[Federal Register: May 22, 2001 (Volume 66, Number 99)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF THE TREASURY
Bureau of Alcohol, Tobacco and Firearms
27 CFR Part 16
[Notice No. 917]
Alcohol Beverage Health Warning Statement (99R-507P)
AGENCY: Bureau of Alcohol, Tobacco and Firearms (ATF), Department of
ACTION: Advance notice of proposed rulemaking.
SUMMARY: The Bureau of Alcohol, Tobacco and Firearms (ATF) is
considering amending the regulations concerning the placement,
legibility, and noticeability of the congressionally mandated health
warning statement required to appear on the labels of all containers of
alcohol beverages. Based on a petition we have received, we wish to
gather information by inviting comments from the public and industry as
to whether the existing regulations should be revised.
DATES: Comments must be received on or before August 20, 2001.
ADDRESSES: Send written comments to: Chief, Regulations Division;
Bureau of Alcohol, Tobacco and Firearms; P.O. Box 50221; Washington, DC
20091-0221; ATTN: Notice No. 917. Written comments must be signed, and
may be of any length.
E-mail comments may be submitted to: firstname.lastname@example.org. E-
mail comments must contain your name, mailing address, and e-mail
address. They must also reference this notice number and be legible
when printed on not more than three pages 8 1/2" x 11" in size. We
will treat e-mail as originals and we will not acknowledge receipt of
e-mail. See the Public Participation section at the end of this advance
notice for requirements for submitting written comments by facsimile.
FOR FURTHER INFORMATION CONTACT: James P. Ficaretta, Regulations
Division, Bureau of Alcohol, Tobacco and Firearms, 650 Massachusetts
Avenue, NW., Washington, DC 20226 (202-927-8210).
Title VIII of the Anti-Drug Abuse Act of 1988, Public Law 100-690
(enacted November 18, 1988), amended the Federal Alcohol Administration
Act (FAA Act) by designating the existing sections of the FAA Act as
"Title I," and by adding at the end a new title, "Title II--
Alcoholic Beverage Labeling." This title, cited as the "Alcoholic
Beverage Labeling Act of 1988" (ABLA), requires that the following
health warning statement appear on the labels of all containers of
alcohol beverages for sale or distribution in the United States:
GOVERNMENT WARNING: (1) According to the Surgeon General, women
should not drink alcoholic beverages during pregnancy because of the
risk of birth defects. (2) Consumption of alcoholic beverages
impairs your ability to drive a car or operate machinery, and may
cause health problems.
The health warning statement requirement applies to alcohol
beverages bottled on or after November 18, 1989, and applies both to
interstate and intrastate sale and distribution of alcohol beverages.
In addition, the health warning statement must appear on containers of
alcohol beverages that are sold, distributed, or shipped to members or
units of the U.S. Armed Forces, including those located outside the
United States. For purposes of the ABLA, the term "alcoholic
beverage" includes any beverage in liquid form which contains not less
than one-half of one percent (.5%) of alcohol by volume and is intended
for human consumption.
The law specifies that the health warning statement "shall be
located in a conspicuous and prominent place on the container of such
beverage, as determined by the Secretary [of the Treasury], shall be in
type of a size determined by the Secretary, and shall appear on a
On February 14, 1990, we issued final regulations in 27 CFR Part 16
implementing the provisions of the ABLA (T.D. ATF-294; 55 FR 5414).
These regulations became effective on November 14, 1990. The final rule
was preceded by a notice of proposed rulemaking (Notice No. 678,
February 16, 1989; 54 FR 7164), which solicited comments on our
temporary regulations (T.D. ATF-282, February 16, 1989; 54 FR 7160).
The temporary regulations applied to products bottled between November
18, 1989, and November 13, 1990.
The final regulations provide that the health warning statement
must appear on the brand label or separate front label, or on a back or
side label, separate and apart from all other information. It must be
readily legible under ordinary conditions, and must appear on a
contrasting background. Furthermore, labels bearing the health warning
statement must be firmly affixed to the container. In order to ensure
that the consumer's attention is drawn to the health warning statement,
the regulations require that the words "GOVERNMENT WARNING" appear in
capital letters and in bold type. The remainder of the warning
statement may not appear in bold type.
The regulations specify the maximum number of characters (i.e.,
letters, numbers, marks) permitted per inch in which the health warning
statement may appear. This requirement is intended to ensure that the
warning statement is more easily read by the average consumer.
Additionally, the regulations prescribe minimum type size requirements
for the health warning statement.
We have received a petition, dated November 17, 1999, filed on
behalf of the Center for Science in the Public Interest (CSPI), four
members of Congress, the National Council on Alcoholism and Drug
Dependence, Inc. (NCADD), and 119 other organizations, requesting an
amendment of the regulations regarding the legibility, clarity, and
noticeability of the health warning statement. The petitioners included
citations to research to support their proposed amendments.
Specifically, the petitioners request that the regulations in Part 16
be amended to require the following:
1. The health warning statement must appear in a prominent place on
the front of the container in a horizontal position. The petitioners
contend that many alcohol producers position the warning statement
vertically on the margin of the label, thus making the label difficult
to read when the container is placed on a shelf. The petitioners also
allege that the warning statement often appears crowded and is embedded
in the surrounding information, making it hard to locate and read.
According to the petitioners, warnings that contain fewer characters
per inch, occupy a larger area on the label, and appear less embedded
in surrounding information tend to be noticed more readily. The
petitioners further state that for maximum effectiveness the warning
information should be easy to locate and should appear in the same
relative position on all labels. Finally, the petitioners claim that
label messages appearing horizontally are significantly more noticeable
than warnings that are printed in a vertical position.
2. The health warning statement must appear in red or black type on
a white background, and be surrounded by a lined border. In addition to
placement on the front of the container, the petitioners claim that the
research suggests two other elements that would
dramatically improve consumer awareness of the alcohol warning
statement, i.e., a clear, lined border surrounding the statement and
text in a highly contrasting color. The petitioners refer to one study
that found that graphic devices such as boxes help consumers recognize
and process a warning message. They refer to another study that found
that color helps immensely to increase awareness of warning labels; in
fact, the higher the contrast between text and background, the more
likely consumers are to notice them.
3. The first two words of the health warning statement, i.e.,
"GOVERNMENT WARNING," must appear in capital letters and boldface
type that is at least 15 percent larger than the remaining text of the
statement. The text of the remaining portion of the warning statement
must be in upper and lower-case lettering. A particular type font
should be required to maximize legibility. According to the
petitioners, one researcher found that the degree to which the phrase
"GOVERNMENT WARNING" stood out from the rest of the label was a
significant predictor of the consumer response time. In this regard,
the petitioners note that in both the statute and the regulations the
words "GOVERNMENT WARNING" appear in capital letters while the text
of the statement appears in upper and lower-case letters. However, the
regulations do not specify that the text of the warning statement must
appear in upper and lower-case letters. The petitioners maintain that
it is harder to read the warning when the entire statement appears in
4. The warning statement must appear together with a red pictorial
device or icon that is a triangle with an exclamation mark inside. As
proposed by the petitioners, the warning statement would appear as
[GRAPHIC] [TIFF OMITTED] TP22MY01.017
According to the petitioners, several studies have shown that the
inclusion of an icon or pictorial element substantially heightens
consumer recognition of a warning label. In studies of the way consumer
eye-movements track warning labels, the petitioners state that one
researcher specifically studied a triangular icon with an exclamation
mark inside it and found that this icon produced significantly faster
response times than warnings without the icon.
With the above modifications, the petitioners believe that the
health warning statement will be "more noticeable, more effective, and
will help insure that the labels on alcoholic-beverage containers meet
the standards for the warning statement as originally set out by
Review of Petition by Other Federal Agencies and the Surgeon
By letters dated December 3, 1999, ATF asked the Food and Drug
Administration (FDA), the National Institute on Alcohol Abuse and
Alcoholism, the Surgeon General, and the Federal Trade Commission (FTC)
to review the petition and provide us with their comments. We also
asked for available information regarding the latest scientific studies
dealing with the design of alcohol warning labels, as well as any
research on warning labels in general.
In his letter of February 15, 2000, the Surgeon General (on behalf
of the Food and Drug Administration, the Centers for Disease Control
and Prevention, the National Institutes of Health, and the Substance
Abuse and Mental Health Services Administration) noted that it has been
more than a decade since the alcohol health warning statement and
implementing regulations were adopted. As such, revisiting this issue
would be a valuable contribution to the public health as the abuse of
alcohol beverages continues to represent a serious public health
problem. The Surgeon General stated the following:
If the current mandatory health warning is to serve a public
function of informing consumers, it is important that periodic
efforts be made to evaluate the placement of the label, its
legibility, the extent to which manufacturers are complying with
current label requirements, and the level of consumer awareness of
the label, particularly under expected conditions of use.
In addition, the Surgeon General indicated that over the last 10
years there has been an abundance of practical experience and science
about ways to design and disseminate health information on product
packaging. For example, he notes that in Canada and Australia much work
has been done to assess the most effective placement of health warnings
on tobacco products. He also notes that the FDA has unique and relevant
experience in this area through the development and evaluation of food
label and nutrient requirements.
By letter dated March 13, 2000, the FTC advised us that it has
experience with respect to health warnings, including the "Surgeon
General's" warnings required on cigarettes and the warnings required
on smokeless tobacco products. In addition, the FTC recently
recommended to Congress that cigar manufacturers and marketers be
required to comply with a system of multiple rotating warnings, similar
to those now in place for cigarettes and smokeless tobacco. The FTC
also provided us with citations to some of the relevant research on
warning labels with respect to size, placement, pictorials, borders,
etc. If ATF decides to explore modifying the requirements with respect
to the health warning statement, the FTC recommends that we conduct
consumer testing of any proposed changes. Based on its experience, the
FTC states that such research is often useful in assessing the
prominence, noticeability, and understandability of warnings.
ATF is requesting information from consumers, consumer groups,
interest groups, associations, and industry members on the desirability
of amending the regulations with regard to the legibility and
noticeability of the mandated Government health warning statement.
Although we are soliciting comments on the following specific
questions, we are also requesting any relevant information on the
1. Are consumers aware that the health warning statement must
appear on the labels of all alcohol beverages sold in the U.S.?
2. Do consumers look for the warning statement on alcohol beverage
3. Do consumers notice the health warning statement on alcohol
beverage containers? Explain.
4. Do consumers read the warning statement on labels of alcohol
beverages? Why or why not?
5. Are consumers familiar with the information contained in the
alcohol health warning statement?
6. Do consumers find the warning statement on alcohol beverages
difficult to read? Explain.
7. Do consumers have examples of alcohol beverages where the
warning statement is legible and noticeable? What makes the warning
statement legible and noticeable?
8. Do consumers believe the regulations need to be amended to make
the warning statement more legible? Explain.
9. What would be the costs associated with adopting any or all of
the changes recommended by the petitioners, to the industry and,
ultimately, the consumer?
As indicated by the Surgeon General, over the last 10 years there
has been an abundance of practical experience and science about ways to
design and disseminate health information on product packaging.
Accordingly, we are requesting scientific information, i.e., scientific
studies, reports, consumer surveys, research literature, etc., that
might be useful in assessing the changes suggested by the petitioners
concerning the legibility of the health warning statement. As mentioned
in the FTC's letter to us, the question of whether any particular
warning is clear and prominent is an empirical one. Information
submitted should not be limited to that completed within the last few
years. Although we believe that such information may be more valid, we
are seeking any pertinent information on the subject.
We are also interested in studies that are currently in progress
and, if available, any interim findings. We would also like to be
advised of any studies currently underway which may not be completed
within the 90-day comment period, along with a projected target date
Executive Order 12866
It has been determined that this advance notice is not a
significant regulatory action as defined by Executive Order 12866.
Accordingly, this advance notice is not subject to the analysis
required by this Executive Order.
We are requesting comments on the petition from all interested
persons. We are specifically requesting comments on the clarity of this
advance notice and how it may be made easier to understand.
Comments received on or before the closing date will be carefully
considered. Comments received after that date will be given the same
consideration if it is practical to do so, but assurance of
consideration cannot be given except as to comments received on or
before the closing date.
ATF will not recognize any material in comments as confidential.
Comments may be disclosed to the public. Any material that the
commenter considers to be confidential or inappropriate for disclosure
to the public should not be included in the comment. The name of the
person submitting a comment is not exempt from disclosure.
You may submit written comments by facsimile transmission to (202)
927-8602. Facsimile comments must:
Reference this notice number;
Be 8 1/2" x 11" in size;
Contain a legible written signature; and
Be not more than three pages long.
We will not acknowledge receipt of facsimile transmissions. We will
treat facsimile transmissions as originals.
Copies of the petition, this notice, and the comments received will
be available for public inspection during normal business hours at: ATF
Public Reading Room, Room 6480, 650 Massachusetts Avenue, NW,
The author of this document is James P. Ficaretta, Regulations
Division, Bureau of Alcohol, Tobacco and Firearms.
List of Subjects in 27 CFR Part 16
Alcohol and alcoholic beverages, Consumer protection, Health,
Authority and Issuance
This notice is issued under the authority of 27 U.S.C. 205 and 215.
Dated: April 25, 2001.
Bradley A. Buckles,
Approved: April 25, 2001.
Timothy E. Skud,
Acting Deputy Assistant Secretary, (Regulatory, Tariff and Trade
[FR Doc. 01-12802 Filed 5-21-01; 8:45 am]
BILLING CODE 4810-31-P