Guidance for Industry and 
   FDA Staff    
 
 
 
Use of Light, Mild, Low, or 
Similar Descriptors in the Label, 
Labeling, or Advertising of 
Tobacco Products 
 
June 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    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, Food and Drug Administration, 
5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.  Alternatively, 
electronic comments may be submitted to http://www.regulations.gov. Please identify 
your comments with the docket number listed in the notice of availability that publishes 
in the Federal Register announcing the availability of this guidance document. 
Comments may not be acted upon by the agency until the document is next revised or 
updated. 
 
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) 1-877-2871373 
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm. 
  2    Contains Nonbinding Recommendations 
 
 
 
Guidance for Industry and 
FDA Staff 
 
 
 
Use of Light, Mild, Low, or 
Similar Descriptors in the Label, 
Labeling, or Advertising of 
Tobacco Products 
 
 
    
 
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 provides information in response to questions related to the use of light, 
mild, low, or similar descriptors in the label, labeling, or advertising of tobacco 
products, as provided in section 911(b) of the Federal Food, Drug, and Cosmetic Act (the 
act), as amended by the Family Smoking Prevention and Tobacco Control Act (Public 
Law 111-31). 
 
I. Background 
 
Section 911(b)(2)(A)(ii) of the act prohibits the use of the descriptors light, mild, or 
low, or similar descriptors in tobacco product label, labeling, or advertising unless an 
FDA order is in effect under section 911(g) with respect to such product. In prohibiting 
the use of light, mild, and low, Congress found that many smokers mistakenly 
believe that cigarettes marketed with these descriptors cause fewer health problems than 
other cigarettes, and that those mistaken beliefs can reduce the motivation to quit 
smoking.  Studies have demonstrated that there has been no reduction in health risk from 
such products, and such products may actually increase the risk of tobacco use.  Congress 
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determined that prohibiting the use of light, mild, and low, and similar descriptors 
was necessary to protect the public health and important to ensuring that tobacco product 
label, labeling, and advertising are truthful and not misleading. 
 
II.  Questions and Answers 
 
1.   What happens on June 22, 2010? 
 
As of June 22, 2010, manufacturers may not manufacture for sale or distribution 
any tobacco products for which the label, labeling, or advertising contains the 
descriptors light, low, or mild, or any similar descriptor, without an FDA 
order in effect under section 911(g) of the act (section 911(b)(3) of the act). 
However, manufacturers may continue to introduce into domestic commerce 
existing inventory of such products for an additional 30 days (section 911(b)(3) of 
the act). 
 
2.   What happens on July 22, 2010? 
 
As of July 22, 2010, manufacturers, including importers of finished tobacco 
products, may not introduce into the domestic commerce of the United States any 
tobacco product for which the label, labeling, or advertising contains the 
descriptors light, low, or mild, or any similar descriptor, irrespective of the 
date of manufacture, without an FDA order in effect under section 911(g) of the 
act (section 911(b)(3) of the act). 
 
3.   How will the prohibition against the use of these descriptors be enforced? 
 
As of July 22, 2010, manufacturers, including importers of finished tobacco 
products, who introduce into domestic commerce any tobacco product for which 
the label, labeling, or advertising contains the descriptors light, low, or 
mild, or any similar descriptor, irrespective of the date of manufacture, will be 
in violation of the act unless an FDA order is in effect under section 911(g) with 
respect to such product (section 911(b)(3) of the act). Under section 902(8) of the 
act, a tobacco product shall be deemed to be adulterated if it is in violation of 
section 911 of the act. 
 
Under section 304 of the act, adulterated tobacco products that are sold or held for 
sale in the United States are subject to seizure, and under section 801(a) of the act, 
adulterated tobacco products that are imported into the United States are subject 
to refusal of admission. In addition, FDA has the authority to initiate, among 
other actions, injunction actions, civil money penalties, and/or criminal 
prosecution to address violations of the act (sections 302 and 303 of the act). 
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4.   May distributors, wholesalers, and retailers distribute or sell tobacco 
products in their possession for which the label, labeling, or advertising 
contains the descriptors light, low, or mild, or any similar descriptor 
after July 22, 2010? 
 
Yes, if the products were manufactured before June 22, 2010, and introduced into 
domestic commerce by the manufacturer, which includes an importer of finished 
tobacco products, before July 22, 2010. 
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