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

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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.
Contains Nonbinding Recommendations

3

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
Contains Nonbinding Recommendations

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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.