The Prohibition of 
Distributing Free Samples of 
Tobacco Products (Revised)* 
Guidance for Industry 
Comments may be submitted at any time for Agency consideration.  Electronic comments may 
be submitted to http://www.regulations.gov. Alternatively, submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Room 1061, Rockville, MD, 20852. All comments should be identified with Docket No. 
FDA-2017-D-0113. 
For questions regarding this guidance, contact the Center for Tobacco Products at (Tel) 
1-877- CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m.  4 p.m. EDT.
Additional copies are available online at  
http://www.fda.gov/TobaccoProducts/Labe ling/RulesRegulationsGuidance/default.htm. You 
may send an e-mail request to SmallBiz.Tobacco@fda.hhs.gov to receive an electronic copy of 
this guidance. You may send a request for hard copies to U.S. Food and Drug Administration, 
Center for Tobacco Products, Attn: Office of Small Business Assistance, Document Control 
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Tobacco Products 
March 2023 
*This is the first revision to the first edition of this guidance, which issued in October 2017.
Revisions are noted by date at the end of the guidance.   Contains Nonbinding Recommendations 
Table of Contents 
I.  INTRODUCTION................................................................................................................ 1 
II.  BACKGROUND .................................................................................................................. 2 
III.  DISCUSSION ....................................................................................................................... 3 
A.  Definitions ................................................................................................................................ 3 
B.  The Free Sample Ban .............................................................................................................. 5 
C.  Tobacco Products Subject to the Free Sample Ban.............................................................. 5 
D.  Tobacco Products Must Be Sold to Consumers .................................................................... 5 
E.  Monetary Payment is Re quire d for Tobacco Product Sale s ............................................. 6 
1.  Coupons and Discounts ...................................................................................................... 7 
2.  Membership and Rewards Programs .................................................................................. 7 
3.  Contests and Games of Chance .......................................................................................... 8 
F.  Business-to-Business Exchanges ............................................................................................ 8 
 
  Contains Nonbinding Recommendations 
The Prohibition of Distributing Free 
Samples of Tobacco Products 
Guidance for Industry1 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic. It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. 
To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the 
title page. 
I.  INTRODUCTION 
This guidance is intended to help tobacco product manufacturers, distributors, and retailers 
understand the prohibition of distributing free samples of tobacco products set forth in Title 21, 
Code of Federal Regulations (CFR), Part 1140 and to explain what you should do in order to 
comply with the regulations. The document explains, among other things, what activities and 
which persons are subject to the regulations, as well as how the prohibition of distributing free 
samples applies to the distribution of tobacco products through: 
  non-monetary exchanges; 
  membership and rewards programs; 
  contests and games of chance; and 
  business-to-business exchanges. 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required. 
 
 
1 This guidance was prepared by the Office of Compliance and Enforcement and Office of Regulations in the Center 
for Tobacco Products at FDA. This guidance finalizes the draft guidance of the same title, which was made available 
for public comment as noted in the Federal Register of January 18, 2017 (82 FR 5583). 
1  Contains Nonbinding Recommendations 
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, amended the Food, Drug, and Cosmetic Act 
(FD&C Act) and provided FDA with the authority to regulate tobacco products. Section 102 of 
the Tobacco Control Act required FDA to reissue the final regulations regarding cigarettes and 
smokeless tobacco promulgated by FDA in 1996 (Regulations Restricting the Sale and 
Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents (1996 
final regulations)),2 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 480,000 deaths each year.3 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.4 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.5  
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.6  
On March 19, 2010, FDA published its final regulations, Regulations Restricting the Sale and 
Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, at 21 
CFR Part 1140. This rule contains a number of provisions restricting the marketing, sale, and 
distribution of tobacco products aimed at limiting youth access to tobacco products.  Among 
other requirements, the regulations prohibit: 
  The distribution of free samples of tobacco products, except for smokeless 
tobacco distributed in qualified adult-only facilities in accordance with 
the regulations; 
  The sale of cigarettes and smokeless tobacco to individuals under 18 years of age; and 
  The sale of cigarettes and smokeless tobacco to individuals under 27 years of age 
without verifying by means of photographic identification that the purchaser is at 
least 18 years of age. 
 
2 See 61 FR 44396 (Aug. 28, 1996). 
3 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 -- 50 Years of Progress: a Report of the Surgeon General, 2014. 
4 Section 2(15) of the Tobacco Control Act. 
5 See sections 2(1), (26), (30)-(32) of the Tobacco Control Act. 
6 See Congressional Record, S6407, June 10, 2009, Statement of Senator Kennedy. 
2  Contains Nonbinding Recommendations 
At the time, the regulations applied to cigarettes, including roll-your-own tobacco; cigarette 
tobacco; and smokeless tobacco products. 
On August 8, 2016, the deeming provisions of FDAs Deeming Rule became effective. See 
Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as 
Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale 
and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products.7 
These provisions expanded FDAs tobacco product authority to include all products meeting the 
statutory definition of a tobacco product, except for accessories of newly deemed tobacco 
products. In addition, on March 15, 2022, the Consolidated Appropriations Act, 2022 (P.L. 117-
103) amended the definition of tobacco product to include products containing nicotine from 
any source, and made tobacco products containing nicotine not made or derived from tobacco 
subject to Chapter IX of the FD&C Act without needing to be deemed by regulation. Thus, the 
ban on distributing free samples applies to all tobacco products that are subject to FDAs tobacco 
product authority, and the minimum purchase age and the identification verification requirements 
apply to covered tobacco products. In deeming these additional tobacco products subject to 
FDAs tobacco product authorities, FDA noted reports that free samples of these products were 
easily and freely accessible by youth, with reports of e- cigarettes being distributed at venues 
likely to attract large audiences and at youth oriented events, such as music festivals and 
motorsports events.8  
III.  DISCUSSION 
A.  Definitions 
Component or part: The term component or part9 is defined in 21 CFR  1140.3 and 
means any software or assembly of materials intended or reasonably expected: 
(1)  to alter or affect the tobacco products performance, composition, 
constituents, or characteristics; or 
(2)  to be used with or for the human consumption of a tobacco product. 
Component or part excludes anything that is an accessory10 of a 
tobacco product. 
 
7 81 FR 28974 (May. 10, 2016). 
8 Id. at 28986 
9 FDA notes that component and part are separate and distinct terms within chapter IX of the FD&C Act. 
However, for purposes of 21 CFR Part 1140 and this guidance, FDA is using the terms component and part 
interchangeably and without emphasizing the distinction. FDA may clarify the distinctions between 
component and part in the future. 
10 The term accessory means any product that is intended or reasonably expected to be used with or for the 
human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; 
and meets either of the following: (1) Is not intended or reasonably expected to affect or alter the performance, 
composition, constituents, or characteristics of a tobacco product; or (2) Is intended or reasonably expected to 
affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but (i) 
Solely controls moisture and/or temperature of a stored product; or (ii) Solely provides an external heat source 
to initiate but not maintain combustion of a tobacco product. 
3  Contains Nonbinding Recommendations 
Covered tobacco product: The term covered tobacco product is defined in 21 CFR  
1140.3 and means any tobacco product deemed to be subject to the Federal Food, Drug, 
and Cosmetic Act under 21 CFR  1100.2, but excludes any component or part that is not 
made or derived from tobacco. 
Distributor: The term distributor is defined in 21 CFR  1140.3 and means any person 
who furthers the distribution of a tobacco product, whether domestic or imported, at any 
point from the original place of manufacture to the person who sells or distributes the 
product to individuals for personal consumption. Common carriers are not considered 
distributors for the purposes of this 21 CFR Part 1140. 
Finished tobacco product: The term finished tobacco product means a tobacco product, 
including all components and parts, sealed in final packaging intended for consumer use 
(e.g., filters or filter tubes sold separately to consumers or as part of kits). 
Manufacturer: The term tobacco product manufacturer is defined in 21 CFR  1140.3 and 
means any person, including any repacker and/or relabeler, who manufactures, fabricates, 
assembles, processes, or labels a finished tobacco product. 
Retailer: The term retailer is defined in 21 CFR 1140.3 and means any person who sells 
tobacco products to individua ls for personal consumption, or who operates a facility 
where vending machines or self-service displays are permitted under 21 CFR Part 1140. 
Tobacco product: The term tobacco product is defined in section 201(rr) of the FD&C 
Act, which states in relevant part: 
(1)  The term tobacco product means any product made or derived 
from tobacco, or containing nicotine from any source, that is 
intended for human consumption, including any component, part, or 
accessory of a tobacco product (except for raw materials other than 
tobacco used in manufacturing a component, part, or accessory of a 
tobacco product). 
(2)  The term tobacco product does not mean an article that is a drug 
under [section 201(g)(1)], a device under [section 201(h)], a 
combination product described in section 503(g) [of the FD&C Act], 
or a food under section 201(f) if such article contains no nicotine, or 
no more than trace amounts of naturally occurring nicotine. 
Note that this definition includes accessories and components and parts of tobacco 
products that are subject to Chapter IX of the FD&C Act, whether they contain nicotine, 
or are made or derived from tobacco and whether they are sold or distributed as finished 
tobacco products.11 
 
11 However, accessories of newly deemed products are not subject to the deeming rule. Thus, although such 
accessories meet the definition of tobacco product, they are not currently subject to regulation under Chapter 
IX of the FD&C Act. 
4  Contains Nonbinding Recommendations 
B.  The Free Sample Ban 
The free sample ban is codified at 21 CFR  1140.16(d)(1), which states, Except as 
provided in [21 CFR  1140.16(d)(2)], no manufacturer, distributor, or retailer may 
distribute or cause to be distributed any free samples of cigarettes, smokeless tobacco, or 
other tobacco products (as such term is defined in section 201 of the Federal Food, Drug, 
and Cosmetic Act). 
The exception described in 21 CFR  1140.16(d)(2) allows for the distribution of free 
samples of smokeless tobacco products in qualified adult only facilities, i.e., facilities 
that meet a number of specific requirements, such as verifying that all customers are at 
least 18 years of age. The focus of this guidance is free samples that are not distributed in 
a qualified adult only facility. 
C.  Tobacco Products Subject to the Free Sample Ban 
The free sample ban prohibits the distribution of free sample of cigarettes, smokeless 
tobacco, or other tobacco products (as such term is defined in section 201 of the Federal 
Food, Drug, and Cosmetic Act). 12 This means that the free sample ban automatically 
applies to all tobacco products subject to FDAs tobacco product authority, including 
components and parts of tobacco products, except smokeless tobacco product samples 
distributed in qualified adult only facilities in accordance with 21 CFR  1140.16(d)(2). 
Unlike other restrictions that the Deeming Rule expanded to include only covered 
tobacco products (i.e., deemed tobacco products made or  derived from tobacco)13 or 
provisions  that FDA intends at this time to enforce only against finished tobacco 
products, 14 the free sample ban applies to all tobacco products that are subject to FDAs 
tobacco product authority, even if they are not made or derived from tobacco and do not 
contain nicotine. This means that the free sample ban prohibits manufacturers, 
distributors, and retailers from giving out free samples of any tobacco product that is 
subject to FDAs tobacco product authorities, including components and parts of tobacco 
products, such as atomizers, clearomisers, and e-liquids. This is an important restriction 
because components and parts of some tobacco products, such as the aerosolizing 
apparatus of e-cigarettes, can be the most expensive part of a tobacco product. If minors 
can obtain the most expensive components or parts of tobacco products as free 
samples, they face less significant barriers to using tobacco products. 
D.  Tobacco Products Must Be Sold to Consumers 
As discussed in the 1996  final  regulations  preamble  and reiterated in  the preamble  to 
the Deeming Rule, the distribution of free samples presents a risk free and cost free 
source of tobacco products for youth15 and frequently occurs in situations that limit the 
 
12 21 CFR  1140.16(d)(1). 
13 21 CFR  1140.14(b). 
14 See e.g., 81 FR 28974 at 28995 (However, at this time, FDA intends to limit enforcement of the premarket 
authorization provisions to finished tobacco products.). 
15 61 FR 44396 at 44460. 
5  Contains Nonbinding Recommendations 
free sample distributors ability to request proof of age.16 By prohibiting the distribution 
of free samples of tobacco products, FDA (and later Congress, by directing FDA to 
reinstate this portion of the 1996 rule) eliminated this source of tobacco products for 
youth by requiring tobacco products to be distributed only through product sales17 that, 
through other parts of the rule reinstated in 2010, are subject to minimum purchase age 
and photographic identification verification requirements.18 The free sample ban and 
these requirements work together to advance the governments interest in reducing youth 
access to tobacco products. This means that manufacturers, distributors, and retailers may 
distribute tobacco products to consumers only through a tobacco product sales 
transaction. 
E.  Monetary Payment is Re quire d for Tobacco Product Sale s 
In a 2012 decision that upheld the free sample ban against a First Amendment challenge, 
the Sixth Circuit Court of Appeals observed that creating opportunities for youth to 
actually try a tobacco product, at no cost, may serve as the best advertisement of all for a 
product that is physiologically addictive, and socially attractive to youth. Discount 
Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509, 541 (6th Cir. 2012), cert. 
denied, 569 U.S. ___, 133 S. Ct. 1966 (2013).19 By implementing the free sample ban for 
the primary purpose of eliminating an easily accessible source of these products to 
young people, 20 the FDA regulations require that consumers face a monetary cost in 
order to receive a tobacco product. This means that retailers must charge consumers 
money for tobacco products and may not, for example, distribute tobacco products in 
exchange for providing contact information or signing up for a mailing list. While contact 
information may have value to manufacturers, distributors, or retailers, providing this 
information comes at no financial cost to the consumer and could be a risk free and cost 
free source of tobacco products for youth. Therefore, distributing a tobacco product in 
exchange for something non-monetary, such as a consumers contact information, is a 
prohibited free sample. 
While the free sample ban does require that manufacturers, distributors, and retailers 
distribute tobacco products to consumers only through tobacco product sales transactions 
and only in exchange for money, there are situations in which the sale of tobacco 
products to consumers at less than full price does not violate the ban. It is important to 
note, however, that other applicable laws, such as state and local laws, may restrict the 
price at which tobacco products may be sold and whether coupons may be redeemed. 
 
16 Id. 
17 See id. (stating, the agency agrees that [the free sample ban] will affect adults by effectively requiring them 
to purchase cigarettes and smokeless tobacco rather than receive them free of charge and the final rule does 
not alter an adults ability to select or purchase cigarettes and smokeless tobacco.). 
18 21 CFR  1140.14(a)-(b). 
19 The United States District Court for the District of Columbia also upheld the free sample ban against a First 
Amendment challenge, and relied in part on Sixth Circuits analysis. See Nicopure Labs, LLC v. FDA, 2017 
WL 3130312, at *44*47 (D.D.C. July 21, 2017).  
20 61 FR 44396 at 44460, quoted with approval in Discount Tobacco City, 674 F.3d at 541. 
6  Contains Nonbinding Recommendations 
The following examples describe FDAs current thinking on how the free samples ban 
generally applies; however, FDA intends to consider the specific facts of potential 
violations on a case-by- case basis to determine whether they present a potential risk 
free and cost free source of tobacco products for youth. 
1.  Coupons and Discounts 
The free sample ban does not prohibit manufacturers, distributors, and retailers from 
selling tobacco products at a discount or accepting coupons that allow consumers to 
purchase tobacco products at a discount.21 Promotions such as selling tobacco products at 
10% off of the regular price or accepting coupons that take dollars or cents off of the 
purchase price of a tobacco product are not prohibited. Promotions such as buy one get 
one free at the time of purchase or two for the price of one are also examples of non-
prohibited discounts because they represent a 50% discount off of the sales price of two 
tobacco products and the free tobacco product is received as part of a tobacco product 
sales transaction. 
Promotions that offer consumers a free tobacco product in a separate transaction that is 
not a tobacco product sales transaction are prohibited where they would allow consumers 
to obtain a free tobacco product sample and also evade the minimum age and ID 
requirements. For example, while buy one pack of cigarettes and get another pack free at 
the time of purchase and two for the price of one promotions are not banned, a buy 
one pack of cigarettes and get a coupon redeemable for a free pack of cigarettes 
promotion would be prohibited unless the manufacturer, distributor, or retailer has 
devised a way to adequately verify that the person redeeming the coupon is the original 
purchaser, because that coupon would let a consumer, including a minor who was not the 
original purchaser, obtain a tobacco product outside of a tobacco product sales 
transaction that requires monetary payment and is subject to minimum age and ID 
requirements. 
2.  Membership and Rewards Programs 
Membership and rewards programs that provide discounts to tobacco product purchasers 
are also not prohibited by the free sample ban as long as they do not result in distribution 
of tobacco products outside of a tobacco product sales transaction subject to minimum 
age and ID requirements. Rewards programs that offer a tobacco product as a reward, 
such as punch card programs (i.e., get a hole punched in the card for each purchase and 
receive a tobacco product when all the holes have been punched), are prohibited except 
where the reward is distributed as part of a tobacco product sales transaction that 
requires monetary payment. For example, if a retailer offered a rewards program in which 
consumers receive every tenth vial  of  e-liquid  for free, the retailer would not be 
prohibited from distributing the free e-liquid as part of a tobacco product sales 
transaction (e.g., with the ninth e-liquid purchase or with the eleventh e-liquid purchase), 
but it could not distribute a free vial of e-liquid to consumers outside of a tobacco product 
 
21 It is important to note, however, that the mail order redemption of coupons is prohibited under 21 CFR  
1140.16(c)(2)(i). 
7  Contains Nonbinding Recommendations 
sales transaction that requires monetary payment, unless the manufacturer, distributor, or 
retailer has devised a way to adequately verify that the person receiving the reward is the 
original purchaser. Distributing a free tenth vial of e-liquid with either the ninth or 
eleventh purchase would not violate the free sample ban because it would effectively 
amount to a discount that is part of a sales transaction requiring monetary payment, not a 
free sample. 
Similarly, membership programs are not prohibited by the free sample ban as long as 
they do not result in distribution of tobacco products outside of a tobacco product sales 
transaction that requires monetary payment and is subject to minimum age and ID 
requirements.  The ban would not prohibit a retailer from offering a discount on tobacco 
product purchases to program members, but it would prohibit the distribution of free 
tobacco products to members outside of a tobacco product sales transaction that requires 
monetary payment.  For example, the ban would not prohibit the sale of membership to a 
club that provides a 10% discount on all tobacco product purchases, but a retailer could 
not sell membership to a club that provides free samples of tobacco products outside of 
tobacco product sales transactions that require payment of money and are subject to 
minimum age and ID requirements. Again, in determining whether a violation has 
occurred, FDA would consider whether the manufacturer, distributor, or retailer has 
devised a way to adequately verify that the person receiving the reward is the member or 
original purchaser. 
3.  Contests and Games of Chance 
Contests and games of chance are generally not prohibited under the free sample ban; 
however, similar to other promotions, the contest prize may not be a tobacco product 
unless it is distributed as part of a tobacco product sales transaction that requires monetary 
payment and is subject to minimum age and ID requirements. For example, the ban does 
not prohibit a retailer from allowing customers to enter into a drawing or raffle and give a 
prize of a tobacco product discount or a coupon redeemable for a free tobacco product at 
the time of another tobacco product purchase, but the retailer could not distribute a free 
tobacco product as a prize outside of a tobacco product sales transaction that requires 
monetary payment and is subject to minimum age and ID requirements. 
While contests and games of chance that do not result in the distribution of free samples 
of tobacco products are not prohibited by the free sample ban, manufacturers, 
distributors, and retailers seeking to have a contest or game of chance with a tobacco 
product as a prize should be aware that a variety of state and Federal laws restrict how 
these promotions may be held. 
F.  Business-to-Business Exchanges 
FDA does not consider this regulation to apply to businesses distributing free samples in 
a limited quantity (i.e., no more than necessary to achieve a business or market goal, such 
as awareness of and exposure to the product for the purposes of product or inventory 
selection) to another business as part of a genuine effort to sell or market a tobacco 
product to that business.   
8  Contains Nonbinding Recommendations 
Document History 
October 2017  First edition of guidance issued. 
March 2023  Sections II and III are revised to reflect statutory amendments made by the 
Consolidated Appropriations Act, 2022 (Pub. L. 117-103). Among other things, the legislation 
amends the definition of tobacco product in section 201(rr) of the FD&C Act to include 
products containing nicotine from any source. 
9