Guidance for Industry      
 
 
 
Compliance With Regulations  
Restricting the Sale and  
Distribution of Cigarettes and  
Smokeless Tobacco to Protect  
Children and Adolescents   
  
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 
number [insert docket number]. 
 
For questions regarding this guidance, contact the Center for Tobacco Products at (Tel) 1-877- 
CTP-1373 (1-877-287-1373) Monday-Friday, 9:00 a.m.  4:00 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, Building 71, Room G33, 10903 New Hampshire Avenue, Silver Spring, MD 20993-
0002. 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Tobacco Products 
 
August 2013   
 
 
 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  DISCUSSION .................................................................................................................... 3 
A.   What and Who Are Subject to the Regulations? .................................................... 3 
B.  Do Other Regulatory Requirements Apply to Me? ................................................ 4 
IV.  SALE AND DISTRIBUTION REQUIREMENTS ........................................................ 4 
V.  PART 1140, SUBPART A  GENERAL PROVISIONS ............................................ 5 
A.   Section 1140.1  Scope......................................................................................... 5 
B.   Section 1140.2  Purpose...................................................................................... 5 
C.   Section 1140.3  Definitions................................................................................. 6 
VI.   PART 1140, SUBPART B  PROHIBITION OF SALE AND DISTRIBUTION TO 
PERSONS YOUNGER THAN 18 YEARS OF AGE .................................................. 10 
A.   Section 1140.10  General Responsibilities of Manufacturers, Distributors, and 
Retailers ................................................................................................................ 10 
B  Section 1140.12  Additional Responsibilities of Manufacturers ...................... 11 
C.   Section 1140.14  Additional Responsibilities of Retailers ............................... 13 
D.   Section 1140.16  Conditions of Manufacture, Sale, and Distribution .............. 18 
E.   Section 1140.16(a)  Restriction on Product Names .......................................... 19 
F.   Section 1140.16(b)  Minimum Cigarette Package Size .................................... 19 
G.   Section 1140.16(c)  Vending Machines, Self-Service Displays, Mail Order 
Sales, and Other Impersonal Modes of Sale...................................................... 20 
H.   Section 1140.16(d)  Free Samples .................................................................... 25 
I.   Section 1140.16(e)  Restrictions on Labels, Labeling, and Advertising .......... 26 
VII.  PART 1140, SUBPART D  LABELING AND ADVERTISING ............................ 27 
A.   Section 1140.30  Scope of Permissible Forms of Labeling and Advertising ... 27 
B.   Section 1140.32  Format and Content Requirements for Labeling and 
Advertising............................................................................................................ 29 
C.   Section 1140.34  Sale and Distribution of Nontobacco Items and Services, 
Gifts, and Sponsorship of Events.......................................................................... 29 
D.   Section 1140.34(a)  Nontobacco Items and Services........................................ 30 
E.   Section 1140.34(b)  Gifts .................................................................................. 30 
F.   Section 1140.34(c)  Sponsorship ...................................................................... 30 
VIII.  EFFECTIVE DATE FOR THE REGULATIONS .................................................... 31 
A.   Section 1140.16(a) ................................................................................................ 31 
B.   Sections 1140.32(a) and 1140.34(b) ..................................................................... 32 
IX.   HOW TO REPORT VIOLATIONS TO FDA ............................................................. 32 
 
ATTACHMENT 1  REGULATION REFERENCES ........................................................... 33    Contains Nonbinding Recommendations 
 
 
1
Guidance for Industry
 
 
 
Compliance With Regulations Restricting the Sale and Distribution 
of Cigarettes and Smokeless Tobacco to Protect Children and 
Adolescents 
 
  This guidance represents the Food and Drug Administrations (FDAs) current thinking on this   
topic. It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations. If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the appropriate number listed on the title page of this 
guidance. 
   
I.  INTRODUCTION 
 
This guidance is intended to assist manufacturers, distributors, retailers, and others who sell 
cigarettes and/or smokeless tobacco in understanding the final Regulations Restricting the Sale 
and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents2 and 
to explain what you should do in order to comply with the regulations.  The document explains, 
among other things: 
 
  what and who are subject to the regulations; 
 
  prohibition on the sale and distribution of certain tobacco products to persons younger 
than 18 years of age; 
 
  restrictions on access, which consist largely of requirements concerning the sale of 
cigarettes and smokeless tobacco; and 
 
  labeling and advertising restrictions 
 
 
The regulations currently apply to cigarettes, including roll-your-own tobacco;3 cigarette 
tobacco;4 and smokeless tobacco products (e.g., moist snuff, snus, dry snuff, nasal snuff, loose 
leaf chewing tobacco, plug chewing tobacco, and twist chewing tobacco). 
 
FDAs guidances, 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 
 
 
1 This guidance document has been prepared by the Center for Tobacco Products at the Food and Drug 
Administration. 
2 See 75 FR 13225 (March 19, 2010). 
3 The definition of cigarette includes roll-your-own tobacco.  See Section 900(3) of the FD&C Act; 21 C.F.R. 
1140.3(a). 
4 Unless otherwise stated, requirements that apply to cigarettes also apply to cigarette tobacco. See section 900(4) of 
the FD&C Act;  1140.3(b). 
  1    Contains Nonbinding Recommendations 
 
 
the word should in Agency guidances means that something is suggested or recommended, but 
not required. 
 
II.  BACKGROUND 
 
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 
111-31; 123 Stat. 1776), enacted on June 22, 2009, amends the Food, Drug, and Cosmetic Act 
(FD&C Act) and provides FDA with the authority to regulate tobacco products.  Section 102 of 
the Tobacco Control Act requires FDA to publish final regulations regarding cigarettes and 
smokeless tobacco which are identical in their provisions to the regulations promulgated by FDA 
in 1996 (Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco 
to Protect Children and Adolescents (1996 final regulations),5 with certain specified exceptions. 
 
In enacting the Tobacco Control Act, Congress made extensive legislative findings regarding the 
lethal and addictive nature of tobacco products, including that tobacco use is the foremost 
preventable cause of premature death in the United States.  Cigarette smoking causes 
approximately 440,000 deaths each year.6   Moreover, advertising, marketing, and promotion of 
tobacco products have been especially directed to attract young persons to use tobacco products 
and these efforts have resulted in increased use of such products by youth (section 2(15) of the 
Tobacco Control Act).  The use of tobacco products is a pediatric disease, and an effective 
program to address this disease includes restrictions on youth access and restrictions on labeling 
and advertising to help reduce the appeal of tobacco products to young people.  See 
sections 2(1), (26), (30)-(32) of the Tobacco Control Act. 
 
Congress recognized that both the 1996 final regulations and the 1995 proposed regulations 
included extensive discussions of the scientific information available at the time and the final 
regulations included FDAs responses to more than 700,000 comments on the proposed 
regulations. 7 
 
On March 19, 2010, FDA published its final regulations entitled Regulations Restricting the 
Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and 
Adolescents, at Title 21, Code of Federal Regulations (CFR), Part 1140.8  Consistent with the 
requirements of section 102 of the Tobacco Control Act, these regulations prohibit the sale of 
cigarettes and smokeless tobacco to any person younger than 18 years of age, and impose 
restrictions on labeling, marketing, and advertising of cigarettes and smokeless tobacco.  Among 
other requirements, the regulations: 
  require retailers to verify a purchasers age by photographic identification; 
  prohibit free samples of cigarettes and restrict distribution of free samples of smokeless 
tobacco to qualified adult-only facilities as defined in the regulation; 
 
 
 
 
 
5 See 61 FR 44396 (Aug. 28, 1996). 
6 See Dept. 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, The Health Consequences of Smoking: a 
Report of the Surgeon General, 2004. 
7 See Congressional Record, S6407, June 10, 2009, Statement of Senator Kennedy. 
8 See 75 FR 13225 (March 19, 2010). 
  2    Contains Nonbinding Recommendations 
 
 
 
  prohibit the sale of cigarettes and smokeless tobacco products through vending machines 
and self-service displays, except in facilities where individuals under the age of 18 are 
not present, or permitted to enter at any time; 
  prohibit the sale or distribution of brand-identified promotional nontobacco items such as 
hats and tee shirts; and 
  prohibit sponsorship of sporting and other events, teams, and entries in those events in the 
brand name of any cigarette or smokeless tobacco product. 
 
Section 1140.32(a) of the regulations establishes format and content requirements for labeling 
and advertising to allow only black text on a white background, with limited exceptions.  Section 
1140.34(b) states that no manufacturer, distributor, or retailer may offer, or cause to be offered, 
any gift or item (other than cigarettes or smokeless tobacco) in consideration of purchasing 
cigarettes or smokeless tobacco.  On March 19, 2012, the United States Court of Appeals for the 
Sixth Circuit issued an Opinion and Judgment that, among other things, found  1140.32(a) and 
1140.34(b) to be unconstitutional under the First Amendment. (See Discount Tobacco et al v. 
United States, 674 F.3d 509 (6th Cir. 2012) (cert. denied)). Therefore, FDA will not seek to 
enforce these provisions. 
 
III.  DISCUSSION 
 
A.  What and Who Are Subject to the Regulations? 
 
The Tobacco Control Act amends the FD&C Act and provides FDA with the authority to 
regulate tobacco products.  FDA has issued part 1140, which prohibits the sale of cigarettes and 
smokeless tobacco to any person under age 18 and places restrictions on marketing, labeling, and 
advertising of cigarettes and smokeless tobacco products. 
 
Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) defines a tobacco product as any product 
made or derived from tobacco 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 does not 
include an article that is a drug under section 201(g)(1) of the FD&C Act, a device under section 
201(h) of the FD&C Act, or a combination product under section 503(g) of the FD&C Act (21 
U.S.C. 353(g)).  Also, a tobacco product must not be marketed in combination with any other 
article or product that is regulated under the FD&C Act (section 201(rr)(4) of the FD&C Act). 
 
Part 1140 currently covers the following tobacco products: 
  cigarettes, including roll-your-own tobacco,9 
  cigarette tobacco,10 and 
  smokeless tobacco products (e.g., moist snuff, snus, dry snuff, nasal snuff, loose leaf 
chewing tobacco, plug chewing tobacco, and twist chewing tobacco). 
 
 
 
 
9 The definition of cigarette includes roll-your-own tobacco. See Section 900(3) of the FD&C Act; 21 C.F.R. 
1140.3(a). 
10 Unless otherwise stated, requirements that apply to cigarettes also apply to cigarette tobacco. See section 900(4) 
of the FD&C Act;  1140.3(b). 
  3    Contains Nonbinding Recommendations 
 
 
The regulations apply to persons who manufacture, distribute, or sell cigarettes, including roll- 
your own-tobacco; cigarette tobacco; and/or smokeless tobacco. 
 
Greater detail is provided in the discussion of Definitions, section V.C of this guidance.  A 
summary table is also provided in Attachment 1  Regulation References. 
 
B.  Do Other Regulatory Requirements Apply to Me? 
 
The Tobacco Control Act, the FD&C Act as amended by the Tobacco Control Act, other laws 
amended by the Tobacco Control Act, and other FDA regulations may impose requirements on 
you in addition to those contained in part 1140.  For example, section 904 of the FD&C Act (21 
U.S.C. 387d) requires tobacco product manufacturers to submit tobacco product ingredient 
information to FDA.  The Agency has issued several guidance documents to assist regulated 
industry in complying with the provisions of the FD&C Act and the Tobacco Control Act.  These 
guidances are posted on our Web site at: 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm. 
Similarly, the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333 et seq.) and the 
Comprehensive Smokeless Tobacco Health Education Act (15 U.S.C. 4401 et seq.) require 
companies to place warnings on cigarette and smokeless tobacco packages and in 
advertisements. 
 
If you fail to comply with a statutory or regulatory requirement that applies to you, tobacco 
products that you manufacture, distribute, advertise, or sell may be considered adulterated or 
misbranded.  You may then be subject to regulatory and enforcement actions, including 
injunctions, seizures, civil money penalties, prosecution, and no-tobacco-sale orders by FDA. 
 
Please note that other federal, state, or local laws may affect you as well.  For example, your 
state or local government may require persons who sell cigarettes or smokeless tobacco to be a 
certain age or require retailers to obtain licenses to sell these products.  To determine whether 
any state or local requirements apply to you, we suggest that you contact your state or local 
authorities. 
 
IV.  SALE AND DISTRIBUTION REQUIREMENTS 
 
The regulations in part 1140 are designed to: 
 
  reduce access to cigarettes and smokeless tobacco by persons under age 18; and 
 
  reduce the appeal of such products to persons under age 18, through restrictions on 
marketing, labeling, and advertising. 
 
In 1996, FDA issued regulations after conducting an extensive review and analysis of the 
scientific and medical literature on cigarette and smokeless tobacco use by children and 
adolescents and examining over 700,000 comments that were submitted on the proposed 
regulations.  Many comments contained helpful information that enabled FDA to revise the 
proposed regulations and to create a practical regulatory system for these products.  The 1996 
final regulations were removed at the direction of the Supreme Court in 2000. 
  4    Contains Nonbinding Recommendations 
 
 
At the direction of Congress as part of the passage of the Tobacco Control Act, the current 
regulations at part 1140 were issued, largely identical to the 1996 version with some specifically 
identified changes.  The regulations are not designed or intended to prevent sales to adults or 
interfere with a manufacturers, distributors, or retailers ability to communicate truthful and 
nonmisleading information to adult consumers. 
 
The regulations are divided into two main components: (1) access provisions, which consist 
largely of requirements concerning the sale of cigarettes and smokeless tobacco; and (2) 
marketing, labeling, and advertising restrictions. 
 
To help you understand these requirements, this guidance examines each section in the order in 
which it appears in part 1140 and provides answers to several questions relating to each section 
of these requirements.  An electronic version of part 1140 is available on the Internet at 
http://www.ecfr.gov/cgi-bin/text- 
idx?c=ecfr;sid=4bfa1e83ce026f1d194a73e021ecfe99;rgn=div2;view=text;node=20100319%3A1 
.5;idno=21;cc=ecfr;start=1;size=25. 
 
Sections V through VII of this guidance discuss subparts A, B, and D of part 1140, respectively. 
 
V.  PART 1140, SUBPART A  GENERAL PROVISIONS 
 
Subpart A on general provisions contains three sections: 
   1140.1 Scope, which explains the scope of the regulations and the possible 
consequences of a failure to comply with any applicable provision in part 1140; 
   1140.2 Purpose, which states the purpose of the regulations; and 
   1140.3 Definitions, which defines certain terms used in part 1140. 
 
Subpart A does not itself impose any obligations on manufacturers, distributors, or retailers, but 
instead provides helpful background on the regulations, particularly with respect to the 
definitions applicable to the regulations. 
 
A.  Section 1140.1  Scope 
 
Section 1140.1 explains that the regulations establish restrictions, under the FD&C Act, on the 
sale, distribution, and use of cigarettes and smokeless tobacco. It also explains that the failure to 
comply with any applicable provision in part 1140 may render the cigarettes or smokeless 
tobacco product misbranded under the FD&C Act.  Among other actions related to 
misbranding, causing a tobacco product to be misbranded after shipment in interstate commerce 
or introducing a misbranded tobacco product into interstate commerce is prohibited under the 
FD&C Act (section 301 of the FD&C Act (21 U.S.C. 331)). 
 
B.  Section 1140.2  Purpose 
 
Section 1140.2 explains that the restrictions on the sale and distribution of cigarettes and 
smokeless tobacco were established in order to reduce the number of children and adolescents 
who use these products and to reduce life-threatening consequences associated with tobacco use. 
  5    Contains Nonbinding Recommendations 
 
 
 
 
When FDA began drafting the regulations in 1995, cigarette sales to children were illegal in all 
states, yet published reports in medical journals estimated that children bought millions of packs 
of cigarettes each year.  Other information available to FDA indicated that most cigarette 
smokers started before they reached 18, and research suggests that the younger people are when 
they begin to smoke, the more likely they are to become adult smokers.11  By reducing the 
number of children who start smoking, the regulations could lower the death rate attributed to 
cigarettes (approximately 440,000 Americans annually). 
 
C.  Section 1140.3  Definitions 
 
The definitions are important because they describe the types of products that are regulated and 
the persons who are subject to the regulations. 
 
1.  What Products Are Subject to Regulation Under Part 1140? 
 
The regulations apply to some, but not all, tobacco products.  Specifically, the regulations 
apply to cigarettes, including roll-your-own tobacco;12 cigarette tobacco; and smokeless 
tobacco.  These items are defined as: 
 
  The term cigarette as defined in section 900(3) of the FD&C Act (and  1140.3(a)) 
(A)  means a product that  
(i)  is a tobacco product; and 
(ii) meets the definition of the term cigarette in section 3(1) of the Federal 
Cigarette Labeling and Advertising Act; and 
(B)  includes tobacco, in any form, that is functional in the product, which, because 
of its appearance, the type of tobacco used in the filler, or its packaging and 
labeling, is likely to be offered to, or purchased by, consumers as a cigarette 
or as roll-your-own tobacco. 
 
Section 3(1) of the Federal Cigarette Labeling and Advertising Act (FCLAA) defines 
the term cigarette to mean: 
(A)  any roll of tobacco wrapped in paper or in any substance not containing 
tobacco, and 
(B)  any roll of tobacco wrapped in any substance containing tobacco which, 
because of its appearance, the type of tobacco used in the filler, or its 
packaging and labeling, is likely to be offered to, or purchased by, consumers 
as a cigarette described in subparagraph (A). 
 
A tobacco product may also meet the definition of a cigarette if it contains 
tobacco, in any form, that is functional in the product, which, because of its 
appearance, the type of tobacco used in the filler, or its packaging and labeling, is 
 
 
11   See Presidents Cancer Panel, Promoting Healthy Lifestyles, p. 64, U.S. Department of Health and Human 
Services, National Institutes of Health, National Cancer Institute, 2007, available at 
http://deainfo.nci.nih.gov/advisory/pcp/annualReports/pcp07rpt/pcp07rpt.pdf. 
12 The definition of cigarette includes roll-your-own tobacco.   See Section 900(3) of the FD&C Act; 21 C.F.R. 
1140.3(a). 
  6    Contains Nonbinding Recommendations 
 
 
likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own- 
tobacco.13  Accordingly, a tobacco product that meets the definition of a cigarette, 
even if it is not labeled as a cigarette or is labeled as a cigar or as some other 
product, may be subject to the regulations.14  In other words, a product is a cigarette 
despite any other names that may be used to describe it, if its appearance, the kind of 
tobacco used in its filler, or the packaging and labeling indicates that it is likely to be 
offered to a consumer or bought by the consumer as a cigarette.  In addition, roll- 
your-own tobacco also meets the definition of cigarette and is thus subject to the 
restrictions in these regulations. 
 
Currently, other tobacco products, such as cigars, little cigars, and pipe tobacco, are 
not subject to these regulations. 
 
  The term cigarette tobacco is defined in section 900(4) of the FD&C Act and in 
 1140.3(b) as any product that consists of loose tobacco that is intended for use by 
consumers in a cigarette.  Unless otherwise stated, the requirements applicable to 
cigarettes under this chapter shall also apply to cigarette tobacco. Under the FD&C 
Act and these regulations, cigarette tobacco is treated the same as cigarettes unless 
specifically stated otherwise.  Thus, cigarette tobacco is subject to the restrictions in 
these regulations. 
 
  The term smokeless tobacco is defined in section 900(18) of the FD&C Act and in 
 1140.3(i) as any tobacco product that consists of cut, ground, powdered, or leaf 
tobacco and that is intended to be placed in the oral or nasal cavity (emphasis 
added). 
 
There are many types of smokeless tobacco. The principal names for the various 
types of smokeless tobacco include:  moist snuff; snus; dry snuff; loose leaf chewing 
tobacco; plug chewing tobacco; and twist chewing tobacco. 
 
Please note that the regulations do not make any distinction between domestic 
cigarettes or smokeless tobacco products and products that are imported into the 
United States.  If you import, distribute, or offer imported cigarettes or smokeless 
tobacco products for sale in the United States, you and your products must comply 
with these regulations. 
 
2.  Who Is Subject to Regulation Under Part 1140? 
 
The regulations apply to (1) manufacturers, (2) distributors, and (3) retailers. 
 
 
 
 
 
 
13 Section 900(3) of the FD&C Act and 21 CFR 1140.3(a). See also guidance to industry and FDA staff entitled 
General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors (Edition 2), 
FDA/CTP, (Dec. 23, 2009) (guidance on General Q&As on Flavored Tobacco), at Question 6, available at 
http://www.fda.gov/downloads/TobaccoProducts/ProtectingKidsfromTobacco/FlavoredTobacco/UCM195420.pdf. 
14 See guidance on General Q&As on Flavored Tobacco, at Question 5. 
  7    Contains Nonbinding Recommendations 
 
 
 
  The term manufacturer includes any person, including any repacker and/or 
relabeler, who manufactures, fabricates, assembles, processes, or labels a finished 
cigarette or smokeless tobacco product.15 
 
For example, if you make cigarettes, you are a manufacturer under these regulations. 
Similarly, if you take finished cigarettes from Company A, remove the cigarettes 
from Company As cartons, and place them in packages with your companys name 
(or any other name) on the package, you are a manufacturer because you repacked 
and relabeled the cigarettes, even though you did not make the finished cigarettes 
themselves. 
 
  The term distributor includes any person who furthers the distribution of cigarettes 
or smokeless tobacco, whether domestic or imported, at any point from the original 
point of manufacture to the person who sells or distributes the product to individuals 
for personal consumption, but excludes common carriers (emphasis added).16 
 
Most distributors who are subject to regulation under part 1140 will be persons who 
run warehousing operations and distribute cigarettes or smokeless tobacco products to 
retailers. 
 
If you own a trucking firm and are contracted to transport cigarettes from a 
warehouse to a retailer, you are likely a common carrier17 and are not subject to 
these regulations even though you technically further the distribution of the tobacco 
product to the retailer. 
 
A distributor also includes any person who is the owner or consignee at the time of 
entry for cigarettes or smokeless tobacco that are imported into the United States. 
Persons who purchase bulk shipments of cigarettes and/or smokeless tobacco from 
foreign countries and sell to manufacturers, distributors, or retailers are considered 
distributors because they are furthering the distribution of cigarettes and smokeless 
tobacco, and are also subject to the regulations under part 1140. 
 
  The term retailer includes any person who sells cigarettes or smokeless tobacco to 
individuals for personal consumption, or who operates a facility where vending 
machines or self-service displays are permitted under [these regulations].18  This 
definition applies regardless of the number of products sold or the price at which they 
are sold. 
 
For example, even if Store A generates most of its sales from selling food products, 
and cigarettes sales represent only a fraction of total sales, the store is a retailer 
 
 
15  1140.3(d). 
16  1140.3(c). 
17 A common carrier means any person (other than a local messenger service or the United States Postal 
Service) that holds itself out to the general public as a provider for hire of the transportation by water, land, or air of 
merchandise (regardless of whether the person actually operates the vessel, vehicle, or aircraft by which the 
transportation is provided) between a port or place and a port or place in the United States (15 U.S.C. 375(3)). 
18  1140.3(h). 
  8    Contains Nonbinding Recommendations 
 
 
subject to regulation under part 1140. The store will be a retailer regardless of 
whether it sells above cost, at cost, or below cost. 
 
Retailers also include persons who operate facilities where vending machines or self- 
service displays (or merchandisers) of cigarettes and/or smokeless tobacco are 
located, even if they technically do not own the vending machines or self-service 
displays themselves.  The reason why persons who operate facilities where vending 
machines or self-service displays are located are considered retailers is described in 
more detail in the discussion for  1140.16 below. 
 
Note that the definitions of distributor, manufacturer, and retailer are not mutually 
exclusive.  In other words, you can be a manufacturer, distributor, and retailer if you 
engage in actions that fall within each of the definitions.  For example, if you make 
finished cigarettes and sell them to individuals for personal consumption, you are a 
manufacturer (because you made the cigarettes) and a retailer (because you sold them 
to individuals). 
 
3.  Who Is Not Subject to Regulation Under Part 1140? 
 
Chapter IX of the FD&C Act does not apply to growers of tobacco, tobacco warehouses, 
and tobacco grower cooperatives, unless they are also manufacturers (section 901(c)(2) of 
the FD&C Act (21 U.S.C. 387a(c)(2)).  The term tobacco warehouse includes any person 
who removes foreign material from tobacco leaf through nothing other than a mechanical 
process; humidifies tobacco leaf with nothing other than potable water in the form of 
steam or mist; or de-stems, dries, and packs tobacco leaf for storage and shipment. 
However, the term tobacco warehouse does not include persons that reconstitute tobacco 
leaves; are manufacturers, distributors or retailers of tobacco products; or apply any 
substances to the tobacco leaves other than water in the form of steam or mist (section 
900(21) of the FD&C Act).  Accordingly, growers of tobacco, tobacco warehouses, and 
tobacco grower cooperatives are not subject to the requirements of part 1140, which is 
deemed to have been issued under Chapter IX of the FD&C Act. 
 
4.  What Is Point of Sale? 
 
The term point of sale means any location at which a consumer can purchase or 
otherwise obtain cigarettes or smokeless tobacco for personal consumption.19 In other 
words, point of sale does not have to be fixed in one location or the same location 
(although most points of sale will probably be fixed structures such as stores). For 
example, if you sell cigarettes from a truck, any advertising and marketing materials that 
appear on the truck, or at the location where consumers purchase the product, or that are 
given to consumers at the time of purchase, would be point-of-sale materials. 
 
 
 
 
 
 
 
 
19  1140.3(g). 
  9    Contains Nonbinding Recommendations 
 
 
VI.  PART 1140, SUBPART B  PROHIBITION OF SALE AND 
DISTRIBUTION TO PERSONS YOUNGER THAN 18 YEARS OF 
AGE 
 
Subpart B, access restrictions, contains four sections: 
   1140.10, which explains general responsibilities of manufacturers, distributors, and 
retailers; 
   1140.12, which explains additional responsibilities of manufacturers; 
   1140.14, which explains additional responsibilities of retailers; and 
   1140.16, which explains conditions of manufacture, sale and distribution. 
 
The sections in subpart B detail how you can distribute or sell cigarettes or smokeless tobacco 
and the locations at and the manner in which these products can be sold. 
 
A.  Section 1140.10  General Responsibilities of Manufacturers, Distributors, and 
Retailers 
 
The regulations in  1140.10 state that each manufacturer, distributor, and retailer is responsible 
for ensuring that the cigarettes or smokeless tobacco products it manufactures, distributes, labels, 
packages, advertises, sells, or otherwise holds for sale comply with all applicable regulatory 
requirements.  Retailers, manufacturers, and distributors who are responsible for an item that 
violates the regulations should remove the violative item or product. 
 
This section is intended to remind parties that they must meet their regulatory obligations under 
part 1140.  You should ensure that you and your cigarettes and smokeless tobacco products are 
in compliance with those regulatory requirements that apply to you and your products.  Note that 
you also may be subject to regulatory action if you assist another person in violating these 
regulations. 
 
In situations where you know that another person is violating the regulations, FDA recommends 
that you notify the party responsible for the violation.  In addition, you may consider: 
 
  permanently discontinuing sales, incentives, or supplies to the party violating the 
regulations; 
 
  temporarily suspending sales, incentives, or supplies to the party violating the 
regulations; or 
 
  establishing contractual provisions that require compliance with applicable regulatory 
requirements. 
 
Some commonly asked questions and answers relating to this section include: 
 
1.   Am I responsible as a manufacturer if I know that a retailer is selling opened 
packages? 
  10    Contains Nonbinding Recommendations 
 
 
Yes.  If you are a manufacturer and you supply cigarettes to a retailer whom you know 
opens cigarette packages and sells individual cigarettes, you may be subject to regulatory 
action for assisting in that violation if you continue to supply cigarettes to that retailer. 
This is a violation under  1140.16(b). 
 
2.   Is a retailer in violation of the regulations if it distributes free samples of smokeless 
tobacco in his establishment at the request of a manufacturer or distributor? 
 
Yes.  If you are a retailer and you do not meet the definition of a qualified adult-only 
facility,20 you may be subject to regulatory action for violating the prohibition on the 
distribution of free samples of smokeless tobacco in anything other than a qualified adult- 
only facility, even though the manufacturer or distributor asked you to distribute those 
samples.  This is a violation of  1140.16(d)(1). 
 
B  Section 1140.12  Additional Responsibilities of Manufacturers 
 
The regulation in  1140.12 imposes an additional responsibility on manufacturers.  Under this 
provision, a manufacturer must remove, from each point of sale (including retail locations), all: 
 
  self-service displays (also known as merchandisers); 
  advertising; 
  labeling; and 
  other items 
that the manufacturer owns and that do not comply with the requirements in part 1140. 
With respect to self-service displays, this means that a manufacturer must remove any self- 
service display that it owns from each retail location unless the self-service display is located in a 
facility where no person under age 18 is present, or permitted to enter, at any time.  See section 
VI.G of this guidance for a more detailed discussion of the exception in 1140.16(c). 
 
Some commonly asked questions and answers relating to this section include: 
 
1.   What is the manufacturers responsibility concerning point-of-sale displays, 
advertising, and labeling? 
 
Under  1140.12, manufacturers must remove from each point of sale all self-service 
displays, advertising, labeling, and other items that the manufacturer owns that do not 
comply with the regulations. 
 
2.   What can the manufacturer who owns a self-service display at a retail facility do to 
comply with the removal requirement? 
 
The manufacturers options include, among others: 
 
 
 
20 See section VI.H of this guidance for the definition of qualified adult-only facility and for additional 
information. 
  11    Contains Nonbinding Recommendations 
 
 
 
  physically removing the noncompliant display from the premises; or 
 
  altering the display so that it does not violate the regulations.  For example, the 
manufacturer could move the display (with the retailers permission) so that a 
person cannot access a product without a retailers help21. 
 
 
3.   What must a manufacturer who has advertising and labeling at a retail facility or 
location do to comply with the removal requirement? 
 
The manufacturer must remove any advertising, labeling, or other items that fail to 
comply with the requirements in Subpart D  Labeling and Advertising.22 
 
For example: 
 
  the manufacturer cannot market, license, sell, or distribute, or cause to market, 
license, sell, or distribute, nontobacco items (e.g., tee shirts and hats) or services 
which bear the brand name, logo, symbol, motto, selling message, recognizable 
color or pattern of colors, or any other mark of product identification that is 
similar or identical to that used for any brand of cigarettes or smokeless tobacco 
( 1140.34(a)). 
 
 
4.   Who determines whether a manufacturer-owned item is not in compliance with the 
regulations? 
 
The initial determination as to whether a manufacturer-owned item complies with the 
regulations should be made by the manufacturer itself.  In most cases, this determination 
should be easy to make.  A manufacturer is responsible for the removal of all violative 
self-service displays, advertising, labeling, and other items that it owns from each point 
of sale.  In addition, FDA will be conducting compliance check inspections and may 
notify you of a violation. 
 
5.   Does a manufacturer have to remove items that other manufacturers own? 
 
Under  1140.12, a manufacturer is responsible for the items that it owns, not items 
owned by other manufacturers.  If you think that an item owned by another company 
violates the law or regulations, you may contact FDA about the potential violation as 
described in section IX of this guidance.  If FDA determines that the item is violative, the 
Agency can take appropriate action with respect to the manufacturer that owns the item. 
 
6.   What if I, as the manufacturer, fail to remove a violative item that I own? 
 
 
 
 
 
21See section VI.G of this document, Section 1140.16(c)  Vending Machines, Self-Service Displays, Mail Order 
Sales, and Other Impersonal Modes of Sale 
22 As noted in section II of this guidance, the United States Court of Appeals for the Sixth Circuit issued an Opinion 
and Judgment that, among other things, found 1140.32(a) and 1140.34(b) to be unconstitutional under the First 
Amendment (see Discount Tobacco. v. United States.) Therefore, FDA will not seek to enforce these provisions. 
  12    Contains Nonbinding Recommendations 
 
 
If you fail to remove a violative item that you own, FDA may find your cigarettes and 
smokeless tobacco products to be misbranded.  Among other things, the FD&C Act 
specifically prohibits misbranding a tobacco product after shipment in interstate 
commerce as well as the introduction of a misbranded product into interstate commerce. 
This means that FDA may take regulatory and enforcement actions against you, 
including: 
 
  seeking civil money penalties; 
  seizing your product; 
  seeking an injunction against you; or 
  criminal prosecution. 
 
C.  Section 1140.14  Additional Responsibilities of Retailers 
 
If you are a retailer,  1140.14 specifies additional obligations, including: 
 
  not selling cigarettes or smokeless tobacco to anyone younger than 18 years of age; 
 
  verifying that any person buying cigarettes or smokeless tobacco is at least 18 years old 
or older by means of photographic identification containing the bearers date of birth for 
all individuals under the age of 27; 
 
  selling cigarettes or smokeless tobacco only in a direct, face-to-face exchange between 
you and your customer, without the help of any electronic or mechanical device,23 except 
in limited circumstances.  See discussion regarding  1140.16(c) in section VI.G of this 
guidance for a more detailed discussion of this exception; 
 
  not breaking open any cigarette or smokeless tobacco package to sell or distribute 
individual cigarettes or any number less than 20 or any quantity of smokeless tobacco 
that is smaller than the smallest package distributed by the manufacturer for individual 
consumer use; and 
 
  removing any violative self-service displays, advertising, labeling, and other items that 
are in the retail facility. 
 
Some commonly asked questions and answers relating to this section include: 
 
1.   What is the legal age for purchasing cigarettes or smokeless tobacco? 
 
The regulations prohibit the sale of cigarettes and smokeless tobacco to anyone younger 
than 18 years of age.  However, these federal regulations do not affect state or local laws 
relating to access to tobacco products that are in addition to, or more stringent than, the 
federal access provisions.  Therefore, a state could establish 19 years of age or older as 
the minimum age for purchasing tobacco products in that state.  Some states and 
localities do, in fact, have more stringent age requirements. 
 
 
 
23 For example, vending machines that dispense cigarettes or smokeless tobacco products with the purchase of a 
token or that can be disabled by remote control do not meet the requirement for a direct, face-to-face exchange. 
These measures do not sufficiently guard against childrens access to tobacco products (61 FR 44396 at 44451, 
comment 69). 
  13    Contains Nonbinding Recommendations 
 
 
2.   Does the retailer have to be 18 years old to sell the products? 
 
The FDA regulations do not directly address the age of the sales clerk.  However, to 
qualify as a facility where individuals under 18 years of age are neither present, nor 
permitted to enter at any time for purposes of having vending machines or self-service 
displays, all clerks in the facility would need to be 18 years of age or older.  Additionally, 
some state or local laws may set a minimum age for clerks selling tobacco products.  We 
suggest you contact the appropriate authorities in your state to determine if there is such 
an age requirement for sales clerks. 
 
 
 
 
3.   Can a retailer sell to a child whose parents (or other adults) have sent him/her into a 
store to purchase these products for the adults use? 
 
No. The regulations prohibit retailers from selling cigarettes or smokeless tobacco to 
anyone younger than 18 years of age, even if that child has a note from a parent or other 
adult. 
 
4.   Are persons younger than 18 years of age who attempt to buy these products subject to 
action for violating this law? 
 
FDAs regulations apply only to manufacturers, distributors, and retailers.  However, 
some states and localities impose penalties on underage children for purchasing, 
possessing, or using tobacco products. 
 
5.   Can a retailer accept an out-of-state drivers license if it has the customers 
photograph and date of birth? 
 
Yes.  This would be a photographic identification containing the owners date of birth. 
 
6.   Is the retailer responsible for preventing parents and other adults from purchasing 
these products for minors? 
 
No.  The regulations require only that the retailer verify the age of the purchaser. 
 
7.   Why did FDA decide that retailers must require all customers who are under the age of 
27 to present a photographic identification? 
 
Research has shown that it is very difficult for retailers to accurately determine the age of 
a customer and that older youth (those who are 16 or 17 years old) are more successful in 
purchasing tobacco products in retail establishments than are younger youth. Therefore, 
in order to ensure that older-looking teenagers are asked for identification, FDA 
concluded that it is important for retailers to request and examine photo IDs from anyone 
who is under the age of 27. 
  14    Contains Nonbinding Recommendations 
 
 
This recommendation was reiterated in a report issued by a Working Group of State 
Attorneys General,24 who studied the problem of illegal tobacco sales to minors and 
concluded that, in order to prevent illegal sales of tobacco products to youth, photo IDs 
must be requested for persons who are significantly older than the minimum legal age to 
purchase these products. To address this issue, retailer training programs developed by 
states, retailer groups, and the tobacco industry typically train retailers to request a photo 
ID from any customer seeking to purchase tobacco who appears to be under the age of 
27.25 
 
8.   What are some examples of FDA-recommended age verifying techniques? 
 
The regulations require retailers to verify a customers age by checking a photo ID that 
shows the persons date of birth.  The regulations do not specify the type of photo ID that 
is acceptable for verifying a persons age, but the most reliable forms of identification are 
issued by national governments, if they contain the bearers date of birth and a 
photograph (such as federal employee or military identification cards, passports), state 
governments (such as drivers licenses), and local governments (such as employee 
identification cards that contain the bearers date of birth and a photograph).  Some 
private companies also publish guides containing photographs and descriptions of valid 
licenses; these guides may be helpful in distinguishing valid or genuine identification 
cards from fraudulent ones. 
 
The regulations specify that you should check proof of age for anyone under the age of 
27, but determining someones age by looking at his or her physical appearance alone can 
be difficult.  Some people look younger than they really are, while others look older than 
they are.  You should use your best judgment in order to protect yourself and your 
customers  particularly your underage customers.  For example, if you are not sure 
whether someone is older than 18 years of age, and you cannot tell whether he or she is 
27 years old, you should ask for a photo ID anyway; this will let you determine whether 
he or she is legally entitled to purchase cigarettes and smokeless tobacco and take the 
guesswork out of the transaction. 
 
Although the regulations do not specify at what point you should verify a consumers 
age, FDA suggests that you ask your customers for photo IDs before you give them 
cigarettes or smokeless tobacco.  This will enable you to hold onto the product if, after 
seeing the customers identification, you discover that the person is too young to 
purchase the product or you think that the identification card is a fake. 
 
Below are a few examples of age verifying techniques that retailers may choose to 
implement to assist employees in verifying a purchasers age: 
 
  Requiring employees to compare the date of birth on the photographic 
identification with a calendar that displays the most recent date that can be shown 
 
 
24 Working Group of State Attorneys General. No Sale: Youth, Tobacco and Responsible Retailing. Developing 
Responsible Retail Sales Practices and Legislation to Reduce Illegal Tobacco Sales to Minors. Findings and 
Recommendations. Baltimore, MD: State of Maryland, Office of the Attorney General, 1994. 
25 Id. 
  15    Contains Nonbinding Recommendations 
 
 
on the photographic identification in order for that person to purchase cigarettes 
and smokeless tobacco; 
  Installing price scanners that are programmed so that when a tobacco product is 
scanned, the register displays a message prompting the employee either to request 
age identification and key in the purchasers date of birth or to verify that the 
purchaser is over 18 years old; and 
  Requiring employees to scan all photographic identifications through an 
electronic age verification device. 
 
 
 
9.   What should a retailer or his employee do when he or she suspects a customers 
identification is fake, altered, or insufficient? 
 
If a retailer or his employee suspects that an ID is unreliable, he or she should refuse the 
sale. Selling to an underage customer violates the regulations.  Fake ID cards may be 
difficult to detect, but many fake cards are obvious due to their poor quality. There are 
also some companies that sell manuals showing pictures of current, valid drivers licenses 
for each state. These manuals may help the retailer to determine whether or not an ID 
card is valid. 
 
10. If a wholesale operation delivers to a store or gas station and the only employee present 
at the time of delivery is someone younger than 18 years of age, can the delivery be 
made under federal law? 
 
Yes.  In that situation, the wholesaler is selling to a retailer, not a customer.  However, 
state or local laws may prohibit the delivery of tobacco products to persons younger than 
a certain age. We suggest you contact the appropriate authorities in your state to 
determine if there is such an age requirement for sales clerks. 
 
11. May retailers use internal compliance check or mystery shopper programs to test 
compliance with part 1140? 
 
 
Yes.  Retailers are encouraged to implement an internal check program, also known as a 
mystery shopper program.  In this type of program, retailers use either a person of legal 
age who is younger than 27 years old (to test whether clerks are requesting photographic 
identification) or a person who is under the legal age (to test whether clerks are both 
requesting photographic identification and refusing to make a sale to underage youth) to 
buy cigarettes or smokeless tobacco.  FDA does not intend to bring enforcement action 
under 1140.14(a) or (b) for purchases made under these programs.  Please also refer to 
the guidance for industry on Tobacco Retailer Training Programs for additional 
information. 
 
 
 
12. How do the regulations affect retailers who sell only tobacco products? 
  16    Contains Nonbinding Recommendations 
 
 
The regulations apply equally to retailers that sell only tobacco products and those that 
sell tobacco products in addition to other things. 
 
13. Can I sell single cigarettes? 
 
No, in most cases.26  In accordance with  1140.14(d) and 1140.16(b), you may not sell 
individual cigarettes (often called singles or loosies) or any package with less than 20 
cigarettes, or any quantity of cigarette tobacco or smokeless tobacco that is smaller than 
the smallest package distributed by the manufacturer for individual consumer use.  FDA 
reviewed several reports indicating that stores in various parts of the United States were 
willing to sell single cigarettes to children.  Single cigarettes, or quantities of cigarette 
tobacco or smokeless tobacco smaller than the smallest package distributed by the 
manufacturer for individual consumer use, are generally cheaper than a full sized pack of 
cigarettes, or a package of cigarette tobacco or smokeless tobacco for individual 
consumer use, and, as a result, may entice children and adolescents to try using these 
products.  Section 1140.14 does not apply to shipping cartons as discussed below. 
 
As described below, there is a very limited exception to this requirement, and it applies 
only to packaged, single cigarettes that are sold in vending machines in facilities27 where 
no person younger than 18 years of age is present, or permitted to enter, at any time. 
 
14. Can I break apart shipping cartons? 
 
Yes.  You can open a shipping container in order to sell individual cartons or packages 
and, in the case of cigarette cartons, open cigarette cartons to sell individual packages. 
However, under  1140.14(d), you cannot: 
 
  break open a cigarette package or carton to sell individual cigarettes or any 
number less than 20 cigarettes, or 
 
  break open a package of cigarette tobacco or smokeless tobacco to sell a portion 
of that product that is smaller than the smallest package distributed by the 
manufacturer for individual consumer use. 
 
15. What is the retailers responsibility concerning point-of-sale displays, advertising, 
labeling, and other items? 
 
Under  1140.14(e), each retailer must ensure that all self-service displays, advertising, 
labeling, and other items located in its establishment that do not comply with the 
regulations are removed or are brought into compliance. 
 
Note that the regulations also require manufacturers to remove items that they own if 
those items violate the regulations. 
 
 
 
26 See  1140.16(c)(2)(ii) concerning the limited exception to sell packaged, individual cigarettes in vending 
machines located in facilities where no person younger than 18 years of age is present, or permitted to enter, at any 
time. 
27 See  1140.16(c) clarifying facilities in which vending machines and self-services displays are permitted. 
  17    Contains Nonbinding Recommendations 
 
 
16. Who determines if a violative item is owned by the manufacturer when there is a 
question as to who owns the violative self-service display, advertising, labeling, or other 
item? 
 
It may not be easy to determine who is responsible for the self-service display, 
advertising, labeling, or other item. For example, the manufacturer and retailer may 
disagree as to who owns the self-service display.  However, the regulations require 
retailers to ensure that all self-service displays, advertising, labeling, and other items in 
their establishments that do not comply with the regulations are removed or brought into 
compliance with these regulations ( 1140.14(e)).  Thus, when there is a question to 
whether the retailer or manufacturer is the owner of a violative item at a point of sale, 
under the regulations, the retailer has the responsibility to ensure that all self-service 
displays, advertising, labeling and other items in its establishment comply or are brought 
into compliance.  This is the retailers responsibility whether or not the manufacturer also 
has some responsibility for the item. 
 
17. Am I responsible for the actions of my employees? 
 
Yes.  Employers are responsible for their employees actions.28  This is true even if the 
employer does not know about the employees actions or the employee fails to take 
corrective action as requested by his or her employer.  As an employer, you are generally 
responsible for the actions of your business, whether it is in the manufacturing, distributing 
or retail sector.  This includes being responsible for the acts of people who work for you. 
 
For this reason, even though the regulations do not require you to train or educate your 
employees about their responsibilities, FDA recommends that you develop educational or 
training materials to require your employees to check proof of age, to know that the 
regulations prohibit sales to anyone younger than 18 years of age, to teach them how to 
check proof of age of anyone under 27, and to inform them of the other requirements in the 
regulations.  In addition, if you are found to be in violation of the regulations, your civil 
money penalties may be reduced if you have an approved training program for your 
employees.  If your state or local government has additional requirements, you may add them 
to your training program as well. 
 
D.  Section 1140.16  Conditions of Manufacture, Sale, and Distribution 
 
Section 1140.16 includes several different regulatory requirements.  Some apply only to 
manufacturers (such as the restriction on product names), some apply only to retailers (such as 
the restriction on impersonal modes of sale), and others apply to manufacturers, distributors, 
and retailers (such as the requirement for maintaining a minimum package size for cigarettes). 
 
 
 
28 See, e.g., U.S. v. Dotterweich, 320 U.S. 277 (1943) (holding that a corporate official is liable for his companys 
violations of the FD&C Act, even in the absence of wrongful action on his part); U.S. v. Park, 421 U.S. 658 (1975) 
(reiterating holding of Dotterweich).  See also Pettit v. Retrieval Master Creditors Bureau, Inc., 211 F.3d 1057 (7th 
Cir. 2000) (debt collection company is responsible for its employees violations of the Fair Debt Collection Practices 
Act); U.S. EEOC v. AIC Sec. Investigations, 55 F.3d 1276 (1995) (employer is liable for employees violations of 
law). 
  18    Contains Nonbinding Recommendations 
 
 
 
 
E.  Section 1140.16(a)  Restriction on Product Names 
 
Under  1140.16(a), manufacturers may not use a trade or brand name of a nontobacco product 
as the trade or brand name for a cigarette or smokeless tobacco product unless the trade or brand 
name was on both a tobacco product and a nontobacco product that were sold in the United 
States on January 1, 1995. 
 
On May 7, 2010, after FDA became aware of concerns regarding this provision, FDA announced 
the availability of the guidance entitled Enforcement Policy Concerning Certain Regulations 
Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco.  The guidance 
discusses FDAs enforcement discretion policy concerning  1140.16(a). Specifically, the 
guidance provides that FDA, while considering what changes to the regulation, if any, would be 
appropriate, intends to exercise its enforcement discretion concerning  1140.16(a) not to begin 
enforcement actions under this provision in cases where: 
 
1.  The trade or brand name of the cigarettes or smokeless tobacco product was registered, 
or the product was marketed, in the United States on or before June 22, 2009; or 
 
2.  The first marketing or registration in the United States of the tobacco product occurs 
before the first marketing or registration in the United States of the nontobacco product 
bearing the same name; provided, however, that the tobacco and nontobacco product 
are not owned, manufactured, or distributed by the same, related, or affiliated entities 
(including as a licensee).29 
 
On November 17, 2011, FDA published a proposal to amend  1140.16(a).30  In that proposal, 
FDA noted that it was aware of concerns raised by the current rule, including its 
constitutionality, and that, after considering those concerns, it was proposing to narrow the scope 
of the rule.  As of the date of this guidance, the proposal is pending and FDAs enforcement 
discretion policy in its 2010 guidance is still in effect. 
 
F.  Section 1140.16(b)  Minimum Cigarette Package Size 
 
If you are a cigarette manufacturer, distributor, or retailer, the regulations state that the minimum 
cigarette package size must contain 20 cigarettes.  Most cigarette packages sold in the United 
States contain 20 cigarettes.  If you distribute or sell cigarette packages that contain less than 20 
cigarettes, you will be in violation of these regulations and subject to regulatory action. 
 
This provision exists because studies and reports indicate that small cigarette packages, which 
can contain anywhere from 8 to 18 cigarettes and are commonly called kiddie packs, are very 
popular with children and adolescents, partly because they are easier to conceal and are less 
expensive than full-size packages. (Cigarette prices are a critically important tool in reducing 
adolescent smoking beyond experimentation.)31  As a result, FDA specifies a minimum cigarette 
 
 
29 75 FR 25282 (May 7, 2010). 
30 76 FR 71281 (November 17, 2011). 
31 See Emery, Sherry, et al., Does cigarette price influence adolescent experimentation? Journal of Health 
Economics, vol. 20, pp. 261-270, 2001. 
  19    Contains Nonbinding Recommendations 
 
 
package size of 20 cigarettes to keep kiddie packs out of the hands of persons younger than 18 
years of age. 
 
Some commonly asked questions relating to this section include: 
 
1.   Do I have to inspect each package to make sure it contains 20 cigarettes? 
 
If you are a distributor or retailer, FDA does not expect you to open each cigarette 
package to check whether it contains 20 cigarettes.  You can rely on the manufacturers 
claim or labeling that the package contains 20 cigarettes. 
 
If you are a manufacturer and your cigarette packages fail to contain at least 20 cigarettes 
in each package, FDA may find your cigarettes to be misbranded and take regulatory 
action against you. 
 
2.   Is there a minimum package size for smokeless tobacco or cigarette tobacco? 
 
The regulations do not contain a minimum package size for smokeless tobacco or 
cigarette tobacco.  However, retailers may not break or otherwise open a cigarette or 
smokeless tobacco package to sell any quantity of smokeless tobacco or cigarette tobacco 
that is smaller than the smallest package distributed by the manufacturer for individual 
consumer use ( 1140.14(d)).  For example, retailers may not open the original 
manufacturers package of smokeless tobacco and cigarette tobacco and sell a portion of 
it to consumers in smaller cups, bags, or other containers. 
 
3.   Is there any exception to the minimum cigarette package size? 
 
There is a very limited exception for packaged, single cigarettes sold in vending 
machines that are located in facilities where no one younger than 18 years of age is 
present, or permitted to enter, at any time (1140.16(c)(2)(ii)). 
 
G.  Section 1140.16(c)  Vending Machines, Self-Service Displays, Mail Order Sales, 
and Other Impersonal Modes of Sale 
 
If you are a retailer, the regulations require you to sell cigarettes or smokeless tobacco to your 
customers only in a direct, face-to-face exchange, subject only to limited exceptions, as 
described below.  This section reinforces this requirement by prohibiting retailers from engaging 
in impersonal modes of sale. 
 
The two limited exceptions are: 
 
  Mail order sales are acceptable under these regulations,32 except that mail-order 
redemption of coupons and distribution of free samples through the mail are not 
permitted.33 
 
 
32 See the preamble to Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to 
Protect Children and Adolescents, 61 FR 44396 at 44435, 44438, 44458-44459 (August 28, 1996), which discusses 
FDAs reasoning behind not prohibiting mail order sales. 
  20    Contains Nonbinding Recommendations 
 
 
 
  Vending machines and self-service displays are permitted in facilities where no one 
younger than 18 years of age is present, or permitted to enter, at any time.  The purpose 
of this exception is to allow retailers to use vending machines and self-service displays as 
long as they ensure that no person younger than 18 years of age is present in their facility 
or permitted to enter at any time. 
 
Some commonly asked questions relating to this section include: 
 
1.   What does FDA mean by a direct, face-to-face exchange? 
 
Retailers are required to physically hand the product to the consumer.  This means that, if 
you are a retailer, you and your employees must: 
 
  see the customer directly, without the use of electronic aids (such as a television 
screen) or mechanical devices (such as an intercom), and, if necessary, verify that 
he or she is at least 18 years old; 
 
  obtain the product for the customer; and 
 
  hand the product to the customer. 
 
This requirement also helps retailers to verify the customers age and to prevent children 
from shoplifting these products. Shoplifting is another means of cigarettes and smokeless 
tobacco products getting into the hands of children. 
 
2.   What is a self-service display under the regulations? 
 
A self-service display is any item that permits a consumer to access and remove 
cigarettes or smokeless tobacco products without a direct, face-to-face exchange between 
the retailer and the customer.  Self-service displays, which also may be referred to as 
merchandisers, come in many different shapes and sizes, ranging from free-standing, 
multishelf kiosks to small display stands that are placed next to a cash register. 
Regardless of the type or size, a self-service display is not a permissible method of selling 
cigarettes or smokeless tobacco in any facility (e.g., pharmacy, convenience store, 
grocery store, gas station, restaurant) where anyone younger than 18 years of age is 
present, or permitted to enter, at any time. So, if anyone younger than 18 years of age is 
present in, or is permitted to enter, your retail facility at any time, you cannot use self- 
service displays and vending machines to sell cigarettes or smokeless tobacco products. 
 
To qualify as a facility where individuals under 18 years of age are neither present nor 
permitted to enter at any time for purposes of having vending machines or self-service 
displays, all employees in the facility would need to be 18 years of age or older. 
 
 
 
33 The regulations permit mail-order sales of cigarettes and smokeless tobacco ( 1140.16(c)(2)(ii)).  The Prevent 
All Cigarette Trafficking Act (PACT Act) (P.L. 111-154) was enacted on March 30, 2010, to amend the Jenkins Act 
and Title 18 to revise provisions governing the collection of taxes on, and trafficking in, cigarettes, including roll- 
your-own cigarettes, and smokeless tobacco.  Among other requirements, the PACT Act requires the U.S. Postal 
Service (USPS), subject to certain narrowly defined exceptions, to refuse to accept for delivery or transmit through 
the mails any package that it knows or has reasonable cause to believe contains any cigarettes or smokeless tobacco. 
  21    Contains Nonbinding Recommendations 
 
 
3.   Can I keep vending machines (including vending machines that sell packaged, single 
cigarettes) or self-service displays in my retail facility that allows anyone younger than 
18 years of age to be present or permitted to enter if I supervise or lock the machine or 
display? 
 
No.  The regulation prohibits all impersonal modes of sale for cigarettes and smokeless 
tobacco products with limited exceptions.  Simply supervising a self-service display or 
vending machine, or using electronic locks, tokens, remote operating mechanisms, or 
taking other actions that continue to give customers an opportunity to access and remove 
cigarettes or smokeless tobacco products without a direct, face-to-face exchange between 
the retailer and the customer is not permitted because these would be considered 
impersonal modes of sale.  These means of limiting access of self-service displays and 
vending machines are often ineffective when it comes to preventing children and 
adolescents from accessing cigarettes or smokeless tobacco. 34 
 
If you are a retailer, the regulations require you to hand the product to the customer in a 
direct, face-to-face exchange with limited exceptions.  For example, if your retail store 
allows anyone younger than 18 years of age to be present, or permitted to enter, at any 
time and you would like to use a display that holds cigarette packages, you cannot keep 
that display on the counter or anywhere else accessible to customers if the customer can 
take the cigarettes without a direct, face-to-face exchange between you and the customer. 
It does not matter whether you can see the customer choose the cigarettes or whether the 
customer has to ask permission to buy the cigarettes.  If you would like to keep the 
display, you can move it behind the counter to an area where customers are not permitted 
to enter, thus maintaining a direct, face-to-face exchange between the retailer and the 
customer and eliminating the self-service aspect of the display.  Alternatively, you can 
restrict access to your facility and ensure that no person younger than 18 years of age is 
present or permitted to enter at any time, as described in the question below. 
 
4.   What types of facilities may qualify to use vending machines (including vending 
machines that sell packaged, single cigarettes) and self-service displays within the 
meaning of  1140.16(c)(2)(ii)? 
 
To be considered a facility that can use vending machines and self-service displays to sell 
cigarettes and/or smokeless tobacco without a face-to-face exchange, no person under the 
age of 18 may be present, or permitted to enter, at any time (emphasis added).  However, 
there may be situations where an area may be treated as including two separate facilities, 
where one has access restrictions at all times, while the other allows individuals younger 
than 18 years of age to be present, or permitted to enter, at least some times.  In the 
examples below, vending machines or self-service displays may be in the area that 
restricts access at all times, but may not be in the area that allows individuals younger 
than 18 years of age to be present, or permitted to enter, at least some times. 
  You own a factory that has 10 buildings on the factory grounds, but you want to 
put a cigarette vending machine in one building.  You would only be expected to 
 
 
 
 
34 See 61 FR 44396 at 44450, comment 68, and 44451, comment 69. 
  22    Contains Nonbinding Recommendations 
 
 
keep people younger than 18 years of age from being present, or permitted to 
enter at any time, in the building that contains the vending machine. 
 
  You rent a store on the ground floor of a public building and the main entrance of 
the building is separate from the entrance to your store.  You would only be 
expected to keep people younger than 18 years of age from being present, or 
permitted to enter at any time, in your store in order to qualify for the exception. 
You would not be responsible for ensuring that people younger than 18 are 
prevented from entering the rest of the building. 
 
  A restaurant that allows people of all ages to be present, or permitted to enter, is 
on one floor of a casino.  On a separate floor with access restrictions, there is a 
vending machine.  In order for this to be permitted, means should be in place 
between the floors, for example someone checking identifications, to ensure that 
no one younger than 18 years of age is present, or permitted to enter, at any time. 
 
  A private club has a hall that is rented to the general public of all ages and a 
separate members-only area that prohibits anyone younger than 18 years of age to 
be present, or permitted to enter, at any time with a vending machine.  In order for 
this to be permitted, means should be in place to restrict access to the members- 
only area.  For example, the door to the members-only area should be locked and 
only adult members, whose age and identification are verified before being 
permitted to enter, have a key.  Minors, including family members, would not be 
allowed to be present, or permitted to enter, in the members-only area at any time. 
 
  An area of a retail store is physically separated from the rest of the store by a door 
or gate.  The retailer may have a self-service display or vending machine in the 
area of the store that is physically separated from the rest of the store if it has 
measures in place that ensure that no one younger than 18 years of age is allowed 
to be present, or permitted to enter, in the restricted area at any time. 
 
 
 
In contrast, an example of noncompliance with  1140.16(c): 
 
  A restaurant with a bar that does not implement restrictions to ensure that no one 
under 18 years of age is present, or permitted to enter, the bar area at any time.  A 
vending machine in any part of the restaurant, including the bar, would be a 
violation of this section. Having a bartender watch the vending machine would be 
insufficient without additional measures to restrict access to all minors at all 
times. 
 
5.   What measures can be implemented to ensure that no person younger than 18 years of 
age is present, or permitted to enter, at any time? 
 
The regulations do not specify how you should prevent people younger than 18 years of 
age from being present in, or permitted to enter, your facility if your facility has vending 
machines or self-service displays for cigarettes and/or smokeless tobacco.  It is up to the 
  23    Contains Nonbinding Recommendations 
 
 
retailer to determine how best to comply with the requirements based on the individual 
retail establishment.  Multiple measures are highly recommended as a single measure 
may not be sufficient to ensure compliance.  Regardless of the measure(s) you use, if you 
want to qualify for the exception, it is important that no one younger than 18 years of age 
is present in, or permitted to enter, the facility at any time. 
 
Examples of measures may include, but are not limited to: 
 
  an employee to check for proof of age at the door at all times  a customer 18 
years of age or older is permitted to enter the facility; however, a customer 
younger than 18 years of age is barred from entering; 
 
  a locked gate or barrier that separates the public area of the store from the adult- 
only area; and 
 
  an establishment with an internal room that implements means to ensure that only 
customers who are 18 years of age or older can enter. 
 
 
6.   Who is responsible for a vending machine in a facility? 
 
FDA recognizes that the person who owns/operates a facility might not be the same 
person who owns a vending machine in the facility.  Nevertheless, as the person who 
owns or operates the facility in which the vending machine is located, you are 
responsible.  You do not have to own the vending machine to be held responsible for 
complying with the requirements. 
 
7.   Can I let people younger than 18 years of age into my facility only on special occasions 
and still legally have a vending machine or self-service display? 
 
Facilities, such as clubs or recreation halls, that are off limits to people younger than 18 
years of age most of the time, but that are occasionally rented for parties or other social 
events where people younger than 18 years of age may be present, or permitted to enter, 
do not qualify for the exception.  Vending machines and self-service displays for 
cigarettes or smokeless tobacco are permitted only in facilities where no one younger 
than 18 years of age can be present in, or be permitted to enter the facility at any time, 
even on special occasions. 
 
8.   Can I qualify for the exemption if I let individuals under 18 years of age into my 
facility only when accompanied by their parents? 
 
No.  If the facility has a vending machine or self-service display for cigarettes or 
smokeless tobacco, no one younger than 18 years of age, including infants and small 
children accompanied by their parents, can be present, or be permitted to enter, in the 
facility at any time.35 
 
 
 
 
35 Please see question 5 above for additional information on measures that a retailer can take to fall within the 
exception. 
  24    Contains Nonbinding Recommendations 
 
 
H.  Section 1140.16(d)  Free Samples 
 
No manufacturer, distributor, or retailer may distribute or cause to be distributed any free 
samples of cigarettes. 
 
A manufacturer, distributor, or retailer may only distribute or cause to be distributed free samples 
of smokeless tobacco in a qualified adult-only facility.  Under the regulations, the term 
qualified adult-only facility means a facility or restricted area that: 
 
1.   requires each person present to provide to a law enforcement officer (whether on or off 
duty) or to a security guard licensed by a governmental entity a government-issued 
identification showing a photograph and a date of birth indicating the holder is at least 18 
years of age (state law may require persons to be older than 18 in some states); 
 
2.   does not sell, serve, or distribute alcohol; 
 
3.   is not located next to or immediately across from (in any direction) a space that is used 
primarily for youth-oriented marketing, promotional, or other activities; 
 
4.   is a temporary structure constructed, designated, and operated as a distinct enclosed area 
for the purpose of distributing free samples of smokeless tobacco adhering to this 
subparagraph; and 
 
5.   is enclosed by a barrier that: 
 
a.   is constructed of, or covered with, an opaque material (except for entrances and 
exits); 
 
b.   extends from no more than 12 inches above the ground or floor (which area at the 
bottom of the barrier must be covered with material that restricts visibility but may 
allow airflow) to at least 8 feet above the ground or floor (or to the ceiling); 
 
c.   prevents persons outside the qualified adult-only facility from seeing into the 
qualified adult-only facility, unless they make unreasonable efforts to do so; and 
 
d.   does not display on its exterior  
 
  any tobacco product advertising; 
 
  a brand name other than in conjunction with words for an area or enclosure to 
identify an adult-only facility; or 
 
  any combination of words that would imply to a reasonable observer that the 
manufacturer, distributor, or retailer has a sponsorship that would violate 
 1140.34(c). 
 
In addition, the free samples of smokeless tobacco that are permitted to be taken out of the 
qualified adult-only facility are limited to one package that contains no more than 0.53 ounces 
(15 grams) of smokeless tobacco per adult consumer per day. 
 
The regulation, however, prohibits manufacturers, distributors, or retailers from distributing or 
causing to be distributed any free samples of smokeless tobacco: 
  to a sports team or entertainment group; or 
  25    Contains Nonbinding Recommendations 
 
 
 
  at any football, basketball, baseball, soccer, or hockey event or any other sporting or 
entertainment event determined by the Secretary to be covered by  1140.16(d)(3). 
 
Some commonly asked questions and answers relating to this section include: 
 
 
1.  Can a manufacturer, distributor, or retailer distribute free samples of smokeless 
tobacco? 
   
Yes.  A manufacturer, distributor, or retailer may distribute free samples of smokeless 
  tobacco products in limited quantities, but only in a qualified adult-only facility. 
   
2.  What are the advertising restrictions for qualified adult-only facilities that distribute 
  free samples of smokeless tobacco? 
   
Under  1140.16(d)(2)(iii)(F), qualified adult-only facilities are not permitted to display 
   on the exterior of the facility  tobacco product advertisements; a tobacco product 
  brand name except for purposes of identifying an area or enclosure as an adult-only 
  facility; or words that imply that the manufacturer, distributor, or retailer has a 
  sponsorship that violates  1140.34(c). 
   
3.  What are the restrictions on distribution of free samples of cigarettes and smokeless 
tobacco products when using rebates or redeeming coupons by mail or from a retail 
    outlet? 
   
Under  1140.16(d)(1), manufacturers, distributors, and retailers may not distribute or 
cause to be distributed any free samples of cigarettes or smokeless tobacco, except as 
    provided under  1140.16(d)(2).  Therefore, rebates or coupons cannot be used as a 
    means to distribute free samples of cigarettes and smokeless tobacco products by mail. 
    In addition, coupons for free samples of cigarettes or smokeless tobacco that do not 
    require purchase cannot be redeemed at a retail outlet. 
   
Note that mail-order redemption of coupons and distribution of free samples of cigarettes 
    or smokeless tobacco through the mail are prohibited under  1140.16(c)(2)(i). 
     
I.  Section 1140.16(e)  Restrictions on Labels, Labeling, and Advertising 
 
No manufacturer, distributor, or retailer may sell or distribute, or cause to be sold or distributed, 
cigarettes or smokeless tobacco with labels, labeling, or advertising that do not comply with 
subpart D of part 1140 and other applicable requirements. 
 
As a manufacturer, distributor, or retailer, you may not sell or distribute, or cause to be sold or 
distributed, cigarettes or smokeless tobacco products that have labels, labeling, or advertising 
that do not comply with these regulations.  Products that do not comply with these regulations 
are considered to be misbranded under the FD&C Act, and selling or distributing misbranded 
products may lead to regulatory action against you.  Also, if you change the manufacturers 
package, label, labeling, or advertising in a way that renders the product misbranded under the 
FD&C Act, this may lead to regulatory action against you. 
  26    Contains Nonbinding Recommendations 
 
 
 
 
If you think that a products label, labeling, or advertising does not comply with the regulations, 
FDA recommends that you not sell or distribute the product, return it to the responsible party, 
ask for products that comply with the regulations, and contact FDA to report the violation. 
 
VII.  PART 1140, SUBPART D  LABELING AND ADVERTISING 
 
Subpart D on labeling and advertising contains three sections: 
   1140.30 Scope of permissible forms of labeling and advertising; 
   1140.32 Format and content requirements for labeling and advertising; and 
   1140.34 Sale and distribution of nontobacco items and services, gifts, and sponsorship 
of events. 
 
A.  Section 1140.30  Scope of Permissible Forms of Labeling and Advertising 
 
Section 1140.30(a)(1) describes the forms of labeling and advertising that are permissible under 
the regulations without prior notice to FDA. A manufacturer, distributor, or retailer can 
disseminate labeling and advertising that bears a cigarette or smokeless tobacco brand name (or 
any other indicia of tobacco product identification) without prior notice in or on the following 
media: 
 
  newspapers; 
  magazines; 
  periodicals or other publications (whether periodic or limited distribution); 
  billboards, posters, and placards; 
  non-point-of-sale promotional material (including direct mail); 
  point-of-sale promotional material; and 
  audio or video formats delivered at a point of sale. 
 
Section 1140.30(a)(2) requires that a manufacturer, distributor, or retailer intending to 
disseminate, or to cause to be disseminated, advertising or labeling for cigarettes or smokeless 
tobacco in a medium that is not listed above notify the Agency 30 days prior to the use of such 
medium.  The notice must describe the medium intended to be used and discuss the extent to 
which the advertising or labeling may be seen by persons younger than 18 years of age.  The 
manufacturer, distributor, or retailer must send this notice to the Office of Compliance and 
Enforcement, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate 
Blvd., Rockville, MD  20850-3229. 
 
In the preamble to the Regulations Restricting the Sale and Distribution of Cigarettes 
and Smokeless Tobacco to Protect Children and Adolescents published in 1996, FDA 
stated that online media are not included within the list of permissible outlets and that 
advertisers should notify the Agency under  1140.30(a)(2) prior to advertising on the 
Internet (61 FR 44396 at 44502).  FDA also stated in the preamble that product 
placements in movies, music videos, and television, if not done at the expense of tobacco 
manufacturers, distributors, or retailers, would not be affected by this rule (61 FR 44396 
at 44501). 
  27    Contains Nonbinding Recommendations 
 
 
 
 
Online and other electronic media are not listed in the permissible forms of advertising without 
prior notice under  1140.30(a)(1). Therefore, CTP expects manufacturers, distributors, or 
retailers engaging in tobacco product advertising through media not listed in  1140.30(a)(1), 
including online media, to notify the Agency 30 days prior to using such media, as required by 
 1140.30(a)(2).  Forms of electronic and online media that require notification under  
1140.30(a)(2) include but are not limited to: 
 
  Internet Web sites 
  Product placements in movies, music videos, and television, if done at the expense of 
tobacco manufacturer, distributor, or retailers 
  Blogs or weblogs (e.g., Blogger, WordPress, Tumblr) 
  Emails sent to consumers 
  Microblogs (e.g., Twitter) 
  Podcasts (e.g., audio sharing) 
  Social networks and online communities (e.g., Facebook, MySpace, LinkedIn, 
Friendster) 
  Video sharing (e.g., YouTube, Blip tv, Vimeo) 
  Widgets or window gadgets 
  Wikis (e.g., Wikipedia) 
  Applications for smart phones and tablet computers (e.g., iPhones, Androids, iPads) 
  Text messaging 
  Instant messaging 
  Pop up or roll-over advertisements on Web sites 
 
Manufacturers, distributors, and retailers must provide the notification required by 
 1140.30(a)(2) for each medium through which they plan to disseminate, or cause to be 
disseminated, advertising and labeling.  If any previous access restrictions are modified 
such that advertising or labeling previously unseen by persons younger than 18 years of 
age may then be seen by persons younger than 18 years of age, the regulated entity should 
submit a new notification under  1140.30(a)(2).  If a regulated entity plans to disseminate 
product labeling or advertising for regulated tobacco products in a medium not listed 
under  1140.30(a)(1), the entity must provide the notification required by 
 1140.30(a)(2) at least 30 days prior to the use of such medium. 
 
The notification provided under  1140.30(a)(2) is not intended to imply that prior approval is 
required. 
The notification to FDA must be submitted the following address:   
        
Food and Drug Administration  
Center for Tobacco Products  
Office of Compliance and Enforcement 
Document Control Center  
Building 71, Room G335 
10903 New Hampshire Avenue 
Silver Spring, MD 20993-0002 
 
  28    Contains Nonbinding Recommendations 
 
1.  Cover letter 
 
To facilitate FDAs review of media notifications, FDA requests that your notification be 
accompanied by a cover letter that includes: 
  Date of the notification; 
  The following subject lines: 
RE:  1140.30(a)(2) Notification of Other Advertising and Labeling 
Medium; 
  The official contact name, address, email, fax number and phone number of the 
person authorized to act as the FDA contact regarding the notification. 
  The name of the most responsible individual of the regulated entity, if the submitter is 
an agent submitting on behalf of the regulated entity; 
  An indication whether the notification is done by or on behalf of a manufacturer, 
distributor, or retailer of the tobacco products covered by the submission. 
 
2.  Information to include in the submission under  1140.30(a)(2) 
 
The notification should include the following information: 
  A list of the tobacco products covered by notification; 
  A detailed description of the advertising or labeling medium; 
  A discussion of the extent to which the advertising or labeling medium may be seen 
by persons younger than 18 years of age; and 
  A discussion of any access restrictions, including restrictions for persons younger 
than 18 years of age to the advertising or labeling medium. 
 
Section 1140.30(c) states that subpart D of the regulation does not apply to cigarette or 
smokeless tobacco package labels. 
 
B.  Section 1140.32  Format and Content Requirements for Labeling and Advertising 
 
On March 19, 2012, the United States Court of Appeals for the Sixth Circuit issued an Opinion 
and Judgment that, among other things, found  1140.32(a) to be unconstitutional under the First 
Amendment. (See Discount Tobacco v. United States.) Therefore, FDA will not seek to enforce 
this provision. 
 
C.  Section 1140.34  Sale and Distribution of Nontobacco Items and Services, Gifts, 
and Sponsorship of Events 
 
Section 1140.34 establishes prohibitions on the following forms of promotions: 
 
  any items (other than cigarettes, smokeless tobacco, or roll-your-own paper) or services, 
which bear the tobacco brand name, logo, symbol, motto, selling message, recognizable 
color or pattern of colors, or any other indicia of product identification identical or 
similar to, or identifiable with, those used for any brand of cigarettes or smokeless 
tobacco; and 
  29    Contains Nonbinding Recommendations 
 
 
 
  sponsorship of any athletic, musical, artistic, or other social or cultural event, or any entry 
or team in any event, in the brand name, logo, symbol, motto, selling message, 
recognizable color or pattern of colors, or any other indicia of product identification 
identical or similar to, or identifiable with, those used for any brand of cigarettes or 
smokeless tobacco. 
 
D.  Section 1140.34(a)  Nontobacco Items and Services 
 
The regulations establish restrictions on promotional items and services.  This provision applies 
to all manufacturers and to distributors of imported products.  If you are a manufacturer or 
distributor of imported cigarettes or smokeless tobacco, you cannot  
 
  market; 
  license; 
  distribute; 
  sell; or 
  cause to be marketed, licensed, distributed or sold 
 
 any item (other than cigarettes, smokeless tobacco, or roll-your-own paper) or service, which 
bears the brand name (alone or in conjunction with any other word), logo, symbol, motto, selling 
message, recognizable color or pattern of colors, or any other indicia of product identification 
that is the same as or similar to, or identifiable with, those used for any brand of cigarettes or 
smokeless tobacco. 
 
E.  Section 1140.34(b)  Gifts 
 
On March 19, 2012, the United States Court of Appeals for the Sixth Circuit issued an Opinion 
and Judgment that, among other things, found 1140.34(b) to be unconstitutional under the First 
Amendment. (See Discount Tobacco v. United States.) Therefore, FDA will not seek to enforce 
this provision. 
 
F.  Section 1140.34(c)  Sponsorship 
 
In brief, if you are a manufacturer, distributor, or retailer, you cannot sponsor or cause to be 
sponsored any  
 
  athletic event; 
  musical event; 
  artistic event; 
  social or cultural event; 
  entry in any event; or 
  team in any event 
 
 if the sponsorship is in the brand name (alone or in conjunction with any other word), logo, 
symbol, motto, selling message, recognizable color or pattern of colors, or any other indicia of 
the product identification identical or similar to, or identifiable with, those used for any brand of 
cigarettes or smokeless tobacco. 
  30    Contains Nonbinding Recommendations 
 
 
For example, for the BRANDNAME Cigarettes brand, assume that the package design for 
BRANDNAME Cigarettes features an orange and white diamond.  Under  1140.34(c), the 
manufacturer may not sponsor a basketball tournament if it would call the tournament the 
BRANDNAME Cigarette Tournament or sponsor the tournament in the name 
BRANDNAME Cigarettes.  The manufacturer also may not sponsor a team using the 
BRANDNAME Cigarettes name or even sponsor a team using only the brands orange and 
white diamond. 
 
The regulations do permit manufacturers, distributors, and retailers to sponsor events, teams, and 
entries using their corporate names, so long as both the corporate name and the corporation were 
registered and in use in the United States before January 1, 1995, and the corporate name itself 
does not include the brand name, logo, symbol, motto, selling message, recognizable color or 
pattern of colors, or any other indicia of the product identification identical or similar to, or 
identifiable with, those used for any cigarette or smokeless tobacco brand.  For example, if the 
XXX Company makes BRANDNAME Cigarettes, the company can sponsor the XXX 
Company Tournament if the name XXX Company and the company itself were registered 
and in use before January 1, 1995. However, a BRANDNAME Tobacco Company that makes 
BRANDNAME Cigarettes cannot sponsor the BRANDNAME Tournament because the 
company name and brand name are similar if not identical. 
 
VIII.  EFFECTIVE DATE FOR THE REGULATIONS 
 
These regulations were published on March 19, 2010, and became effective on June 22, 2010. 
This enabled manufacturers, distributors, and retailers to take whatever steps they needed to 
settle their existing business affairs, to adjust their business operations, and to plan future 
business operations that comply with these regulatory requirements. 
 
If you violate any of these regulations, FDA may initiate enforcement action against you. 
However, as described in this guidance, FDA intends to exercise enforcement discretion with 
respect to  1140.16(a). In addition, FDA will not seek to enforce  1140.32(a) and 1140.34(b). 
 
A.  Section 1140.16(a) 
 
Under this section of the regulations, manufacturers may not use a trade or brand name of a 
nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product 
unless the trade or brand name was on both the tobacco product and a nontobacco product sold in 
the United States on January 1, 1995.  As discussed above, on November 17, 2011, FDA 
published a proposal to amend this provision, entitled Restrictions on the Sale and Distribution 
of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.36 While FDA 
considers what changes, if any, would be appropriate, it intends to exercise its enforcement 
discretion concerning  1140.16(a) not to bring enforcement actions under this provision for the 
duration of its consideration in cases where: 
 
  the trade or brand name of the cigarette or smokeless tobacco product was registered, or 
the product was marketed, in the United States on or before June 22, 2009; or 
 
 
 
36 76 FR 71281 (November 17, 2011). 
  31    Contains Nonbinding Recommendations 
 
 
 
  the first marketing or registration in the United States of the tobacco product occurs 
before the first marketing or registration in the United States of the nontobacco product 
bearing the same name provided, however, that the tobacco and nontobacco product are 
not owned, manufactured, or distributed by the same, related, or affiliated entities 
(including as a licensee).37 
 
B.  Sections 1140.32(a) and 1140.34(b) 
 
On March 19, 2012, the United States Court of Appeals for the Sixth Circuit issued an Opinion 
and Judgment that, among other things, found  1140.32(a) and 1140.34(b) to be 
unconstitutional under the First Amendment. (See Discount Tobacco v. United States.) 
Therefore, FDA will not seek to enforce these provisions. 
 
 
 
IX.  HOW TO REPORT VIOLATIONS TO FDA 
 
Members of the general public can report violations to FDAs Center for Tobacco 
Products via: 
 
  email (ctpcompliance@fda.hhs.gov); 
 
  phone (1-877-CTP-1373); or 
 
  mail (Food and Drug Administration, Center for Tobacco Products, Document Control 
Center, Building 71, Room G335, 10903 New Hampshire Avenue Silver Spring, MD 
20993-0002). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
37 See 75 FR 25271 (May 7, 2010). 
  32    Contains Nonbinding Recommendations 
 
 
Attachment 1  Regulation References 
 
  Who Is Subject to      Regulation Section      Where I Can Find This   
the Regulations    Information in This 
  Guidance Document? 
Manufacturers,  1140.10  General Responsibilities  See section VI.A 
Distributors, and 
Retailers 
Manufacturers  1140.12  Additional Responsibilities  See section VI.B 
of Manufacturers 
Retailers  1140.14  Additional Responsibilities  See section VI.C 
of Retailers 
Manufacturers,  1140.16  Conditions of Manufacture,  See section VI.D 
Distributors, and  Sale, and Distribution 
Retailers 
Manufacturers,  1140.30  Permissible Labeling and  See section VII.A 
Distributors, and  Advertising 
Retailers 
Manufacturers,  1140.34  Sale and Distribution of  See section VII.C 
Distributors, and  Nontobacco Items and Services, Gifts, 
Retailers  and Sponsorship of Events 
 
  33