[Federal Register: July 31, 2007 (Volume 72, Number 146)]
[Proposed Rules]
[Page 41859-41884]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31jy07-26]
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Part III
Department of the Treasury
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Alcohol and Tobacco Tax and Trade Bureau
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27 CFR Parts 4, 5, 7, and 24
Labeling and Advertising of Wines, Distilled Spirits and Malt
Beverages; Proposed Rule
[[Page 41860]]
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DEPARTMENT OF THE TREASURY
Alcohol and Tobacco Tax and Trade Bureau
27 CFR Parts 4, 5, 7, and 24
[Notice No. 73; Ref: Notice No. 41]
RIN 1513-AB07
Labeling and Advertising of Wines, Distilled Spirits and Malt
Beverages
AGENCY: Alcohol and Tobacco Tax and Trade Bureau, Treasury.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to
amend its regulations to require a statement of alcohol content,
expressed as a percentage of alcohol by volume, on all alcohol beverage
products. This statement may appear on any label affixed to the
container. TTB also proposes to require a Serving Facts panel on
alcohol beverage labels, which would include a statement of calories,
carbohydrates, fat, and protein. Industry members may also choose to
disclose on the Serving Facts panel the number of U.S. fluid ounces of
pure alcohol (ethyl alcohol) per serving as part of a statement that
includes alcohol content expressed as a percentage of alcohol by
volume. The proposed regulations would also specify new reference
serving sizes for wine, distilled spirits, and malt beverages based on
the amount of beverage customarily consumed as a single serving.
However, TTB is not defining a standard drink in this document. TTB
proposes to make these new requirements mandatory three years after the
date of publication of the final rule in the Federal Register. The
agency proposes these amendments to ensure that alcohol beverage labels
provide consumers with adequate information about the product.
DATES: Comments must be received on or before October 29, 2007.
ADDRESSES: You may send comments on this notice to one of the following
addresses:
http://www.regulations.gov (Federal e-rulemaking portal;
follow the instructions for submitting comments); or
Director, Regulations and Rulings Division, Alcohol and
Tobacco Tax and Trade Bureau, P.O. Box 14412, Washington, DC 20044-
4412.
See the Public Participation section of this notice for specific
instructions and requirements for submitting comments, and for
information on how to request a public hearing.
You may view copies of this notice and any comments we receive
about this proposal at http://www.regulations.gov. A direct link to the
appropriate Regulations.gov docket is also available on the TTB Web
site at http://www.ttb.gov/regulations_laws/all_rulemaking.shtml. In
addition, you also may view copies of this notice and any comments we
receive about this proposal by appointment at the TTB Information
Resource Center, 1310 G Street, NW., Washington, DC 20220. To make an
appointment, telephone (202) 927-2400.
FOR FURTHER INFORMATION CONTACT: Lisa M. Gesser, Regulations and
Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box
128, Morganza, MD 20660; telephone (301) 290-1460; or Joanne C. Brady,
Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade
Bureau, P.O. Box 45797, Philadelphia, PA 19149; telephone (215) 333-
7050.
SUPPLEMENTARY INFORMATION:
I. Introduction
The Alcohol and Tobacco Tax and Trade Bureau (TTB) and its
predecessor agencies have considered the issue of requiring calorie and
nutrient information on alcohol beverage labels in the past. As a
result of a rulemaking initiative in 1993, TTB's immediate predecessor
agency, the Bureau of Alcohol, Tobacco and Firearms (ATF), concluded
that, at that time, there was no significant consumer interest in
having nutrition information on alcohol beverage labels. Ultimately,
ATF did not implement rules on this issue. For a detailed description
of the rulemaking history concerning nutrition labeling on alcohol
beverages see TTB Notice No. 41, 70 FR 22274 (April 29, 2005).
The issue of requiring the labeling of alcohol beverage products
with calorie and nutrient information was not raised again until 2003,
when TTB received a petition requesting rulemaking action to require an
``Alcohol Facts'' panel and ingredient labeling. Shortly thereafter,
TTB was contacted by an industry member requesting approval to label
its products with nutrition and other information on a ``Serving
Facts'' panel. These panels, as well as TTB's authority to regulate
alcohol beverage labels and advertisements, are discussed in detail
below.
II. Petition for ``Alcohol Facts'' Label and Ingredient Labeling
On December 16, 2003, the Center for Science in the Public Interest
(CSPI), the National Consumers League (NCL), 67 other organizations,
and eight individuals, including four deans of schools of public
health, petitioned TTB to change the alcohol beverage labeling
regulations. Hereinafter, we refer to this petition as ``the
petition.'' After receipt of the petition, additional individuals wrote
to TTB requesting the addition of their names to the petition. The
petition asked TTB to require that labels of all alcohol beverages
regulated by TTB include the following information in a standardized
format:
The beverage's alcohol content expressed as a percentage
of volume;
A standard serving size;
The amount of alcohol (in fluid ounces) contained within
each standard serving;
The number of calories per standard serving;
The ingredients (including additives) from which the
beverage is made;
The number of standard drinks per container; and
The current definitions of moderate drinking for men and
women published in the ``Dietary Guidelines for Americans,'' which is
issued jointly by the United States Department of Health and Human
Services and the United States Department of Agriculture (USDA).
The petitioners proposed that all alcohol beverage containers bear
this information on an ``Alcohol Facts'' panel. The petitioners
provided the following example for a 750 milliliter bottle of wine:
[[Page 41861]]
[GRAPHIC] [TIFF OMITTED] TP31JY07.004
The petition asked that the words ``Alcohol Facts'' be immediately
followed by a declaration of the number of standard drinks (servings)
per container. The petitioners asked that, consistent with the
``Dietary Guidelines for Americans,'' (http://www.health.gov/DietaryGuidelines
) a serving should be defined as 12 ounces of beer, 5
ounces of wine, and 1.5 ounces of 80-proof distilled spirits. The
petitioners further recommended that for alcohol beverages not fitting
into one of those standard categories, a serving should be defined as
an amount of fluid containing approximately 0.5 ounces of ethyl
alcohol. The petitioners recommended that a consistent graphic symbol
(for example, a beer mug, wine glass, or shot glass) should appear
first, followed by the number of drinks in the container (for example,
``Contains 5 Servings''). The petition proposed requiring this
information on labels of all malt beverages, wines, and distilled
spirits products regulated by TTB that contain more than one-half of
one percent alcohol by volume. The graphics and type size for the
Alcohol Facts label should follow the Nutrition Labeling Education Act
standards as set out in the Food and Drug Administration (FDA)
regulations at 21 CFR 101.9(d), the petitioners suggested. Further, the
petitioners stated that ingredient information should appear on the
label immediately below, but segregated from, the ``Alcohol Facts''
box.
The petitioners suggested that current regulatory requirements
force consumers to guess about the calorie content of alcohol beverages
and the alcohol content of malt beverages. The petitioners included a
summary of the results of a census-balanced, nationally representative
telephone study conducted in September of 2003, among 600 Americans,
ages 18 and older. The study was conducted by the Global Strategy
Group, an independent polling and marketing research firm. The results
were that 91 percent of respondents supported requiring ingredient
labeling on alcohol beverages; 94 percent supported requiring alcohol
content on alcohol beverage labels; 89 percent supported the mandatory
labeling of calorie content for alcohol beverages; and 84 percent
supported the labeling of serving size information.
III. Requests for Voluntary Serving Facts Labeling
Following receipt of the petition, TTB was contacted by an alcohol
beverage industry member that wished to label its products with
nutrient and other information on a ``Serving Facts'' panel.
Subsequently, TTB received other requests from industry members to
label products with similar information.
In July and then again in September of 2004, TTB posted on its Web
site, http://www.ttb.gov, a summary of specifications for a planned
ruling concerning the manner in which alcohol beverage labels and
advertisements might permissibly reflect information about a single
serving in a Serving Facts panel, consistent with the statutory and
regulatory standards administered by TTB. The Bureau sought input from
interested parties, including the alcohol beverage industry, consumers,
and consumer interest groups, about what information should be
permitted on such a panel and in what format the Serving Facts panel
should appear.
In the first posting, TTB solicited comments on a variety of
options. The Bureau informally asked for comments on an optional
Serving Facts panel that would include the serving size in fluid ounces
based on what was previously specified in TTB Ruling 2004-1 (1.5 fluid
ounces for distilled spirits, 5 fluid ounces for wines, and 12 fluid
ounces for malt beverages, regardless of alcohol content). The panel
would also include the number of servings per container, and for each
serving the following information:
Fluid ounces of ethyl alcohol (to the nearest tenth of an
ounce);
Calories;
Fat (in grams);
Carbohydrates (in grams); and
Protein (in grams).
The Bureau also informally solicited comments on whether the term
``standard drink'' should be defined and whether it and the number of
standard drinks in a serving should be permitted on alcohol beverage
labels and in advertisements. Finally, we solicited comments on the
optional use of three icons similar to the ones at the bottom of the
label presented below:
[[Page 41862]]
[GRAPHIC] [TIFF OMITTED] TP31JY07.005
In the second posting on our Web site, TTB informally solicited
comments on an alternative label approach that omitted the icons and
standard drink references. An example of this approach is as follows:
[GRAPHIC] [TIFF OMITTED] TP31JY07.006
As a result of the two Web postings, TTB received several comments
concerning a voluntary Serving Facts panel. The comments reflected
strong and varying opinions. A significant proportion of those who
commented felt that the issue should be addressed in public notice and
comment rulemaking rather than in a TTB ruling. Furthermore, many
commenters believed that certain elements of the Serving Facts panel
would tend to confuse or mislead consumers about the product. In
response to the issues raised by the commenters, on December 28, 2004,
TTB issued a press release indicating that we would address these
issues in an advance notice of proposed rulemaking.
IV. Notice No. 41
On April 29, 2005, TTB published in the Federal Register (70 FR
22274) Notice No. 41, an advance notice of proposed rulemaking entitled
``Labeling and Advertising of Wines, Distilled Spirits, and Malt
Beverages; Request for Public Comment.'' Notice No. 41 sought public
comment on a wide range of alcohol beverage labeling and advertising
issues to help the agency determine what regulatory changes in alcohol
beverage labeling and advertising requirements, if any, TTB should
propose in future rulemaking documents. Specifically, TTB sought
comments on the petitioned ``Alcohol Facts'' panel and ingredient
labeling, the ``Serving Facts'' panel presented in TTB's informal
request for comments, and each panel's elements. Additionally, TTB
requested comments on allergen labeling and the labeling of calorie and
carbohydrate claims.
In the preamble to Notice No. 41, TTB announced its interim policy
on the use
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of Serving Facts panels on labels, as follows:
Pending the completion of rulemaking proceedings, TTB does not
intend to issue certificates of label approval bearing the optional
``Serving Facts'' panel. We believe it is important to have the
benefit of public comments on these issues before making a decision
as to whether the new elements in the panel might tend to mislead
consumers.
During the 60-day comment period, we received several requests from
alcohol beverage industry representatives and organizations to extend
the comment period for an additional 60 to 90 days beyond the original
June 28, 2005, closing date. In support of the extension requests,
industry members noted that some of the questions posed in the notice
were broad and far reaching from a policy standpoint, while others were
very technical, requiring research and coordination within the affected
industries. In response to those requests, we extended the comment
period for an additional 90 days. See Notice No. 48, 70 FR 36359, June
23, 2005. The extended comment period for the ANRPM closed on September
26, 2005.
V. TTB's Authority To Prescribe Alcohol Beverage Labeling and
Advertising Regulations
A. Internal Revenue Code
The Internal Revenue Code of 1986 (IRC) provides the Secretary with
authority to issue regulations regarding the marking and labeling of
containers of distilled spirits, wines, and beers. See 26 U.S.C. 5301,
5368, and 5412. This authority is based on the Secretary's
responsibility to protect the revenue and to collect the taxes imposed
on alcohol beverages by Chapter 51 of the IRC.
B. Federal Alcohol Administration Act
Sections 105(e) and 105(f) of the Federal Alcohol Administration
Act (FAA Act), codified in the United States Code at 27 U.S.C. 205(e)
and 205(f), set forth standards for regulation of the labeling and
advertising of wine (containing at least 7 percent alcohol by volume),
distilled spirits, and malt beverages, generally referred to as alcohol
beverage products throughout this notice. These sections give the
Secretary of the Treasury the authority to issue regulations to prevent
deception of the consumer, to provide the consumer with ``adequate
information'' as to the identity and quality of the product, to
prohibit false or misleading statements, and to provide information as
to the alcohol content of the product.
The statutory requirements with respect to alcohol content differ
among the three alcohol beverage categories. The FAA Act requires
alcohol content statements on labels of distilled spirits products. The
Act also requires alcohol content statements for wines with an alcohol
content of over 14 percent alcohol by volume, leaving such statements
optional for wines with an alcohol content below that level. The Act,
when originally enacted, prohibited such statements on malt beverage
labels, unless required by State law, but that prohibition was
overturned in 1995 by the U.S. Supreme Court in Rubin v. Coors Brewing
Company, 514 U.S. 476 (1995).
The labeling and advertising provisions of the FAA Act also give
the Secretary the authority to prohibit, irrespective of falsity,
statements relating to age, manufacturing processes, analyses,
guarantees, and scientific or irrelevant matters that are likely to
mislead the consumer. In the case of malt beverages, the labeling and
advertising provisions of the FAA Act apply only if the laws of the
State into which the malt beverages are to be shipped impose similar
requirements. TTB is responsible for the administration of the FAA Act
and the regulations promulgated under it.
C. Legislative History of the Federal Alcohol Administration Act
With respect to TTB's authority to regulate the labeling of alcohol
beverage products under the FAA Act, the Act's legislative history
provides some insight as to the general purpose of the labeling
provisions:
* * * the provisions of this bill show that the purpose was to
carry that regulation into certain particular fields in which
control of interstate commerce in liquors was paramount and
necessary. The purpose was to provide such regulations, not laid
down in statute, so as to be inflexible, but laid down under the
guidance of Congress, under general principles, by a body which
could change them as changes were found necessary.
Those regulations were intended to insure that the purchaser
should get what he thought he was getting, that representations both
in labels and in advertising should be honest and straight-forward
and truthful. They should not be confined, as the pure-food
regulations have been confined, to prohibitions of falsity, but they
should also provide for the information of the consumer, that he
should be told what was in the bottle, and all the important factors
which were of interest to him about what was in the bottle.
See Hearings on H.R. 8539 before the Committee on Ways and Means, House
of Representatives, 74th Cong., 1st Sess. 10 (1935).
VI. Discussion of Comments on Notice No. 41
In response to Notice No. 41, TTB received over 19,000 comments
from consumers, consumer advocacy groups, Government officials, alcohol
beverage industry members and associations, health organizations, and
other concerned individuals.
A. Comments Regarding Alcohol Content
In Notice No. 41, TTB requested comments on the issue of whether
the regulations should be amended to require an alcohol content
statement on all alcohol beverage labels. There was significant
disagreement as to whether the listing of alcohol content should be
mandatory.
Many professional health organizations (including, among others,
the American Society of Addiction Medicine, the American Medical
Association (AMA), the American Nurses Association, and the American
Council on Science and Health) as well as the Distilled Spirits Council
of the United States (DISCUS), CSPI, NCL, and many consumers and other
commenters supported mandatory alcohol content labeling for all alcohol
beverage products. CSPI commented:
Requiring all alcoholic beverages, whether beer, wine, distilled
spirits, malternatives, or others, to be labeled for alcohol content
is essential. Alcohol can be harmful when consumed in excess and
even addictive for a substantial number of consumers. For that
reason, labeling should provide clear information that allows
consumers to measure and moderate their drinking. [Emphasis in the
original.]
As previously stated above, the original petition from CSPI, NCL,
and others, noted that a consumer survey indicated that 94 percent of
respondents supported mandatory alcohol content labeling on alcohol
beverages, with 77 percent of consumers strongly supporting such a
requirement. The petitioners argued that ``the growing popularity of
new, non-standard types of alcoholic beverages (e.g., lite beers, ice
beers, malt liquors, hard lemonades, hard colas, wine coolers, other
ready to drink `alcopops,' fortified wines, and `zippers [ready-to-
drink liquor shots],' makes it even more difficult for consumers to
accurately estimate their alcohol consumption.''
Some commenters suggested that mandatory alcohol content labeling
is especially important given the problems caused by alcohol abuse. The
Marin Institute suggested that ``clear, consistent and informative
labeling--particularly with respect to alcohol content and serving
size--will help
[[Page 41864]]
consumers avoid some of these problems by reducing over consumption.''
The NCL also suggested that ``better information about alcohol content
per serving is especially important and should be given the highest
priority because of the many public health problems caused by excessive
consumption of alcohol.''
The Consumer Federation of America (CFA), a nonprofit association
of 300 local, state and national consumer interest groups representing
more than 50 million Americans, stated:
Given the many public health problems caused by excessive
consumption of alcohol, providing consumers better label information
about alcohol content should be TTB's highest priority in this
rulemaking. Providing consumers more information about alcohol
content would help consumers make responsible drinking decisions and
would help them follow the Dietary Guidelines' advice on moderate
alcohol consumption. Potential benefits include reduced alcohol
abuse, reduced drunk driving, and a reduction in the many diseases
attributable to excessive alcohol intake.
The CFA further stated that such alcohol content is arguably required
by the FAA Act, noting that it requires labels of alcohol beverages to
provide ``adequate information'' on the identity, quality, and alcohol
content of regulated products. The CFA also noted that the FAA Act
provision prohibiting alcohol content information on labels of malt
beverages was struck down as unconstitutional by the U.S. Supreme Court
in Rubin v. Coors Brewing Company over ten years ago.
DISCUS noted that both large and small distillers have had a
mandatory alcohol content labeling requirement for the past seventy
years, and suggested that all alcohol beverage products should be
required to bear alcohol content information, as this information is
used by consumers to drink responsibly.
Other commenters, most notably members of the beer industry,
objected to the extension of mandatory alcohol content labeling
requirements to all malt beverages. The Beer Institute, a national
trade association that represents domestic and international brewers,
stated:
The alcohol content of most beer is in a very narrow range, and
consumers are generally aware of that fact. A weighted average of
the alcohol content of the top 20 brands of domestic and imported
beer based on 2004 sales data is 4.5 percent alcohol by volume.
These brands account for 78.1 percent of the beer volume sold in the
United States in 2004. Flavored malt beverage brands, none of which
is in the top 20 brands, are required to display alcohol content by
volume.
The Brewers Association, an organization representing approximately
1,400 small brewers and thousands of homebrewers and beer enthusiasts,
commented in support of optional alcohol content statements on beer
labels, but suggested that imposing mandatory alcohol content labeling
requirements for malt beverages ``would stand congressional intent on
its head and impose unnecessary costs on the industry.'' The comment
noted that the FAA Act, as enacted, prohibited brewers from stating
alcohol content on labels unless required by State law, and suggested
that while the Supreme Court had overturned, on First Amendment
grounds, the ban on the use of voluntary alcohol content statements,
Congress had never distanced itself from its original intent on this
matter. The Brewers Association thus stated that ``[w]hile TTB has, out
of necessity, adjusted its alcohol content labeling rules to
accommodate the demands of the First Amendment, it should not go
further by imposing a rule that would require the very information that
Congress saw fit to prohibit.'' [Emphasis in the original.]
The Serving Facts and Alcohol Facts panels presented in Notice No.
41 included alcohol content. Both panels expressed alcohol in U.S.
fluid ounces of pure alcohol, and the Alcohol Facts panel also
expressed alcohol content in percentage of alcohol by volume.
Commenters disagreed on how to express alcohol content on an
information panel. Diageo and many other commenters supported the
listing of alcohol content in U.S. fluid ounces per serving, asserting
that this information could be used by consumers to regulate their
alcohol intake and follow the Dietary Guidelines advice on moderate
drinking. It should be noted that the 2005 Dietary Guidelines provide
that for purposes of explaining moderation, 12 fluid ounces of regular
beer, 5 fluid ounces of wine, or 1.5 fluid ounces of 80-proof distilled
spirits count as one drink; thus, the implication is that a ``drink''
would be equal to about 0.6 fluid ounces of pure alcohol. Some
commenters further asserted that a consumer would not as easily be able
to determine how many ``drinks'' he or she is consuming if alcohol
content were only expressed as a percentage of alcohol by volume.
The National Consumers League suggested that ``the alcohol content
of a beverage is a function of both serving size and percent alcohol by
volume. Providing the amount of alcohol per serving would express
alcohol content in a single number and thereby enable consumers to make
comparisons between different products based on their alcohol
content.''
The staff of the United States Bureau of Consumer Protection, the
Bureau of Economics, and the Office of Policy Planning of the Federal
Trade Commission (hereinafter collectively referred to as the FTC
staff) supported disclosure of alcohol content in ounces of pure
alcohol, stating:
The amount of alcohol in beverages varies widely. Many popular
beverages--12 ounces of regular beer containing 5% alcohol by volume
(`ABV'), 5 ounces of wine containing 12% ABV or 1.5 ounces of 80
proof distilled spirits--deliver 0.6 ounces of pure alcohol.
Numerous other popular beverages, however, contain more or less
alcohol. Beers in the marketplace range from approximately 3.3% to
17% ABV, thus delivering between 0.39 and 2 ounces of pure alcohol
per serving. Wines range from 6% to 18% ABV, i.e., providing between
0.3 and 0.9 ounces of alcohol in a 5-ounce serving. Distilled
spirits range from 15% to 75% ABV, i.e., providing 0.22 to 1.1
ounces of alcohol per serving. [Footnotes omitted.]
The FTC staff suggested that information about alcohol on labels
may help consumers make better-informed decisions, stating that
``research shows that in many instances, consumer decisions are made at
the point of purchase.'' [Footnote omitted.]
CSPI, which originally proposed the listing of alcohol content on
labels as both a percentage of alcohol by volume and in U.S. fluid
ounces of pure alcohol, submitted a comment reflecting a change in this
position. CSPI explained that it no longer favored the labeling of
alcohol in U.S. fluid ounces of pure alcohol, stating that ``[a]lthough
a single drink of an alcoholic beverage may contain approximately 0.6
ounces of alcohol, CSPI believes that it is unnecessary--and perhaps
confusing--to put such information on a label.'' CSPI further stated
that ``[c]onsumers do not think in those terms, but rather understand
that drinks are served generally in standard, common sizes that vary
according to the product.''
Also voicing its opposition to the ounces of pure alcohol approach,
a major brewer stated that when alcohol content is listed in fluid
ounces per serving, the number of fluid ounces will rise and fall
according to the serving size and, more importantly, will rise and fall
according to the amount the consumer actually consumes. The brewer and
many other commenters stated that depicting alcohol content in this
manner may mislead consumers. The brewer suggested that alcohol content
when expressed as a percentage of alcohol by volume is succinct, clear,
accurate, neutral, easy to understand, and easy to compare. It also
stated that
[[Page 41865]]
the percentage of alcohol by volume requires no explanation,
definition, or graphic icon, but is a consistent measure that does not
vary or fluctuate with the size of the drink.
The Beer Institute opposed expressing alcohol content in fluid
ounces for the following reasons:
As compared to labeling beverages in terms of their alcohol
concentration, or percent alcohol by volume, labeling beverages in
ounces of absolute alcohol is misleading because beverage
categories, types, and packages vary in alcohol potency. To achieve
the informational goals of TTB and various petitioners, a consumer
must compare disparate serving sizes for each product, number of
servings in a container, and amount of pure alcohol contained in the
stated serving size. Furthermore, the use of a standard serving size
is not consistent with the manner in which many alcohol beverages
are actually consumed. [Emphasis in original.]
Several commenters further asserted that the display of a
percentage of alcohol by volume remains the best means of indicating
alcohol content on a product label or in advertising. Some commenters
noted that the higher the percentage, the stronger the alcohol and its
effect.
Several other commenters stated that displaying alcohol content in
U.S. fluid ounces per serving is unnecessary, misleading, and
potentially harmful to the consumer. Other commenters contended that
such labeling may be in violation of State law and regulations, as most
states require alcohol content to be listed as a percentage of alcohol
by volume.
Several public health organizations suggested other methods of
depicting alcohol content. These include content expressed as a
percentage of alcohol by weight, and alcohol expressed in grams.
TTB Response
TTB believes that the alcohol content of a beverage is one of the
most important pieces of information about that product. We agree with
those commenters who stated that labels should provide the consumers
with this very basic information. We also believe that consumers use
information about alcohol content to measure and moderate their
drinking.
As previously noted, the provisions of the FAA Act regarding the
labeling of alcohol content differ by commodity. Accordingly, the
current regulations that implement the labeling provisions of the FAA
Act also differ by commodity. Alcohol content statements are already
required for all distilled spirits products. See 27 CFR 5.32(a)(3),
5.37 and 19.643(b). Wines containing more than 14 percent alcohol by
volume must also bear alcohol content statements; however, under
current regulations wines with an alcohol content of at least 7 percent
but no more than 14 percent by volume may be labeled with the
designation ``table wine'' or ``light wine'' in lieu of a percent
alcohol by volume statement. See 27 CFR 4.36(a). Finally, with the
exception of certain flavored malt beverages that derive alcohol from
added ingredients (see 27 CFR 7.22(a)(5)), malt beverages are not
required to bear an alcohol content statement under current
regulations.
In previous documents published in the Federal Register, TTB and
its predecessor agency, ATF, have indicated an intention to examine the
issue of requiring alcohol content on malt beverage labels. In 1993,
after the United States District Court for the District of Colorado
first struck down the ban on alcohol content on malt beverage labels as
unconstitutional, and before the case went to the Supreme Court, which
also held that the ban violated the First Amendment, ATF issued an
interim rule allowing optional alcohol content labeling for malt
beverages. See T.D. ATF-339, 58 FR 21228 (April 19, 1993). In the
preamble to that final rule, ATF stated that it believed that ``if a
future court action ultimately does not uphold the existing statute
prohibiting statements of alcoholic content, or if future legislative
action removes the current statutory prohibition, then ATF would
consider making the statement of alcoholic content mandatory on labels
of malt beverages.'' See 58 FR 21229. Similarly, in 2005, in the
preamble to the final rule on flavored malt beverages, TTB addressed
comments that favored mandatory alcohol content for all malt beverages
by stating that while we were ``not unsympathetic to the comments
suggesting mandatory alcohol content labeling for all malt beverages,
we are not in a position to implement such a rule without notice and
public comment.'' See TTB T.D.-21, 70 FR 194, 221 (January 3, 2005).
After reviewing the comments received in response to Notice No. 41,
TTB is now proposing to require alcohol content statements on the
labels of all alcohol beverage products, including table wines and all
malt beverages. As noted by CSPI, alcohol can be harmful when consumed
in excess; thus, labeling should provide information that allows
consumers to measure and moderate their drinking. We received many
comments that made similar points from public health organizations,
including the American Society of Addiction Medicine, the AMA, the
American Nurses Association, and the American Council on Science and
Health.
We agree with those commenters who suggested that providing
consumers with more information about alcohol content may help them
make responsible drinking decisions. The Beer Institute commented that
the alcohol content of most beer is generally in a narrow range, with a
weighted average of the alcohol content of the top 20 brands in 2004
being 4.5 percent alcohol by volume. However, while most beer sold is,
in fact, within this narrow range, we are also aware of beers being
sold today in the United States with an alcohol content as high as 24
percent alcohol by volume. Unless the brewer chooses to place this
information on the label, the consumer has no way of knowing whether
the alcohol content of the malt beverage he is purchasing is 4.5
percent alcohol by volume or over 5 times that amount. Consumers should
not be forced to resort to guesswork about this important element of
the alcohol beverages they consume. While table wines fall by
definition within a certain range of alcohol content, those wines at
the top of the range (14 percent) have an alcohol content twice as high
as those wines at the bottom of the range (7 percent). Again, this is
important information to consumers, and it should be presented on the
label. We agree with the suggestion by the FTC staff that because of
the significant variety in the alcohol content of alcohol beverages,
label disclosures about alcohol content may assist consumers in
choosing among categories and brands.
The Brewers Association suggested that requiring alcohol content
statements on malt beverages would be contrary to the congressional
intent expressed when the FAA Act was enacted in 1935. We recognize
that the FAA Act, as enacted, specifically prohibited the placement of
alcohol content statements on malt beverage labels, unless required by
State law. This provision of the law was found to be unconstitutional
by the Supreme Court in Rubin v. Coors Brewing Co., 514 U.S. 476
(1995). This action by the Court leaves the Secretary with authority to
either allow or require alcohol content statements on malt beverage
labels. In fact, as previously noted, we have already issued
regulations requiring alcohol content statements on certain flavored
malt beverage labels.
We also recognize that the FAA Act does not require alcohol content
statements on labels of wines containing 14 percent alcohol by volume
or less. Accordingly, as stated above, our
[[Page 41866]]
regulations implemented under the FAA Act provide that labels for such
products may either express alcohol content as a percentage of alcohol
by volume or they may bear the type designation to which they are
entitled based on the product's alcohol content (for example, ``table
wine'' or ``light wine.'') See 27 CFR 4.36.
The implementing regulations under the IRC require alcohol content
to be labeled on all wine containers; however, they incorporate by
reference the rules under 27 CFR part 4. See 27 CFR 24.257(a)(3). This
incorporation of the rules under part 4 results in a somewhat
inconsistent effect. The IRC regulations require wines under 7 percent
by volume (which are not ``wines'' under the FAA Act and thus fall
under the FDA's labeling jurisdiction) to bear a percent-alcohol-by-
volume statement; however, they do not require the same statement on
wines with an alcohol content of 7 to 14 percent alcohol by volume. TTB
believes that the listing of alcohol content should be consistent for
all wines regardless of their alcohol content. Accordingly, we are
proposing to amend Sec. 24.257(a)(3) of the TTB regulations to require
alcohol content, expressed in terms of percent-alcohol-by-volume, on
all wine labels. We believe that this amendment would serve an
important revenue purpose, as the alcohol content of a wine is one
factor in determining its tax classification. See 26 U.S.C. 5041(b). We
also believe that our statutory authority under the FAA Act allows us
to issue regulations regarding the placement of the mandatory alcohol
content statement.
Accordingly, TTB is proposing that alcohol content, expressed as a
percentage of alcohol by volume, must appear on labels for all alcohol
beverages subject to our labeling jurisdiction under the FAA Act.
TTB is proposing to allow the mandatory alcohol content statement
to appear on any label affixed to the container including, at the
option of the industry member, as part of a Serving Facts panel as
discussed later in this document. This approach is required in order to
conform to a trade agreement among the United States, Australia,
Argentina, Canada, Chile, and New Zealand, in which it was agreed that
wines may be imported bearing certain common mandatory information
(including alcohol content) on any wine label on the container, as long
as such information is in a single field of vision. TTB is further
proposing to remove Sec. Sec. 4.32(a)(3), 5.32(a)(3) and 7.22(a)(5),
which mandate placement of alcohol content statements for wine,
distilled spirits, and malt beverages on the brand label. Under the
proposed regulatory changes, listing alcohol content on a Serving Facts
panel or elsewhere on the label would satisfy the labeling requirement.
After careful consideration of the comments, TTB continues to
believe that the display of a percentage of alcohol by volume is the
best way to express alcohol content on a product label or in
advertisements. We believe that consumers are familiar with alcohol
content expressed in this manner. By contrast, consumers have little or
no familiarity with alcohol expressed in U.S. fluid ounces of pure
alcohol. Indeed many commenters, including CSPI, suggested that such
statements might confuse consumers.
However, we note that several commenters suggested that presenting
alcohol in fluid ounces per serving may provide consumers with useful
information. As the NCL noted in its comment, providing this
information may enable consumers to more easily make comparisons
between different products based on their alcohol content.
TTB does not believe that the disclosure of alcohol in fluid ounces
is inherently misleading; however, we agree that consumers are used to
seeing alcohol content expressed as a percentage of alcohol by volume
and might be confused by a statement of alcohol in fluid ounces,
without some context in which to evaluate this information. For these
reasons, TTB is not proposing that the panel include a mandatory
statement of alcohol in U.S. fluid ounces of pure alcohol per serving.
We agree that the number of fluid ounces of alcohol per serving might
be confusing in isolation; however, we believe that it would not be
confusing if presented together with a traditional alcohol content
statement. Furthermore, this information might be useful to consumers,
and would allow them to compare the quantity of alcohol contained in
single servings of different commodities without doing mathematical
calculations.
Accordingly, we are proposing to permit the additional display of a
statement of the number of fluid ounces of alcohol per serving, as long
as it includes a statement of alcohol content expressed as a percentage
of alcohol by volume. The proposed rule further provides that the
heading ``fl oz of alcohol'', if it appears in the Serving Facts panel,
must be indented beneath the heading ``Alcohol by volume.''
As previously noted, the proposed rule would allow the mandatory
alcohol content statement to appear on the Serving Facts panel or
elsewhere on the label, or both on the Serving Facts panel and
elsewhere; however, if the industry member chooses to list the number
of fluid ounces of pure alcohol in the product, the proposed rule
provides that such information must appear as part of the Serving Facts
panel. As noted in the comments, the percentage of alcohol by volume in
a given product does not change based on the serving size; however, the
number of ounces of pure alcohol does. Thus, to provide context for the
consumer, the ounces of pure alcohol must appear as part of the Serving
Facts panel, which also discloses the serving size and the number of
servings per container. Because the number of fluid ounces of alcohol
per serving must appear together with the alcohol content statement,
this means that industry members choosing to disclose the number of
ounces of alcohol per serving must put both this statement and the
percentage of alcohol by volume together in the Serving Facts panel.
We believe that by allowing the use of a statement of fluid ounces
of alcohol only if it appears directly underneath a statement of
alcohol content on a Serving Facts panel, consumers may come to
understand the relationship between alcohol content expressed as a
percentage of alcohol by volume and the expression of the number of
fluid ounces of pure alcohol per serving.
B. Comments Regarding Calorie and Nutrient Labeling and Advertising
In Notice No. 41, TTB requested comments on the issue of listing
calorie and nutrient information on alcohol beverage labels and in
advertisements. Over 18,500 consumers who responded to Notice No. 41
indicated that they would like to see this additional information on
alcohol beverage labels.
Most of these comments were form letters generated through a
letter-writing campaign initiated by Diageo, a major alcohol beverage
producer, through its Web site at http://www.knowyourdrink.com.
Consumers who visited the Web site were invited to submit a comment to
TTB on this issue. If consumers chose to submit a comment, the Web site
would then generate and forward one of over 20 different form letters
to TTB. Many of these consumers expressed confusion as to why alcohol
beverage labels do not currently bear this type of information, and
some expressed the belief that TTB prohibited the use of this
information on labels. The response by consumers who took the time to
show their support for calorie and nutrient information on alcohol
[[Page 41867]]
http://www.knowyourdrink.com Web site was numerically significant (over
18,000).
TTB received many other comments in support of the display of
calorie and nutrient information per serving. Many of these commenters
stated that they use facts about calories and nutrient content of the
products they eat and drink to balance their diets. Several commenters,
including the NCL, suggested that calorie information on alcohol
beverage labels would help consumers maintain their weight within a
healthy range consistent with the ``Dietary Guidelines for Americans''
advice. Commenting on this issue, CSPI explained that:
* * * Alcohol provides a significant portion of calories (3% to
5%) in the American diet (for heavier drinkers, it contributes even
more generously) and many drinkers and other consumers watch their
calorie intake in order to help maintain a healthy weight.
Particularly today, when drinking is widely portrayed as an adjunct
(if not a prerequisite) to a healthy lifestyle, and popular, newer,
ready-to-drink concoctions often contain more than 200 calories per
serving, calorie information takes on added importance. Obesity and
excessive weight represent substantial threats to individual and
public health. The medical and other costs related to those problems
are staggering, and continue to grow, along with the human
suffering. Calorie labeling could provide a constant, low-cost
reminder that alcohol consumption adds generally empty,
discretionary calories to the diet. Along with other educational and
policy approaches, such labeling could help raise awareness and
potentially provide information that consumers can use to modify
their drinking behavior.
The NCL, as well as Shape Up America, which is a non-profit
organization concerned with public health issues, referred to a recent
FDA report, Report of the Obesity Working Group, ``Calories Count,''
March 12, 2004, available at (http://www.cfsan.fda.gov/dms/owg-toc.html
), which concludes that maintaining a healthy weight is a
matter of counting and balancing calories consumed and expended. Shape
Up America explained that awareness of the calorie content of food and
beverages is essential to implementing this energy balance strategy.
Many other commenters, including the American Council on Science and
Health, a consumer education consortium concerned with public health
issues, asserted that at a time when the prevalence of obesity is
becoming a significant public health threat, information about the
content of all foods and beverages should be presented to consumers in
a standardized, clear format to allow them to make well-informed
choices.
The American Dietetic Association (ADA), which is the largest
association of food and nutrition professionals and represents nearly
65,000 members, also commented in support of calorie and nutrient
labeling. The ADA asserted that nutrition and ingredient labeling of
alcohol beverage products will contribute positively to public health
measures to reduce the current burden of chronic disease, including
obesity, hypertension, diabetes, and dyslipidemia. The ADA stated that
it supports initiatives to label wine, distilled spirits, and malt
beverages to provide information consumers can use to maintain health,
including a healthy body weight, and to manage chronic conditions such
as diabetes. This comment asserted that such information would be best
conveyed within the context of dietary guidance based on the ``Dietary
Guidelines for Americans 2005,'' which includes advice on the
consumption of alcohol beverage products. The ADA also stated that the
growing health care costs associated with the rise in chronic diseases
and conditions, which can be attributed to over-consumption of foods
and beverages, including those containing alcohol, more than justify
the costs of revising labels.
TTB received several comments from individuals who suffer from
diabetes. These commenters explained that access to nutrition
information is critical to their efforts to control their disease. One
commenter states that ``as a diabetic, I am especially interested in
the carbohydrate content of all food and beverages. This is vital
information in order to determine necessary insulin administration.''
Another commenter, a State policy maker and also a diabetic, stated
that he regularly checks labels for portion size and nutritional
content. He explained that this type of information is invaluable in
his efforts to control his disease. Another commenter, The Social &
Health Research Center, explained that between 2001 and 2004 diabetes
rates grew by 55 percent. They state that the key to this disease is
prevention, and explained that a large national study, the Diabetes
Prevention Program, reported that high risk individuals who practiced
healthy lifestyles were able to reduce their diabetes risk by 58
percent. This commenter, like others, stressed that it is extremely
important for people with diabetes and at risk for diabetes, who choose
to drink alcohol, to have complete information about the contents of
these beverages. The commenter further stated that alcohol is a
significant source of calories and that excessive alcohol consumption
makes it difficult to ingest sufficient nutrients within an
individual's daily calorie allotment and to maintain a healthy weight.
The FTC staff also commented in support of amending the TTB
regulations to require that alcohol beverage labels disclose alcohol
and nutrient content (calories, carbohydrates, fat, and saturated fat)
per serving, stating that such a change would be likely to have
beneficial effects on consumers and competition. The FTC staff did not
comment on the listing of protein. Their comment asserted that
information on labels about the attributes of alcohol beverages would
help consumers select beverages they prefer, including making
selections consistent with the recommendations of public health
agencies. Additionally, the FTC staff indicated that such labeling
would encourage manufacturers to compete based on the nutritional (for
example, calorie and carbohydrate content) attributes of their
beverages. The FTC staff also stated that such requirements should not
extend to advertisements because advertising differs from labeling in
important ways that make it likely that the costs of mandatory
disclosure in advertisements would outweigh its benefits.
The FTC staff also noted that alcohol varies significantly in
calories per serving, pointing to beers that ranged from 95 to 340
calories per serving; spirits that ranged from 48 to 180 calories per
serving, and wines that ranged from 100 to 235 calories per serving.
This comment also noted ranges in carbohydrate content, with beers
ranging from 5 to 22 grams of carbohydrates per serving, spirits
ranging from 0 to 18 grams of carbohydrates per serving, and wines
ranging from 1 to 18 grams of carbohydrates per serving. While alcohol
beverages generally do not contain fat, there are distilled spirits
specialty products that contain fat from cream, milk, or coconut.
TTB did not receive any specific comments against providing calorie
information on alcohol beverage labels; however, a few commenters were
generally opposed to listing any calorie or nutrient information on
alcohol beverage labels. Some of these commenters stated that alcohol
beverage products are consumed for pleasure and not for nutritional
content; therefore, nutritional and calorie content labeling should not
be required. One commenter cautioned that alcohol consumption is not a
part of a healthy lifestyle and that those on diets should not be
drinking any alcohol.
A few commenters were opposed to listing information about certain
nutrients. The AMA, while expressing
[[Page 41868]]
support for the listing of the number of calories as well as the number
of grams of carbohydrate, fat, and protein per serving, suggested that
fats and protein only be listed if they reach a threshold.
Like the AMA, CSPI suggested that the listing of fats and proteins
should be permitted only if they meet a certain meaningful, minimum
threshold amount. CSPI commented that listing information on
carbohydrate, fat, and protein content on alcohol beverage labels
provides little value to consumers and may even do harm. Specifically,
CSPI expressed concern that listing such information on alcohol
beverage labels might suggest to consumers that the product is akin to
food and represents an ordinary source of nutrition.
Several other commenters stated that nutrition information on
alcohol beverage products should be limited to only calories and
carbohydrates. One commenter suggested that listing protein on alcohol
beverage labels might convince a consumer to drink more of the product
to get more protein. Some commenters also expressed concern that
listing fat content could open the door to ``no-fat'' claims for
alcohol beverages, which are typically directed towards health foods.
A few commenters expressed concern that listing nutrient content on
alcohol beverage labels could be misleading. A large brewing company
commented that the Alcohol Facts panel would be inappropriate, and
stressed the differences in the labeling of food and alcohol beverages.
The commenter made the following point:
Food labels present detailed nutrient content and dietary
information in the context of a healthy diet. The servings of listed
items such as carbohydrates, cholesterol, protein and fat are
expressed not only in grams, but also in a percentage daily value
based on a 2,000 calorie diet. The 2,000 calorie diet has no
equivalent in alcohol products, which have no recommended daily
nutritional value. Furthermore, adding nutritional recommendations
would contradict TTB's statements opposing the placement of health
claims on alcohol beverage labeling.
The Beer Institute commented that TTB should move with extreme
caution on any rulemaking to mandate or permit nutritional labeling
similar to that required by FDA on the food and beverage products it
regulates. Its comment suggested that any such change should only be
considered after thorough research and a formal agency determination
that changes in the label format or display of additional information
would be consistent with the intent of Congress and in the public
interest. The Beer Institute instead supported the current TTB policy
of voluntary disclosure of a statement of average analysis on labels
for all types and categories of alcohol beverages. (TTB Ruling 2004-1
allows the use of calorie and carbohydrate references on alcohol
beverage labels and in advertisements as part of, or in conjunction
with, a statement of average analysis listing the serving size as well
as the number of calories, and the number of grams of carbohydrates,
protein, and fat, per serving.)
TTB Response
As noted earlier in this document, the purpose of the FAA Act is,
in part, to ensure that alcohol beverage products are labeled and
advertised in a manner that will provide the consumer with ``adequate
information'' as to the identity and quality of the product, and to
prohibit false or misleading statements. As explained in the
legislative history, Congress purposefully avoided laying out specific
statutory requirements, opting instead to lay down general guidance so
that the Department of the Treasury would have the flexibility to draft
regulations and change them when necessary. Congress further intended
that the purchaser or consumer should be told what was in the bottle,
and all the important factors which were of interest to the consumer
about the product.
The comments resulting from Notice No. 41 clearly indicate that
consumers are very interested in having information about the calorie
and nutrient content of the alcohol beverage products they purchase.
These consumers expressed the view that this information should be
available on the product's label. In fact, many commenters feel that
this information is vital to health decisions they make on a daily
basis. These comments seem consistent with the results of the survey
submitted with the CSPI and NCL petition, in which 89 percent of the
respondents supported mandatory labeling of calorie content on alcohol
beverage labels, with 65 percent of the respondents strongly supporting
such a requirement.
TTB agrees with those commenters who indicated that the calorie and
nutrient content of alcohol beverages may constitute important
information for consumers interested in monitoring their overall intake
of calories, carbohydrates, protein, and/or fat. TTB believes it is
important for consumers to have the ability to make informed decisions
about the alcohol beverage choices they make. To make informed choices,
consumers should have access to information on the calorie, nutrient,
and alcohol content of alcohol beverage products. Without this
information, TTB believes a consumer cannot adequately judge the
consequences of the beverage selections that he or she makes.
TTB notes that thousands of comments generated by the http://www.knowyourdrink.com
Web site stated or implied that TTB does not
allow the placement of calorie, carbohydrate, protein, and fat
information on alcohol beverage labels. This is incorrect. As explained
above, TTB's current policy, as most recently set forth in TTB Ruling
2004-1, is to allow producers who wish to put this information on
alcohol beverage labels to do so, as long as they include a complete
statement of average analysis which lists the number of calories, and
the number of grams of carbohydrates, protein, and fat, per serving.
The fact that so many of the consumer commenters were unaware that this
information already appears on many alcohol beverage labels gives rise
to questions as to whether our current policy, which allows the
optional placement of calorie and nutrient information on alcohol
beverage labels, provides adequate information to consumers about the
identity and quality of the product. Given the fact that consumers are
used to seeing calorie and nutrient information presented in a
standardized format on food labels, it is possible those labels that
currently bear statements of average analysis are not presenting this
information in a way that is consistent and easy for consumers to
notice and understand.
Based on our review of the comments, TTB believes that the calorie
and nutrient content of alcohol beverages may constitute a material
factor in a consumer's decision to purchase such beverages, and that
under the FAA Act and as supported by its legislative history it is
appropriate to require that labels present this data for the consumer's
consideration. In this respect, our mandate under the FAA Act to ensure
that consumers have adequate information about the identity and quality
of the product is similar to the intent under those provisions of the
current Food and Drug Cosmetic Act (FD&C Act) that state that the
labeling of a food is misleading if it fails to reveal the material
facts with respect to the consequences that may result from use of the
food. See 21 U.S.C. 321.
TTB does not agree with those commenters who suggested that certain
nutrients should not be labeled unless they meet a certain threshold
level. For 30 years, brewers have included calories, carbohydrates, fat
and protein
[[Page 41869]]
in a statement of average analysis on labels of malt beverages that
made calorie or carbohydrate claims. We have seen no evidence that
these labels misled consumers into believing that such products
constituted good sources of nutrients. Furthermore, such statements are
not specific health claims or health-related statements. Our current
regulations define the term ``health-related statement'' to include
statements and claims of nutritional value, but go on to provide that
``statements concerning caloric, carbohydrate, protein, and fat content
do not constitute nutritional claims about the product.'' See 27 CFR
4.39(h)(1)(i), 5.42(b)(8)(1)(A) and 7.29(e)(1)(i).
Finally, as pointed out by the FTC staff, there is a significant
range in calories and carbohydrates among alcohol beverages. While most
alcohol beverages do not contain fat, some distilled spirits specialty
products contain fat from cream, milk, or coconut. Consumers should be
able to readily determine the calorie and nutrient content of an
alcohol beverage before deciding whether to purchase or consume the
product.
Accordingly, pursuant to TTB's statutory authority under the FAA
Act to require information on labels that will provide consumers with
adequate information about the quality and identity of the product, we
are proposing to amend the TTB regulations to require a ``Serving
Facts'' panel on alcohol beverage labels, and to require such a panel
on any advertisement that makes a calorie or carbohydrate
representation. We believe that this information should be presented to
consumers in a uniform, standardized format that is prominent on the
label, so that consumers may easily avail themselves of this important
information. The format and other elements included in the ``Serving
Facts'' panel are discussed later in this document.
C. Comments Concerning Inclusion of a Definition of Moderate Drinking
on Alcohol Beverage Labels
In Notice No. 41, TTB sought comments on the feasibility and
desirability of an Alcohol Facts panel containing, among other
information, the statement: ``U.S. Dietary Guidelines advice on
moderate drinking: No more than two drinks per day for men, one drink
per day for women.'' Several commenters supported the idea of
displaying this definition of moderate drinking on alcohol beverage
labels. Specifically, these commenters stated that this information
will help consumers moderate their drinking.
DISCUS cautioned that including the Dietary Guidelines advice
regarding moderate drinking may run afoul of the Bureau's rules and
current guidance to industry regarding health claims and other health-
related statements. The Beer Institute asserted that the Dietary
Guidelines statement represented in the Alcohol Facts panel is a health
statement; therefore, TTB should prohibit it. Further, the Beer
Institute contended that the Dietary Guidelines are detailed and
carefully sourced, making the information impractical to disclose in a
meaningful manner on a label or in an advertisement.
TTB Response
The Dietary Guidelines recommend that if adults choose to drink
alcohol beverages, they should consume them only in moderation. The
term ``moderation'' is defined in the Dietary Guidelines as the
consumption of up to one drink per day for women and up to two drinks
per day for men. For purposes of illustrating moderation, the Dietary
Guidelines explain that 12 fluid ounces of regular beer, 5 fluid ounces
of wine, or 1.5 fluid ounces of 80-proof (40 percent alcohol by volume)
distilled spirits, count as one drink. The Dietary Guidelines further
state that this definition of moderation is not intended as an average
over several days but rather as the amount consumed on any single day.
In addition to the definition of moderate drinking, the Dietary
Guidelines provide approximately two pages of additional information
about responsible alcohol consumption and what that means.
For example, the Dietary Guidelines caution that even moderate
alcohol consumption may have adverse affects in specific situations and
on specific individuals. The Dietary Guidelines explain that
individuals who plan to drive, operate machinery, or take part in other
activities that require attention, skill, or coordination should avoid
drinking alcohol beverages. Additionally, the Dietary Guidelines advise
that children and adolescents, women of child bearing age who may
become pregnant, pregnant and lactating women, individuals taking
medications that can interact with alcohol, and individuals with
specific medical conditions, should not drink at all. Even moderate
drinking during pregnancy may have behavioral or developmental
consequences for the baby, the Dietary Guidelines stress. Finally, the
Dietary Guidelines also suggest that individuals of any age who cannot
restrict their drinking to moderate levels should not drink at all.
This last category is obviously hard to define, and may include many
individuals who do not even realize that they fall within it.
Based on our consideration of the comments, TTB believes that
labeling alcohol beverage products with information about the
definition of moderate drinking could tend to mislead consumers,
without more specific cautionary information about those individuals
for whom even moderate consumption may create health risks. While many
consumers may be concerned about moderate consumption, the Dietary
Guidelines also advise many individuals that they should not consume
any alcohol at all. We must avoid creating the misleading impression
that the Dietary Guidelines condone the consumption of one or two
alcohol beverages per day for those who should not consume any alcohol
at all. Accordingly, this notice does not propose to include the
definition of moderate drinking from the Dietary Guidelines as part of
a Serving Facts panel.
D. Comments Regarding Labeling Alcohol Beverages With Standard Drink
and Serving Size Information
In Notice No. 41, both the Alcohol Facts and Serving Facts panels
introduced the concept of a standard drink or standard serving size
based on the Dietary Guidelines advice on alcohol consumption. The
Alcohol Facts proposal in the petition suggested labeling that would
include a declaration of the number of standard drinks (servings) per
container. As noted above, the petitioners suggested that a serving
should be defined as 12 ounces of beer, 5 ounces of wine, and 1.5
ounces of 80-proof distilled spirits. The petition also suggested that
for any alcohol beverages not fitting into one of those categories, a
serving should be defined as the amount of fluid containing
approximately 0.5 fluid ounces of pure alcohol. The petitioners later
submitted comments in response to Notice No. 41 to change that figure
to 0.6 fluid ounces of pure alcohol, which aligns their suggested
definition with the standard drink definition on the ``Serving Facts''
panel.
TTB received many comments in support of defining and listing
standard drink information on labels and in advertisements. Many
commenters suggested that standard drink information on alcohol
beverage labels would help consumers measure, moderate, and make more
informed decisions about their alcohol consumption. A number of
commenters suggested that any information panel
[[Page 41870]]
would be more useful to consumers if TTB clearly defines what
constitutes a ``serving'' of the product.
Some commenters asserted that standard drink information listed on
products would help consumers compare products across product
categories. One commenter, a university professor and licensed clinical
psychologist, indicated that a majority of his students have the
impression that a beer is less intoxicating than a shot of distilled
spirits. Further, he stated, it is essential that consumers understand
that the alcohol content of beer and wine is no less significant than
the alcohol content of distilled spirits. He explained, ``[m]any of my
clients, and those of my colleagues, will assert with absolute
certainty that they do not have a drinking problem because they `only
drink beer.' '' He concluded that providing information as to what
constitutes a standard serving of alcohol would be a more useful method
of conveying alcohol content information than the tremendously
misleading existing standards using alcohol by volume and proof, he
concluded.
TTB also received many comments opposing the listing of standard
drink or standard serving size information on alcohol beverage labels
and in advertisements. The strongest opposition came from the brewing
industry. Specifically, a large brewer and other brewers and brewing
industry associations commented that a ``standard drink'' contradicts
the reality of how different types of alcohol beverages are packaged,
poured, and consumed. These commenters noted that alcohol beverages
vary in alcoholic strength not only among the categories but within
each category as well. They also noted that while beer is usually
consumed without being mixed, distilled spirits are often used and
consumed in mixed drinks, which are measured using shot glasses of
various volumes or are free poured. Because of these variations, these
commenters asserted that standard servings do not exist.
One commenter, a journalist who has covered alcohol beverages from
both a recreational and health perspective for 10 years, argued that
using the terms ``serving'' and ``standard drink'' synonymously, as in
the CSPI petition, is a dangerous and irresponsible move. He made the
following points:
Servings are based strictly on volume both in the FDA
regulations and in the consumer's mind. Standard drinks, which refer to
how much alcohol is in one drink as defined by the Dietary Guidelines,
must take into account alcohol content.
Great variations in alcohol strength exist in both the
wine and beer categories, with many higher-alcohol wines containing 150
percent or more of the alcohol strength of their lower-alcohol
counterparts and with higher-alcohol beers occasionally topping 300
percent of the strength of the average beer.
The standard drink equivalency is oversimplified and
disregards the tremendous variation in alcoholic strength.
CSPI also commented on this issue, stating:
Providing ``standard drink'' information, though useful in some
more general education contexts, might not be helpful on labels of
particular products. For example, many over-sized containers, such
as 16-ounce beers, are ordinarily sold--and meant to be consumed--as
a single serving.
A large brewer noted that FDA has undertaken a fundamental re-
examination of its labeling regulations concerning serving size and
published an advance notice of proposed rulemaking (ANPRM) on April 4,
2005 (70 FR 17010) seeking comments from consumers on a variety of
issues. The FDA ANPRM stated that most consumers in focus groups
conducted by FDA ``indicated that they incorrectly thought a serving
size was a recommended portion size, rather than a standardized unit of
measure.'' (See 70 FR 17012.) Given FDA's concern that consumers may
perceive a serving size as a recommended portion size, the large brewer
suggested that ``TTB should not make rules that would involve the
display of serving size on labels for alcohol beverages until FDA has
decided whether, and if so, how to amend its regulations concerning
serving size on food products. Acting prior to the FDA's decision-
making process would be premature and possibly counterproductive.''
TTB Response
As explained above, TTB Ruling 2004-1 set forth the following
serving sizes: 1.5 fl. oz. for distilled spirits; 5 fl. oz. for wines;
and 12 fl. oz. for malt beverages. These sizes were based on the 2000
Dietary Guidelines, which suggested that the above amounts ``count as a
drink'' for purposes of determining ``moderation,'' assuming that the
distilled spirits are 80-proof and the malt beverages are ``regular
beer.'' It should be noted that the 2005 Dietary Guidelines provide the
same guidance with respect to what counts as a drink for purposes of
explaining ``moderation;'' however, in illustrating the calorie content
of various alcohol beverages, the 2005 Dietary Guidelines set forth
``example serving volumes'' of various products as follows: 12 oz. for
regular and light beers; 5 oz. for white and red wines; 3 oz. for sweet
dessert wines, and 1.5 oz. for 80 proof distilled spirits (such as gin,
rum, vodka, and whiskey). Moreover, the Guidelines go on to note that
higher alcohol content and mixing alcohol with other beverages will
increase the number of calories in the beverage.
TTB acknowledged in its ``Frequently Asked Questions on TTB Ruling
2004-1,'' published on the TTB Web site, that there ``are some good
arguments for setting standardized serving sizes based on the alcohol
content of the product; however, we believe that before we set
permanent standards, we should engage in rulemaking to solicit comments
from the public and the industry.''
As indicated above, commenters varied in their opinions on the
standard drink issue. TTB agrees with those commenters who asserted
that alcohol beverages are not commonly packaged, poured, served, or
consumed in standard drinks with exactly 0.6 fluid ounces of pure
alcohol. In fact, rarely would the packaged or consumed quantity of an
alcohol beverage product equal a ``standard drink'' of exactly 0.6
fluid ounces of pure alcohol. Some products will contain less than one
standard drink while others will contain multiple standard drinks.
Additionally, TTB believes that consumers are likely to be confused
about the difference between the terms ``standard drink'' and ``serving
size.''
In this proposed rule, we take into account the variations in the
way that different commodities are consumed, and the fact that there
are significant variations in alcohol content within the different
categories of malt beverages, wines, and distilled spirits. We note
that the Federal Food, Drug, and Cosmetic Act at 21 U.S.C. 343
(q)(1)(A)(i), defines a serving size as ``an amount customarily
consumed'' [emphasis added]. Serving sizes for all food and beverage
products regulated by FDA are based on this definition rather than on
the amount recommended by any dietary guidance. TTB believes that
serving sizes for alcohol beverage products also should be based on
customary consumption and not solely on the broad categories outlined
in the Dietary Guidelines advice on moderate drinking. Those categories
do not explicitly take into account either what is customarily consumed
or what the alcohol content variations are within each respective
category.
TTB believes that what is ``customarily consumed'' should be
determined on an individual package
[[Page 41871]]
basis according to the way the product is packaged, the alcohol content
of that product, and how the product is typically consumed. Since the
amount customarily consumed varies widely among and within the three
alcohol beverage categories, TTB agrees with those commenters who argue
that one standard for calculating the serving size does not fit all
alcohol beverage product categories. Not only are there differences
among wines, distilled spirits, and malt beverages in how they are
packaged, sold, and consumed, there are differences within each
category as well. For example, a lower alcohol distilled spirits
product, such as a specialty product with an alcohol content of 5
percent by volume, packaged in a 200 ml bottle (about 8 fl. oz.) might
reasonably be consumed on one occasion, while higher alcohol distilled
spirits in the same size bottle might typically be consumed over more
than one occasion. While a 12 fl. oz. (355 ml) bottle of beer is
typically considered one serving, this may not be true where the beer
has an alcohol content of over 10 percent alcohol by volume. In fact,
some specialty malt beverages have alcohol content levels of over 20
percent by volume, making it less likely that such products would be
consumed in one setting. Additionally, dessert wines, which have a
higher alcohol content, are typically consumed in smaller servings than
table wines.
Accordingly, TTB is not proposing to define a standard drink but is
instead proposing to adopt specific serving size reference amounts for
each alcohol beverage product category based on the amount customarily
consumed as a single serving. See Section VII of this notice for a
detailed description of the serving size reference amounts for each
category. TTB recognizes that these serving size reference amounts do
not reflect the multiple servings or ``helpings'' that may be consumed
on a single occasion. Serving size reference amounts are not intended
as recommended consumption amounts but rather are intended to be used
as a reference amount for the consumer to determine nutrient and
calorie intake. We specifically invite comments on these serving size
reference amounts including whether each accurately represents the
amount of the product category that is customarily consumed. TTB would
welcome any data that might enable us to identify a better standard for
the amount customarily consumed for a specific product category,
including consumer research or studies, or statistical data about
consumption patterns.
It should be noted that the proposed serving size reference amounts
are largely based on the quantities set forth in TTB Ruling 2004-1 (5
fluid ounces for wines, 1.5 fluid ounces for distilled spirits, and 12
fluid ounces for malt beverages), with some significant differences.
Most importantly, any product with an alcohol content outside the range
of a typical product within the commodity classification may require a
different serving size. For example, under TTB Ruling 2004-1, a 12 fl.
oz. (355 mL) can of 8 percent alcohol by volume distilled spirits
cocktail would contain approximately 8 servings, while an 8 percent
alcohol by volume can of malt beverage would only contain one serving.
In contrast, the proposed rule takes into account the alcohol content
of the product in determining the serving size. We discuss the proposed
serving sizes for wines, distilled spirits, and malt beverages in more
detail in Section VII of this document.
E. Comments Concerning the Title of Any Alcohol Beverage Product
Information Panel
In response to Notice No. 41, we received several comments
concerning the title of any information panel TTB ultimately permits or
requires on alcohol beverage labels and in advertisements. These
commenters expressed varying opinions as to what such a label should be
called. One commenter stated that the caption ``Alcohol Facts'' does
not best reflect the information components that would be set forth in
such a panel. This commenter further suggested that the caption
``Serving Facts'' is more appropriate to describe components in a
serving of an alcohol beverage product. On the other hand, several
commenters urged TTB to call such a label ``Alcohol Facts'' to
distinguish it from the Nutrition Facts panel, which is present on
other food and beverage products. One commenter explained that this
approach was used by FDA to distinguish the label on dietary
supplements (``Supplement Facts'') from the label on foods, and thus
serves as a precedent for a similar name for the panel on alcohol
beverage products.
TTB Response
TTB agrees with those commenters who believe that the title
``Serving Facts,'' is a better descriptor of the information presented
in the panel, as that information will include more than just facts
about alcohol content. Therefore, TTB is proposing ``Serving Facts'' as
the title for the mandatory information panel.
F. Comments Concerning the Serving Facts Graphic
TTB did not receive any specific comments in support of the graphic
(shot glass, wine glass, and beer mug icons, with equal signs between
the icons) depicted on the ``Serving Facts'' label in Notice No. 41.
Many commenters, including brewers, wineries, and various industry
associations, were strongly opposed to the graphic. This graphic, the
commenters claim, is a political expression of ``equalization.''
Further, the commenters asserted that this image is used commonly by
the distilled spirits trade associations in their attempt to achieve
parity with wine and beer in various regulated areas, such as taxes,
access to markets, advertising, and other forms of regulatory control.
The Wine Institute, a trade association representing California
wineries, stated as follows in opposition to the graphic:
The equivalency graphic is an oversimplification of the concept
of alcohol exposure. In context, the U.S. Dietary Guidelines' use of
serving sizes to define moderation along with their recommendations
offers useful information to consumers. It takes two pages for the
Dietary Guidelines to explain its recommendation in clear and
concise fashion. It is a message that cannot be reduced to a single
ambiguous and misleading graphic. The use of the graphic out of the
context of qualifying language or balance provides only a partial
picture and might be as likely to mislead the consumer as those that
are actually false.
The Wine Institute also argued that the graphic is subject to
different interpretations and provides little in the way of useful
information. This comment stated that most hard liquor is not consumed
in a shot glass and most wine is not presented in carefully measured 5-
ounce glasses.
TTB Response
The comments show strong opposition to the use of the graphic
described above on alcohol beverage labels and in advertisements. TTB
believes that very rarely would a glass of beer, wine, or distilled
spirits contain exactly 0.6 U.S. fluid ounces of pure alcohol. TTB
agrees that such a graphic is subject to interpretation and could
mislead consumers. Thus, we are not proposing to include this graphic
as part of the Serving Facts panel.
G. Costs Associated With Mandatory Labeling Requirements
We received several comments regarding the costs associated with
any type of new mandatory labeling requirements, including new
[[Page 41872]]
requirements for the labeling of nutrient information and alcohol
content. These comments generally referred to the costs of new labeling
in general, rather than breaking down the costs associated with each of
these different proposals.
Many of these comments were from small alcohol beverage producers
who stated that any new labeling requirements, particularly mandatory
ingredient labeling, would be too costly and would place them at a
distinct disadvantage because larger producers are better equipped to
comply. Small producers described such costs as follows:
Costs of new labeling equipment or costs to upgrade
current equipment.
Production disruption costs due to installation of new
equipment.
Costs of label redesign and new label stocks.
Costs of laboratory testing equipment or laboratory
services.
The Brewers Association submitted a comment opposing the adoption
of any new mandatory labeling requirements in the regulations other
than the labeling of major allergens present in levels scientifically
proven to be harmful to at-risk individuals and the disclosure of
certain nutrient information for products labeled or advertised with
calorie or carbohydrate claims. This comment stated that almost any
other new mandatory labeling requirement ``would dramatically impact
nearly every aspect of a small brewer's business, from its choice in
ingredients to its ability to access markets. If TTB moves forward with
mandatory labeling requirements, small brewers would face a potentially
devastating economic double hit--the first from significantly higher
production and administration costs and the second from severe
restraints on their brewing creativity.''
The Brewers Association conducted a survey of its members on the
impact of new mandatory labeling requirements. Based on the cumulative
responses of 97 small packaging brewers (who represent a combined
volume of 5,698,924 barrels of the approximately 7 million barrels
produced by small brewers), the Brewers Association concluded that
``mandatory ingredient and nutrition labeling requirements would
significantly increase small brewers' costs of doing business and deter
the creativity and innovation that has made craft brewing both popular
and profitable as small businesses.''
The comment from the Brewers Association estimated that the
aggregate average costs of new mandatory labeling requirements for
respondents by size ranged from $35,530 per brewer for smaller brewers
to $1.5 million per brewer for larger brewers. The Brewers Association
stated that such mandatory labeling requirements would have a
substantial financial impact on all small brewers. The survey also
revealed that additional labeling costs would cause about 27 percent of
survey respondents to cease bottling operations, and that mandatory
ingredient or calorie labeling would force approximately 29 percent of
survey respondents to withdraw from interstate sales.
Some small wineries expressed similar concerns. For example, one
small winery commented that new mandatory requirements for ingredient
and nutrition information would be disastrous, noting that many of its
annual lots were less than 100 cases and that the laboratory work
required for each lot would be a prohibitive cost for small lots.
Another winery stated that it did not have the laboratory equipment to
test for carbohydrate and calorie content. Many wineries argued that
nutrition is not a concern for consumers when choosing an alcohol
beverage, and they questioned whether consumers were interested in
either ingredient or nutrition labeling on alcohol beverage products.
Both small winemakers and small brewers expressed their concern
that new labeling requirements would negatively affect their market
share. One small winemaker commented that such label requirements would
make it even more difficult for small family wineries to compete with
large wine conglomerates and low cost imports. Another small winemaker
stated that any new labeling requirement would be onerous to all but
the largest wineries that make 100,000 gallons or larger batches of
wine. The commenter further suggested that if TTB imposes any new
requirements, wines that are produced in batch quantities of less than
5,000 gallons should be exempt. The Brewers Association also suggested
an exemption for small brewers if TTB imposes any new label
requirements.
Some consumers who commented on this issue were concerned about the
effect any new labeling requirements would have on small alcohol
beverage producers. One commenter suggested longer phase-in periods for
any mandatory requirements for small alcohol beverage producers. The
commenter further suggested the possibility that brewers of small
volume beers could be required to post this information on their Web
sites, thereby eliminating the cost of printing new labels.
On the other hand, we also received comments suggesting that the
cost of additional labeling would not be excessive, given the benefits
to consumers. CSPI and one individual commenter referenced a past cost
assessment done by FDA that evaluated relabeling costs for a final rule
adding trans fatty acid labeling requirements to foods (see 68 FR
41434, 41477, July 11, 2003). In the study, FDA estimated that the
average low relabeling cost per ``stock keeping unit'' (SKU) would be
about $1,100 and the average high relabeling cost per SKU would be
about $2,600. (An SKU is a specific product sold in a specific size.)
CSPI and the individual commenter applied these FDA relabeling cost
estimates to the alcohol beverage labeling changes aired for comment in
the Notice No. 41. Applying the estimates to a winery selling 5 types
of wine, they computed the average total cost of relabeling to be
between $5,500 and $13,000 for the winery. They then applied the
estimates to a particular brand of wine, stating that if the winery
produced 320,000 9-liter cases (3,840,000 750 ml bottles), ``[e]ach of
those bottles would incur a cost of $0.000677--less than 7/100ths of a
penny--if the cost were $2,600 per sku.''
TTB Response
A number of the comments discussed above suggested that we exempt
small businesses from any new labeling requirement. Alcohol beverage
products manufactured by small businesses are typically made in smaller
batches, and each batch may be prepared a little differently each time.
For example, craft brewers often produce seasonal malt beverages in
very small quantities and small wineries often produce wine in batches
of less than 5,000 gallons.
Even if a rule is not a significant regulatory action, Executive
Order 12866 requires us to design regulations in the most cost-
effective manner to achieve the regulatory objective. We seek to tailor
our regulations to impose the least burden on society, including
individuals, businesses of differing sizes, and other entities,
consistent with the regulatory objective.
We have considered several options to reduce the regulatory burdens
and economic costs imposed by the proposed rule. One option would be to
exempt small businesses from the requirements of the rule; however, we
are not proposing that option for two related reasons. One of the
primary purposes of the proposed rule is to enhance consumer
protection; this purpose would be defeated by a permanent exemption for
small businesses. There is no reason to believe that consumers of
alcohol beverages
[[Page 41873]]
produced by small producers are less interested in obtaining
information about the alcohol, calorie, and nutrient content of the
beverages they consume. Moreover, we question whether such a permanent
exemption would be consistent with the mandate, in the FAA Act, to
ensure that labels provide consumers with adequate information about
the identity and quality of the product.
A second option we considered was a delay in the effective date of
any final rule in order to provide adequate time for the industry to
develop new labeling materials, deplete existing inventories, and
coordinate the proposed labeling changes with their already scheduled
labeling changes. TTB believes that most alcohol beverage industry
members change their labels at least once every three years. This is
consistent with FDA's conclusion, in a recent proposed rule relating to
the labeling of health claims involving soluble fiber from certain
foods, that ``firms typically update their label about every 3 years.''
(See 72 FR 5367 and 5372, February 6, 2007.) For this reason, TTB
proposes a delayed effective date of three years from the date any
final rule is published in the Federal Register. We further propose
that manufacturers, bottlers, and importers who wish to label their
products with a Serving Facts panel and alcohol content statement
before the rule comes into effect may begin to do so as long as they
adhere to the requirements of the final rule.
TTB believes that by delaying the implementation date for the new
labeling requirements, costs associated with label redesign and new
label stocks would be significantly reduced. A three-year
implementation period would allow affected industry members to use up
existing label stocks and coordinate the redesigning of their labels
with an already planned label redesign. We believe this option will
minimize costs or burdens associated with the proposed new label
information. Again, this is consistent with FDA's conclusion, in its
proposed rule involving the labeling of health claims involving soluble
fiber from certain foods, that if companies can add new labeling
statements at the same time that they would normally update their
labels, ``the cost of adding the new information on the package
approaches zero.'' (See 72 FR 5372.)
In addition to the proposed delayed effective date, we are
proposing regulatory text that allows flexibility on the placement and
appearance of the Serving Facts information. TTB also proposes to
permit listing Serving Facts information in a linear fashion for
containers 50 milliliters or smaller. See the regulatory text for an
illustration of the linear display. In providing such flexibility, TTB
believes that industry members would not have to purchase new, or
upgrade current, labeling equipment. Instead, existing labeling
equipment could be used. TTB is also seeking comments on whether the
proposed linear display for small containers should be permitted on all
containers irrespective of their size.
Several commenters mentioned the costs associated with laboratory
analysis of products. However, we believe that this will not impose a
significant burden on small businesses. According to the FDA Labeling
Cost Model Final Report (revised January 2003), the costs associated
with analytical testing are the same regardless of how the product is
packaged and sold; thus, manufacturers incur costs on a product (or
formula) basis. (See 72 FR 5567.) TTB has determined that the costs
associated with the analytical testing required for the proposed new
labeling requirements would be approximately $250 per formulation. To
develop these cost estimates, we obtained price quotes in the spring of
2007 from four different companies that test alcohol beverage products.
Accordingly, TTB believes that the costs associated with this proposal
are not significant.
VII. Proposed Regulatory Changes
Based on the above, TTB is proposing to amend parts 4, 5, 7 and 24
of the TTB regulations to set forth requirements for mandatory alcohol
content and for the presentation of certain calorie and nutrient
information in a mandatory ``Serving Facts'' panel. These changes
involve the addition of a new subpart L in part 4, a new subpart J in
part 5, and a new subpart J in part 7, as well as conforming changes
elsewhere in parts 4, 5, 7, and 24. We discuss the proposed regulatory
amendments in more detail below.
A. Mandatory Alcohol Content Statement
As stated in TTB's response to comments concerning alcohol content,
TTB proposes in Sec. Sec. 4.32(b)(3), 5.32(b)(11), and 7.71(a) to
require an alcohol content statement, expressed as a percentage of
alcohol by volume, on the labels of all alcohol beverage products,
including table wines and malt beverages.
B. Mandatory Serving Facts Panel
As stated above, TTB proposes a mandatory nutrient information
panel that must include the following information: The title ``Serving
Facts''; serving size; the number of servings per container; the number
of calories per serving; and the number, in grams per serving, of
carbohydrates, fat, and protein. The Serving Facts label may also bear
the mandatory alcohol content statement as a percentage of alcohol by
volume. TTB also proposes to allow, on a voluntary basis, the
disclosure of the number of U.S. fluid ounces of pure alcohol per
serving, as part of a statement that includes alcohol content expressed
as a percentage of alcohol by volume.
(1) Serving Size and Servings per Container
TTB is proposing to define the term ``serving'' or ``serving size''
as the amount of the alcohol beverage customarily consumed as a single
serving, expressed in both U.S. fluid ounces and, in parentheses, in
milliliters for wines, distilled spirits, and malt beverages. In new
Sec. Sec. 4.111(b), 5.81(b), and 7.91(b), TTB is proposing the use of
serving size reference amounts, specific to each alcohol beverage
category, which in each case most closely approximates the amount of
the product that a consumer customarily drinks as a single serving.
This amount is specified as a reference amount used only as a basis for
the consumer to determine nutrient and calorie intake and not as a
recommended consumption amount. These rules are intended to ensure as
much uniformity as possible in labeling serving sizes within a product
category. TTB proposes the following serving size reference amounts for
each category:
Wine: For wines with an alcohol content of not more than
14 percent alcohol by volume, the serving size is 5 fluid ounces (about
148 milliliters). For wines with an alcohol content higher than 14
percent alcohol by volume and not more than 24 percent alcohol by
volume, the serving size is 2.5 fluid ounces (about 74 milliliters).
Distilled spirits: For distilled spirits products
containing not more than 10 percent alcohol by volume, the serving size
is 12 fluid ounces (about 355 milliliters). For products containing
over 10 percent and not more than 18 percent alcohol by volume, the
serving size is 5 fluid ounces (about 148 milliliters). For products
containing over 18 percent alcohol by volume, the serving size is 1.5
fluid ounces (about 44 milliliters).
Malt beverages: For malt beverages with an alcohol content
of not more than 10 percent alcohol by volume, the serving size is 12
fluid ounces (355 milliliters). For malt beverages with an alcohol
content higher than 10 percent
[[Page 41874]]
alcohol by volume, the serving size is 5 fluid ounces (148
milliliters).
Since wines and distilled spirits are subject to metric standards
of fill under the TTB regulations, the proposed serving sizes for these
categories are set forth in both fluid ounces and milliliters. We
recognize that consumers may use fluid ounces rather than milliliters
when pouring a glass of wine or a shot glass of distilled spirits. For
consistency purposes, TTB is proposing to require serving sizes for
malt beverages to be set forth in both fluid ounces and milliliters.
(2) Percentage of Alcohol by Volume
In new Sec. Sec. 4.111(c), 5.81(c), and 7.91(c) for wines,
distilled spirits, and malt beverages, respectively, TTB proposes to
provide that if Serving Facts panels on labels or in advertisements
include any information about alcohol content, the alcohol content must
be expressed on those panels as a percentage of alcohol by volume. The
Bureau is also proposing to amend Sec. Sec. 4.32, 5.32, and 7.22 to
remove the requirement that an alcohol content statement appear on the
brand label, so as to permit its inclusion in a Serving Facts panel or
elsewhere on the label. We are also proposing to make conforming
changes to Sec. Sec. 4.36 and 7.71(a). Finally, we are proposing to
amend Sec. 24.257(a)(3) to provide that alcohol content, expressed as
percent-by-volume, is required on labels for all products meeting the
IRC definition of a ``wine.''
(3) Alcohol Expressed in Fluid Ounces
In new Sec. Sec. 4.111(d), 5.81(d), and 7.91(d), TTB is proposing
to permit the display of the number of U.S. fluid ounces of pure
alcohol per serving as long as this statement is as part of a statement
that includes alcohol content, expressed as a percentage of alcohol by
volume.
(4) Calories
In new Sec. Sec. 4.111(e), 5.81(e), and 7.91(e), TTB proposes
standards for expressing a statement of the calorie content per serving
for wines, distilled spirits and malt beverages, respectively.
(5) Carbohydrates
In new Sec. Sec. 4.111(f), 5.81(f), and 7.91(f), TTB proposes
standards for expressing carbohydrate content per serving for wines,
distilled spirits, and malt beverages, respectively.
(6) Fat
In new Sec. Sec. 4.111(g), 5.81(g), and 7.91(g), TTB proposes
standards for expressing fat content per serving for wines, distilled
spirits, and malt beverages, respectively.
(7) Protein
In new Sec. Sec. 4.111(h), 5.81(h), and 7.91(h), TTB proposes
standards for expressing protein content per serving for wines,
distilled spirits, and malt beverages, respectively.
C. Format and Placement of the Serving Facts Panel
New Sec. Sec. 4.112, 5.82, and 7.92 set forth proposed formatting
specifications for the Serving Facts panel. While TTB would encourage
presentation of the Serving Facts information in a horizontal or
vertical panel format for all products, TTB proposes to permit listing
Serving Facts information in a linear fashion for containers 50
milliliters or smaller. See the regulatory text for an illustration of
the linear display. TTB is also seeking comments on whether the
proposed linear display for small containers should be permitted on all
containers irrespective of their size. In addition, new Sec. Sec.
4.113, 5.83, and 7.93 would permit the panel to appear anywhere on the
alcohol beverage container or in the advertisement that is visible to
the consumer.
D. Tolerance Levels
New Sec. Sec. 4.114, 5.84, and 7.94 codify the existing tolerance
levels specified in TTB Procedure 2004-2, Testing of Calorie,
Carbohydrate, Protein, and Fat Content of Alcohol Beverages; Acceptable
Tolerance Levels, which apply to label and advertisement statements of
calorie, fat, carbohydrate and protein content. These sections also
cross reference the tolerance levels for alcohol content as specified
in the current regulations.
VIII. Public Participation
A. Comments Sought
We request comments from anyone interested on the regulatory
proposals outlined in this notice. All comments must reference Notice
No. 73 and include your name and mailing address. They must be legible
and written in language acceptable for public disclosure. Although we
do not acknowledge receipt, we will consider your comments if we
receive them on or before the closing date. We regard all comments as
originals.
TTB specifically solicits comments on the proposed serving size
reference amounts for wines, distilled spirits, and malt beverages. Are
these figures a reasonably accurate representation of the amount of the
product customarily consumed as a single serving? If not, what data or
other information should TTB consider that would give a better estimate
of the amount customarily consumed for a specific product category? Are
the proposed reference amounts more accurate than the serving sizes set
forth in TTB Ruling 2004-1 (1.5 fl. oz. for distilled spirits, 5 fl.
oz. for wines, and 12 fl. oz. for malt beverages, regardless of the
alcohol content)? Why or why not? Should TTB instead retain the serving
sizes set forth in Ruling 2004-1?
We also solicit comments on whether the proposed elements of the
Serving Facts panel will provide consumers with adequate information
about the identity and quality of the product. For example, should the
panel include additional elements? Alternatively, should certain
elements (such as protein or fat content) be required only if the
levels of these nutrients reach a certain threshold? Why or why not?
Would it be confusing to the consumer to see protein and fat content on
some labels but not on others? Why or why not?
Additionally, TTB seeks comments on whether the proposed linear
display for small containers should be permitted on all containers
irrespective of their size. Why or why not? Would allowing the linear
display on all containers reduce the costs associated with compliance
while providing consumers with adequate information about the products?
Finally, TTB solicits comments on the expected economic impact of
the proposed rule, especially the impact on small businesses. Does the
proposed delayed effective date suffice to limit the negative impact on
small businesses and reduce overall costs of compliance while ensuring
that consumers are protected? How many small businesses would be
impacted by the proposed rule, and what would be the economic impact of
the proposal on these small businesses? Please explain in detail and
provide specific cost data.
We welcome comments on all other issues presented in this Notice.
B. Submitting Comments
You may submit comments on this notice by one of the following two
methods:
Federal e-Rulemaking Portal: To submit a comment on this
notice using the online Federal e-rulemaking portal, visit http://www.regulations.gov
and select ``Alcohol and Tobacco Tax and Trade
Bureau'' from the agency drop-down menu and click ``Submit.'' In the
resulting docket list, click the ``Add Comments'' icon for the
appropriate docket number and complete the resulting comment form. You
may
[[Page 41875]]
attach supplemental files to your comment.\1\ A direct link to the
appropriate Regulations.gov docket is also available on the TTB Web
site at http://www.ttb.gov/regulations_laws/all_rulemaking.shtml.
---------------------------------------------------------------------------
\1\ More complete information on using Regulations.gov,
including instructions for accessing open and closed dockets and for
submitting comments, is available through the site's ``User Tips''
link.
---------------------------------------------------------------------------
Mail: You may send written comments to the Director,
Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade
Bureau, P.O. Box 14412, Washington, DC 20044-4412.
If you are commenting on behalf of an association, business, or
other entity, your comment must include the entity's name as well as
your name and position title. If you comment via http://www.regulations.gov
, please enter the entity's name in the
``Organization'' blank of the comment form. If you comment via mail,
please submit your entity's comment on letterhead.
You may also write to the Administrator before the comment closing
date to ask for a public hearing. The Administrator reserves the right
to determine whether to hold a public hearing.
C. Confidentiality
All submitted comments and attachments are part of the public
record and subject to disclosure. Do not enclose any material in your
comments that you consider to be confidential or inappropriate for
public disclosure.
D. Public Disclosure
On the Federal e-rulemaking portal, we will post, and you may view,
copies of this notice and any electronic or mailed comments we receive
about this proposal. To view a posted document or comment, go to http://www.regulations.gov
and select ``Alcohol and Tobacco Tax and Trade
Bureau'' from the agency drop-down menu and click ``Submit.'' In the
resulting docket list, click the appropriate docket number, then click
the ``View'' icon for any document or comment posted under that docket
number.
All submitted and posted comments will display the commenter's
name, organization (if any), city, and State, and, in the case of
mailed comments, all address information, including e-mail addresses.
We may omit voluminous attachments or material that we consider
unsuitable for posting.
You also may view copies of this notice and any electronic or
mailed comments we receive about this proposal by appointment at the
TTB Information Resource Center, 1310 G Street, NW., Washington, DC
20220. You may also obtain copies at 20 cents per 8.5- x 11-inch page.
Contact our information specialist at the above address or by telephone
at 202-927-2400 to schedule an appointment or to request copies of
comments or other materials.
IX. Regulatory Analysis and Notices
A. Regulatory Flexibility Act
We certify under the provisions of the Regulatory Flexibility Act
(5 U.S.C. 601 et seq.) that this proposed rule will not have a
significant economic impact on a substantial number of small entities.
Based on the comments we received in response to Notice No. 41, we
believe that the proposed rule will not impose, or otherwise cause, a
significant increase in reporting, recordkeeping, or other compliance
burdens on a substantial number of small entities. The proposed rule is
not expected to have significant secondary or incidental effects on a
substantial number of small entities. Accordingly, a regulatory
flexibility analysis is not required. Pursuant to section 7805(f) of
the Internal Revenue Code of 1986, we will submit this notice of
proposed rulemaking to the Chief Counsel for Advocacy of the Small
Business Administration for comment on its impact on small businesses.
As noted in the comment discussion in this proposed rule, several
commenters suggested that new labeling requirements would impose
significant costs on small businesses. Commenters stated that these
costs would include the costs of new labeling equipment or costs to
upgrade current equipment to accommodate a back label, production
disruption costs due to installation of new equipment, costs of label
redesign and new label stocks, and costs of laboratory testing
equipment or laboratory services.
In response to these comments, TTB considered options to minimize
the regulatory burdens and economic costs imposed by the proposed rule.
One option we considered was to exempt small businesses from the
requirements of the rule. However, as previously noted, we are not
proposing such an exemption because it might be inconsistent with our
mandate to ensure that alcohol beverage labels provide consumers with
adequate information about the identity and quality of these products.
A second option we considered was a delay in the effective date of
any final rule in order to provide adequate time for the industry to
develop new labeling materials, deplete existing inventories, and
coordinate the proposed labeling changes with their already scheduled
labeling changes. Most alcohol beverage industry members change their
labels at least once every three years.
Accordingly, as explained earlier in this document, TTB is
proposing a delayed effective date of three years from the date any
final rule is published in the Federal Register. We further propose
that manufacturers, bottlers, and importers who wish to label their
products with a Serving Facts panel and alcohol content statement
before the final rule comes into effect may begin to do so as long as
they adhere to the requirements of the final rule.
TTB believes that by delaying the implementation date for the new
labeling requirements, costs associated with label redesign and new
label stocks would be significantly reduced. A three-year
implementation period would allow affected industry members to use up
existing label stocks and coordinate the redesigning of their labels
with an already planned label redesign. We believe this option will
minimize costs or burdens associated with the proposed new label
information.
In addition to the proposed delayed effective date, we are
proposing regulatory text that allows flexibility on the placement and
appearance of the Serving Facts information. We are also proposing to
permit a linear display of the Serving Facts information on containers
50 milliliters or smaller. In providing such flexibility, TTB believes
that industry members would not have to purchase new, or upgrade
current, labeling equipment. Instead, existing labeling equipment could
be used. TTB is also soliciting comments on whether we should also
permit the linear display on all labels irrespective of the container
size and whether doing so would reduce the costs associated with
compliance while adequately informing consumers about the products.
Several commenters mentioned the costs associated with laboratory
analysis of products. However, we believe that this will not impose a
significant burden on small businesses. As noted earlier in this
document, according to the FDA Labeling Cost Model Final Report, the
costs associated with analytical testing are the same regardless of how
the product is packaged and sold; thus, manufacturers incur costs on a
product (or formula) basis. TTB has determined that the costs
associated with the analytical testing required for the proposed new
labeling requirements would be approximately $250 per formulation. To
develop these cost
[[Page 41876]]
estimates, we obtained price quotes in the spring of 2007 from four
different companies that test alcohol beverage products. Accordingly,
TTB believes that the costs associated with this proposal are not
significant.
We specifically solicit comments on the number of small producers,
importers and bottlers that may be affected by this proposed rule and
the impact of this proposed rule, if adopted as a final rule, on those
small businesses. We ask any small business that believes that it would
be significantly affected by this proposed rule to submit a comment
telling us how the rule would affect it.
B. Executive Order 12866
We have determined that this proposed rule is not a significant
regulatory action as defined in Executive Order 12866. Therefore, a
regulatory assessment is not required.
C. Paperwork Reduction Act
The collections of information contained in this notice of proposed
rulemaking have been submitted to the Office of Management and Budget
(OMB) for review in accordance with the Paperwork Reduction Act of 1995
(44 U.S.C. 3507(d)). Comments on the collections of information may be
sent by e-mail to OMB at Alexander_T._Hunt@omb.eop.gov, or by paper
mail to the Office of Management and Budget, Attention: Desk Officer
for the Department of the Treasury, Office of Information and
Regulatory Affairs, Washington, DC 20503, with copies to the Alcohol
and Tobacco Tax and Trade Bureau at the address previously specified.
Because OMB must complete its review of the collections of information
between 30 and 60 days after publication, comments on the information
collections should be submitted not later than August 30, 2007.
Comments are specifically requested concerning:
Whether the proposed collections of information are
necessary for the proper performance of the functions of the Alcohol
and Tobacco Tax and Trade Bureau, including whether the information
will have practical utility;
The accuracy of the estimated burden associated with the
proposed collections of information (see below);
How to enhance the quality, utility, and clarity of the
information to be collected;
How to minimize the burden of complying with the proposed
collections of information, including the application of automated
collection techniques or other forms of information technology; and
Estimates of capital or start-up costs and costs of
operation, maintenance, and purchase of services to provide
information.
The collection of information in this proposed regulation is in 27
CFR Sec. Sec. 4.32, 4.62, 4.111, 4.112, 4.113, 4.114, 4.115, 4.116,
5.32, 5.63, 5.81, 5.82, 5.83, 5.84, 5.85, 5.86, 7.22, 7.52, 7.91, 7.92,
7.93, 7.94, 7.95, 7.96, and 24.257(a)(3) and involves disclosures of
information on labels and performance standards for statements made on
labels and in advertisements of alcohol beverages. This information is
required to prevent deception of the consumer and will be used to
provide the consumer with adequate information as to the identity and
quality of alcohol beverage products. In addition, the collection of
information under Sec. 24.257(a)(3) will be used to protect the
revenue. These collections of information are mandatory. The likely
respondents are businesses or other for-profit institutions, including
associations, corporations, partnerships, and small businesses.
This information constitutes only a portion of the labeling and
advertising information on alcohol beverages required under authority
of the Federal Alcohol Administration Act (FAA Act) and the Internal
Revenue Code of 1986, as amended (IRC). OMB has previously approved a
collection of information for Labeling and Advertising Requirements
Under the FAA Act under control number 1513-0087.
Estimated total annual reporting and/or recordkeeping
burden: 7,071 hours.
Estimated average annual burden hours per respondent and/
or recordkeeper: One hour.
Estimated number of respondents and/or recordkeepers:
7,071.
Estimated annual frequency of responses: One.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a valid
control number assigned by OMB.
X. Drafting Information
The principal authors of this document are Lisa M. Gesser and
Joanne C. Brady, Regulations and Rulings Division, Alcohol and Tobacco
Tax and Trade Bureau.
List of Subjects
27 CFR Part 4
Administrative practice and procedure, Advertising, Customs duties
and inspection, Imports, Labeling, Packaging and containers, Reporting
and recordkeeping requirements, Trade practices, Wine.
27 CFR Part 5
Administrative practice and procedure, Advertising, Customs duties
and inspection, Distilled spirits, Imports, Labeling, Packaging and
containers, Reporting and recordkeeping requirements, Trade practices.
27 CFR Part 7
Administrative practice and procedure, Advertising, Customs duties
and inspection, Imports, Labeling, Malt Beverages, Reporting and
recordkeeping requirements, Trade practices.
27 CFR Part 24
Administrative practice and procedure, Claims, Electronic funds
transfers, Excise taxes, Exports, Food additives, Fruit juices,
Labeling, Liquors, Packaging and containers, Reporting and
recordkeeping requirements, Research, Scientific equipment, Spices and
flavorings, Surety bonds, Vinegar, Warehouses, Wine.
Proposed Amendments to the Regulations
For the reasons discussed in the preamble, TTB proposes to amend 27
CFR, chapter I, parts 4, 5, 7, and 24, as set forth below:
PART 4--LABELING AND ADVERTISING OF WINE
1. The authority citation for 27 CFR part 4 continues to read as
follows:
Authority: 27 U.S.C. 205, unless otherwise noted.
2. In Sec. 4.32, remove and reserve paragraph (a)(3) and add new
paragraphs (b)(3) and (b)(4) to read as follows:
Sec. 4.32 Mandatory label information.
* * * * *
(b) * * *
(3) Alcohol content, in accordance with Sec. 4.36.
(4) A Serving Facts panel, in accordance with subpart L of this
part.
* * * * *
3. Revise Sec. 4.36 to read as follows:
Sec. 4.36 Alcohol content.
(a) Mandatory statement. The alcohol content for wines must be
stated on wines as a percentage of alcohol by volume. For example,
``Alcohol--% by volume,'' or similar appropriate phrase, or in
accordance with the requirements set forth in Sec. 4.111(c) of subpart
L of this part; Provided, that if the word ``alcohol'' and/or
``volume'' are
[[Page 41877]]
abbreviated, they shall be shown as ``alc.'' (alc) and/or ``vol.''
(vol), respectively.
(b) Tolerances. The following tolerances shall be allowed either
above or below the stated percentage:
(1) A tolerance of 1.5 percent for wines containing 14 percent or
less of alcohol by volume.
(2) A tolerance of 1 percent for wines containing more than 14
percent of alcohol by volume.
(c) Regardless of the tolerances normally permitted in statements
of alcohol content, such statements must definitely and correctly
indicate the class, type and taxable grade of the wine so labeled and
nothing in this section shall be construed as authorizing the
appearance upon the labels of any wine of an alcohol content statement
that indicates that the alcohol content of the wine is within the
prescribed limitations on the alcohol content of any class, type, or
taxable grade of wine when in fact it is not.
4. Amend Sec. 4.62 by redesignating paragraph (c) as paragraph (d)
and adding a new paragraph (c) to read as follows:
Sec. 4.62 Mandatory statements.
* * * * *
(c) Calorie and carbohydrate claims. If the advertisement makes an
explicit or implicit calorie or carbohydrate claim, it must include a
Serving Facts panel in accordance with subpart L of this part and an
alcohol content statement disclosing the percentage of alcohol by
volume.
* * * * *
5. Add a new Subpart L to read as follows:
Subpart L--Nutrient Information
Sec.
4.111 Serving Facts panels.
4.112 Format for Serving Facts panels.
4.113 Placement of Serving Facts panels.
4.114 Tolerance Levels.
Subpart L--Nutrient Information
Sec. 4.111 Serving Facts panels.
(a) General. A Serving Facts panel required under Sec. 4.32(b)(4)
must include the following information: The single serving size; the
number of servings per container; the number of calories per serving;
and the number, in grams per serving, of carbohydrates, fat, and
protein. Alcohol content statements, as provided in paragraphs (c) and
(d) of this section, may appear on the Serving Facts panel.
(b) Single serving size and servings per container--(1) Definition.
The term ``single serving'' or ``serving size'' means an amount of the
wine customarily consumed as a single serving, expressed in U.S. fluid
ounces, and in parentheses, in milliliters to the nearest whole number.
This amount is not a recommended amount, but rather is only a reference
amount to help the consumer determine his or her nutrient and calorie
intake. The single serving or serving size reference amounts for wines
are:
------------------------------------------------------------------------
a single serving or serving
For products containing: size is:
------------------------------------------------------------------------
At least 7% and not more than 14% alc/vol. 5 fluid ounces (148
milliliters).
Over 14% and not more than 24% alc/vol.... 2.5 fluid ounces (74
milliliters).
------------------------------------------------------------------------
(2) Single and multi-serving containers. Products packaged and sold
in containers with a volume of less than or equal to a single serving
reference amount described in this section must be labeled as a single
serving. Products packaged and sold in containers with a volume of more
than a single serving reference amount described in this section will
be treated as multi-serving containers and the number of servings per
container must be labeled to the nearest \1/4\ serving.
(c) Percentage of alcohol by volume. The Serving Facts panel may
include a statement of alcohol content as a percentage of alcohol by
volume, to which the tolerance ranges in Sec. 4.36 apply. A statement
of alcohol content in the Serving Facts panel will satisfy the
requirement for listing alcohol content in Sec. 4.32(b)(3).
(d) Alcohol expressed in fluid ounces. A Serving Facts panel may
declare the number of U.S. fluid ounces of pure alcohol (ethyl alcohol)
per serving, expressed to the nearest tenth of an ounce, only if the
panel also includes a statement of alcohol content expressed as a
percentage of alcohol by volume, presented in accordance with Sec.
4.112(g).
(e) Calories. A Serving Facts panel must express the calorie
content per serving to the nearest 5-calorie increment up to and
including 50 calories, and to the nearest 10-calorie increment above 50
calories. An amount less than 5 calories may be expressed as zero.
(f) Carbohydrates. A Serving Facts panel must express carbohydrate
content to the nearest gram per serving, except that the carbohydrate
content may be expressed as zero if a serving contains less than 0.5
gram.
(g) Fat. A Serving Facts panel must express fat content in grams
per serving to the nearest 0.5 gram below 5 grams and to the nearest
gram above 5 grams. If the serving contains less than 0.5 gram, the fat
content may be expressed as zero.
(h) Protein. A Serving Facts panel must express protein content in
grams per serving to the nearest gram. If the serving contains less
than 0.5 gram, the protein content may be expressed as zero.
Sec. 4.112 Format for Serving Facts panels.
The wine label or advertisement must present the Serving Facts
panel in, or in a manner that closely follows, the specifications set
forth in this section. While TTB encourages presentation of the Serving
Facts information in a panel format as specified in paragraph (a)
through (l) of this section, TTB will also permit the listing of
Serving Facts information in a linear fashion for containers 50
milliliters or smaller. See paragraph (m) of this section for an
illustration of an appropriate linear display.
(a) The Serving Facts panel information must be set off within a
box by use of hairlines with all black or one color type, printed on a
white or other neutral contrasting background.
(b) The Serving Facts panel may be presented in either a horizontal
or vertical orientation.
(c) All information within the Serving Facts panel must:
(1) Appear in a single easy-to-read type style;
(2) Appear in upper and lower case letters;
(3) Have at least one point leading (that is, space between lines
of text); and
(4) Not include letters that touch other letters, numbers, or
lines.
(d) The Serving Facts information specified in Sec. 4.111 must
appear in the panel in the following order:
(1) Serving size;
(2) Servings per container;
(3) Percentage of alcohol by volume (if included in the Serving
Facts panel);
(4) Alcohol in U.S. fluid ounces (if included in the Serving Facts
panel);
(5) Calories;
(6) Carbohydrates;
(7) Fat; and
(8) Protein.
(e) The following information must not appear in bold and must be
in type or printing not smaller than 1 millimeter for containers of 237
milliliters (8 U.S. fluid ounces) or less or not smaller than 2
millimeters for containers of more than 237 milliliters:
(1) ``Serving Size'', including the numeric figure denoting the
size in U.S. fluid ounces and, in parentheses, in milliliters.
(2) ``Servings Per Container'', including the numeric figure
denoting
[[Page 41878]]
the correct number (rounded to the nearest \1/4\ serving); and
(3) Numeric figures denoting alcohol content, calories, and
carbohydrate, fat, and protein content.
(f) The following headings must be highlighted by bold or extra
bold type or printing that prominently distinguishes them from other
information, and they must appear in type or printing size no smaller
than that specified below:
(1) ``Serving Facts'' (type or printing size no smaller than 2
millimeters for containers of 237 milliliters or less and no smaller
than 4 millimeters for containers of more than 237 milliliters);
(2) ``Amount Per Serving'' and ``Amount Per Bottle'' (type or
printing no smaller than 1 millimeter f