Determination of the Period 
Covered by a No-Tobacco- 
Sale Order and Compliance 
With an Order (Revised)* 
Guidance for 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 the Docket No. FDA-2015-
D-0404. 
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 
March 2023 
* This is the first revision to the first edition of this guidance, which issued in August 2015.  
  Contains Nonbinding Recommendations 
Table of Contents 
I.  INTRODUCTION................................................................................................................ 1 
II.  BACKGROUND .................................................................................................................. 2 
III.  DISCUSSION ....................................................................................................................... 2 
A.  What definitions apply to this guidance? ................................................................. 2 
B.  When may FDA seek an NTSO? ............................................................................... 3 
C.  What is the period of time an NTSO will cover? ..................................................... 3 
D.  How does FDA initiate and impose NTSOs? ............................................................ 5 
E.  What happens after an NTSO has been imposed? .................................................. 5 
1.  What steps could a retailer take to ensure compliance with an NTSO? ................. 5 
2.  How will FDA monitor compliance with an NTSO? .............................................. 6 
3.  What happens if a retailer violates an NTSO? ....................................................... 6 
4.  What happens after an NTSO has been lawfully fulfilled? ..................................... 6 
F.  How can a consumer learn which retailers have received NTSOs? ....................... 6 
G.  What compliance assistance is available to retailers? ............................................. 6 
 
i  Contains Nonbinding Recommendations 
Determination of the Period Covered by a 
No-Tobacco-Sale Order and Compliance  
With an Order 
Guidance for Tobacco Retailers1 
 
 
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 the approach 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. 
 
I.  INTRODUCTION 
This guidance describes FDAs current thinking with respect to imposing a no-tobacco-sale order 
(NTSO) on a retailer who has committed repeated violations of restrictions promulgated under 
section 906(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et 
seq.), including FDAs Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco to Protect Children and Adolescents, codified at 21 CFR part 1140. It 
supplements FDAs current policies as described in FDAs guidance for FDA and tobacco 
retailers, Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers. This 
guidance discusses, among other things, the factors FDA will consider in determining the period 
of time covered by an NTSO and a retailers compliance with an NTSO. Additional information 
regarding procedures FDA follows when it initiates a civil money penalty (CMP) or an NTSO 
action may be found in FDAs guidance for industry and FDA staff, Civil Money Penalties and 
No-Tobacco-Sale Orders for Tobacco Retailers: Responses to Frequently Asked Questions 
(CMP and NTSO FAQs guidance).  
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. 
 
1 This guidance was prepared by the Office of Compliance and Enforcement and the Office of 
Regulations in the Center for Tobacco Products at FDA. 
1  Contains Nonbinding Recommendations 
II.  BACKGROUND 
On June 22, 2009, President Obama signed the Family Smoking Prevention and Tobacco Control 
Act (Tobacco Control Act) into law. The Tobacco Control Act amended the FD&C Act to give 
FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco 
products to protect the public health generally and to reduce tobacco use by minors. Section 
906(d) of the FD&C Act authorizes FDA to issue regulations that restrict the sale and 
distribution of tobacco products if FDA determines such regulations would be appropriate for the 
protection of the public health. Section 303(f)(8) of the FD&C Act authorizes FDA to impose an 
NTSO against a person found to have committed repeated violations, at a particular retail outlet, 
of restrictions on the sale and distribution of tobacco products promulgated under section 906(d) 
of the FD&C Act, such as FDAs Regulations Restricting the Sale and Distribution of 
Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.  
In addition to its authority to seek NTSOs, FDA has the authority to seek CMPs from retailers 
for violations of the FD&C Act and implementing regulations. FDA may pursue a CMP and an 
NTSO separately or together. Further, FDA has authority to pursue other enforcement actions for 
FD&C Act violations based on the individual circumstances, including injunctions, criminal 
prosecution, and seizures.  
III.  DISCUSSION 
A.  What definitions apply to this guidance? 
For purposes of this guidance, FDA intends to use the following definitions.  
No-tobacco-sale order (NTSO): The term no-tobacco-sale order refers to an order 
prohibiting the sale of tobacco products at a retail outlet indefinitely or for a specified 
period of time under section 303(f)(8) of the FD&C Act.  
Person: The term person is not limited to a natural person, but includes individual, 
partnership, corporation, and association (section 201(e) of the FD&C Act). 
Retailer: The term retailer means any person, government, or entity who sells tobacco 
products to individuals for personal consumption, or who operates a facility where self-
service displays of tobacco products are permitted (section 900(14) of the FD&C Act). 
Repeated violation: For purposes of section 303(f)(8) of the FD&C Act, which relates to 
NTSOs, the Tobacco Control Act defines the term repeated violation to mean at least 
5 violations of particular requirements over a 36-month period at a particular retail outlet 
that constitute a repeated violation... (section 103(q)(1)(A) of the Tobacco Control Act).  
Tobacco product: The term tobacco product means any product made or derived from 
tobacco, or containing nicotine from any source, that is intended for human consumption, 
including any component, part, or accessory of a tobacco product (except for raw 
materials other than tobacco used in manufacturing a component, part, or accessory of a 
tobacco product). The term tobacco product does not mean an article that under the 
Federal Food, Drug, and Cosmetic Act is: a drug (section 201(g)(1)); a device (section 
2  Contains Nonbinding Recommendations 
201(h)); a combination product (section 503(g)); or a food (section 201(f)) if such article 
contains no nicotine, or no more than trace amounts of naturally occurring nicotine 
(section 201(rr) of the FD&C Act).  
B.  When may FDA seek an NTSO? 
FDA conducts inspections at retail outlets to evaluate compliance with the requirements of 
the FD&C Act and implementing regulations relating to tobacco products. If FDA finds 
that a retailer has committed repeated violations of the restrictions on the sale and 
distribution of tobacco products promulgated under section 906(d) of the FD&C Act 
(including restrictions codified at part 1140) at a particular retail outlet, then FDA may seek 
to impose an NTSO on that retailer prohibiting the sale of tobacco products at that outlet. 
FDA considers there to be repeated violations for purposes of section 303(f)(8) if: 
  There are at least five violations of requirements issued under section 906(d) of the 
FD&C Act at a particular outlet; 
  Each of the five violations represents the second or subsequent violation of a 
particular requirement; and 
  Each of the five violations occurs within 36 months.  
FDAs current policy is to consider each retail location to be a separate retail outlet when 
determining if there are repeated violations that provide grounds for FDA to seek an 
NTSO. A retail chain may receive multiple separate CMP and NTSO complaints for 
violations of part 1140, but for purposes of counting violations for CMPs and NTSOs, 
each retail outlet would be treated individually.  
C.  What is the period of time an NTSO will cover? 
In determining the period to be covered by an NTSO or amount of a CMP, FDA must 
take into account the nature, circumstances, extent, and gravity of the violations and, with 
respect to the violator, ability to pay, effect on ability to continue to do business, any 
history of prior such violations, the degree of culpability, and such other matters as 
justice may require (section 303(f)(5)(B) of the FD&C Act).  
The following table shows the maximum period of time FDA intends to seek when 
imposing an NTSO on a retailer. This maximum period takes into account the number of 
NTSOs previously imposed on the retailer. In general, FDA intends to file a complaint 
seeking the maximum time period. However, based on information that may 
subsequently become available to FDA, including information provided by the retailer in 
an answer to the complaint or during a settlement conference or hearing, FDA may 
reduce the time period taking into consideration the factors described above and 
information regarding whether the retailer has taken effective steps to prevent selling 
tobacco products to minors. In determining whether to impose the NTSO or reduce the 
period of time FDA seeks to impose in the NTSO, FDA will generally consider whether a 
retailer has taken effective steps to prevent the sale of tobacco products in violation of the 
minimum age requirements, including: 
  adopting and enforcing a written policy against sales to minors; 
3  Contains Nonbinding Recommendations 
  informing its employees of all applicable laws 
  establishing disciplinary sanctions for employee noncompliance; and 
  requiring its employees to verify age by way of photographic identification or 
electronic scanning device. 
See section 103(q)(1)(G) of the Tobacco Control Act and section 303(f)(5) of the FD&C 
Act.  
Number of NTSOs received by Retailer  Maximum Period of Time for NTSO 
First NTSO  30 Calendar Days 
Second NTSO  6 Months 
Third (and subsequent) NTSO  Permanent NTSO 
The Tobacco Control Act does not establish specific periods of time to be covered by an 
NTSO, but does allow for an NTSO to permanently prohibit a retailer from selling 
tobacco products (section 303(f)(5)(B) of the FD&C Act). FDA believes that imposing 
NTSOs on a schedule with gradually increasing periods of time, as laid out above, is 
appropriate based on the following considerations. First, if there are grounds for imposing 
an NTSO, the retailer has already engaged in repeated violations of the law and 
regulations restricting the sale and distribution of tobacco products, and therefore has a 
prior history of violations. Second, the restrictions codified in part 1140 are intended to 
protect the public health, especially children and adolescents, and FDA therefore 
considers repeated violations of these restrictions to be very serious. Nearly 9 out of 10 
adult daily smokers smoked their first cigarette by age 18 (87 percent).2 If the current 
trajectory of smoking rates continues, 5.6 million children alive today will die 
prematurely as a result of smoking.3 Third, FDA believes that imposing NTSOs where 
the periods of time gradually increase, starting with a maximum of 30 days and then a 
maximum of 6 months before issuing an order permanently prohibiting the sale of 
tobacco products, strikes an appropriate balance between considerations related to the 
number, extent, and gravity of the violations on one hand, and the retailers ability to 
continue to do business on the other hand. The increasing periods of time for which FDA 
intends to impose NTSOs are also consistent with the scheme of increasing CMPs for 
violations laid out in the Tobacco Control Act.  
FDA also considered how similar penalties are addressed at the state level. FDA found 
that the number of violations that triggers a states imposition of a similar penalty and the 
length of time that state laws and regulations allow for suspension of the sale of tobacco 
products at a retailer vary greatly among the states. The periods covered by similar 
 
2 U.S. Department of Health and Human Services. The Health Consequences of Smoking: 50 Years of Progress. A 
Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease 
Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking 
and Health, 2014, p. 708. 
3 U.S. Department of Health and Human Services. The Health Consequences of Smoking: 50 Years of Progress, 
p. 667. 
4  Contains Nonbinding Recommendations 
penalties at the state level range from days to indefinite revocation of a retailers license. 
FDAs decision to pursue a maximum of 30 days for an initial NTSO and a maximum of 
6 months for a second NTSO is consistent with the increasing periods authorized by 
many states laws and regulations. FDA also found that many states may suspend or 
revoke a retailers license after multiple violations. Thus, FDAs approach to have a third 
NTSO that permanently prohibits the sale of tobacco products is not inconsistent with 
states revocation of a retailers license after repeated violations of laws relating to the sale 
of tobacco products.  
An NTSO that permanently prohibits an individual retail outlet from selling tobacco 
products must allow the retail outlet, after a specified period of time, to request that FDA 
compromise, modify, or terminate the order (section 303(f)(5)(B) of the FD&C Act). In 
determining whether to compromise, modify, or terminate any NTSO, FDA must 
consider whether a retailer has taken effective steps to prevent violations of the minimum 
age requirements for the sale of tobacco products, including: 
  adopting and enforcing a written policy against sales to minors; 
  informing its employees of all applicable laws; 
  establishing disciplinary sanctions for employee noncompliance; and 
  requiring its employees to verify age by way of photographic identification or 
electronic scanning device. 
Section 103(q)(1)(G) of the Tobacco Control Act.  
D.  How does FDA initiate and impose NTSOs? 
Before entry of an NTSO, a person is entitled to a hearing pursuant to the procedures 
established through FDAs regulations for assessing CMPs (section 303(f)(8) of the 
FD&C Act). Thus, FDA will follow the procedures set forth in 21 CFR part 17. The CMP 
and NTSO FAQs guidance provides answers to frequently asked questions regarding the 
procedures FDA follows when it initiates a CMP or an NTSO action. Among other 
information, the CMP and NTSO FAQs guidance describes options retailers have for 
responding to a complaint.  
E.  What happens after an NTSO has been imposed? 
1.  What steps could a retailer take to ensure compliance with an NTSO? 
The NTSO will state the period of time during which the retailer cannot sell tobacco 
products. While an NTSO is in effect, a retailer may want to consider taking additional 
action to ensure that no tobacco products are sold in the establishment. These actions 
could include, for example: 
  Drapes/curtains over the products: A retailer may cover its tobacco products with 
drapes, curtains, or some other covering so the tobacco products cannot be accessed 
for sale or distribution. 
  Removal of products: A retailer may remove the tobacco products from the area of the 
store that is visible to the customers or from the store entirely.  
5  Contains Nonbinding Recommendations 
The retailer may use other approaches to ensure that no regulated tobacco products are 
being sold at the retail establishment during the period covered by the NTSO. FDA 
recommends that the retailer explain the means by which it intends to comply with the 
terms of the NTSO.  
2.  How will FDA monitor compliance with an NTSO? 
FDA may conduct unannounced compliance checks at a retail establishment during the 
period covered by the NTSO to ensure the establishment is complying with the terms of 
the order. If FDA determines that there has been another violation of the FD&C Act or its 
implementing regulations during a compliance check, FDA may choose to initiate a 
subsequent enforcement action during the period a retailer is subject to an NTSO.  
3.  What happens if a retailer violates an NTSO? 
The sale of tobacco products in violation of an NTSO is a prohibited act under section 
301(oo) of the FD&C Act. Thus, if the retailer sells tobacco products in violation of an 
NTSO, the retailer   may be subject to further enforcement actions such as criminal 
prosecution or injunction. 
4.  What happens after an NTSO has been lawfully fulfilled? 
FDA may visit the retail establishment after the terms of the NTSO have been met to 
assess compliance with the FD&C Act and implementing regulations after the retailer 
resumes tobacco sales. If violations are observed during such inspections, FDA may 
assess a CMP or impose an NTSO, or both, or initiate other enforcement actions, as 
appropriate. Compliance with the terms of an NTSO or a subsequent nonviolative 
inspection does not eliminate any past violations from the retailers history. That is, past 
violations may be used to support additional enforcement   actions, including subsequent 
NTSOs.  
F.  How can a consumer learn which retailers have received NTSOs? 
FDA maintains information regarding which retailers have violated laws or regulations 
relating to tobacco products on the Center for Tobacco Products (CTP) Web site. The 
CTP Web site includes a searchable database to review the results of compliance check 
inspections. When an NTSO is imposed on a retailer, FDA intends to post the 
information on the CTP Web site.  
G.  What compliance assistance is available to retailers? 
Small businesses may contact CTP by email at smallbiz.tobacco@fda.hhs.gov or by 
phone at 1- 877-CTP-1373. 
   
6  Contains Nonbinding Recommendations 
Document History 
March 2023The definition of tobacco product is updated to reflect the statutory amendments 
made by the Consolidated Appropriations Act, 2022 (Pub. L. 117-103). Among other things, the 
legislation amends the definition of tobacco product in section 201(rr) of the FD&C Act to 
include products containing nicotine from any source. 
7