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U.S. Department of Health and Human Services

Tobacco Products

Letter to Tobacco Manufacturers on Tobacco Products Labeled or Advertised with the Descriptors “Light,” “Low,” “Mild,” or Similar Descriptors

Food and Drug Administration
Center for Tobacco Products
9200 Corporate Boulevard
Rockville MD 20850-3229

June 17, 2010

Dear Tobacco Manufacturer:

The Food and Drug Administration (FDA) is providing this notice to remind manufacturers, including importers of finished tobacco products, that on or after 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 Federal Food, Drug, and Cosmetic Act (FFDCA or the Act) (section 911(b)(3) of the Act). 

In addition, on or after 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 the same section of the law cited above. 

Tobacco use is the leading preventable cause of death in the United States.  In prohibiting the use of “light,” “mild,” and “low,” Congress found that many smokers mistakenly believe that cigarettes marketed with those 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 has determined that prohibiting the use of “light,” “mild,” and “low” and similar descriptors is necessary to protect the public health and important to ensure that tobacco product label, labeling, and advertising are truthful and not misleading. 

On or after 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) of the Act with respect to such product (section 911(b)(3) of the Act).  Under section 301(pp) of the Act, the introduction or delivery for introduction into interstate commerce of a tobacco product in violation of section 911 is a prohibited 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 the Act, adulterated products sold or held for sale in the United States may be subject to seizure under section 304 of the Act.  In addition, manufacturers, including importers of finished tobacco products, may be subject to injunction actions, civil money penalty proceedings, and/or criminal prosecution for violating the requirements of the Act (FFDCA, sections 301, 302, 303).  FDA intends to use the full range of enforcement tools within the Agency’s authority to ensure compliance with the new requirement. 


For more information, please see the guidance for industry and FDA staff titled, “Use of ‘Light,’ ‘Mild,’ ‘Low,’ or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products” found at:  http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm214597.htm.  If you have any questions about this provision of the new law, please contact FDA at 1-877-CTP-1373 , or email them to:  TobaccoIndustryQuestions@fda.hhs.gov. 

 

Sincerely,

/s/

Lawrence R. Deyton, M.S.P.H., M.D.
Director, Center for Tobacco Products