Contains Nonbinding Recommendations 
Draft - Not for Implementation 
Draft Guidance for Industry and 
FDA Staff  
 
 
The Scope of the Prohibition Against 
Marketing a Tobacco Product in 
Combination with Another Article or 
Product Regulated under the Federal 
Food, Drug, and Cosmetic Act 
 
 
 
DRAFT GUIDANCE 
 
This guidance document is being distributed for comment purposes only.  
Document issued on: September 30, 2009. 
 
Comments and suggestions regarding this draft document should be submitted within 90 days 
of publication in the Federal Register of the notice announcing the availability of the draft 
guidance.  Submit written comments 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. 
 
For questions regarding this document contact Michele Mital at 301-796-4800.  
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Tobacco Products 
 
  1 Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
Preface 
 
Additional Copies 
Additional copies are available from the Internet at http://www.fda.gov/TobaccoProducts .  
You may also send an e-mail request to Michele.Mital@fda.hhs.gov to receive an electronic 
copy of the guidance. 
 
  2 Contains Nonbinding Recommendations 
Draft - Not for Implementation 
Draft Guidance for Industry and FDA 
Staff 
 
  
 
The Scope of the Prohibition Against 
Marketing a Tobacco Product in 
Combination with Another Article or 
Product Regulated under the Federal Food, 
Drug, and Cosmetic Act  
 
This draft guidance, when finalized, will represent the Food and Drug Administration's 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.  
I.  Introduction  
 
This guidance is intended for manufacturers, retailers, importers, and FDA staff.  The 
guidance describes FDAs current thinking regarding the scope of the provision prohibiting 
the marketing of a tobacco product in combination with another product regulated under the 
Federal Food, Drug, and Cosmetic Act (FDCA).  It is not intended to be an exhaustive 
analysis of all activities that may or may not fall within the scope of the prohibition. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's 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.  Discussion 
 
 
Section 201(rr)(4) of the FDCA, as amended by the Family Smoking Prevention and 
Tobacco Control Act (FSPTCA), states:  
 
  3 Contains Nonbinding Recommendations 
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A tobacco product shall not be marketed in combination with any other article 
or product regulated under this Act (including a drug, biologic, food, cosmetic,  
medical device, or a dietary supplement) 
 
This guidance discusses certain activities that FDA believes do or do not fall within the scope 
of the prohibition.  The guidance is not intended to be an exhaustive analysis of all activities 
that may or may not fall within the scope of the prohibition. 
 
A.   FDA believes the following activities are included within the scope of section 201(rr)(4) 
of the FDCA and, therefore, are prohibited:  
 
A tobacco product and a non-tobacco product regulated under the FDCA are physically, 
chemically, or otherwise combined or mixed to produce a single entity that is marketed as 
containing both products.  For example: 
  
  Mouthwash (which may be a drug or a cosmetic under the FDCA) is added to 
the ingredients of a cigarette and the cigarette is identified as containing 
mouthwash. 
  Compressed or powdered tobacco is added to candy or gum (which are foods 
under the FDCA) and the candy or gum is identified as containing a tobacco 
product.  
  Nicotine that is derived from tobacco is added to water, juice, or soda (which 
are foods under the FDCA) and the water, juice, or soda is identified as 
containing a tobacco product. 
 
A tobacco product and a non-tobacco product regulated under the FDCA are packaged 
together in a single package or as a unit.  For example: 
 
  A pack of cigarettes is shrink-wrapped or sold in a box, bag, or other container 
with a bottle of mouthwash.   
  A pack of cigarettes is shrink-wrapped or sold in a box, bag, or other container 
with a skin cream. 
 
A coupon for a discount on a specifically identified non-tobacco product regulated under the 
FDCA is offered contingent upon the purchase of a tobacco product. For example: 
 
  A coupon for a 50 cent discount on a specifically identified mouthwash is 
offered contingent upon the purchase of a pack of cigarettes.   
 
B.  FDA believes the following activities are not included within the scope of section 
201(rr)(4) of the FDCA and, therefore, are not prohibited under that section: 
 
A tobacco product and a non-tobacco product regulated under the FDCA are advertised on 
the same store sign or in the same store circular.  For example: 
 
  4 Contains Nonbinding Recommendations 
Draft - Not for Implementation 
  Cigarettes and mouthwash are advertised on the same sign in a store window 
or in the same store advertising circular. 
 
A tobacco product and a non-tobacco product regulated under the FDCA are sold in the 
same retail establishment or advertised in the same place.  For example: 
 
  Cigarettes and mouthwash are sold in the same store or are advertised in the 
same magazine. 
 
Two or more tobacco products are packaged together in a single package or as a unit. 
 
  A pack of cigarettes is sold in a box, bag, or other container with a package of 
pipe tobacco. 
 
 
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