Alcohol Beverages: Labeling and Health Claims
Report for Congress
Labeling and Health Claims
Updated April 10, 2003
Donna V. Porter
Specialist in Life Sciences
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress
Alcohol Beverages: Labeling and Health Claims
On March 3, 2003, the Alcohol and Tobacco and Trade Bureau published final
rules that would prohibit manufacturers from making any substantive claims in
labeling or in advertising regarding health benefits associated with alcohol beverage
consumption, unless specific criteria are met. This publication follows several years
of debate over whether statements of health benefits should be allowed to appear on
Regulation of alcohol beverages fell under the jurisdiction of the Department
of Treasury’s Bureau of Alcohol, Tobacco and Firearms (BATF) until it was renamed
Alcohol and Tobacco Tax and Trade Bureau (TTB), following the creation of the
Department of Homeland Security. All alcohol beverage labels must undergo
premarket approval by the Bureau, which will be referred to as TTB throughout this
report. The Food and Drug Administration (FDA) and the Department of Agriculture
are responsible for the regulation of labeling on non-alcohol beverages, food and
meat products. Since 1987, FDA and TTB have worked under a memorandum of
understanding which clarifies and delineates the enforcement responsibilities of each
agency with respect to regulation of alcohol beverages found to be adulterated.
In general, labeling requirements are specific to the food or alcohol beverage
product being marketed. Since 1988, alcohol beverages have been required to carry
government warnings about alcohol consumption and its impact on driving and/or
pregnancy. In the last decade, food products have been allowed to carry nutrient
content and health claims, if they meet certain regulatory requirements. Early in
1999, TTB announced that it would allow wine manufacturers to place health
information on their labels for the first time. However, it subsequently proposed
rules to prohibit such messages on alcohol beverages, unless specific criteria are met.
TTB’s initial decision to allow health messages on wine labels was based on the
message’s reference to the U.S. Dietary Guidelines. The guidelines state that “if
alcohol beverages are consumed, it should be done in moderation.” The
accompanying text outlines the hazards of excessive intake, individuals who should
avoid drinking, and recent evidence that moderate drinking may be associated with
lower coronary heart disease risk in some individuals.
Three bills were introduced in the 106th Congress in response to the initial TTB
decision to allow health messages on wine labels. The Alcohol Beverage Labeling
Act of 1999 (S. 431) would have transferred all authority for alcohol beverage
labeling from TTB to the Department of Health and Human Services. The Alcohol
Abuse, Prevention and Treatment Trust Fund Act of 1999 (S. 432) would have
increased the rate of tax on wine and dedicated those revenues to programs for the
prevention and treatment of alcohol abuse. The Alcohol Beverage Label Preservation
Act of 1999 (S. 433) would have prohibited additional statements and representations
related to alcohol beverages and health beyond the government warning already
required. Two other bills, H.R. 2094 and H.R. 2161, were concerned with alcohol
beverage shipments. No action was ever taken on these bills, and no alcohol labelingth
legislation has been introduced since the 106 Congress.
Health Effects of Alcohol Consumption ............................2
Government Guidance on Alcohol................................3
Current Regulatory Jurisdiction...................................4
Memorandum of Understanding..................................5
Alcohol Beverages: Labeling, Claims and Warning Requirements........6
Foods: Labeling, Claims and Warning Requirements.................9
Alcohol Beverage Legislation...................................11
Key Issues Concerning Health Claims on Alcohol Beverages..........11
Labeling and Health Claims
On March 3, 2003, the Alcohol and Tobacco Tax and Trade Bureau (TTB)
published final rules that would prohibit the appearance in labeling or advertising of
any statement that makes a substantive claim regarding health benefits associated
with alcohol beverage1 consumption, unless specific criteria are met. This
announcement followed several years of debate on whether to allow health benefit
statements to appear on wine products. For more than a decade, mandatory health
warnings have appeared on all alcohol beverages.
Alcohol consumption is difficult to quantify accurately, and there is no
universally acceptable classification system or standard for a safe level of drinking.
The amount and type of alcohol beverages Americans drink, and changes in overall
drinking levels, are generally determined by monitoring product sales. Per capita
consumption is not possible to determine so it is derived from sales data to represent
an estimate of the average amount of alcohol consumed per person. The result is
“apparent per capita consumption,” which is calculated by dividing alcohol sales or
shipment data from every state and the District of Columbia by the U.S. population
aged 14 years or older, to determine the consumption expressed in gallons of pure
alcohol. The estimates attribute average consumption to all individuals in the
population, regardless of their actual consumption; thus the data have limitations in
determining actual consumption.
Total annual per capita alcohol consumption rose from 1935, when consumption
was 1.2 gallons, to 1982 when consumption reached a high of about 2.75 gallons,
before falling to a level of 2.21 gallons by 1999 for the population 14 years and
older.2 Beer makes the greatest contribution to apparent per capita alcohol
consumption in the United States, while wine has made the least. Almost all of the
recent decline in alcohol use can be attributed to a reduction in the use of distilled
1 Note: Several terms are used for beverages containing an alcohol content greater than 7%
of volume: alcohol beverages, alcoholic beverages and beverage alcohol. For purposes of
this report the term alcohol beverages will be used.
In 2000, about 62% of all individuals surveyed reported being drinkers,
including 68% of men and 56% of women.3 By level of alcohol consumed as self-
estimated and reported by current drinkers, 71% reported light and 22% reported
moderate consumption. In 2000, 7% of individuals aged 18 years and over described
themselves as heavy alcohol users, defined as five or more drinks on at least one
occasion in the past month. Among current drinkers, about 32% of individuals in
this age group reported consuming five or more drinks on at least one occasion in the
past year, including 43% of men and 19% of women. This level of alcohol
consumption was most common among young adults 18-24 years of age.
Health Effects of Alcohol Consumption
Considerable attention has been paid to the issue of the health effects of alcohol
consumption. Excessive alcohol consumption can have widespread deleterious
effects throughout the body, with consequences that include neuropsychological and
reproductive abnormalities and increased susceptibility to infection. The adverse
consequences of alcohol abuse may vary considerably depending on such factors as
the amount consumed, gender, age, and nutritional status of the individual. The
contribution of excessive alcohol intake to liver damage, heart and cardiovascular
disease, high blood pressure and stroke, mental impairment, interference with normal
endocrine function, and dysregulation of immune defenses have been well-
documented.4 Chronic liver disease and cirrhosis, which are frequently associated
with alcohol abuse, ranked as the tenth leading cause of death in 1997.5 Particular
concern focuses on early drinking which seems to increase lifetime risk of
alcoholism.6 An estimated 14 million adults either abuse or are physically dependent
on alcohol.7 The effects of excessive drinking are the primary basis for opposition
to allowing health benefit statements on alcohol beverages (described below).
However, increasing attention has focused on epidemiologic data that suggests
potential health benefits may result from moderate alcohol consumption. A decade
ago, numerous media reports introduced the American public to what was termed the
“French Paradox.”8 The reports described how the French population, while
consuming a higher fat diet, smoking more and exercising less than Americans,
3 U.S. Dept of Health and Human Services. Centers for Disease Control and Prevention.
Health, United States, 2002 with Chartbook on Trends in the Health of Americans. DHHS
Pub. No. (PHS) 2002-1232. July 2002.
4 U.S. Dept. of Health and Human Services. Public Health Service, National Institutes of
Health. National Institute on Alcohol Abuse and Alcoholism. Ninth Special Report to the
U.S. Congress on Alcohol and Health. From the Secretary of Health and Human Services.
5 U.S. Dept. of Health and Human Services. Healthy People 2010. Final Report.
Washington, D.C. November, 2000.
6 Squires, S. Early Drinking Said to Increase Alcoholism Risk. Washington Post. January
8 Kazman, S. Here’s to Honesty in Liquor Labels. Wall St. Journal. February 18, 1999. p.
experienced only half as many heart attacks as the U.S. population. The difference
in cardiovascular disease was suggested to result from moderate alcohol
consumption, especially red wine, by the French. As defined in the scientific
literature, moderate alcohol consumption consists of 1-2 drinks a day and is believed
to be beneficial in reducing the risk of coronary artery disease (CAD). A recent
published report from the Harvard School of Public Health indicates that two drinks
a day will reduce the risk of heart attack in individuals by at least 25%.9 Research
and debate continue on several possible metabolic pathways that may be affected by
moderate alcohol consumption, which may result in reducing the risk of CAD. The
implications of epidemiological and experimental findings may hold valuable
information for clinical practice and public health policies in the future.
While moderate drinking may reduce the risk of CAD in some individuals, other
population subgroups, such as pregnant women and individuals who are operating
motor vehicles or heavy machinery, are advised to avoid drinking alcohol beverages.
Individuals with a family history of alcoholism need to exercise caution in their
decision to drink. Currently, the epidemiological studies have suggested that
moderate drinking is associated with improved cardiovascular health.10 Certain
individuals who are at high risk of CAD, especially men over 45, postmenopausal
women and smokers, may benefit from the cardioprotective effects of alcohol
beverages more than persons at low risk. Further study is needed to verify whether
the relationship is supported by additional research scrutiny.
Government Guidance on Alcohol
Over the years, the use of alcohol beverages has been addressed in at least two
government-sponsored initiatives: dietary guidance and health objectives. The fifth
edition of the Dietary Guidelines for Americans released by the U.S. Departments of
Agriculture (USDA) and HHS stated in its tenth “rule” that: “If you drink alcoholic
beverages, do so in moderation.”11 This wording or similar language has appeared
in each edition of the Dietary Guidelines since the first one in 1980. The
accompanying text for this “rule” has expanded over time and outlines the hazards
of excessive intake of alcohol. The text reports that current research suggests that
moderate drinking is associated with a lower risk for coronary heart disease in some
individuals. Moderation is defined as no more than one drink per day for women and
two drinks per day for men. A single drink would amount to 12 ounces of regular
beer, 5 ounces of wine, or 1.5 ounces of 80-proof distilled spirits. The increased
health risks from higher intakes are also provided: high blood pressure, stroke, heart
disease, certain cancers, accidents, violence, suicides, birth defects, and overall
mortality. The problems from excessive consumption are reviewed: cirrhosis of the
9 Rimm, E. et al. Moderate Alcohol Intake and Lower Risk of Coronary Heart Disease:
Meta-analysis of Effects on Lipids and Hemostatic Factors. British Medical Journal. v. 319
December 11, 1999. p.1523-1528.
10 Zakhari, S. and E. Gordis. Moderate Drinking and Cardiovascular Health. Proceedings
Assoc. Amer. Physicians. v. 111, no. 2. March/April 1999. p. 148-158.
11 U.S. Dept. of Agriculture. Dept. of Health and Human Services. Nutrition and Your
Health: Dietary Guidelines for Americans. Washington, D.C. Fifth Edition., 2000.
liver, inflammation of the pancreas, damage to brain and heart, and malnutrition.
The text identifies individuals who should not drink: children and adolescents;
anyone who consumes more than moderate amounts; pregnant women; individuals
on prescription and over-the-counter drugs; and individuals driving or undertaking
activities that require skill or attention.
In the final report submitted by the Dietary Guidelines scientific advisory
committee, the alcohol guideline was unchanged.12 However, the accompanying text
draft was revised to place greater emphasis on excessive consumption of alcohol and
updating statements based on current scientific evidence. It provides information on
moderate drinking, which was comparable to the text in the previous edition. While
the text does mention the potential benefit of lowering coronary heart disease risk in
men over 45 and women over 55, it continues to identify the subgroups of individuals
who should not drink at all. The sixth edition is anticipated in 2005 and preliminary
activities in its preparation are currently underway.
The final version of Healthy People 2010 Objectives was released by HHS in
November, 2000.13 These objectives, published about every decade since 1979, are
a 10-year plan for improving the nation’s public health. The recent document
identified 10 leading indicators of health status, one of which is substance abuse
(alcohol and drugs). The specific alcohol objectives seek to decrease the proportion
of adolescents using alcohol, and to reduce the proportion of adults engaging in binge
drinking. The text reviews the health and social impact of alcohol use and abuse. It
reports that the trends in alcohol abuse by adolescents ages 12-17 remained at a level
of about 20% from 1992-1997, with 8% reporting binge drinking and 3% considered
to be heavy drinkers (five or more drinks on the same occasion on each of 5 or more
days in the past month). For adults, binge drinking has remained at about 16% since
Current Regulatory Jurisdiction
The Department of the Treasury and its BATF was responsible for the regulation
of alcohol beverages, until it was renamed the Alcohol and Tobacco Tax and Trade
Bureau (TTB), following the creation of the Department of Homeland Security. The
Bureau regulates the qualification and operations of domestic distilleries, wineries
and breweries, as well as importers and wholesalers in the alcohol beverage industry.
The TTB National Laboratory Center is the primary tester of new alcohol products
prior to their marketplace introduction, as well as the facility that determines whether
any product currently on the market poses a health hazard to consumers.
TTB conducts a full range of regulatory functions within the alcohol beverage
industry. Under the provisions of the Federal Alcohol Administration Act of 1935
(FAAA) as amended, the Bureau is authorized to fully regulate the industry and to
provide consumer protection. In addition to collecting the alcohol beverage excise
12 U.S. Dept. of Agriculture. Dept. of Health and Human Services. Report of the Dietary
Guidelines Advisory Committee. Final Report. Released February 18, 2000. 129 p.
13 U.S. Dept. of Health and Human Services. Healthy People 2010. Final Report.
Washington, D.C. November, 2000.
taxes and preventing any unlawful practices in the alcohol beverage industry, TTB
is charged with protecting consumers by preventing false or misleading claims on
beverage labels and in advertising. To ensure alcohol beverage labels do not contain
misleading information and do adhere to regulatory mandates, the Bureau examines
all label applications for premarket approval. TTB enforces the Government Health
Warning Statement requirements (see below), prohibits health or exaggerated quality
claims, monitors industry advertising, and conducts investigations of suspected label
fraud. Certificates of Label Approval are issued by the Bureau for every alcohol
beverage offered for sale in interstate commerce in the United States. The agency is
responsible for all malt liquor products and all wine and distilled spirits that contain
more than 7% of alcohol by volume.
In contrast, the Food and Drug Administration’s (FDA) Center for Food Safety
and Applied Nutrition is responsible for regulating the safety and labeling of other
beverages and most food products. FDA regulates these products under the
provisions of the Food, Drug and Cosmetic Act of 1938, as amended (FDCA). The
agency does not review food product labels prior to marketing, but conducts post
market compliance checks on food labels. It is responsible for the regulation of a few
food products that contain small amounts of alcohol (less than 7% of volume), such
as fruit juices and candies. The U.S. Department of Agriculture’s (USDA) Food
Safety and Inspection Service is responsible for the regulation of meat and poultry
products. USDA’s jurisdiction is authorized by the Meat Inspection Act of 1907 and
the Poultry Products Inspection Act of 1957. The Department reviews all meat and
poultry product labels prior to marketing. Finally, the Federal Trade Commission is
responsible for the regulation of the advertising of food products.
Memorandum of Understanding14
Since 1987, FDA and TTB have worked under a memorandum of understanding
(MOU) that clarifies and delineates the enforcement responsibilities of each agency
for alcohol beverages considered to be adulterated (unsafe) under FDCA. The MOU
facilitates communication and exchange between the agencies; confirms TTB policy
on the labeling of ingredients and substances in alcohol beverages that pose a public
health problem; and clarifies and coordinates the responsibilities of each agency
concerning the identification, testing and recall of adulterated alcohol beverages. The
Bureau is charged with the administration and enforcement of the FAAA, which it
implements through the issuance of permits and procedures that require the prior
approval of all labels. TTB is responsible for the promulgation and enforcement of
regulations with respect to labeling of distilled spirits, wine and malt beverages.
When FDA determines that the presence of an ingredient in food products, including
alcohol beverages, poses a recognized public health problem and must be identified
on the product label, TTB is responsible for promulgating labeling regulations for
alcohol beverages consistent with its health policy for these products. The agencies
consult on a regular basis concerning the propriety of promulgating regulations
concerning the labeling of other ingredients and substances for alcohol beverages.
14 U.S. Food and Drug Administration. Compliance Policy Guides. Memorandum of
Understanding Between the Food and Drug Administration and the Bureau of Alcohol,
Tobacco and Firearms. Guide 7155g.04. FDA-225-88-2000. November 20, 1987. 8 p.
Alcohol Beverages: Labeling, Claims and Warning
The labeling requirements for alcohol beverages include several different
elements, depending on the product.15 Wine bottle labels are required to contain
brand name; class, type or other designation; blends; manufacturers/distributors’
name and address; net contents, and when present, FD&C yellow no. 5 coloring,
saccharin warning statement, and sulfites declaration. Distilled spirits bottles are to
list the following mandatory statements: responsible advertiser; class and type;
alcohol content; percentage of neutral spirits and name of the commodity from which
the product is distilled. Labeling requirements for malt beverages include brand
name; class; name and address, net contents, and when present, FD&C yellow no. 5
coloring, declaration of sulfites, saccharin and aspartame warnings. TTB reviews all
product labels and certifies their approval prior to marketing.
All alcohol beverages bottled or imported for sale in the United States are
required to carry a warning label mandated by the Alcohol Beverage Labeling Act of
1988. Since its November 18, 1989 effective date, the following statements are
required to appear on the labels:
GOVERNMENT WARNING: (1) According to the Surgeon General, women
should not drink alcoholic beverages during pregnancy because of the risk of
birth defects.(2) Consumption of alcoholic beverages impairs your ability to
drive a car or operate machinery, and may cause health problems.
In November 1999, the Center for Science in the Public Interest, along with a
coalition of public health, consumer, safety and child-protection organizations and
four Members of Congress, petitioned TTB to improve the legibility, clarity and
noticeability of the congressionally mandated health warnings required on alcohol
beverage labels.16 In December 1999, TTB sent letters to FDA, FTC, the National
Institute on Alcohol Abuse and Alcoholism, and the Surgeon General requesting
review and comment on CSPI’s petition. While comments were received on the
petition, no final decision on how to proceed has yet been announced, despite a signal
from the agency that it would be forthcoming.17
In February 1999, after several years’ debate over the wine industry’s request,
TTB approved the use of health messages on wine labels.18 The new label statements
were based on the information in the Dietary Guidelines for Americans that address
alcohol beverage consumption. Either of these two messages were allowed:
15 Code of Federal Regulations. Section 27. Ch 1. Parts 4.30, 5.31, 7.1.
16 CSPI et al. Petition to improve the legibility, clarity and noticeability of health warnings
required by the Alcoholic Beverage Labeling Act of 1988. Submitted to BATF. November
17 Buckles, B.A. Director of BATF. Speech before the American Vintners Association
March 20, 2000. Washington, D.C. 3 p.
18 U.S. Dept. of Treasury. Office of Public Affairs. Treasury News. Treasury Announces
Actions Concerning Labeling of Alcoholic Beverages. RR-2937. February 5, 1999.
To learn the health effects of wine consumption, send for the Federal
Government’s Dietary Guidelines for Americans; Center for Nutrition Policy andth
Promotion, USDA 1120 20 Street, NW, Washington, D.C. 20036 or visit its
Web site - [http://www.usda.gov/cnpp/] or
The proud people who made this wine encourage you to consult your family
doctor about the health effects of wine consumption.
Under existing law, TTB believed it could only deny such labeling statements19
if they were false and misleading. The wine labeling health effect statements were
approved because they met the Bureau’s factual standards of not being false or
misleading, and no health claim was made. In TTB’s view, consumers were simply
being directed to several sources of information about the health effects of alcohol
TTB based its decision in part on a survey of current wine drinkers conducted
by the Substance Abuse and Mental Health Service Administration’s Center for20
Substance Abuse Prevention (SAMHSA). The survey findings were obtained
through mall interviews and focus groups using three label messages. The results
indicated that for most of those surveyed, drinking patterns would not be influenced
by any label message tested. The survey also revealed that the word “moderate,”
when associated with drinking, had virtually no meaning to most individuals
surveyed. In addition, wine drinkers indicated that the amount of alcohol which
constituted “moderate” was less than they considered to be moderate.
Reaction to the TTB decision to allow the health effects statement to appear on
the wine labels varied. Prior to the agency issuing its decision, Surgeon General and
Assistant Secretary for Health Dr. Satcher, in a letter to TTB, expressed his concern
about allowing the wine label claim.21 Numerous health and consumer groups also
opposed the label, with concerns that ranged from the alcohol abuse issue to
questions about the strength of the scientific evidence supporting the health benefits.
Members of the 1995 Dietary Guidelines advisory committee indicated that the text
submitted to the agencies for that edition of the Guidelines was modified in the final
publication and that they had no intention of implying endorsement of alcohol
beverage consumption for health benefits.22 Several bills introduced in Congress
were intended to relieve the Bureau of jurisdiction over these products as a result of
the proposed rule(see below). On the other side, wine manufacturers who had
requested use of the claim were pleased with TTB’s decision. Members of the
distilled spirits segment of the industry were also considering a request to use similar
label messages, since the Dietary Guidelines text is not specific in its wording to
20 DHHS. Substance Abuse and Mental Health Services Administration Center for
Substance Abuse Prevention. The Effect of Wine Labels on Public Perception. Main
Findings. January 30, 1998. PHD752. 14 p.
21 Letter to Arthur Libertucci, Asst. Dir. Alcohol and Tobacco, BATF from Dr. David
Satcher, Asst. Sec. for health and Surgeon General. January 12, 1999. 3 p.
22 Uncle Sam Never Said Drink for Your Health. Marin Institute, Summer 1996.
wine, but states that current research suggests that moderate drinking is associated
with a lower risk for coronary heart disease in some individuals.23
Partially as a result of the negative reaction to the announcement allowing wine
labels to carry health-related messages, the Bureau announced in May 1999 that it
would initiate rulemaking on this issue.24 The announcement included the agency’s
intent to publish a proposed rule for notice and comment within several months, with
completion of the final rule on alcohol beverage health statements within 2 years. In
the interim, the agency indicated that wine makers would continue to be allowed to
use the health statements that it already had approved, with the understanding that the
rulemaking might change the type of statement allowed.
TTB proposed the regulation for the health labeling of alcohol beverages in
October 1999. 25 The rule would prohibit the appearance on labels or in advertising
of any statement that makes a substantive claim regarding health benefits associated
with the consumption of alcohol beverages, unless such claims are properly qualified,
balanced, sufficiently detailed, and specific. In addition, the claims would have to
outline the categories of individuals for whom any positive health effects would be
outweighed by numerous negative health effects. TTB also proposed to prohibit any
advertisements that attribute health benefits to the consumption of alcohol beverages,
unless such statements are appropriately qualified in a manner that is not likely to
result in either consumer confusion or deception. The Bureau requested comments
on the question of whether the negative consequences of alcohol consumption or
abuse disqualify, as misleading, these products entirely from entitlement to any
health-related statements. It also sought comments on whether health-related
statements on alcohol beverage labels and advertising, that directs consumers to
information sources, such as the U.S. Dietary Guidelines, are misleading, and
whether TTB should continue to approve such statements. The agency stated that the
proposed regulation was intended to ensure that labels and advertisements do not
contain statements or claims that would tend to mislead consumers about the
potential health consequences of alcohol consumption. The closing date for
comments was February 22, 2000.
Subsequently, TTB announced that it would hold public hearings in five cities
concerning health claims and other health-related statements on the labeling of
alcohol beverages.26 The public hearings were scheduled to be held in Washington,
D.C., San Francisco, Atlanta, Chicago, and Dallas between April and September
23 Solomon, J. Distillers consider health-benefit labels. Wall St. J. February. 10, 1999. B11
24 New wine labels to be reexamined. San Francisco Chron. Wire Story. May 15, 1999.
25 U.S. Dept. of Treasury. Bureau of Alcohol, Tobacco and Firearms. Health Claims and
Other Health-Related Statements in the Labeling and Advertising of Alcohol Beverages.
Notice of Proposed Rulemaking. Federal Register. v. 64, no.205. October 25, 1999.
26 U.S. Dept. of Treasury. Bureau of Alcohol, Tobacco and Firearms. Health Claims
Statements in the Labeling and Advertising of Alcohol Beverages. Public Hearing. Federal
Register. v. 65, no.29. February 28, 2000. p.10434-10436.
2000. The final rule was not to be published until after these meetings were
On March 3, 2003 the Department of the Treasury published the final rule on
health claims and related statements in the labeling and advertising for alcohol
beverages.27 The regulation requires that TTB evaluate health claims on a case-by-
case basis to determine if such claims would tend to mislead consumers. It codifies
the Bureau’s long-standing position that any substantive health benefit claim is
considered misleading, unless it is truthful and adequately substantiated by
scientific/medical evidence; sufficiently details and qualified with respect to
categories of individuals for whom the claim applies; adequately discloses the health
risks associated with alcohol consumption and outlines the categories of individuals
for whom any level of alcohol consumption may cause health risks. The rule
requires that any such claim include appropriate qualifications and disclaimers about
health risks associated with alcohol consumption. In addition, health-related
directional statements that are not substantive health claims must nonetheless include
a disclaimer to clarify that the statement does not advocate the consumption of
alcohol beverages for health reasons or some other appropriate disclaimer to avoid
misleading consumers. TTB will consult with FDA as needed on the use of specific
health claims on labels. If FDA determines that a specific claim is a drug claim that
is not in compliance with the requirements of FDCA, TTB will not approve the use
of such statements on labels. The rule is scheduled to go into effect on June 2, 2003.
Foods: Labeling, Claims and Warning Requirements
In the early 1990s, FDA and USDA undertook a comprehensive overhaul of
food labeling, with primary focus on improving nutrition information and consistency
across food labels for consumers. The Nutrition Labeling and Education Act of 1990
(NLEA) provided FDA with the mandate to implement the labeling changes, while
USDA agreed to implement similar changes under its existing authority. The new
labeling rules required for the first time that labels provide nutrition information and
a complete ingredient listing on most foods. In addition, food products were allowed
to provide nutrient content and health claims under certain circumstances. The
requirements for the labeling, claims and warnings on food products are numerous.28
For purposes of this report, only those provisions that are comparable to those for
alcohol beverages are reviewed. The following discussion generally applies to both
labeling on the food products regulated by FDA and the meat and poultry products
regulated by USDA.
Food and meat product labels must provide mandatory information on the
standard of identity, language requirements, net quantity of contents, name and
address of manufacturer, ingredients, manufacturing code, prominence of required
statements, and the universal product code. Mandatory wording is required for
27 U.S. Dept. of Treasury. Alcohol and Tobacco and Trade Bureau. Health Claims and
Other Health-Related Statements in the Labeling and Advertising of Alcohol Beverages.
Final Rule. Federal Register. v. 68, no.41. March 3, 2003. p.10076-10106.
28 CRS Report 91-146, Nutrition Labeling and Education Act of 1990: P.L. 101-535, Donna
V. Porter. (archived)
nutrition labeling, grades, information on special dietary use, and when present, a
sulfite declaration and warning statements for aspartame, saccharin and FD&C
yellow dye #5. Optional information includes dating and certain other symbols.
Provisions of NLEA allowed nutrient content and health claims for foods that
were authorized in advance by the government. Nutrient content claims are label
statements that provide relative quantitative statements about the presence or absence
of a nutrient in the food product. Examples include low fat, reduced salt, high fiber
or high calcium. A manufacturer wishing to make a new nutrient content claim must
first petition the agency. FDA then must review the petition and propose a regulation
for the new claim before it can become a final regulation, after notice and comment
Health claims are messages that describe the relationship between a nutrient (or
other food substance) and a disease or health-condition. These claims are allowed
if a regulation authorizing them has been issued by FDA. NLEA created a petition
process requiring manufacturers to provide the publicly available scientific evidence
that it believes established the basis for the diet and health relationship. The
petitioner also must provide information about the claim that will be made and the
proposed wording. NLEA requires the agency to conduct a review to determine
whether the science supports the existence of the relationship. FDA was directed to
authorize a health claim when, based on the totality of the publicly available
scientific evidence from well-designed studies, there is significant scientific
agreement (SSA) among qualified scientific experts that the claim is supported by the
evidence. This review is subject to notice and comment rulemaking. In short, health
claim statements in labeling are to be specific, affirmative statements that are
accurate, based on the totality of the scientific evidence and able to convince
qualified individuals that the food substance, when used in a dietary context, will
have the stated impact on a disease or other health-related condition. Health claims
are not allowed if a food contains certain components that are present at a level that
would represent a health risk. Disqualifying levels were set for total fat, saturated fat,
cholesterol, and sodium.
The Food and Drug Administration Modernization Act of 1997 (FDAMA, P.L.
97-105) provided an alternative mechanism for the authorization of health claims, in
part because the interested parties recognized the time-consuming, resource-intensive
nature of the NLEA-mandated scientific review process. Fast-track options were
viewed as possible when the scientific work had already been done elsewhere.
FDAMA directed that health and nutrient content claims could be authorized under
circumstances where an authoritative statement (AS) had been issued by a scientific
body with nutrition research expertise of the federal government or the National
Academy of Sciences. The Act identified four criteria for statements to be
considered authoritative: the statement has to be currently in effect, concern a
relationship (or nutrient level), be published, and can not be a statement of an
individual employee of the authoring organization. The manufacturer planning to
make the claim must notify the agency that a claim will be made, based on an AS.
The notification must contain the exact wording of the claim and the AS supporting
it, a description of the determination that the requirements for an AS are satisfied,
and a balanced representation of the scientific literature to which the claim refers.
The substance that is the subject of the claim must also be safe and lawful and
present at a level in the food that is sufficiently high in an appropriate form to justify
the claim. FDA then has 120 days to determine whether the claim meets the agency’s
criteria, allowing it to be made.
Alcohol Beverage Legislation
Several bills were introduced in the 106th Congress that concerned alcohol
beverages, of which three bills relate directly to TTB labeling activities. The Alcohol
Beverage Labeling Act of 1999 (S. 431) would have amended the Alcohol Beverage
Labeling Act of 1988 to grant authority to the Secretary of Health and Human
Services for all functions that are exercised currently by the Secretary of the Treasury
related to the 1988 Act. Determination of the functions and related resources to be
transferred would be made by the Office of Management and Budget. The personnel
currently responsible for those functions at the Department of the Treasury would be
transferred to HHS. The bill was referred to the Committee on Commerce, Science
A related bill, the Alcohol Abuse, Prevention and Treatment Trust Fund Act of
1999 (S. 432), would have amended the Internal Revenue Code of 1986 to increase
the rate of tax on wine and dedicate the resulting increased revenue to programs for
the prevention and treatment of alcohol abuse. The current tax rate on wine is
considerably below that of beer and distilled spirits. This bill was referred to the
Committee on Finance.
A third bill, the Alcoholic Beverage Label Preservation Act of 1999 (S. 433),
would have prohibited additional statements and representations related to alcohol
beverages and health. The bill would have prohibited any alcohol beverage container
from carrying any statement or representation relating to alcohol beverages and
health, other than the current Government Warning statements required by the 1988
Act, as outlined above. It was referred to the Committee on Commerce, Science and
Two other bills addressed the issue of alcohol shipments. H.R. 2094, the State
Responsible Alcohol Access Enforcement Act, would have allowed enforcement of
laws prohibiting certain alcohol shipments, and required FTC to conduct a study and
determine whether additional authority is needed to regulate the sale, marketing and
advertising of alcohol beverages in remote forms of commerce. H.R. 2161, the
Alcohol Shipment to Minor Prohibition Act, would have prohibited the shipping of
alcohol beverages to minors. Both bills were referred to the Committee on Judiciary.
No final action was taken on any bills on alcohol beverages in the 106th Congress and
no bills that address these issues have been introduced since.
Key Issues Concerning Health Claims on Alcohol Beverages
The TTB’s final regulation for the health labeling of alcohol beverages prohibits
the appearance on labels of any statement that makes a substantive claim regarding
health benefits associated with the consumption of alcohol beverages, unless such
claims are properly qualified, balanced, sufficiently detailed, and specific, along with
outlining the categories of individuals for whom any positive health effects would be
outweighed by numerous negative health effects. The final rule also prohibits any
advertisements that attribute health benefits to the consumption of alcohol beverages,
unless such statement is appropriately qualified in a manner that is not likely to result
in either consumer confusion or deception. The agency had sought comments on
whether the negative consequences of alcohol consumption or abuse disqualify, as
misleading, these products entirely from entitlement to any health-related statements
and whether health-related statements on alcohol beverage labels and advertising
directing consumers to authoritative sources of information are misleading,
warranting termination of their approval. The agency has stated its intention to
ensure that labels and advertisements do not contain statements or claims that would
tend to mislead consumers about the significant health consequences of alcohol
Feasibility. In the current health claim regulatory environment, it seems
possible to interpret TTB’s final rule in several ways. The regulation seems to
suggest that making such claims is possible, if the manufacturer (or the Bureau) can
craft statements that adequately qualify the health messages to convey the level of
substantiation and/or provide an authoritative statement to support it. However, the
difficulty of establishing such qualifying statements has been demonstrated by
FDA’s recent experience with health claims when only limited or preliminary
scientific evidence on a relationship is available. The challenge arises in determining
when the scientific evidence available is “enough” to make any meaningful
statement, and then crafting the claim to be truthful and not misleading to consumers.
The claim generally needs to be coupled with a disclaimer to provide a context that
clarifies the level of evidence supporting the claim. The challenge arises in wording
the claim and disclaimer so as not to mislead consumers. The only way to adequately
ascertain success in consumer interpretation and understanding is to conduct
consumer research on the claim and disclaimer before they appear on the product.
The limited space on most packaging further complicates the extent to which
adequate information can be provided for consumers’ use.
Alternatively, the TTB’s rule might be viewed as suggesting an outright
prohibition of any health claim for alcohol. This view seems to be supported by the
agency’s solicitation of comments on whether negative health effects deny any
entitlement to health claims, in light of the agency’s recognition of (and request for
comments on) the negative consequences of alcohol use. One of the bills in the 106th
Congress would have prohibited these claims on alcohol beverages. However, an
outright prohibition might raise first amendment constitutional questions. In 1996,
the Competitive Enterprise Institute (CEI) filed suit against TTB to challenge the
agency’s delay in acting on CEI’s petition to issue a rule allowing truthful statements
concerning the health benefits of moderate drinking on alcohol beverage labeling and
advertisements. The case, which had challenged the constitutionality of TTB’s ban
on information about the cardiovascular benefits of moderate alcohol consumption
on product labels and advertisements, was settled in 1998 by the district court
granting the government’s motion for summary judgment on CEI’s challenge to the
denial of its rulemaking petition. In 1999, FDA lost a case before the United States
Court of Appeals for the D.C. Circuit in Pearson v. Shalala, when the court held
unconstitutional under the first amendment FDA rules that prohibited four separate
health claims related to dietary supplements. The court decision required that FDA
not only allow the claims, but also craft disclaimers to assure that consumers are not
misled by them. Efforts are currently underway at FDA to broaden the use of health
claims with disclaimers to the health claims on conventional foods.
If health claims are to be allowed, one option might be to consolidate or locate
them together with the required warning labels. Placing the warning statement on the
side or back of containers, while the health information statement would likely
appear on the front seems to have the potential for consumer confusion. A
streamlined statement containing the most pertinent parts of both statements could
be developed. For example, a revised consolidated statement might read:
GOVERNMENT WARNING: (1) According to the Surgeon General,
pregnant women and anyone operating a car or machinery should not
drink; (2) Learn about the health effects of alcohol beverages by consulting
your family doctor or sending for the federal government’s Dietary
Guidelines for Americans; Center for Nutrition Policy and Promotion,
USDA 1120 20th Street, NW, Washington, D.C. 20036 or visit its Web site
[ http://www.usda.gov/cnpp/ ].
While consolidating the messages, the regulations could continue to require the
government warning statement, and allow manufacturers to include the additional
statement of health effects on a voluntary basis.
Allowing the current practice of directing consumers to the Dietary Guidelines
or physicians for further information on health effects for all alcohol beverage
products might be seen as consistent with existing policy for food labeling regarding
authoritative statements. However, food labeling regulations prohibit claims on
products that contain certain ingredients that are present at harmful levels. A similar
policy does not currently exist for the alcohol content of beverages. Furthermore,
there is the difficulty of establishing harmful or unsafe levels of alcohol. In addition,
identifying physicians as the source of additional information assumes that they are
knowledgeable about both negative and potentially positive health effects of alcohol
beverages and can advise their patients accordingly.
Agency Jurisdiction. Currently, TTB has regulatory jurisdiction over all
alcohol beverages and FDA regulates other beverages and most foods. Separate
agencies can establish separate standards for labeling the products in their jurisdiction
so TTB policy does not necessarily have to be consistent with that of FDA.
However, different labeling requirements can be potentially confusing to consumers,
who might assume that labeling and other regulations are set by a single agency or
consistent across government agencies. For example the nutrition information now
required on food products is not available to consumers on alcohol beverages, which
can add significant caloric intake to the daily diet. Transferring alcohol labelingth
authority to FDA, as proposed in one of the bills from the 106 Congress, would
promote consistency, with the assumption that the agency would require comparable
rules for all product claim messages. Alternatively, options might include leaving
responsibility for the labeling and claims standards to the discretion of TTB;
directing the two agencies to work together under the existing MOU to achieve
comparable claims requirements; or requiring TTB to adopt the comparable rules to
FDA’s nutrient composition and claims rules.
Any proposal to transfer authority to FDA raises the issue of the pre-market
label approval that is currently required for alcohol beverages. This requirement
would be a departure from current FDA policy in that food labels are not pre-
approved. Since FDA does not currently have authority to review food labels prior
to marketing, continued requirements to do so for alcohol beverages would need to
be addressed, since it is tied to other responsibilities that TTB would be likely to
retain. Another issue would concern the possibility of using “structure-function”
claims on alcohol beverages, if such a transfer in jurisdiction took place. This type
of claim, which is currently allowed for foods and supplements, is a truthful, not
misleading statement on how a substance affects the structure or function of the body
and only requires the manufacturer to notify the agency that the claim will be made.
Substantiation of the claim needs to be in the manufacturer’s possession, but the level
of scientific support required for a structure-function claim is considerably less than
for a health claim. Finally, FTC is responsible for food advertising and has long
sought to make advertising as consistent with labeling rules as allowed under its
Further Research. Additional research and/or consensus may be needed
before the issue of health claims for alcohol beverages can be fully resolved. Since
there are questions as to how well the research supports a claim on the benefits
versus the risks of alcohol beverage consumption, legislation could be considered to
require either additional research and/or a consensus review to determine the benefits
of alcohol consumption. This type of work could generate some type of authoritative
statement on the relationship. The bill language could be written to provide that
claims would only be allowed if they were made in the same manner and under the
same conditions as NLEA and FDAMA claims, including disqualifying levels of
substances that present a health risk. Finally, the claim wording might also be
required to state the limitation of the benefit, i.e., benefit is only observed when total
consumption is limited to 1-2 number of drinks per day (depending on sex and age).
Consumer Behavior. Finally, the eternal issue arises as to the impact that
warning and health benefit labels have in general on consumer behavior. Consumers
are well aware of the food label and nutrition facts panel following the education
effort carried out by a public-private partnership after NLEA passage and the final
rules were published. Consumer use of the food label, especially the changes to
improve it since 1990, have been examined by several researchers. The public-
private partnership educational effort was organized to coordinate the efforts of many
groups/organizations with limited resources, and its success in reaching consumers
with the message has been well documented.29 Consumers are aware of and report
using the nutrition facts panel, ingredient information and claims in their purchases.
However, less clear is the long-term impact of this knowledge on eating habits and
Health claim statements on food product labels may, in the end, have very little
impact on consumer behavior. Advertising statements and nutrient content flags
29 Guthrie, J, B. Derby & A. Levy. What people know and do not know about nutrition. In:
America’s Eating Habits. Changes & Consequences. U.S. Dept. of Agriculture. Ag. Info.
Bull. no.750. April 1999. p. 243.
across the front of packages may have more influence on consumer purchases and
indirectly on food consumption than health claims. Similarly, consumers are aware
of the alcohol warning labels, but it is unclear whether they have any effect on
drinking habits. The SAMHSA survey conducted on the possible addition of health
benefit statements to alcohol labels suggests that the additional statements will not
influence consumers’ drinking habits. The literature on the impact of the alcohol
beverage warning labels suggest that over time, knowledge of the label statements
increased consumer awareness.30 However, a recent study on alcohol warning labels
conducted by the Center for Science in the Public Interest found that the statements
were difficult to notice due to the size, lacked prominence, and readibility of the
statements, which were serious barriers to their overall effectiveness.31 Nevertheless,
the long term impact of this knowledge on drinking habits is unclear. Awareness and
an ability to repeat the messages, whether the statements are warning labels or health
messages, does not necessarily translate into behavior change, whether concerned
with food or alcohol beverage products.
30 Wolfgan, L. Charting Recent Progress: Advances in Alcohol Research. Alcohol Health
& Research World. v. 21, no.4. September 22, 1997. p. 277