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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2017]
[CITE: 21CFR1143.3]
See Related Information on Required warning statement regarding addictiveness of nicotine. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER K--TOBACCO PRODUCTS

PART 1143 -- MINIMUM REQUIRED WARNING STATEMENTS

Sec. 1143.3 Required warning statement regarding addictiveness of nicotine.

(a) Packages. (1) For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States such product unless the tobacco product package bears the following required warning statement on the package label: "WARNING: This product contains nicotine. Nicotine is an addictive chemical."

(2) The required warning statement must appear directly on the package and must be clearly visible underneath any cellophane or other clear wrapping as follows:

(i) Be located in a conspicuous and prominent place on the two principal display panels of the package and the warning area must comprise at least 30 percent of each of the principal display panels;

(ii) Be printed in at least 12-point font size and ensures that the required warning statement occupies the greatest possible proportion of the warning area set aside for the required text;

(iii) Be printed in conspicuous and legible Helvetica bold or Arial bold type (or other sans serif fonts) and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other printed material on the package;

(iv) Be capitalized and punctuated as indicated in paragraph (a)(1) of this section; and

(v) Be centered in the warning area in which the text is required to be printed and positioned such that the text of the required warning statement and the other information on the principal display panel have the same orientation.

(3) A retailer of any tobacco product covered by paragraphs (a)(1) and (2) of this section will not be in violation of this section for packaging that:

(i) Contains a health warning;

(ii) Is supplied to the retailer by the tobacco product manufacturer, importer, or distributor, who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable, and

(iii) Is not altered by the retailer in a way that is material to the requirements of this section.

(b) Advertisements. (1) For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for any such tobacco product manufacturer, packager, importer, distributor, or retailer of the tobacco product to advertise or cause to be advertised within the United States any tobacco product unless each advertisement bears the required warning statement specified in paragraph (a)(1) of this section.

(2) For print advertisements and other advertisements with a visual component (including, for example, advertisements on signs, shelf-talkers, Internet Web pages, and electronic mail correspondence), the required warning statement must appear in the upper portion of the area of the advertisement within the trim area as follows:

(i) Occupy at least 20 percent of the area of the advertisement;

(ii) Appear in at least 12-point font size and ensures that the required warning statement occupies the greatest possible proportion of the warning area set aside for the required text;

(iii) Appear in conspicuous and legible Helvetica bold or Arial bold type (or other similar sans serif fonts) and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other material on the advertisement;

(iv) Be capitalized and punctuated as indicated in paragraph (a)(1) of this section;

(v) Be centered in the warning area in which the text is required to appear and positioned such that the text of the required warning statement and the other textual information in the advertisement have the same orientation; and

(vi) Be surrounded by a rectangular border that is the same color as the text of the required warning statement and that is not less than 3 millimeters (mm) or more than 4 mm.

(3) This paragraph (b) applies to a retailer only if that retailer is responsible for or directs the health warning required under the paragraph. However, this paragraph does not relieve a retailer of liability if the retailer displays, in a location open to the public, an advertisement that does not contain a health warning or contains a health warning that has been altered by the retailer in a way that is material to the requirements of this section.

(c) Self-certification. A tobacco product that would otherwise be required to bear the warning in paragraph (a)(1) of this section but does not contain nicotine is not required to bear the warning in paragraph (a)(1) of this section on packages or advertisements if the tobacco product manufacturer has submitted to FDA a confirmation statement certifying to be true and accurate that the product does not contain nicotine and that the tobacco product manufacturer has data to support that assertion. Any product not required to bear the warning in paragraph (a)(1) of this section must include the statement "This product is made from tobacco." on all packages and advertisements in accordance with the requirements of this part.

(d) Small packages. A tobacco product that would otherwise be required to bear the warning in paragraph (a)(1) of this section but is too small or otherwise unable to accommodate a label with sufficient space to bear such information is exempt from compliance with the requirement provided that the information and specifications required under paragraphs (a)(1) and (2) of this section appear on the carton or other outer container or wrapper if the carton, outer container, or wrapper has sufficient space to bear the information, or appear on a tag otherwise firmly and permanently affixed to the tobacco product package. In such cases, the carton, outer container, wrapper, or tag will serve as the location of the principal display panels.

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