Contains Nonbinding Recommendations 
 
 
 
Guidance for Industry 
   and FDA Staff    
 
 
 
Enforcement Policy Concerning 
Certain Regulations Restricting 
the Sale and Distribution of 
Cigarettes and Smokeless Tobacco 
 
Document issued on May 7, 2010 
 
 
 
 
For questions regarding this guidance, contact the Center for Tobacco Products at (Tel) 1-877- 
287-1373 or refer to 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm. 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Tobacco Products 
  1    Contains Nonbinding Recommendations 
 
 
 
Preface 
 
 
 
Public Comment 
 
Written comments and suggestions may be submitted at any time for Agency consideration to 
the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Alternatively, electronic comments may be 
submitted to  http://www.regulations.gov. All comments should be identified with the docket 
number listed in the notice of availability that publishes in the Federal Register. 
 
 
 
Additional Copies 
 
Additional copies are available from:  
Food and Drug Administration 
Center for Tobacco Products 
Document Control Center 
Building 71, Room G335 
10903 New Hampshire Avenue 
Silver Spring, MD 20993-0002 
(Tel) 1-877-287-1373 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm 
  2    Contains Nonbinding Recommendations 
 
 
 
Guidance for Industry and FDA Staff 
 
 
 
Enforcement Policy Concerning 
Certain Regulations Restricting 
the Sale and Distribution of 
Cigarettes and Smokeless Tobacco 
   
This guidance represents the Food and Drug Administration's (FDA's) 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. 
   
 
 
 
This guidance is intended to provide information related to certain provisions of the 
regulations restricting the sale and distribution of cigarettes and smokeless tobacco.  See 
75 Federal Register 13225 (March 19, 2010).  These regulations are effective June 22, 
2010.1 More specifically, this guidance provides clarifying information related to FDAs 
enforcement policy concerning 21 CFR sections 1140.16(a) and 1140.32(a) of the final 
rule. 
 
Section 1140.16(a). 
 
Under this section of the final rule, 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.  FDA is aware of 
concerns regarding this provision and is considering what changes, if any, would be 
appropriate to address those concerns.2   While FDA has this issue under consideration, it 
intends to exercise its enforcement discretion concerning 21 CFR 1140.16(a) not to 
 
 
1 The final rule published March 19, 2010, in the Federal Register, and is available at the Center for 
Tobacco Products website: http://www.fda.gov/tobaccoproducts. 
2   Under section 102(a)(3)-(4) of Family Smoking Prevention and Tobacco Control Act (21 USC 387a- 
1(a)(3)-(4)), FDA may amend the final rule after issuing a proposed rule for notice and comment. 
  3    Contains Nonbinding Recommendations 
 
 
 
commence enforcement actions under this provision for the duration of its consideration 
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 non-tobacco product 
bearing the same name; provided, however, that the tobacco and non-tobacco product are 
not owned, manufactured, or distributed by the same, related, or affiliated entities 
(including as a licensee). 
 
 
 
Section 1140.32(a). 
 
Under this section of the final rule, manufacturers, distributors, and retailers must use 
only black text on a white background for labeling or advertising (with certain 
exceptions). The United States District Court for the Western District of Kentucky 
recently issued an order permanently enjoining FDA from enforcing section 21 CFR 
1140.32(a) (formerly section 897.32(a) of the 1996 final rule) (Commonwealth Brands, 
Inc. v. United States, No. 1:09-CV-117-M (W.D. Ky. Jan. 4, 2010)).  The injunction 
prevents enforcement of this provision against the parties to the case in any jurisdiction in 
the United States.  On March 8, 2010, the government filed an appeal from that order. 
 
As required by section 102 of the Tobacco Control Act, the effective date for 21 CFR 
1140.32(a) is June 22, 2010.  At this time, however, in light of the court's order in 
Commonwealth Brands, FDA intends to exercise its enforcement discretion concerning 
21 CFR 1140.32(a) not to commence enforcement actions under this provision during the 
pendency of the litigation irrespective of whether the entity is a party to the pending 
lawsuit or located in the Western District of Kentucky. 
  4