[Code of Federal Regulations]
[Title 16, Volume 1]
[Revised as of January 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 16CFR307.4]

[Page 331-332]
 
                     TITLE 16--COMMERCIAL PRACTICES
 
                   CHAPTER I--FEDERAL TRADE COMMISSION
 
PART 307_REGULATIONS UNDER THE COMPREHENSIVE SMOKELESS TOBACCO HEALTH 
EDUCATION ACT OF 1986--Table of Contents
 
Sec. 307.4  Prohibited acts.

    (a) No manufacturer, packager, or importer of any smokeless tobacco 
product shall distribute, or cause to be distributed, in commerce any 
smokeless tobacco product in a package that, in accordance with the 
labeling requirements of the Act and these regulations, does not bear 
one of the following warning statements.

WARNING: THIS PRODUCT MAY CAUSE MOUTH CANCER

WARNING: THIS PRODUCT MAY CAUSE GUM DISEASE AND TOOTH LOSS

WARNING: THIS PRODUCT IS NOT A SAFE ALTERNATIVE TO CIGARETTES


Each smokeless tobacco product shall upon being prepared for 
distribution in commerce for retail sale, but before it is distributed 
to be offered for retail sale, be labeled in accordance with the Act and 
regulations in this part. In the case of an importer, the label 
statements may be affixed in the country of origin or after importation 
into the United States, but shall be affixed before the smokeless 
tobacco product is removed from bond for sale or distribution. This 
section does not apply to any smokeless tobacco product that is 
manufactured, packaged, or imported in the United States for export from 
the United States, if the product is not in fact distributed in commerce 
for use in the United States.
    (b) No manufacturer, packager, or importer of any smokeless tobacco 
product shall advertise or cause to be advertised (other than through 
the use of billboard advertising) within the United States any smokeless 
tobacco product unless the advertising bears one of the warning 
statements as required by the Act and the regulations and set forth in 
Sec. 307.4(a). This requirement is not applicable to company and 
divisional names, when used as such, to signs on factories, plants, 
warehouses, and other facilities related to the manufacturer or factory 
storage of smokeless tobacco, to corporate or financial reports, to 
communications to security holders and others who customarily receive 
copies of these communications, to employment advertising, to 
advertising in tobacco trade publications, or to promotional materials 
that are distributed to smokeless tobacco wholesalers, dealers, or 
merchants, but not to consumers. In addition, this requirement does not 
apply to shelf-talkers and similar product locators with a display area 
of 12 square inches or less.
    (c) No manufacturer, packager, or importer shall fail to submit a 
plan to the Commission which specifies the method that will be used to 
rotate, display, and distribute the statements required by the Act and 
regulations in this part. The Commission shall approve a plan if the 
plan provides for the rotation, display, and distribution of the 
statements in a manner that complies with the Act and these regulations. 
Authority to approve plans submitted by smokeless tobacco manufacturers, 
packagers, and importers has been delegated by the Commission to the 
Associate Director for Advertising Practices. Where significant issues 
not previously considered by the Commission are present, however, those 
plans will be referred by the Associate Director for Advertising 
Practices to the Commission in the first instance. This delegation is 
authorized by section 1(a) of the Reorganization Plan No. 4 of 1961 in 
order to enhance the efficiency and

[[Page 332]]

result in expedited treatment of these plans. Pursuant to section 1(b) 
of the Reorganization Plan, the Commission will retain the discretionary 
right to review the actions of the delegate. Any smokeless tobacco 
manufacturer, packager, or importer may within 30 days of the delegate's 
action file with the Secretary of the Commission a request for full 
Commission review of the action. If no review is sought by petition of 
the submitter of a plan or any intervenor or upon the Commission's own 
initiative within 30 days of the action, or if a review is sought and 
denied in this 30 day period, the delegate's action shall be deemed to 
be the action of the Commission.
    (d) A manufacturer, packager, or importer of smokeless tobacco 
products shall be deemed to be in compliance with the Act and these 
regulations if it has taken reasonable steps to:
    (1) Provide, by written contract or other clear instructions, for 
the rotation of the label statements required by the Act;
    (2) Give clear instructions and, if possible, furnish materials 
(such as film negatives, acetates, or other facsimiles) for the 
production of smokeless tobacco packages and advertising that contain 
the required warning statements; and
    (3) Prevent and correct mistakes, errors, or omissions that have 
come to its attention.

In the event of the distribution of labels or the publication of 
advertisements that do not conform with the Act and these regulations, 
the burden of establishing that reasonable steps have been taken 
(including fulfilling the conditions described in paragraphs (d) (1) 
through (3) of this section) to comply shall rest with the manufacturer, 
packager, or importer of smokeless tobacco.

[51 FR 40015, Nov. 4, 1986, as amended at 56 FR 11662, Mar. 20, 1991]