Tobacco Retailer  Training 


Programs 
(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-2010-D-0350.  
 
For  questions  regarding this  guidance,  contact the Center for Tobacco Products at (Tel) 1-877
CTP-1373  (1-877-287-1373)  Monday-Friday,  9 a.m.    4  p.m. EDT.  
 
Additional   copies  are  available online at  
http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.   You  
may send an e-mail  request to SmallBiz.Tobacco@fda.hhs.gov  to receive an electronic  copy of  
this guidance.  You may send a request for hard copies  to U.S.  Food and Drug Administration,  
Center for Tobacco Products,  Attn:  Office of Small  Business  Assistance,  Document Control  
Center, Bldg.  71,  Rm. G335,  10903  New  Hampshire  Ave., Silver  Spring,   MD 20993-2000.  
 
 
U.S. Department  of  Health and Human Services 
 
Food and Drug  Administration  

Center for Tobacco Products 
 
 
August  2018  
 
 
OMB  control number:  0910-0745
  
Expiration Date:  12/31/2019
  
See  additional PRA statement  in Section VI of  the guidance*
  
 
   
* This is a revision to the fourth edition of this guidance, which was issued in June 2018.   Revisions are noted  
by date at the  end  of the guidance.  Contains Nonbinding Recommendations  
 
Table of Contents  
 
 
 
I.   INTRODUCTION ...................................................................................................... 1
  
II.   BACKGROUND ........................................................................................................ 2
  
A.   Provisions  Regarding Sale and Distribution ....................................................................  3 
 
B.   Provisions  Regarding Advertising and Promotion  ...........................................................  4 
 
C.   Required  Warning Statements .......................................................................................  5 
 
D.   Civil Money Penalties ....................................................................................................  6 
 
E.   No-Tobacco-Sale Orders................................................................................................  8 
 
III.   GENERAL INFORMATION  .................................................................................... 8
  
A.   What  definitions apply?.................................................................................................  8
  
B.   What products are covered by this guidance?  ................................................................10
  
IV.   RETAILER TRAINING PROGRAMS ................................................................... 10
  
A.   What are the recommended  elements  to be included in a retailer training program?  ........10
  
B.   What are  the recommendations  for  training frequency, methods, and review?  .................16
  
C.   What hiring and management practices support a retailer training program?..................17
  
V. 	  HOW CIVIL MONEY PENALTIES WILL BE ASSESSED FOR VIOLATIONS 
 
OF REGULATIONS ................................................................................................ 18
  
VI.   PAPERWORK REDUCTION  ACT OF  1995 ..........................................................  19
  
DOCUMENT HISTORY.................................................................................19
  
    i   Contains Nonbinding Recommendations  
 
Tobacco  Retailer Training Programs
  
 
 
 
1
 
Guidance for  Industry  
 
 
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  document  is intended to assist  retailers in implementing  training programs for  
employees  to learn about  and comply with the Federal laws, including   regulations,  regarding:  
 
	   Sale and distribution  of, including  youth access  to,  tobacco products  
	   Advertising  and promotion  of  cigarettes, smokeless  tobacco, and  covered  tobacco 
products  
 
The  Family Smoking  Prevention and Tobacco Control  Act (Tobacco Control  Act)  (Public  Law  
111-31; 123 Stat.  1776) does  not require  retailers to implement   retailer training  programs.   
However,  the statute  does provide  for lower  civil  money penalties  for violations   of  access, sale,  
and distribution   restrictions,  advertising  and promotion  restrictions, and required warning 
statements  promulgated  under section 906(d)  of  the  Federal Food,  Drug, and Cosmetic Act  
(FD&C Act), as  amended by the Tobacco Control  Act, for retailers who have implemented  a 
training program  that complies  with standards developed by FDA for such programs.  FDA  
intends  to promulgate   regulations  establishing  standards  for approved retailer  training programs.   
In the interim,   however,  for  retailers  who wish to implement   training programs,  this  guidance  
document explains:  
 
	   Recommendations  for elements to be  included in a  retailer training  program   
	   Recommended hiring and management practices   
                                              
1  This guidance was prepared by the Office of Compliance and Enforcement and the Office of Regulations in the 
Center for Tobacco Products at FDA.  
 
1 
 
  Contains Nonbinding Recommendations  
 
	   The civil  money  penalties  that may  be assessed  against  retailers  for violations   of  
restrictions  promulgated  under section 906(d)  of  the FD&C Act, as  amended by the  
Tobacco Control  Act  
	   How the penalty structure differs  for retailers  with and without  approved training 
programs  
 
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.   
 
 
II.   BACKGROUND  
 
The Tobacco Control  Act  grants  FDA important  authority to regulate  the manufacture,  
marketing,  and distribution  of tobacco products  to protect the  public  health generally and to 
reduce tobacco use by minors.   
 
Section 906(d) of the  FD&C  Act, as  amended by the Tobacco Control  Act, states  that  [t]he  
Secretary may by regulation require  restrictions  on the sale and distribution  of a tobacco product,  
including  restrictions  on the access  to, and the advertising  and promotion  of,  the tobacco product,  
if  the Secretary determines  that such regulation  would be appropriate  for the protection of the  
public health.  
 
Section 102 of the Tobacco Control  Act required  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)),2   with 
certain specified exceptions.  The regulation (codified at  21 CFR part 1140)  is deemed to be  
issued under  chapter  IX  of the FD&C Act, as  amended by the Tobacco Control  Act.   The  
regulation  contains  provisions   designed to limit   young peoples access  to cigarettes  and 
smokeless tobacco products,  as  well  as  restrictions  on advertising  and promotion  of  cigarettes  
and smokeless  tobacco  products,  to curb the appeal  of these products to minors  (75 FR  13225;  
March 19,  2010).  
 
On August  8,  2016,  FDAs  final  regulations   entitled 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 Products3  (the Deeming  Rule)  became effective and  
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.  As a  
result  of the Deeming Rule,  some restrictions  in parts  1140 now apply to covered tobacco 
                                              
2  See  61 FR  44396  (Aug.  28, 1996).  
3  81 FR 28974  (May.  10, 2016).  
 
2 
 
  Contains Nonbinding Recommendations  
 
products in addition  to cigarettes  and smokeless tobacco.   Additionally,   the Deeming Rule  added 
21 CFR part 1143,  which contains  requirements  for  required warning statements for  cigarette 
tobacco, roll-your-own  tobacco,  cigars,  and other  covered tobacco products.  
 
A.   Provisions Regarding Sale and Distribution  
 
The regulations  impose,  among other things,   the following  restrictions  on sale and distribution 
of,  including  youth access to,  tobacco products.4  
 
Retailers of  tobacco products MUST:  
 
1.	   Not sell  cigarettes,  smokeless tobacco, or  covered tobacco products  to persons  younger  
than 18 years of age (21 CFR 1140.14(a)(1)  and  (b)(1)).  
2.	   Verify  the age of purchasers of cigarettes,  smokeless tobacco, and covered tobacco 
products  who are  under  the age of 27 by means of  photographic   identification  that  
contains  the bearers  date of birth (21 CFR 1140.14(a)(2)  and  (b)(2)).  
3. 	  Only  sell cigarettes or  smokeless tobacco in direct,  face-to-face transactions,  with  limited  
exceptions (21  CFR 1140.14(a)(3)  and  1140.16(c)).  
4. 	  Not sell  cigarettes and smokeless  tobacco using vending machines  or self-service 
displays  unless they are located in a facility  where the retailer  ensures  that persons  
younger  than 18 years of age  are  not  present or  permitted to enter at any time  (21 CFR  
1140.14(a)(3) and  1140.16(c)).   
5. 	  Not sell  covered tobacco products using vending machines unless  they are  located in a  
facility  where the retailer ensures that persons younger  than 18 years  of age are  not  
present at any time (21 CFR  1140.14(b)(3)).  
6.	   Remove  or  bring into compliance  all self-service displays,   advertising,  labeling  and other  
items located in the  retailers establishment  that  do not comply with the  requirements  
under  21 CFR 1140 (21 CFR 1140.14(a)(5)).   
7.	   Not break or  otherwise  open packages  of cigarettes  to sell  or distribute  single  cigarettes  
or sell any package with less than 20 cigarettes (21 CFR 1140.14(a)(4),   21 CFR  
1140.16(b)).   
8. 	  Not break or  otherwise  open any cigarette or  smokeless tobacco package to sell or  
distribute  any quantity of cigarette tobacco or smokeless  tobacco that is  smaller  than the  
smallest  package distributed  by the  manufacturer for individual   use (21 CFR  
1140.14(a)(4)).  
9. 	  Not distribute   free  samples  of tobacco products,  except  for  samples  of smokeless  tobacco 
products  in a qualified  adult-only  facility,   as  defined by the regulations   (21 CFR 
1140.16(d)).  
 
                                              
4 For the full text  of the regulation, refer to 21 CFR  parts 1140 and 1143.  
 
 
3 
 
  Contains Nonbinding Recommendations  
 
Additionally,   certain requirements  went   into effect  on May 10,  2018.  For these requirements,  
FDA has provided a  compliance date of  August 10, 2018.5   On July 5,  2018,  the U.S.  District  
Court  for the District  of Columbia   enjoined  FDA  from  enforcing the  warning requirements for  
cigars  and pipe  tobacco (21 CFR 1143.3 and 1143.5)  until  60 days after the final  disposition  of  
the plaintiffs   appeal  in  the case:  Cigar Assn of America v. FDA,  No. 1:16-cv-01460   (D.D.C.) 
(order granting injunction  pending appeal); see also Cigar Assn of America v. FDA, No. 18
5195 (D.C.  Cir.).  FDA  will  not seek to enforce  the  warning requirements  for cigars  and pipe  
tobacco until  that order is  lifted.  Under these requirements  retailers  of tobacco products  MUST:6   
 
10.  Not sell or offer to sell cigarette tobacco,  roll-your-own  tobacco,  or covered tobacco 
products  other  than cigars unless  the product  package bears  the required warning 
statement  on the package label:  WARNING: This  product contains nicotine.   Nicotine is  
an addictive chemical.  (21 CFR 1143.3(a)).7  
11.  Not sell  or offer to sell  a cigar  product  (other  than cigars  sold individually  and not in the  
product package)  unless  the product  package bears one of the warning statements in 21 
CFR  1143.5(a)(1)  on  the package label.  (21 CFR 1143.5(a)(1)).  
12.  Not sell  or offer to sell  cigars  individually 	 and not  in the product  package,  unless  the  
required warning statements in 21 CFR 1143.5(a)(1)  are  posted at the retailers  point-of
sale  as described in 21  CFR 1143.5(a)(3).  (21 CFR  1143.5(a)(3)).  
 
B.   Provisions Regarding Advertising and Promotion  
 
The regulations  impose,  among other things,   the following  restrictions  on advertising and 
promotion  of cigarettes,  smokeless tobacco,  and covered tobacco products.8  
Retailers  of  tobacco products MUST:  
 
1.	   Notify the Agency 30 days prior  to the use of advertising or labeling  for  cigarettes or  
smokeless  tobacco which the retailer  intends  to disseminate  or cause  to be disseminated 
                                              
5  See  FDAs guidance for industry, Extension of Certain Tobacco Product Compliance Deadlines Related to the 
Final Deeming Rule  (Nov. 2017),  available at: 
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm557714.htm.  
6  For the three requirements listed above (numbers 10-12), retailers may continue to sell and distribute tobacco 
products with packaging that does not bear the required health warning statements after the effective date, but only if  
the products  were manufactured before the effective date of the warning statement requirements.  See  21 CFR  
1143.13(a).   For more information on compliance dates, see FDAs guidance for industry, Extension of Certain  
Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (August, 2018),  available at: 
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm557714.htm.   
7  The nicotine addictiveness warning statement is not required for products that do not contain nicotine if the  
tobacco product manufacturer has submitted to FDA a confirmation  statement certifying to be true and accurate that 
the product does not contain nicotine and that the tobacco product manufacturer has data to support that assertion.  
 
However, such products must include a statement: This product is made from tobacco. (21 CFR 1143.3(c)). 
8  On March 19, 2012,  the United States Court of Appeals for the Sixth Circuit issued an Opinion and Judgment that, 
among other things, found 21 CFR 1140.32(a)  and 21 CFR 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).)  Therefore, FDA will  not  
seek to enforce these  provisions.  
 
 
4 
 
  Contains Nonbinding Recommendations  
 
in a  medium  that  is not listed in 21 CFR  1140.30(a)(1).   The  notice shall describe  the  
medium  and discuss  the extent  to which the advertising or labeling  may be seen by 
persons  younger  than 18 years  of age.  The retailer  shall  send this  notice  to the U.S. Food 
and Drug Administration,   Center for  Tobacco Products, Document Control  Center,  
Building  71,  Room G335,  Attn:  Office  of  Compliance  and Enforcement, 10903 New  
Hampshire Avenue,  Silver Spring,   MD  20993 (21 CFR  1140.30(a)(2)).  
 
2. 	  Not sponsor,  or  cause  to be sponsored,  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  similar  to, or identifiable   with,  those used for  any brand of cigarettes or  
smokeless tobacco (21 CFR  1140.34(c)).   
 
Additionally,   certain requirements  went  into  effect  on May 10,  2018.  For these requirements,  
FDA has  provided a  compliance date of  August 10, 2018.9   On July 5,  2018,  the U.S.  District  
Court  for the District  of Columbia   enjoined  FDA  from  enforcing the warning requirements  for  
cigars  and pipe  tobacco (21 CFR 1143.3 and 1143.5)  until  60 days after the final  disposition  of  
the plaintiffs   appeal  in  the case:  Cigar Assn of America v. FDA,  No. 1:16-cv-01460   (D.D.C.) 
(order  granting injunction  pending appeal); see also Cigar Assn of America v. FDA, No. 18
5195 (D.C.  Cir.).  FDA  will  not seek to enforce  the  warning requirements  for cigars  and pipe  
tobacco until  that order is  lifted.  Under these requirements  retailers  of tobacco products  MUST:  
 
1. 	  Not  advertise or  cause to be advertised any cigarette tobacco, roll-your-own  tobacco, or  
covered tobacco products other than cigars unless each advertisement  bears  the required 
warning statement:  WARNING: This product  contains nicotine.   Nicotine is  an 
addictive  chemical. (21 CFR  1143.3(b)).10  
2. 	  Not advertise or cause to  be advertised  any  cigar unless  each  advertisement  bears  one of  
the  required warning statements  specified in 21 CFR  1143.5(a)(1).  (21 CFR 1143.5(b)).  
 
C.   Required  Warning Statements  
 
As described in sections  II.A.  and B. above,  the regulations  impose,  among other things,  warning 
statement requirements  for  the sale, offer for sale, and advertising  of  cigarette tobacco, roll-your
own tobacco,  cigars,  and other  covered tobacco products.11  
 
For cigarette tobacco, roll-your-own  tobacco, and covered tobacco products  other  than cigars, the  
package or advertising  must contain the statement  WARNING:  This  product  contains  nicotine.   
Nicotine is  an addictive  chemical.  (21 CFR 1143.3(a)(1)  and 1143.3(b))  and meet the format  
requirements  of  21 CFR  1143.3(a)(2)  and (b)(2), respectively.   As  stated above, on July 5, 2018,  
the U.S. District  Court  for the District  of Columbia   enjoined  FDA from enforcing the warning 
                                              
9  See  footnote five,  supra.  

10  See  footnote six,  supra. 
 
11This guidance applies only to warning statement requirements promulgated under FD&C Act section 906(d), 
 
which are subject to the penalty schedules prescribed by section 103(q)(2) of the Tobacco Control Act, described 

infra. 
 
 
5 
 
  Contains Nonbinding Recommendations  
 
requirements  for cigars  and pipe  tobacco (21 CFR 1143.3 and 1143.5)  until  60 days  after  the  
final  disposition  of the plaintiffs   appeal  in the case:  Cigar Assn of America v. FDA,  No. 1:16
cv-01460  (D.D.C.) (order  granting injunction  pending appeal); see also Cigar Assn of America 
v. FDA,  No. 18-5195 (D.C.  Cir.).  FDA  will  not  seek to enforce the warning requirements  for  
cigars  and pipe  tobacco until  that order  is  lifted.    
 
For cigar  products,  the package  or advertising must contain one  of the  warning statements  
required by 21 CFR 1143.5(a)(1)  and meet the  format  requirements  of 1143.5(a)(2)  and (b)(2),  
respectively.  For cigars  sold individually  and not  in the product  package,  the required warning 
statements in 21 CFR 1143.5(a)(1)  must  be posted at the retailers  point-of-sale and  meet format  
requirements,  as described  in  21 CFR  1143.5(a)(3).   As stated above,  on July 5,  2018,  the U.S.  
District  Court  for the District  of Columbia   enjoined FDA from  enforcing  the warning 
requirements  for cigars  and pipe  tobacco (21 CFR 1143.3 and 1143.5)  until  60 days  after  the  
final  disposition  of the plaintiffs   appeal  in the case:  Cigar Assn of America v. FDA,  No. 1:16
cv-01460  (D.D.C.)  (order  granting injunction  pending appeal); see also Cigar Assn of America 
v. FDA,  No. 18-5195 (D.C.  Cir.).  FDA  will  not  seek to enforce the warning requirements  for  
cigars  and pipe  tobacco until  that order  is  lifted.    
 
It  is important  to note that  retailers of  cigarette tobacco, roll-your-own  tobacco,  cigars,  and other  
covered tobacco products  will  not  be found in violation  of the warning statement  requirements  
for packaging that:  
	   Contains a  health warning.  
	   Is supplied to the  retailer by the  tobacco product  manufacturer, importer,  or distributor,  
who has  the required state, local,  or Alcohol  and Tobacco Tax and Trade Bureau (TTB)
issued  license  or permit,  if applicable.    
	   Is not  altered by  the retailer  in  a way that is  material  to the requirements  of sections  
1143.3(a)  and 1143.5(a). 
 
(21 CFR 1143.3(a)(3)  and 1143.5(a)(4)  

 
Additionally,  the  warning statement  requirement for  advertisements outlined  in sections  
1143.3(b) and 1143.5(b) apply to a  retailer only if  that  retailer  is  responsible  for or  directs the  
health warning required under the  paragraph.  However, this does not relieve a  retailer  of  liability 
if  the retailer  displays,   in a location open to the public,   an advertisement  that:  
	   Does not contain a health warning  
	   Contains  a health  warning  that has been altered by  the retailer  in  a way that is  material  to  
the requirements  of sections  1143.3(b)  and 1143.5(b)   
(21 CFR 1143.3(b)(3)  and 1143.5(b)(3))  
 
D.   Civil Money Penalties  
 
Section 103(q)(2)  of the Tobacco Control  Act includes  two schedules  for assessing civil  money 
penalties  against retailers for violations   of  restrictions  promulgated  under section 906(d)  of  the  
 
6 
 
  Contains Nonbinding Recommendations  
 
FD&C Act, as  amended by the Tobacco Control  Act.12   Under each  schedule, violators  are  
subject to increasing penalties  for  subsequent  violations   within prescribed time periods.   
 
Specifically,   section 103(q)(2)(A)  sets forth the civil  money penalty structure as  follows:13  
 
(i)  With respect to a  retailer  with an approved training program,  the amount  of the civil  
penalty shall not  exceed   
 
  (I) in the case  of the first  violation,   $0.00 together  with the issuance of  a  warning letter to 
the retailer;14   
 
  (II)  in the  case of  a second violation  within a 12-month period, $250;  
 
  (III)  in the  case of  a third violation  within a 24-month period, $500;   
 
  (IV)  in the  case of  a fourth violation  within a 24-month period, $2,000;   
 
  (V)  in the  case of  a fifth violation  within a 36-month  period, $5,000;  and  
 
  (VI) in  the case of a sixth or  subsequent violation  within a  48-month period, $10,000  as  
determined  by  the Secretary  on  a case-by-case basis.  
 
(ii)  With  respect  to a retailer  that does  not have  an approved training program,  the amount  of  
the  civil  penalty shall not  exceed    
 
  (I) in the case  of the first  violation,   $250;   
 
  (II)  in the  case of  a second violation  within a 12-month period, $500;   
 
  (III)  in the  case of  a third violation  within a 24-month period, $1,000;   
 
  (IV)  in the  case of  a fourth violation  within a 24-month period, $2,000;   
 
  (V)  in the  case of  a fifth violation  within a 36-month  period, $5,000;  and  
 
                                              
12 Section 303(f)(9)  of the FD&C Act establishes civil money penalties for violations of tobacco product  
requirements under the FD&C Act.   This guidance only applies to civil money penalties for retailer violations of 
regulations issued under section 906(d) of the FD&C Act; it does not apply to civil money penalties issued under 
section  303(f)(9) for other violations. 
13 The Civil Money Penalty amounts listed in this guidance reflect the amounts listed in the statute.   FDA is required 
to update these amounts  annually to reflect inflation by the Federal Civil Penalties Inflation Adjustment Act  of 1990 
(Pub. L. No. 101-410,  104 Stat. 890 (1990)), as amended by the Federal Civil Penalties Inflation Adjustment Act  
Improvements Act of 2015 (Sec. 701 of the Bipartisan Budget Act of 2015, Pub. L. No. 114-74 (2015), codified at 
28 U.S.C. 2461 note 2(a)).    For the most up-to-date amounts, please see 45 CFR 102.3 or the CTP website at:  
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm232109.htm   
14 Although the penalty for the first violation is $0.00, consistent with the statute CTP will  issue a Warning Letter.  
 
7 
 
  Contains Nonbinding Recommendations  
 
  (VI) in the case  of a  sixth or subsequent  violation  within a  48-month period,  
  $10,000  as determined by  the Secretary on  a case-by-case basis.  
 
For  the  first  three violations   in a 24-month period, retailers  with an approved training program  
are  subject to lower maximum  penalties  than retailers without  such programs.   Section 
103(q)(2)(B)  of the  Tobacco Control  Act defines  approved training  program as a training  
program  that complies  with standards  developed by the FDA for such programs.    
 
FDA intends  to promulgate  regulations   establishing  standards  for approved retailer  training 
programs.   Until it does,  the Agency intends  to seek penalties  in accordance with the  section  for 
retailers with an approved training program  (section 103(q)(2)(A)(i)  of  the Tobacco Control  
Act), whether or not  the retailer  has  implemented  a training program.   However,  FDA may 
consider  any evidence  of a training program  (e.g., training curriculum,   a  test  provided  to 
employees  and their  test  scores)  in determining  whether to further  reduce the civil  money penalty 
during settlement negotiations   for retailers who violate  the  regulations.15    
 
E.   No-Tobacco-Sale Orders  
 
In addition  to civil  money penalties,  the statute allows  the Secretary to impose  no-tobacco-sale 
orders  on retailers who repeatedly violate  restrictions  promulgated under section 906(d) of  the  
FD&C Act, as  amended by the Tobacco Control  Act.  Specifically,   section 103(c)  of the Tobacco 
Control  Act  amends  section 303(f)  of the FD&C Act  (21 U.S.C.  333(f))  to add the following:  
 
If the Secretary finds  that a  person has committed repeated violations   of restrictions  
promulgated  under  section 906(d) at  a  particular  retail outlet  then the  Secretary may impose  a  
no-tobacco-sale  order on that person prohibiting  the sale of  tobacco products  in that outlet.  A  
no-tobacco-sale order  may be  imposed with a  civil  penalty  . . . .  
 
 
III.   GENERAL INFORMATION  
 
A.   What  definitions apply?  
 
The  following  definitions   apply for  purposes of this guidance:  
 
1.	   Cigarette:   The term  cigarette (a)  means a product  that  is a tobacco product  and 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 900(3)  of  the FD&C  Act; 21 U.S.C.  387(3)).  This  
definition  refers  to a provision  of the  Federal Cigarette  Labeling and Advertising  Act  
                                              
15 For additional information, see Guidance for FDA and Tobacco Retailers:   Civil Money Penalties and No-
Tobacco-Sale Orders For Tobacco  Retailers, available at  
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM252955.pdf.  
 
8 
 
  Contains Nonbinding Recommendations  
 
which defines the term  cigarette  as: 
 
(1)  The term cigarette means 

(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) (15 U.S.C. 1332).  
2.	   Cigarette Tobacco:  The  term cigarette tobacco  means 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  chapter  IX  of the FD&C Act  shall  
also apply to cigarette  tobacco (section 900(4)  of the FD&C Act  (21 U.S.C. 387(4)).  
3. 	  Component or part:  The term  component  or  part16  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 accessory17  of  a tobacco product  (21 CFR  1140.3  and 
1143.1).  
4.	   Covered tobacco product: The  term  covered tobacco product  means any tobacco 
product  deemed to be subject to the  Federal Food,  Drug, and Cosmetic Act  by 21 CFR   
1100.2,  but  excludes  any component  or part that is  not  made or derived from  tobacco  (21 
CFR 1140.3  and 1143.1).  
5. 	  Package  or  packaging  means  a  pack,  box,  carton, or  container  of  any kind or, if no other  
container,  any wrapping (including  cellophane),  in which a  tobacco product is offered for  
sale, sold,  or otherwise distributed  to consumers  (21 CFR 1143.1).  
6. 	  Point-of-sale  means any  location at  which a  consumer  can purchase or otherwise  obtain 
tobacco products  for personal  consumption  (21 CFR 1143.1).  
7. 	  Required warning statement  means  a  textual  warning statement required to be on 
packaging and in advertisements  for  cigarette tobacco, roll-your-own  tobacco, cigars, and 
other  covered tobacco products  (21 CFR 1143.1).  
8. 	  Smokeless Tobacco:  The term smokeless  tobacco  means 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 (section 900(18)  of the FD&C Act;  21 U.S.C.  387(18)).  
9.	   Retailer:  The term retailer  means  any person,  government,   or entity who  sells tobacco  
products  to individuals   for personal  consumption,   or who operates a  facility where self
                                              
16  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.  
17  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 (21 CFR  1140.3  and 1143.1).  
 
9 
 
  Contains Nonbinding Recommendations  
 
service displays  of tobacco products  are  permitted (section 900(14)  of the FD&C Act;  21 
U.S.C. 387(14)).  
 
B.   What products are covered by this guidance?  
 
The regulations  in 21 CFR part 1140  apply  to cigarettes,  cigarette tobacco,  smokeless tobacco, 
and covered tobacco products  (e.g.,  cigars, pipe tobacco,  e-cigarettes,  e-liquids   that contain 
nicotine).   The regulations  in 21 CFR part 1143 apply to cigarette tobacco,  roll-your-own 
tobacco, and  covered tobacco products.    
 
IV.   RETAILER TRAINING PROGRAMS  
 
A retailer  training program should provide the  information  and tools necessary for  employees to 
comply with the  Federal laws,  including  regulations,   restricting the sale and distribution,  
including  youth access,  and the advertising and promotion  of cigarettes,  smokeless tobacco, and 
covered tobacco products.18   FDA believes  that the elements  described  in  this  guidance are 
important  components  of  an effective retailer training  program  based  on the best  available 
evidence to date.  
 
Some  retailers  may already have a training program  in place  for other purposes  (e.g., company 
policy,  State or local  law).  FDA recommends  that retailers  who  want to train  employees about  
Federal requirements  incorporate  the  elements described in this guidance  into their existing 
training program, as  appropriate.    
 
As  soon as  practicable,  current employees  should receive comprehensive  training on the Federal  
laws, including   regulations,   restricting the sale and distribution,   including  youth access,  and the  
advertising and promotion  of cigarettes,  smokeless tobacco,  and covered tobacco products.19   
New  employees  should receive  the  training prior  to selling cigarettes,  smokeless tobacco, or  
covered tobacco products.   
 
A.   What  are the recommended elements to be included in a retailer training  
program?  
 
The training should include  detailed information  on the Federal laws, including   regulations,  
concerning  the  sale  and distribution,   including  youth access,  and the advertising  and promotion 
of cigarettes,  smokeless  tobacco,  and covered tobacco products.   Training content should include  
information  on all  of the following:  
 
1.   Applicable Laws and Penalties    
 
                                              
18  See section II of this guidance. 
 
19  FDA notes that there may be additional, and possibly  stricter, State and local laws relating  to the sale and 
 
distribution of, access to, and advertising and promotion of cigarettes, smokeless tobacco, and covered tobacco 

products.   Retailers should consult with State and local authorities for further information.  

 
10  

  Contains Nonbinding Recommendations  
 
Training content should describe Federal laws, including  regulations,  restricting  the sale 
and distribution,   including  youth access, and the advertising and promotion  of cigarettes,  
smokeless tobacco,  and covered tobacco products.  These laws,  including  regulations,   are 
briefly summarized in section II of this  guidance.  Training  content  also should discuss  
the penalties  for violations   of  these  laws.   
 
  2.   Health Effects of Youth Tobacco Use   
 
Training program  content  should include a  description of  the  health and economic effects  
of tobacco use, especially when tobacco use begins  at a  young age.   FDA recommends  
that  retailers describe the negative health effects  of youth tobacco use.  For example,  the  
Congressional  Findings   in the  Tobacco Control  Act,  Surgeon Generals Reports, and 
other authoritative  scientific  studies have  reported the  following:     
 
	   Tobacco use is  the foremost  preventable  cause  of premature death in  America.  It  
causes over  480,000  deaths in the United States each year, and approximately 
8,600,000  Americans  have chronic illnesses  related to smoking.20,  21  
	   Smoking  costs the United States $193 billion  every year  from  health care  costs  
and lost  productivity  from  premature death.  The actual  costs  are even higher  
because lost  productivity  from  illness  is  not included  in this  estimate.22  
	   Cigarette smoking harms nearly every organ in the  body.   Smoking  is known to 
cause  many serious diseases, including  multiple   cancers  (lung, kidney, bladder,  
acute  myeloid  leukemia,   mouth and throat, larynx,  esophagus,  stomach, pancreas,  
cervix); chronic  lung disease;  heart  attacks;  stroke; aortic aneurysm; pneumonia;  
reduced lung function in infants, adolescents, and  adults; respiratory symptoms in 
children and adolescents;  asthma-related symptoms;  reduced fertility   in women;  
pregnancy complications   including  premature  birth,  low birth weight;  sudden 
infant  death syndrome  (SIDS); peptic  ulcer disease;  adverse  surgical  outcomes;  
osteoporosis  and hip fractures  in women;  periodontal  disease; and cataracts.   
There are also studies linking  many other diseases  to  cigarettes.23  
	   Smokeless  tobacco causes  oral  cancer, esophageal  cancer, and pancreatic cancer.   
Using smokeless tobacco  may also cause heart  disease,  gum  disease, oral lesions  
                                              
20  Section 2(13)  of the Tobacco Control Act. 
 
21  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 659, 2014. 
  
22  Centers for Disease Control and Prevention, Smoking-Attributable Mortality, Years of Potential Life Lost, and 
 
Productivity LossesUnited States, 2000-2004,  Morbidity and Mortality Weekly Report, 57(45); 1226-28, Nov.  

14, 2008, available  at  http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5745a3.htm.  

23  U.S.  Department of Health and Human Services, The Health Consequences of Smoking, A Report of the 
 
Surgeon General; 2004, available at  http://www.cdc.gov/tobacco/data_statistics/sgr/2004/index.htm.  

 
 
11  

  Contains Nonbinding Recommendations  
 
other  than cancer, reduced sperm count,  and pregnancy complications   including 
premature birth and low birth weight.24  
	   The  adverse  health impact  of  smoking is not limited  to adults.   Smoking  among 
children and adolescents causes  their lungs  to not fully develop and causes  a  
premature and accelerated decline in lung function beginning  in early adulthood.   
Smoking  also causes  respiratory symptoms  and asthma-related symptoms  in 
children and adolescents.25  
	   Cigarettes,  smokeless tobacco,  and covered tobacco products  contain nicotine,   an 
addictive chemical.26  
	   Data  suggest that  youth are  particularly  susceptible  to becoming addicted to 
tobacco.27  
	   Virtually  all  new  users of tobacco products  are  under  the minimum  legal  age to  
purchase such products.28  
 
Retailers  also should inform  employees  that one  way to prevent  the significant   adverse  
consequences of tobacco use is to prevent youth from  purchasing cigarettes,  smokeless 
tobacco,  and covered tobacco products.  
 
A retailer may choose to use  other examples and/or statistics in its training program  than 
what  is recommended above; however, the  training  program should incorporate  specific  
examples and/or statistics  related to the  health effects  of  youth tobacco use.  
 
  3.   Written  Company Policies    
 
Retailers should adopt and enforce  a  written policy covering Federal laws, including  
regulations,  related to the sale and distribution,   including  youth access,  and the  
advertising and promotion  of cigarettes,  smokeless tobacco,  and covered tobacco 
products.29   This policy should be  shared with all  employees  both verbally and in writing,  
acknowledged by the  employees,  and documented in their  training records.  
 
4.   Comprehensive Description of Tobacco Products Covered by Laws Prohibiting  
the Sale of Tobacco Products to Youth   
 
                                              
24  World Health Organization.   Smokeless Tobacco  and Some Tobacco-specific  N-Nitrosamines.   International 
Agency for Research on Cancer (IARC) Monographs on the Evaluation of Carcinogenic Risks to Humans  Volume 
89;  2007,  available at  http://monographs.iarc.fr/ENG/Monographs/vol89/mono89.pdf.  
25  U.S.  Department of Health and Human Services, The Health Consequences of Smoking, A Report of the 
Surgeon General; 2004, available at 
http://www.cdc.gov/tobacco/data_statistics/sgr/2004/complete_report/index.htm.  
26  U.S.  Department of Health and Human Services, The Health Consequences of Smoking: Nicotine Addiction, A 
Report of the Surgeon General; 1988. 
27  U.S.  Department of Health and Human Services, How Tobacco Smoke Causes Disease: The Biology and  
Behavioral Basis for Smoking-Attributable Disease, A Report of the Surgeon General; 2010,  available at 
http://www.surgeongeneral.gov/library/tobaccosmoke/report/full_report.pdf.  
28  Section 2(4)  of the Tobacco Control Act.  
29  See section II of this guidance.  
 
12  

  Contains Nonbinding Recommendations  
 
The  training curriculum   should clearly define  which products sold in the  retail  
establishment  are considered  to be cigarettes,  smokeless tobacco,  and covered tobacco 
products  under  the Tobacco Control  Act and are  therefore subject  to the Federal  
regulations  prohibiting  their sale  to individuals   under the  age  of 18.  
 
5.   Age Verification Techniques  
 
Program content  should clearly describe both Federal law  and company policies  on 
requiring  identification,   including  the age  that triggers  photographic   identification 
verification  and what constitutes  acceptable forms  of identification.     
 
	   Photographic Identification Containing  Date  of Birth Requirements.   Unless 
otherwise required  by law, FDA  recommends  that  retailers have in  place a policy  
that:  
 	  Permits only government-issued  photographic  identification  containing  a  
date of birth  (e.g., State-issued drivers  license or identification   card,  
military  identification   card, passport,  or immigration   card)  as acceptable 
forms  of identification  for establishing  a legal  age  to purchase cigarettes,  
smokeless tobacco,  and covered tobacco products.    
 	  Specifies  that the photographic   identification  cannot be expired.   
 	  Includes  appropriate  measures  to determine  the authenticity  of the  
government-issued  photographic  identification  (as  further  described 
below).  
 	  Instructs employees  to decline  a  sale when the  customer has no 
photographic  identification,  the  photographic  identification  contains  no 
date of birth,  or the photographic   identification  has  expired.  
 
	   The  Importance of  Closely Examining Photographic  Identification.  The  
training curriculum   should teach retail  personnel  about  the need to closely 
examine  photographic  identification  to ensure  that it establishes  both that  the  
person identified  is of  legal  age  to purchase  cigarettes,  smokeless tobacco, and 
covered tobacco products  and that  the identification  belongs  to the  person who is  
presenting it.   The  training curriculum   also should instruct employees  to decline  a  
sale because  of  concerns about  the authenticity of  the photographic   identification.    
This  portion of  the training should stress  that many illegal   sales are  made to 
minors  who produce identifications   showing that  they are  under the  legal  age  to 
purchase cigarettes,  smokeless tobacco,  and covered tobacco products.  
Specifically,   studies  have shown that illegal  sales to minors  frequently occur  
when a retail  employee  fails  to verify the age  of  the purchaser who has produced 
the identification,   especially when the minor  appears to be confident,  produces  a  
 
13  

  Contains Nonbinding Recommendations  
 
photographic   identification  without  being asked,  and appears to be over  the age  of  
18.30,  31  
 
	   How to Verify the Authenticity  of Photographic Identification.  Program content  
should include  information  on the  features of  a photographic   identification  that  
should be checked.  These could include,  but  are  not  limited  to:    
 	 Close  examination  of the picture  and physical  characteristics listed  on  the 
identification  (such as  height,  weight,  and eye  color)  to ensure that  the  
identification  belongs  to the person who has presented it.   
 	 Examination  of  the identification  to ensure any required watermarks or  
State seals are present.  
 	 Examination  of the  identification  for visual  clues to assist in determining 
whether it  belongs  to an of age or underage  customer in States  where  
photographic   identification  has different  features for  individuals   under  age  
21 or under  age  18 (such as vertical  versus horizontal   orientation  or  
different font color  on the  date  of birth).    
 
	   Altered Photographic  Identification.   Training also should discuss how to 
determine  whether a  photographic   identification  might  have been altered and what  
an employee  should do if  a photographic   identification  appears to be altered.   
Specifically,   the  training  program  should provide detailed information  on signs of  
an altered photographic   identification,   which include,   but are  not limited  to:    
	  Any sign of tampering  
	  Peeling lamination    
	  Smudged print  
	  Differences in font  on the date of birth or expiration  date  
 
	   Specific Age-Verifying Techniques.   Training content  should include detailed 
information  on company-approved  techniques  designed to ensure that the date of  
birth on photographic   identification  is  read and clearly understood.  For example,  
retailers may choose  to implement   one or  more of  the following  techniques  to 
assist employees  in  calculating  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 on the  photographic   identification  in order for that  person to 
purchase cigarettes,  smokeless tobacco,  and covered tobacco products.  
 	 Installing  price  scanners that are  programmed so that  when a  tobacco 
product  is scanned,  the register  displays  a  message prompting  the  
                                              
30  Pearson, D., et al., Youth tobacco sales in a metropolitan county:   factors associated with compliance,  American 

Journal of Preventive Medicine, 33(2); 91-97, 2007.  

31 Klonoff, E., and Landrine, H., Predicting Youth Access to Tobacco:   The Role of Youth Versus Store-Clerk 

Behavior and Issues of Ecological Validity,  Health Psychology, 23(5); 517-24, 2004.  

 
14 
 
  Contains Nonbinding Recommendations  
 
employee either  to request age identification  and key in the purchasers  
date of birth or to verify that  the purchaser is over  the age  of  26.  
 	 Requiring  employees to scan all photographic   identifications   through an 
electronic age verification  device.  
 
	   Insufficient Photographic Identification.  Training also should inform  
employees  of how  and when they should ask for  a  second piece  of photographic  
identification  containing  the purchasers date  of  birth and instruct  employees  to 
decline  a  sale  when the photographic   identification  does not appear  to be  
authentic.  
 
  6.   Refusing Sales  
 
	   Practical Guidance for Refusing Sales When  Appropriate.   FDA recommends  
that training  programs  incorporate  role-playing  (e.g., practice  sessions with retail  
employees  playing  roles  as clerks  and customers  to simulate  possible  sales  
transactions)  to ensure  that  employees can effectively apply training  information 
and perform  the  tasks  outlined  in the training program.  Role-playing  should 
address difficult   situations  and should assist employees  in determining  when and 
how to:  
 	 Decline purchase attempts by a minor  made with written  parental  
permission.  
 	 Decline to sell cigarettes,  smokeless tobacco, and covered tobacco 
products  to underage persons  who are  friends and acquaintances.  
 	 Decline a sale when the customer  has no photographic   identification,   the  
photographic   identification  contains  no date of birth,  the photographic  
identification  has  expired,  the photographic   identification  does not  appear  
to be authentic,  or the photographic   identification  shows the customer  to 
be underage.  
 	 Resist customer  pressure.  
 	 Seek management  assistance,  when necessary.  
 
Other situations  or issues  should be included in role-playing   exercises, as  needed.    
 
	   The Right to Refuse Sales  When Acting in Good Faith.  The  training curriculum  
should teach retail  personnel  that employees  are  not  required to make a cigarette,  
smokeless tobacco,  or covered tobacco product  sale if  there is any question that  
doing so would violate  the law.  
 
  7.   Testing to Ensure  That Employees Have the Knowledge Required   
 
Retailers should require employees  to take  a  written test,  using any content, format,  and 
method determined by the retailer  to be appropriate,  that covers the Federal  laws, 
including   regulations,   related to the sale and distribution,  including  youth access,   and the  
 
15  

  Contains Nonbinding Recommendations  
 
advertising and promotion  of cigarettes,  smokeless tobacco,  and covered tobacco 
products.32   Each employee  should attain a score  sufficient  to demonstrate  that he or she  
possesses the  knowledge  necessary to comply with  the law.  Retailers  should maintain 
records documenting  that all  individual   employees  have been trained,  including:  
	   One copy of the test given to employees  and the correct answers.   
	   A record of the test results for  each employee,  including  the employees  name, the 
date(s) of testing,  the test given to the  employee  (if the  retailer  has more than one  
test for such training),   and the employees  test  score.33  
 
Retailers  should determine  the format of  the records (e.g., paper,  electronic)  and should 
retain  the records for 4 years in order  to be able  to provide  evidence  of a  training  program  
during the 48-month time period covered by the  civil  money penalty schedules  in section 
103(q)(2)(A)  of the Tobacco Control  Act.  
 
B.   What  are the recommendations for  training  frequency,  methods, and 
review?  
 
  1.   Frequency   
 
Current employees should be  trained as  soon as  practicable.   New  retail  employees  
should be trained prior  to selling  cigarettes,  smokeless tobacco,  and covered tobacco 
products.   All employees should receive refresher  training,   including,   but not limited  to,  
any  necessary re-training,   updates to company policies  or the  law, testing,  and role-
playing  exercises.  Refresher  training should be provided at least yearly and more  
frequently as needed.   For  instance, retailers  should consider requiring  refresher  training 
and testing for  employees if  a  retail  employee is  found selling cigarettes,  smokeless 
tobacco,  or covered tobacco products  to persons under  the age of 18.   
 
  2.   Methods   
 
The training curriculum   may be delivered by any appropriate  method,  including,   but  not  
limited   to, in-store training while on the  job,  a  trainer  in a  classroom setting, via  written 
materials  provided to store personnel  for self-study,  or via  Web or  other computer-based 
applications.    
 
  3.   Training Program Review Following a Violation of the Regulations  
 
FDA  recommends that  retailers review and update their training  program,  as  needed, and 
take appropriate  corrective action after  any violation  of the regulations  restricting sale  
and distribution,  including  youth access, and advertising and promotion  of cigarettes,  
smokeless tobacco,  and covered tobacco products.   Retailers should document any 
modifications   to the training program  following  such a  review  and should retain the  
records for 4 years in order  to be able  to provide  evidence  of a  training  program  during 
                                              
32  See section II of this guidance. 
 
33  Retailers may determine how to document and  retain this information (e.g., logbook, spreadsheet, database). 
 
 
16  

  Contains Nonbinding Recommendations  
 
the 48-month time period covered by the  civil  money penalty schedules  in section 
103(q)(2)(A)  of the Tobacco Control  Act.  
 
C.   What  hiring  and management practices support a retailer training  program?  
 
FDA recommends  that appropriate retailer  hiring  and  management  practices be implemented  as  
part of a retailer  training program.  
 
  1.   Hiring Practices  
 
FDA recommends  that retailers  consider  requiring  employees  who sell  cigarettes,  
smokeless  tobacco,  and covered tobacco products  to be at least 18  years  of  age.34   Studies  
have shown that employees  under  the age of 18 are  more likely  to sell  tobacco to minors  
than are older clerks.35   Also,  facilities  that  employ persons younger  than 18 years  of age  
must not have  vending machines  for  the sale of cigarettes,  smokeless  tobacco,  or covered  
tobacco products  (21 CFR 1140.14(a)(3);  21 CFR 1140.14(b)(3);   21 CFR 1140.16(c)(1)),  
or self-service displays  for  the  sale of  cigarettes or smokeless  tobacco (21  CFR  
1140.16(c)(1)).  
 
  2.   Management Practices  
 
Retailers  should consider  implementing  an internal compliance check program,  also 
known as  a  mystery shopper program, taking into account  any State or local  laws related  
to such programs.   Internal compliance  checks  should be  performed at  random and 
varying times  of the day and at least once every 6 months.  Employees  who fail  the  
internal  compliance  check should be notified immediately  and given additional  training.  
 
Retailers who have in-store videotaping  should periodically  review the  tapes  to ensure  
that employees  are  complying  with sales  to minor  laws  and store policies  related to 
reducing the illegal   sale of  cigarettes, smokeless tobacco, and covered tobacco products  
to underage  youth.  Specifically,   retailers  should review  the tapes to ensure that store  
employees  are  requesting and examining  photographic   identification  from customers who 
are under  the age of 27.  
 
Retailers should consider establishing  company policies  that take employee  performance  
on compliance  checks  into account.  In particular,  retailers  should consider  establishing 
appropriate corrective measures,  in accordance with State and  local  law, for employee 
noncompliance.   FDA recommends  that retailers  document  the procedures  and corrective  
actions  for their  internal  compliance  check program.  Such records should be retained for  
4 years in order to be able  to provide  evidence  of a  training  program  during the 48-month 
                                              
34  FDA regulations do not establish a minimum age for employees who sell tobacco products, but some State or  
local laws may do so.   FDA recommends that retailers contact State and local authorities for information about any 
age requirements. 
35 DiFranza, J.R., and Coleman, M., Sources of tobacco for youths in communities with vigorous enforcement of 
tobacco sales laws, Tobacco Control, 10; 323-328, 2001.  
 
17  

  Contains Nonbinding Recommendations  
 
time period covered by the civil  money penalty schedules in section 103(q)(2)(A)  of  the  
Tobacco Control  Act.  
  
To ensure that  management  has a vested interest  in  employee compliance with  laws  
prohibiting  the sale  of  cigarettes, smokeless tobacco, and covered  tobacco  products  to 
underage  youth, retailers  also should consider making a  stores  compliance rate  a  
component  of a  retail  supervisors  performance  reviews, if permitted by law.  
 
V. 	  HOW CIVIL MONEY PENALTIES WILL BE ASSESSED FOR VIOLATIONS  
OF REGULATIONS  
 
The Tobacco Control  Act  does not require retailers to implement   retailer training  programs.   
However, it  provides  for two schedules  of civil  money penalties  for violations   of restrictions  
promulgated  under  section 906(d) of the  FD&C  Act, as  amended by the  Tobacco  Control Act,  
pertaining  to the sale and distribution  of  tobacco products, including  youth access,  and  
advertising and promotion  restrictionsa schedule of  lower penalties  for retailers  who have 
implemented  a  training  program that complies  with the  standards  set  by FDA  and a  schedule of  
higher  penalties  for those  who have not.    
 
Retailers are  under no obligation  to submit  their  training programs for FDA  review  because  this  
is  a  voluntary program.   Until FDA  promulgates regulations establishing  standards  for approved 
retailer  training  programs, the  Agency intends to seek penalties in accordance  with section 
103(q)(2)(A)(i)  of the  Tobacco Control  Act  (for retailers  with an approved retailer training  
program),  whether or  not  the retailer  has implemented  a  training program.   FDA may consider  
further reducing the  civil  money penalty for  retailers who have  implemented  a  training  program.    
 
Retailers  who have received a Complaint   for Civil  Money Penalties  or No-Tobacco-Sale Order  
and who wish to submit  evidence that  they have  a  training  program in place, for  purposes of  
settlement  negotiations,   may do so when filing  an Answer  to the Complaint.   Retailers  who have  
not received a  Complaint   should not submit  their training  programs for FDA review.   
 
The Complaint   for Civil  Money Penalties  or No-Tobacco-Sale Order  and the accompanying 
cover  letter will  include  detailed information  on how to file  an Answer  and submit  related 
documentation,   including  evidence  that a retailer  has a  training  program.  Until  FDA  
promulgates  regulations  establishing  standards for approved retailer  training  programs,  the  
Agency may consider  any evidence  of a training program  (e.g., the training curriculum,   the test  
provided to employees  and their  test scores)  in determining  whether to further reduce  the  civil  
money penalty for retailers who violate  the  regulations.36   
 
                                              
36 For additional information, see Guidance for FDA and Tobacco Retailers:   Civil Money Penalties and No-
Tobacco-Sale Orders  For Tobacco  Retailers, available at  
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM252955.pdf.  
 
18  

  Contains Nonbinding Recommendations  
 
 
VI.   PAPERWORK REDUCTION ACT OF 1995
  
This guidance  contains  information  collection  provisions   that  are  subject to review  by the  Office  
of Management and Budget (OMB)  under the  Paperwork Reduction Act  of  1995 (44 U.S.C.  
3501-3520).  
The  time required to complete this  information  collection  is estimated to average  10  hours per  
response,  including  the  time  to review  instructions,  search existing  data  sources,  gather the data 
needed,  and complete  and review the information  collection.  Send comments  regarding this  
burden estimate or  suggestions  for  reducing this burden to:  
Food and Drug Administration  
Center for Tobacco Products  
Document Control  Center  
Building  71,  Room G335  
10903 New  Hampshire Avenue  
Silver Spring, MD  20993  
 
An agency may not conduct or  sponsor,  and a  person is not required to respond to, a  collection  of  
information  unless  it  displays  a  currently valid OMB control  number.  The OMB control  number  
for  this  information  collection  is  0910-0745  (expires  12/31/2019).  
 
 
DOCUMENT HISTORY:  
	   September 2013   Final guidance was  issued.  
 
	   June 2014   Pages 4-5 were  updated with new  Civil  Money Penalty amounts that reflect  
inflation,   as  required by the  Federal Civil  Penalties Inflation Adjustment  Act; references  
to CTPs  address updated throughout   the  document.  
 
	   May 2018    Throughout   the document,  edits  were  made to improve  the clarity  of the  
document  and to  reflect the provisions   that apply to covered tobacco products  under  the  
Deeming Rule; Pages  2 and 3 were  edited to discuss the Deeming Rule; Pages  6 and 7  
were updated to reflect  amendments to the  Civil  Money Penalty Inflation  Adjustment  Act  
and to include  reference  to the CTP  website  for current amounts; Pages  8 and 9 have  been 
edited to include  definitions   for the terms accessory, component  or part, and 
covered tobacco product.  
 
	   June  2018   A footnote  was  added to page 4 to clarify that  the effective date of the new  
health warning requirements  for covered tobacco products,  cigarette tobacco, and RYO  
tobacco is  with respect  to the date of manufacture.  
	   August 2018   Section II  of guidance  is  revised  to reflect  a stay of  enforcement of  the  
warning requirements  for cigars  and pipe  tobacco (21 CFR    1143.3 and 1143.5)  after 
the  United States  District Court  for the  District  of Columbia   granted plaintiffs   motion 
 
19  

  Contains Nonbinding Recommendations  
 
for an injunction  pending appeal.  Cigar Assn of America v. FDA, No. 1:16-cv-01460 
(D.D.C.)  (order  granting injunction  pending appeal).    
  Clarifying  and corrective  edits  made throughout   the document.  
 
 
20