  does not intend to take enforcement action  against  a  retailer  for  at least 30 calendar  
days  from the date  notice of  the NSE order  is posted on FDAs misbranded and adulterated NSE  
Tobacco Products website.5  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  inventory.6    
 
                                                 
5  FDA Misbranded and  Adulterated NSE Tobacco  Products  website is located here:  
https://www.fda.gov/tobaccoproducts/labeling/tobaccoproductreviewevaluation/ucm371765.htm.   In the event FDA  
receives an appeal from an applicant  within 30 calendar days from the issue date of the NSE order, then FDA does  
not intend  to post  notice of  the  NSE order  on its  misbranded and adulterated NSE Tobacco  Products  website unless  
and until it affirms the order.  
6  The products discussed in this guidance document still  may be subject to enforcement action at any time for other  
violations of the FD&C  Act (i.e., violations of provisions besides the premarket requirements under  sections  
910(a)(2)(A)(i), 910(a)(2)(B),  910(a)(3),  and 905(j)(1)(2)  of  the FD&C Act).  
2  
  Contains Nonbinding Recommendations  
Draft    Not for Implementation  
 
FDAs  guidance documents, including this guidance,  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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