An HTML version of this document is available at
http://www.ftc.gov/bcp/policystmt/ad-food.htm
------------------------------------------------------------
May 13, 1994
ENFORCEMENT POLICY STATEMENT ON FOOD ADVERTISING
I. INTRODUCTION
The Federal Trade Commission (FTC) is issuing this statement to
provide guidance regarding its enforcement policy with respect to
the use of nutrient content and health claims in food
advertising. The Commission believes the statement is appropriate
in light of the passage of the Nutrition Labeling and Education
Act of 1990 (NLEA),0 and the Food and Drug Administration's (FDA)
January 6, 1993, issuance of food labeling regulations
implementing the NLEA.1
The FTC, FDA, and USDA share jurisdiction over claims made by
manufacturers of food products pursuant to a regulatory scheme
established by Congress through complementary statutes. Section 5
of the Federal Trade Commission Act (FTC Act) (hereinafter
"Section 5") prohibits "unfair or deceptive acts or practices,"
and, in the case of food products, Sections 12 and 15 of the FTC
Act prohibit "any false advertisement" that is "misleading in a
material respect."2 FDA's authority is embodied in part in
Section 403(a) of the Federal Food, Drug, and Cosmetic Act (FDCA)
which prohibits "labeling [that] is false or misleading in any
particular."3 Since 1954, the FTC and the FDA have operated under
a Memorandum of Understanding,4 under which the Commission has
assumed primary responsibility for regulating food advertising,
while FDA has taken primary responsibility for regulating food
labeling.5
The NLEA amended Section 403 of the FDCA and effected broad
changes in the regulation of nutrition claims on food labels. In
addition to requiring nutrition information on virtually all food
products, the NLEA directed FDA to standardize and limit the
terms permitted on labels, and allows only FDA-approved nutrient
content claims and health claims to appear on food labels.6 While
the NLEA is designed in part to prevent deceptive and misleading
claims on labels, Congress also intended that nutrient content
and health claims educate consumers in order to assist them in
maintaining healthy dietary practices.7 The NLEA also mandated
that FDA undertake a consumer education effort to educate
consumers about the new food label and the importance of diet to
health.8 Therefore, in keeping with its recently expanded and
unique jurisdictional mandate, the requirements set forth in
FDA's regulations have a broader purpose than preventing false
and misleading claims in food labeling.
The NLEA applies only to labeling and did not change the FTC's
statutory authority to prohibit deceptive acts or practices under
Section 5 of the FTC Act. Nevertheless, in light of the
comprehensive regulatory scheme established for food labeling
claims by the NLEA, the Commission is issuing this statement to
clarify how its own authority relates to issues raised by FDA's
food labeling regulations.
The Commission recognizes the importance of consistent treatment
of nutrient content and health claims in food advertising and
labeling and seeks to harmonize its advertising enforcement
program with FDA's food labeling regulations to the fullest
extent possible under the statutory authority of the FTC Act. The
Commission also recognizes the scientific expertise of FDA in
this area. The Commission has traditionally accorded great weight
to FDA's scientific determinations in matters of nutrition and
health and will continue to do so. In addition, as a general
matter, it is unlikely that the Commission will take action under
Sections 5 and 12 of the FTC Act regarding nutrient content and
health claims if they comply with FDA's regulations.9
The principal elements of the Commission's authority to regulate
nutrient content and health claims in food advertising are set
forth below in the discussion of the Commission's legal framework
in Part II of this statement. Part III of the statement addresses
the Commission's approach to harmonization with the NLEA and
FDA's regulations in the area of nutrient content claims in food
advertising. Part IV of the statement addresses the Commission's
approach to health claims in food advertising. Claims made in
food advertising may raise issues addressed in more than one
section of this statement. Advertisers, therefore, should comply
with all relevant provisions of the statement and not simply the
provision that seems most directly applicable.
In issuing this statement, the Commission recognizes that the FDA
intends its regulatory approach to be dynamic, designed to
respond to changes in science and consumer understanding of
nutrition and diet-disease issues. Therefore, while the
Commission's purpose in issuing this statement is to provide
guidance on how it will enforce Sections 5 and 12 in the food
advertising area, the statement is not intended to provide a
comprehensive analysis of how each of FDA's regulations relates
to the Commission's enforcement policy. Instead, this statement
focuses on the general issues that are likely to remain relevant
to the Commission's regulation of food advertising over time, as
specific provisions in the FDA regulations are amended.
II. LEGAL FRAMEWORK FOR COMMISSION ACTION
As noted above, the FTC regulates food advertising under its
statutory authority to prohibit deceptive acts or practices under
Section 5 of the FTC Act. The Commission has set forth its
interpretations of this authority in its Deception Policy
Statement10 and its Statement on Advertising Substantiation.11
FTC food cases, applying the principles articulated in these
statements, have also established a growing body of precedent
against which food advertisers can assess the lawfulness of their
claims.12
As set out in the Deception Statement, the Commission will find
an advertisement deceptive under Section 5 and, therefore,
unlawful, if it contains a representation or omission of fact
that is likely to mislead consumers acting reasonably under the
circumstances, and that representation or omission is material.13
The first step in a deception analysis is to identify
representations made by an advertisement. A representation may be
made by express or implied claims. An express claim directly
makes a representation. The identification of an implied claim
requires an examination of both the representation and the
overall context of the ad,14 including the juxtaposition of
phrases, images, and the nature of the claim and the
transaction.15 In other words, in ascertaining the meaning of an
advertisement, the Commission will focus on the ad's overall net
impression.16
In addition to deception arising from affirmative representations
in an advertisement, the omission of material information may
also be deceptive in certain circumstances. First, deception can
occur through omission of information that is necessary to
prevent an affirmative representation from being misleading.17
Second, "it can also be deceptive for a seller to simply remain
silent, if he does so under circumstances that constitute an
implied but false representation."18 However, "[n]ot all
omissions are deceptive, even if providing the information would
benefit consumers."19 As with advertisements that contain
affirmative representations, the test for whether an omission is
deceptive is whether the overall impression created by the ad is
deceptive.20
The next step in identifying deception in an ad requires the
Commission to consider the representation from the perspective of
a consumer acting reasonably under the circumstances.21 Finally,
a representation must be material, i.e., likely to affect a
consumer's choice or use of a product or service.22 Express
claims and claims involving health or safety are presumptively
material.23
In addition, objective claims carry with them the implication tha
[vy are supported by valid evidence. It is deceptive, therefore,
to make an express or implied nutrition or health benefit claim
for a food unless, at the time the claim is made, the advertiser
possesses and relies upon a reasonable basis substantiating the
claim.24 A reasonable basis consists of competent and reliable
evidence. In the context of nutrient content or health claims,
substantiation will usually.equire competent and reliable
scientific evidence sufficient to support the claim that is
made.25 Commission orders generally require that scientific
evidence consist of tests, analyses, research, studies or other
evidence conducted and evaluated in an objective manner by
persons qualified to do so, using procedures generally accepted
in the relevant profession to yield accurate and reliable
results.26 The substantiation must also be examined in the
context of the entire body of relevant evidence, particularly if
it produces results that are contrary to that body of evidence.
III. NUTRIENT CONTENT CLAIMS;
A. Claims Describing the Absolute and Comparative Nutrient
Content of Foods;
As mandated by the NLEA, FDA's regulations define certain
absolute and comparative terms that can be used to characterize
the level of a nutrient in a food. "Absolute" terms (e.g., "low,"
"high," "lean") describe the amount of nutrient in one serving of
a food. "Relative" or comparative terms (e.g., "less," "reduced,"
"more") compare the amount of a nutrient in one food with the
amount of the same nutrient in another food. With very few
exceptions, only these specific terms, and certain approved
synonyms, may be used on food labels to characterize the level of
a nutrient, although interested parties may petition FDA to
authorize new nutrient content terms and synonyms.27
3.1. Absolute Nutrient Content Claims
Prior to the finalization of FDA's regulations, there was no
comprehensive set of standardized definitions for absolute terms
such as "low" and "high" to describe the level of a nutrient in a
food. Now that FDA has established a standard metric to describe
the nutrient content of foods, the Commission will apply FDA's
definitions for absolute nutrient content terms when those terms
are used in the same context in advertising. In general, the
Commission will use FDA's serving size or reference amounts
customarily consumed, as set forth in FDA's regulations, in its
analysis of a claim. If, however, an advertiser chooses to depict
a non-standard serving size in an advertisement, the Commission
will require the advertiser to meet the FDA's standard both for
the reference amount customarily consumed and for the serving
size depicted.28
The Commission has previously indicated that where a claim is
subject to the joint jurisdiction of the FTC and the FDA, it will
accord significant deference to the FDA's standards.29 Consumer
understanding will be improved if the agencies responsible for
regulating the use of express or implied absolute nutrient
content descriptors have consistent requirements for use of these
terms. Multiple governmental definitions for the same terms would
have the potential to mislead consumers.30
Similarly, the use in advertising of FDA-defined terms in a
manner inconsistent with FDA's definitions is likely to mislead
consumers. The uniform and detailed nutrient content information
required on food labels, as well as the NLEA-mandated educational
effort, are likely to familiarize consumers with both the
FDA-defined terms and their definitions, further reinforcing
consumer expectation that nutrient content terms are consistently
applied.
Furthermore, the principle that certain claims may be deceptive
unless they are based on a common standard of measurement or
testing is well founded under Section 5.31 At the same time,
statements that a food is "high" or "low" in a particular
nutrient are objective product claims that imply support by a
reasonable basis.32 The Commission generally determines what
level of substantiation constitutes a reasonable basis by
weighing the six factors set forth in Pfizer, Inc. and subsequent
cases.33 Applying those factors here leads the Commission to
conclude that to avoid deception, advertisers should meet FDA's
definitions for absolute nutrient content claims.
Where FDA has not established any standard metric, such as "low"
or "high," for a specific nutrient, the Commission will closely
review claims in food advertising that characterize the level of
that nutrient.34 The Commission has traditionally deferred to
FDA's scientific and public health determinations, and will
consult with FDA and other government and public health
authorities regarding the significance of the nutrient for which
such a claim is made.
3.2. Comparative Nutrient Content Claims
FDA's regulations also establish definitions for comparative
terms that characterize the nutrient content of a labeled food
relative to that of a comparison or "reference" food. These
definitions require that a food bearing a comparative term meet
specified minimum percentage differences in the relevant
nutrient. For example, the regulations permit use of the terms
"less" and "reduced" only where there is a minimum 25 percent
difference in the relevant nutrient. In addition, comparative
claims must disclose the reference food, the percentage
difference in the nutrient between the labeled and reference food
(e.g., "50 percent less fat than our regular cheese"), and
quantitative information regarding the absolute amount of the
nutrient in the labeled and reference foods (e.g., "fat reduced
from 6 g. to 3 g. per serving").
Comparative nutrient content claims that comply with FDA's
regulations will generally comply with Section 5.35 The
Commission will scrutinize carefully comparative nutrient content
claims that characterize nutrient differences in ways that do not
comply with FDA's regulations. However, a comparative advertising
claim that is accurately qualified to identify the nature of a
nutrient difference and to eliminate misleading implications36
may comply with Section 5, even if the nutrient difference does
not meet FDA's prescribed differences for purposes of labeling.37
In examining comparative claims, several principles are likely to
be applied by the Commission. First, comparative claims should
make clear the basis for the comparison.38 Claims should identify
the reference food to which the product is being compared to so
that the appropriate comparison is clear to consumers. Second,
consistent with the position it has taken on the use of
descriptors, the Commission believes that advertisers using
unqualified comparative terms must meet FDA's minimum percentage
difference requirements for those claims. FoBM?/vmple, if an ad
represents that a food has "less fat than Brand X," without
indicating the percentage or absolute difference in fat, the
Commission will rely on FDA's 25% minimum difference requirement
in determining whether the claim is deceptive.
Third, comparative claims should not overstate the significance
of a nutrient difference.39 For this reason, some comparative
claims may need to be qualified in a manner sufficient to ensure
that consumers are not misled regarding the significance of the
nutrient difference. For example, a simple statement of
percentage difference for a food that contains only a small
amount of a nutrient, such as "our crackers have one-third less
fat than Brand X," may suggest that the nutrient difference is
greater in an absolute sense than it actually is. This type of
claim may need further qualification to prevent the claim from
creating a misleading impression (e.g., "one third less fat than
Brand X -- theirs has 3 g., ours has 2 g.").
Even where nutrient differences are substantial in an absolute
sense, careful qualification may be necessary for products that
despite such absolute reductions, still contain appreciable
amounts of a nutrient, to ensure that consumers are not misled
regarding the absolute level of the nutrient. Thus, a claim such
as "20% less fat in our frozen entree compared to Brand X,"
regarding a product that nevertheless contains a significant
amount of fat, may need to identify the quantitative amount of
fat in the advertised food and the reference food (e.g., "20%
less fat than Brand X -- Brand X has 25 g. fat, ours has 20 g.
fat"), particularly in situations where consumers are not likely
to be aware that the item is generally high in fat.
In summary, the Commission ordinarily will not challenge
comparative nutrient content claims that comply with FDA's
regulations, and will carefully scrutinize comparative nutrient
content claims that characterize nutrient differences in ways
that do not comply with FDA's regulations.40
3.3. Synonyms for Nutrient Content Claims
In addition to authorizing the use of only a limited set of
defined nutrient content terms on food labels, FDA's regulations
authorize the use of only certain synonyms for these defined
terms.41 The impetus behind Congress's requirement that FDA limit
defined terms and synonyms may be found in the educational and
public health goals of the NLEA -- to promote consumer
understanding of the meaning of the terms through a limited
lexicon that will allow consumers to make informed dietary
choices.42
The Commission will examine advertising to ensure that claims
that characterize the level of a nutrient, including those using
synonyms that are not provided for in FDA's regulations, are
consistent with FDA definitions. Commission precedent establishes
that an advertisement that can reasonably be interpreted in a
misleading way is deceptive, even though other, nonmisleading
interpretations may be equally possible.43 Thus, when express or
implied claims suggest that a food product meets the standard for
use of an FDA-defined term, advertisers should ensure that the
food actually meets the relevant FDA standard. For example,
depending on the context of an ad, use of the phrases "packed
with" or "lots of" to describe the level of fiber in a food could
convey to some reasonable consumers that the food is "high" in
fiber. Because FDA's regulations define the terms "good source"
and "high" with respect to fiber,44 consumers are likely to be
misled if a "high fiber" claim is implied by an ad for a food
that is only a "good source" of fiber.
3.4. Implied Nutrient Content Claims
As defined in FDA's regulations, an implied nutrient content
claim is a claim that: (i) Describes the food or an ingredient
therein in a manner that suggests that a nutrient is absent or
present in a certain amount (e.g., "high in oat bran"); or (ii)
Suggests that the food, because of its nutrient content, may be
useful in maintaining healthy dietary practices and is made in
association with an explicit claim or statement about a nutrient
(e.g., "healthy, contains 3 grams (g) of fat").45
Under this definition, statements about ingredients may or may
not be nutrient content claims.46 FDA has generally adopted a
case-by-case approach to statements about ingredients that
depends on the overall context of the label. The regulations also
provide, however, that certain ingredient statements will be
treated as nutrient content claims whenever they appear on
labels.47
The Commission's approach to implied claims also relies on an
analysis of the overall context in which a claim appears. As
explained above, the Commission evaluates the overall impression
created by an ad, including the ad itself, the arrangement of
phrases and images in the ad, and the nature of the claim being
made, in order to determine whether a representation is likely to
mislead reasonable consumers.48 If the net impression produced by
an ad is likely to mislead reasonable consumers, the ad is
deceptive and violates Section5.
FTC food cases and consent agreements also demonstrate the
principle that statements regarding ingredients may have nutrient
content implications. For example, advertising may implicitly
characterize the amount of a nutrient in a product through
representations regarding the ingredients with which the product
is made.49 An ad may imply that a food is free of a particular
nutrient by suggesting that the product is free of ingredients
that are essentially the same from the consumer's perspective.50
Consistent with its statutory authority and its commitment to
harmonization, the Commission will look closely at advertisements
that may implicitly characterize the level of a nutrient. The
Commission will give great weight to any FDA determinations
concerning ingredient statements in analyzing the net impression
conveyed by an ad.
2.B. Nutrient Content Claim Disclosures
As mandated by the NLEA, FDA's nutrient content labeling
regulations require a number of disclosures. These mandated
disclosures include, but are not limited to: (1) a referral
statement to the nutrition panel, required whenever a nutrient
content claim is made;51 (2) disclosure of nutrients (fat,
saturated fat, cholesterol, and sodium) present in a food at a
level that FDA has concluded increases the risk of diet-related
disease, required whenever a nutrient content claim is made;52
and (3) "triggered" disclosures of the amount of certain related
nutrients when claims concerning fiber, saturated fat, and
cholesterol appear.53
As set forth in Part II above, disclosure of material information
that is necessary to prevent deception may be required under
Section 5 of the FTC Act.54 For example, it is misleading to fail
to disclose qualifying information necessary to prevent an
affirmative statement from creating a misleading impression.55
However, a seller's silence in circumstances that do not give a
particular meaning to the silence is not deceptive.56 The failure
to provide nutrition information that consumers may find useful
in improving their diet, while subject to challenge under the
NLEA with respect to labels, therefore, is not necessarily
subject to challenge as deceptive under Section 5.57 In the
context of advertising that makes affirmative nutrient content
claims, the Commission's analysis of deception by omission will
be based on a consideration of whether a nutrient content claim
gives rise to a misleading impression absent disclosure of other
nutrition information.
Some of FDA's disclosures appear designed to fulfill the
educational goals of the NLEA, which are beyond the scope of the
Commission's law enforcement mandate. For example, all nutrient
content claims on a label must be accompanied by a statement
referring the consumer to the nutrition panel, where complete
nutrition information regarding the product is found.58 While a
complete nutrition portrait of a food may be useful to consumers,
it is unlikely that the absence of this referral statement from
an advertisement would render the ad deceptive to consumers.
In contrast, other disclosures mandated for food labels may also
appropriately be required under certain circumstances to prevent
deception in advertising under Section 5. In determining whether
such disclosures are necessary to prevent deception, the
Commission will consider several factors. First, the Commission
will carefully evaluate nutrient content claims for foods that
contain a nutrient at a level considered by FDA to increase the
risk of a diet-related disease.59 When the context of an ad as a
whole conveys to consumers the net impression that the food makes
only positive contributions to a diet, or does not contain any
nutrients at levels that raise the risk of diet-related disease,
the failure to disclose the presence of risk-increasing nutrients
is likely to be deceptive.60
Second, the Commission will also scrutinize nutrient content
claims for cholesterol, saturated fat, and fiber. Congress
enacted "special rules"61 requiring that claims for these
nutrients trigger disclosure of other nutrients.62 Consumers
often may infer that certain nutrient claims imply a
characterization of the amount of another nutrient. Similarly,
where different nutrients are linked to the same health issue
(for example, cholesterol and saturated fat, or dietary fiber and
total fat), a claim regarding one of these nutrients is likely to
give rise to a misleading impression regarding the benefit of the
food absent disclosure of the presence of the other nutrient.
Under these circumstances, the failure to correct these
misimpressions through adequate disclosures is likely to be
deceptive.
IV. HEALTH CLAIMS63
FDA's regulations for health claims in food labeling establish
general standards for the use of claims that characterize the
relationship of a substance in a food to a disease or
health-related condition.64 These general standards include,
among other things: (1) limiting authorization of health claims
only to those categories for which there is "significant
scientific agreement" that the relevant diet-disease relationship
is supported by the scientific evidence;65 (2) establishing
disqualifying levels for total fat, saturated fat, cholesterol,
and sodium, above which foods are disqualified from bearing any
health claims;66 (3) for the specific substance that is the
subject of a health claim, setting a threshold level for the
amount of such substance in the food, that is either sufficiently
low or sufficiently high to support the health claim;67 (4)
requiring that foods bearing health claims have some minimal
nutritional value;68 and (5) requiring that health claims
identify those factors, other than dietary intake of the
substance, that affect the diet-disease relationship.69 In
addition, as required by the NLEA, FDA's regulations provide a
petition process for interested persons to seek FDA authorization
of additional health claims.70
The Commission shares the concerns underlying the NLEA, and
embodied in FDA's regulations, that health claims be adequately
substantiated and presented in a manner that is truthful and not
misleading. These same principles form the foundation of the
Commission's well-established deception and advertising
substantiation doctrines, described in Part II above. The
Commission's approach to the regulation of health claims in food
advertising and FDA's approach to such claims in labeling
therefore share many basic elements.
2.A. Standard for Substantiation of Health Claims
The NLEA directed FDA to promulgate regulations authorizing
claims about diet-disease relationships only if FDA determined,
based on the totality of the publicly available scientific
evidence (including evidence from well-designed studies conducted
in a manner which is consistent with generally recognized
scientific procedures and principles), that there is significant
scientific agreement, among experts qualified by scientific
training and experience to evaluate such claims, that the claim
is supported by such evidence.71
The NLEA directed FDA to apply this "significant scientific
agreement" standard in determining whether there was adequate
substantiation to permit health claims for ten specific
diet-disease relationships.72 After reviewing the scientific
literature, FDA issued regulations authorizing a number of
specific categories of health claims.
The Commission's standard for substantiation of health claims in
food advertising shares many elements with FDA's approach to such
claims in labeling. Like FDA, the Commission imposes a rigorous
substantiation standard for claims relating to the health or
safety of a product, including health claims for food products.73
The Commission's standard that such claims be supported by
"competent and reliable scientific evidence" has been more
specifically defined in Commission orders addressing health
claims for food products to mean: tests, analyses, research,
studies or other evidence based on the expertise of professionals
in the relevant area, that have been conducted and evaluated in
an objective manner by persons qualified to do so, using
procedures generally accepted in the profession to yield accurate
and reliable results.74 Thus, both the Commission and FDA look to
well-designed studies, including clinical research and other
forms of reliable and probative scientific evidence, in
evaluating health claims for foods.
In addition, the Commission, like FDA, evaluates substan tiation
for health claims in the context of the surrounding body of
evidence, and does not look to isolated studies, especially if
those studies are unrepresentative of the larger body of
evidence. However, the Commission does not require food
advertisers to establish that there is scientific consensus in
support of their claims. Similarly, FDA has clearly indicated
that its "significant scientific agreement" standard does not
require that such agreement represent a "full consensus among
scientists."75
In evaluating health claims, the Commission looks to a number of
factors to determine the specific level of scientific support
necessary to substantiate the claim.76 Central to this analysis
is an assessment of the amount of substantiation that experts in
the field would consider to be adequate. The Commission regards
the "significant scientific agreement" standard, as set forth in
the NLEA and FDA's regulations, to be the principal guide to what
experts in the field of diet-disease relationships would consider
reasonable substantiation for an unqualified77 health claim.78
Thus, it is likely that the Commission will reach the same
conclusion as FDA as to whether an unqualified claim about the
relationship between a nutrient or substance in a food and a
disease or health-related condition is adequately supported by
the scientific evidence.
The Commission also recognizes the importance of the petition
process, established under the NLEA and FDA's regulations, as a
mechanism for authorizing health claims in food labeling. The
Commission will look with particular care at any health claims
not specifically considered by the FDA in this process. The
absence of an FDA determination that a health claim is
scientifically valid will be a significant factor in the
Commission's assessment of the adequacy of substantiation for the
claim.79
While the Commission's approach to evaluation of unqualified
health claims will generally parallel FDA's assessment of whether
there is significant scientific agreement supporting the relevant
diet-disease relationship, the Commission recognizes that there
may be certain limited instances in which carefully qualified
health claims may be permitted under Section 5 although not yet
authorized by the FDA, if the claims are expressly qualified to
convey clearly and fully the extent of the scientific support. At
the same time, however, the Commission believes that qualified
claims based on evidence that is inconsistent with the larger
body of evidence have the potential to mislead consumers, and,
therefore, are likely to violate Section 5.
The Commission recognizes the need to scrutinize closely
qualified claims to maintain the credibility of health claims in
food advertising and labeling. The Commission will therefore be
especially vigilant in examining whether qualified claims are
presented in a manner that ensures that consumers understand both
the extent of the support for the claim and the existence of any
significant contrary view within the scientific community.80 In
the absence of adequate qualification, the Commission will find
such claims deceptive.81
2.B. Health Claims for Foods That Contain a Nutrient at a
Level That Increases the Risk of a Disease
FDA's health claim regulations identify four nutrients -- total
fat, saturated fat, cholesterol, and sodium -- the consumption of
which has been associated with increased risk of certain diseases
or health-related conditions, particularly cancer, cardiovascular
disease, and hypertension. For each of these nutrients, the
regulations establish levels above which foods containing the
nutrient are disqualified from bearing health claims.82 The
disqualifying levels set by FDA were based on an analysis of what
level of these nutrients in a food would increase, "to persons in
the general population, the risk of a diet-related disease,
taking into account the significance of the food in the total
daily diet."83
The Commission will rely heavily on FDA's scientific
determination as to what levels of total fat, saturated fat,
cholesterol, and sodium may increase the risk of a diet-related
disease or other health condition84 and, while not necessarily
prohibiting all health claims in advertising for such foods that
contain such levels, will carefully scrutinize health claims for
such foods to ensure that the claims are truthful and adequately
qualified.85 Situations involving risk-increasing levels
established by FDA should not be interpreted as an exhaustive
list of instances in which a broad, unqualified health claim for
a food may be found deceptive by the Commission.
Unqualified health claims in advertising for such foods are
likely to be deceptive when the risk-increasing nutrient is
closely related to the subject health claim. Often the presence
and significance of such a nutrient will have to be disclosed.
Without such disclosures, consumers could infer from the health
message that the food does not present any related health
risks.86 The failure to disclose the presence and significance of
risk-increasing nutrients that are closely related to the health
claim for such foods is likely to constitute an omission of a
material fact and render the health claim deceptive.87
For example, a claim that a food will reduce the risk of one
specified disease is likely to convey to reasonable consumers
that the food will not increase the risk of some other health
condition closely related to that disease. Thus, an unqualified
claim that a food is low in saturated fat and cholesterol, and
therefore compatible with a diet designed to reduce the risk of
cardiovascular disease, would be deceptive if the food contained
so much sodium that it might increase the risk of hypertension
and thus, cardiovascular disease.88 To prevent deception, a
health claim for such a food is likely to need a disclosure that
clearly conveys both the presence and significance of the
risk-increasing nutrient.89
Even when the risk-increasing nutrient does not bear directly on
the health condition that is the subject of the health claim, it
may be necessary to disclose the presence of a risk-increasing
nutrient. Depending on context, a specific health claim may
convey to consumers a broader message that the food is healthful
in all respects. For example, a health claim describing the
benefits of calcium in reducing the risk of osteoporosis, when
made in advertising for a dairy product that is high in saturated
fat, may create the deceptive impression among reasonable
consumers that consuming the dairy product will reduce the risk
of osteoporosis without increasing the risk of any other
health-related condition or disease, for example, heart disease.
To prevent deception, a health claim for such a food may need to
include a disclosure that conveys the presence and significance
of the risk-increasing nutrient.90
In those instances, as outlined above, where disclosure of a
risk-increasing nutrient level is necessary to prevent deception,
the Commission will carefully scrutinize the disclosure to ensure
that it is adequate to convey clearly the limited nature of the
health claim being asserted.
2. C. Nutrient/Substance Levels Sufficient to Ensure
Meaningful Health Benefits
In addition to establishing levels of total fat, saturated fat,
cholesterol, and sodium, above which foods are disqualified from
bearing health claims, FDA's regulations also establish threshold
levels for the specific nutrients that are the subject of
particular health claims made in food labeling. If a health claim
is about the effects of consuming a substance at decreased
dietary levels (e.g., lowering saturated fat and cholesterol
intake to reduce the risk of coronary heart disease), FDA sets
the threshold at a level that it determines is "sufficiently low
to justify the claim."91 If a claim relates to the effects of
consuming the substance at other than decreased dietary levels
(e.g., increasing calcium intake to reduce the risk of
osteoporosis), FDA sets the threshold at a level that it
determines is "sufficiently high to justify the claim."92 In
establishing these "high" and "low" thresholds, FDA specifically
considered both whether these levels were sufficient to advance
the public health policy of assisting consumers in maintaining
healthy dietary practices,93 and whether health claims for foods
not meeting such thresholds would be "misleading because the
nutrient levels [were] not low enough, or not high enough, to
really contribute to the claimed effect."94
The Commission shares FDA's view that health claims should not be
asserted for foods that do not significantly contribute to the
claimed benefit. A claim about the benefit of a product carries
with it the implication that the benefit is significant.95 Thus,
consistent with its position on the use of absolute nutrient
content descriptors and unqualified comparative nutrient content
claims, the Commission will ordinarily apply FDA's thresholds for
specific nutrient levels in examining unqualified health claims
for the specific nutrient levels that are the subject of the
particular health claim.
The Commission recognizes, however, that there may be certain
limited instances in which it is possible to craft a qualified,
truthful, and nonmisleading claim comparing the relative health
benefits of a food product to other products for which the food
can be substituted, even if the nutrient level does not meet
FDA's prescribed threshold for the food. Such comparative claims,
encouraging consumers to substitute a food that is significantly
lower or higher in the relevant nutrient than other foods in the
same category, will be unlikely to mislead consumers if the
claimed benefit from the substitution will contribute
significantly to the claimed health effect.
In addition, such comparative claims must be sufficiently
qualified to make clear to consumers that the benefit derives
only from the substitution of the advertised food for a
significantly less healthful alternative and that the subject
product does not otherwise offer an overall health benefit. It
may be necessary to disclose the actual level of the nutrient
that is the basis for the claim and its significance to prevent
deception.96
2.D. Minimum Nutritional Value for Foods Bearing Health
Claims
Under FDA's regulations, any food bearing a health claim must not
only meet the threshold level for the specific substance or
nutrient that is the subject of the health claim, as discussed in
Part IV, Section C., supra, but also must contain a sufficient
amount of at least one of six nutrients and substances specified
by FDA.97 For example, a food that is sufficiently low in total
fat to meet FDA's threshold level for a health claim about
dietary fat and cancer would also need to contain one or more of
the six specific nutrients or substances at a sufficient quantity
to ensure that the food contributed significantly to a healthful
diet. Like FDA's threshold levels, this rule ensures that health
claims are reserved for foods that contribute significantly to a
healthy diet.98
The Commission shares FDA's view that health claims may be
misleading to the extent that they encourage consumers to choose
foods that provide calories but have little or no nutritional
value, under the mistaken belief that their choices will
contribute to a healthy diet. The Commission believes that, like
claims for foods that fail to meet FDA's threshold levels, health
claims for foods with little or no positive nutritional value
have the potential to be deceptive since they imply that the
health benefit being asserted is significant.99 Therefore, the
Commission will generally give great deference to FDA's standards
for minimum nutritional value for foods bearing unqualified
health claims.
The Commission recognizes, however, that there may be some
instances in which it is possible to craft a qualified, truthful,
and nonmisleading claim comparing the relative health benefits of
a food product to other products for which the food can be
substituted, even if the food does not meet FDA's minimum
nutritional value standards. While the food bearing such a
qualified comparative health claim may not contribute in any
absolute sense to a healthful diet, the substitution of such food
for a less healthful food in the same category could result in a
meaningful contribution toward the claimed health effect without
detracting from the healthfulness of the overall diet.100
As noted in Part IV, Section C., supra, such comparative claims
must be sufficiently qualified to convey clearly that the claimed
health benefit derives only from the substitution of the
advertised food for a significantly less healthful alternative.
2.E. Relevance of Dietary Factors to Claimed Health Benefit
For each category of health claims approved by FDA, the
regulations present model health claim language that places the
health benefits to be derived from consuming a nutrient in the
context of other factors that bear on the relevant disease or
health-related condition.101 For example, in authorizing claims
about calcium/osteoporosis, FDA developed model language
explaining how other factors like gender, age, ethnicity, and
exercise bear on the relationship between calcium consumption and
osteoporosis.102 FDA's model health claims are intended to ensure
that health claims are complete, truthful and not misleading. The
model statements therefore include reference to the fact that
factors other than consumption of the food also bear on the
claimed health effect.103
The Commission shares FDA's concern that health claims for food
products may mislead consumers if they oversimplify the
diet-disease relationship or otherwise overstate the relative
significance of dietary factors in achieving certain health
effects. Health claims in food advertising should therefore be
sufficiently qualified to avoid implying to reasonable consumers
that consumers can achieve the claimed effect simply by consuming
the food and without regard to other factors, such as overall
diet, exercise, age, or family history, that may either
contribute or detract from the claimed effect.
However, while the Commission recognizes the desirability of
educating consumers about the role of other factors that bear on
the risk of disease and how such factors interact with diet, the
Commission must evaluate whether the failure to disclose such
qualifying information in a claim about the health effects of a
food would mislead consumers. As explained above, not all
omissions of information are deceptive in violation of Section 5.
In assessing whether an omission is deceptive, the Commission
examines whether the omitted information would be necessary to
prevent an affirmative claim from creating a misleading
impression.104
The Commission will not require food advertisers to include in
advertising containing health claims all potentially relevant
information about the specific diet-related disease, or
affirmatively to disclose that the risk of the disease depends on
many factors, unless such disclosure is necessary to prevent
consumers from being misled about the significance of diet as one
of those factors. Indeed, in many forms of advertising it would
not be feasible to include all nutritional information that may
be of interest to consumers. While the additional dietary and
nondietary factors associated with a health condition may be of
interest to consumers, in most cases Section 5 would not require
full disclosure of such information to prevent consumers from
being misled by statements about the contribution of a particular
food to a health effect.
FOOTNOTES:
0 Nutrition Labeling and Education Act of 1990, Pub. L. No.
101-535, 104 Stat. 2353 (codified in part at 21 U.S.C. section
343(i), (q) and (r)).
1 Simultaneously, the Food Safety and Inspection Service (FSIS)
of the United States Department of Agriculture (USDA) issued its
own nutrition labeling regulations relating to meat and poultry
products. While FSIS's regulations were not mandated by the NLEA,
these regulations were intended to implement the NLEA's goals for
products regulated by USDA. Although the principles in this
statement relate to FDA's regulations, the Commission intends to
apply similar principles to consideration of claims for products
regulated by USDA.
2 15 U.S.C. section section 45, 52, 55 (1980).
3 21 U.S. section 343(a). USDA's authority is derived from the
Federal Meat Inspection Act, 21 U.S.C. section 601(n)(1)
(prohibiting labeling of meat or meat products that is "false or
misleading in any particular"), and the Poultry Products
Inspection Act, 21 U.S.C. section 453(h)(1) (prohibiting labeling
of poultry products that is "false or misleading in any
particular").
4 Working Agreement Between FTC and Food and Drug Administration,
4 Trade Reg. Rep. (CCH) 9,850.01 (1971) (hereinafter "Memorandum
of Understanding").
5 The Memorandum of Understanding also reaffirms the agencies'
shared commitment to prevent deception of the public, to
coordinate their work to eliminate duplication of effort, and to
promote consistency in handling matters of mutual concern.
6 The NLEA defines a "nutrient content claim" as any claim that
expressly or by implication "characterizes the level of any
nutrient." 21 U.S.C. section 343(r)(1)(A) (Supp. 1990). A "health
claim" is defined as any claim that characterizes the
relationship of any nutrient to a "disease or health related
condition." 21 U.S.C. section 343(r)(1)(B) (Supp. 1990).
7 "Health claims supported by a [sic] significant scientific
agreement can reinforce the Surgeon General recommendations and
help Americans to maintain a balanced and healthful diet.
Similarly, statements regarding the level of these nutrients in
foods will assist Americans in following the Surgeon General's
guidelines." House Committee on Energy and Commerce, Nutrition
Labeling and Education Act of 1990, H.R. Doc. No. 538, 101st
Cong., 2d Sess. 9-10 (1990).
8 NLEA, section 2(c).
9 The Commission notes that the manner in which such information
is conveyed in advertising may differ from the way it would be
presented in labeling. The Commission cautions advertisers to
consider carefully the importance of the context in which they
make claims. Some claims that would technically comply with FDA's
labeling regulations might be deceptive in advertising if the
context of the ad renders the express message of the claim
misleading.
10 See Cliffdale Associates, Inc., 103 F.T.C. 110, 176 (1984),
reprinting as appendix letter dated Oct. 14, 1983, from the
Commission to The Honorable John D. Dingell, Chairman, Committee
on Energy and Commerce, U.S.C. House of Representatives
("Deception Statement").
11 FTC Policy Statement on Advertising Substantiation, 48 Fed.
Reg. 10,471 (1984), reprinted in Thompson Medical Co., 104 F.T.C.
648, 839 (1984), aff'd, 791 F.2d 189 (D. Cir. 1986), cert.
denied, 479 U.S.C. 1086 (1987) ("Substantiation Statement").
12 See, e.g., cases cited infra notes 26, 29, 32, 36, 50, 51, 74,
75, 81, 87, 96.
13 Deception Statement, 103 F.T.C. at 183.
14 Kraft, Inc., FTC Dkt. No. 9208, slip op. at 7 (Jan. 30, 1991),
aff'd, 970 F.2d 311 (7th Cir. 1992), cert. denied, 113 S. Ct.
1254 (1993) (citing Thompson Medical Co., 104 F.T.C.C. at 789,
799; Cliffdale Associates, 103 F.T.C.C. at 164; Deception
Statement, 103 F.T.C.C. at 176).
15 Deception Statement, 103 F.T.C.C. at 176. The Commission may
rely on its own expertise in finding claims that are reasonably
clear from the face of an advertisement. Kraft, 970 F.2d at 319,
and cases cited therein. If the Commission is unable to conclude
that an implied claim is conveyed based on a review of the ad
itself, the Commission may rely on extrinsic evidence
demonstrating that the ad implies a claim. Kraft, slip op. at 7;
Thompson Medical, 104 F.T.C. at 789.
16 Kraft, slip op. at 7-8; Removatron Int'l Corp., 111 F.T.C.
206, 292 (1988), aff'd, 884 F.2d 1849 (1st Cir. 1989); Thompson
Medical, 104 F.T.C. at 790.
17 Deception Statement, 103 F.T.C. at 175 n.4; see also
International Harvester Co., 104 F.T.C. 949, 1057 (1984);
Campbell Soup Co., FTC Dkt. No. 9223 (Aug. 18, 1992) (consent
order).
18 International Harvester, 104 F.T.C. at 1058.
19 Deception Statement, 103 F.T.C. at 175 n.4; International
Harvester, 104 F.T.C. at 1059.
20 Deception Statement, 103 F.T.C. at 175 n.4.
21 Deception Statement, 103 F.T.C. at 177.
22 Id. at 182.
23 Kraft, slip op. at 22-23, Thompson Medical, 104 F.T.C. at
816-17; Deception Statement, 103 F.T.C. at 182-83.
24 Substantiation Statement, 104 F.T.C. at 839.
25 See, e.g., Kraft, slip op. at 2 (scientific evidence required
to substantiate calcium content claims and comparative calcium
content claims); Bertolli, Inc., FTC Dkt. No. C-3396 (Aug. 17,
1992) (consent order) (scientific evidence required to
substantiate claims regarding edible oil's impact on any
physiologic function or risk factor for disease or other health
benefit); Pacific Rice Prods., FTC Dkt. No. C-3395 (Aug. 17,
1992) (consent order) (scientific evidence required to
substantiate claims regarding health benefits derived from
consumption of products); see also Thompson Medical, 104 F.T.C.
at 822.
26 See Bertolli; Pacific Rice.
27 21 C.F.R. section 101.69(b) (1993).
28 See, e.g., Nestle Food Co., FTC Dkt. No. C-2265 (Jan. 21,
1992) (consent order) and Presto Food Prods., Inc., FTC Dkt. No.
C-3480 (Feb. 23, 1994) (consent order) (resolving allegations
that low fat claims based on the small serving of nondairy
creamers that might be used in coffee were deceptive when made
with respect to a larger serving that might be used over cereal
or fruit or in cooking).
29 See Thompson Medical, 104 F.T.C. at 826.
30 In the past, courts have upheld the Commission's position that
inconsistent meanings for the same terms have the potential to
mislead consumers. In FTC v. Brown & Williamson Tobacco Corp.,
778 F.2d 35 (D. Cir. 1985), the court held that Brown &
Williamson had deceptively advertised its Barclay cigarettes as
"1 mg. tar." The 1 mg. tar rating was a result of the cigarettes'
different design, which caused the amount of tar that Barclay
cigarettes delivered to smokers to be disproportionately greater
than that delivered by cigarettes that were similarly rated under
the FTC rating system. Considering the claim against the
background of the Commission's tar and nicotine rating system,
the court affirmed the Commission's position that the claim
misled consumers who had come to rely on the FTC rating system to
make comparative assessments regarding cigarettes.
31 E.g., Presto Food Prods., Inc., FTC Dkt. No. C-3480 (Feb. 23,
1994) (consent order); Clorox Co., FTC Dkt. No. C-3427 (May 17,
1993) (consent order); Isaly Klondike Co., FTC Dkt. No. C-3412
(Jan. 28, 1993) (consent order); Nestle Food Co., FTC Dkt. No.
C-2265 (Jan. 21, 1992) (consent order).
32 Substantiation Statement, 104 F.T.C. at 839.
33 81 F.T.C. 23, 64 (1972); Thompson Medical, 104 F.T.C. at 813,
821; Bristol-Myers, 102 F.T.C. at 321. These are: (1) the type of
product advertised, (2) the type of claim, (3) the benefits of a
truthful claim, (4) the ease of developing substantiation for the
claim, (5) the consequences of a false claim, and (6) the amount
of substantiation that experts in the field believe is
reasonable.
34 Under FDA's regulations, a label claim characterizing the
level of a nutrient (i.e., a nutrient content claim) is
prohibited unless made in accordance with the regulations. 21
C.F.R. section 101.13(b) (1993). However, the label of a product
may contain a statement of the amount of a nutrient, such as "1
g. of omega-3 fatty acids" if it does not explicitly or
implicitly characterize the level of the nutrient. 21 C.F.R.
section 101.13(i)(3) (1993). Thus, statements that merely note
the amount of a nutrient without characterizing the level are
permitted even for nutrients not approved to appear on the
nutrition panel.
35 This principle is already apparent from recent Commission
consent orders, which provide safe harbors for those claims
specifically permitted in labeling. See, e.g., Nestle Food Co.,
FTC Dkt. No. C-2265 (Jan. 21, 1992) (consent order) (providing
that nothing in the relevant portions of the order shall prohibit
certain representations regarding total fat, saturated fat or
cholesterol if such representations are specifically permitted in
labeling, for the serving size advertised or promoted, by FDA
regulation); Isaly Klondike Co., FTC Dkt. No. C-3412 (Jan. 28,
1993) (consent order) (providing that nothing in the Order shall
prevent respondent from making representations specifically
permitted in labeling for food by the NLEA regulations).
36 As it has in the past, the Commission emphasizes that truthful
comparisons may need to be sufficiently qualified to remove
deceptive implications. See Policy Statement in Regard to
Comparative Advertising, 16 C.F.R. section 14.15 (1979)
(comparative advertising regarding objective measurable
attributes must have sufficient clarity or disclosures to ensure
that such comparisons are not deceptive).
37 For example, a small nutrient difference that appears as part
of a claim touting the multidimensional nutritional differences
offered by a product is less likely to overstate the significance
of that difference than would such a claim standing alone. Thus,
an advertiser may seek to signal to consumers that, while it has
reduced total fat and saturated fat in its product by 25%, it has
also achieved a small reduction in sodium compared with other
products in the category. In these circumstances, a truthful
claim that makes clear that the sodium reduction is less than the
25% reduction in other nutrients and does not overstate the
significance of this incidental reduction is unlikely to mislead
consumers.
38 See Policy Statement in Regard to Comparative Advertising, 16
C.F.R. section 14.15 (1979). The Commission's Guides for the Use
of Environmental Marketing Claims also include this requirement.
16 C.F.R. section 260.6(d) (1993).
39 See P. Lorillard Co. v. FTC, 186 F.2d 52, 57 (4th Cir. 1950)
(advertising claiming that cigarette was lowest in nicotine, tar
and resins challenged in part because the difference was, in
fact, insignificant); Sun Co., FTC Dkt. No. C-3381 (May 6, 1992)
(consent order) (challenging advertising for octane gasoline that
represented gas would provide superior power that would be
significant to consumers).
40 Although the term "light" is defined in FDA's regulations as a
comparative descriptor, the term also has been used to describe
the food itself, much like an absolute descriptor such as "low."
As reflected in FDA's preamble and regulations, the term also is
associated chiefly with substantial reductions in fat or
calories. See 58 Fed. Reg. 2351-2358. Given the unique
characteristics of the term "light" as reflected in FDA's
regulations, it is unlikely that the term can be used in
advertising without undue confusion unless the food meets FDA's
definitions. Accordingly, the Commission will apply FDA's
definition for "light" in determining whether advertising using
the term is deceptive.
41 21 C.F.R. section 101.13(b) (1993). Interested parties may
petition FDA to authorize additional synonyms. 21 C.F.R. section
101.69(b)(2) (1993).
42 58 Fed. Reg. 2319-20 (1993). See Nutrition Labeling and
Education Act of 1990, section 403(4)(2)(A)(i).
43 Chrysler Corp. v. FTC, 561 F.2d 357, 363 (D. Cir. 1977);
Kraft, slip. op. at 6 n.8. See also Deception Statement, 103 F.T
at 178 n.21 ("A secondary message understood by reasonable
consumers is actionable if deceptive even though the primary
message is accurate").
44 21 C.F.R. section 101.54(b) and (c) (1993).
45 21 C.F.R. section 101.13(b)(2) (1993).
46 58 Fed. Reg. 2371 (1993).
47 For example, the regulations state that "a claim that a food
contains oat bran is a claim that it is a good source of dietary
fiber; that a food is made only with vegetable oil is a claim
that it is low in saturated fat; and that a food contains no oil
is a claim that it is fat free." 21 C.F.R. section 101.65(c)(3)
(1993).
48 Kraft, slip op. at 7-8; Removatron, 111 F.T.C. at 292;
Thompson Medical, 104 F.T.C. at 790. See also FTC v. Sterling
Drug, 317 F.2d 669, 674 (2d Cir. 1963) (the Commission examines
"the entire mosaic : rather than each tile separately").
49 Kraft, 970 F.2d at 322 (upholding Commission's finding that
claims about the amount of milk in processed cheese slices were,
in context, implied claims about calcium content).
50 See Estee Corp., 102 F.T.C.C. 1804 (1983) (consent order)
(advertisements that claimed that foods sweetened with
high-fructose corn syrup did not contain sugar and were accepted
by the American Diabetes Association implied (falsely) that the
foods were appropriate for people who needed to avoid sugar).
51 21 C.F.R. section 101.13(g) (1993).
52 21 C.F.R. section 101.13(h) (1993). As discussed in Part IV,
infra, these same levels of nutrients serve to disqualify foods
from bearing health claims. See 21 C.F.R. section 101.14(a)(5)
(1993).
53 See 21 C.F.R. section 101.54(d) (requirements for fiber
claims); 21 C.F.R. section 101.62(c) (requirements for saturated
fat claims); 21 C.F.R. section 101.62(d) (requirements for
cholesterol claims).
54 Deception Statement, 103 F.T.C. at 176.
55 International Harvester, 104 F.T.C. at 1057.
56 Id. at 1059.
57 Id. at 1058 ("[n]ot all omissions are deceptive, even if
providing the information would benefit consumers").
58 21 C.F.R. section 101.13(g) (1993).
59 See North American Philips Corp., 111 F.T.C. 139, 177-84
(1988) (Initial Decision) (according great weight to other
government agencies' determinations regarding the significance of
a chemical added to drinking water by the water filter and thus
whether the failure to disclose this fact was material).
60 Id. at 175 (Commission's complaint alleged, and the
Administrative Law Judge found, that failure to disclose that
water filter device introduced a potentially hazardous chemical
into drinking water was misleading in light of representations
that device would remove organic chemicals and clean the water).
61 House Committee on Energy and Commerce, Nutrition Labe1ing
Education Act of 1990, H.R. Rep. No. 538, 101st Cong. (1990).
62 21 U.S.C. section 343(r)(2)(A)(iii)-(v).
63 FDA's definition of a health claim includes two basic
elements: (1) a substance or nutrient; and (2) the relationship
of that substance or nutrient to a disease or health-related
condition. 21 C.F.R. section 101.14(a)(1) (1993). Thus, claims on
food labels are not governed by FDA's health claims regulations
unless they include either express or implied references to both
a substance and a disease. FDA's approach to implied health
claims is similar to the Commission's in that this definition
includes claims in which the disease element is implied through
symbols or by other means, looking at the context of the entire
label. Id.; see also discussion of FDA's definition of implied
health claims, 58 Fed. Reg. 2483 (1993). Like FDA, the Commission
examines food claims in the context of the entire advertisement
to determine whether an implied health claim is being made.
Therefore, the Commission may determine in certain instances,
based on its review of the entire context of an advertisement,
that a nutrient content claim, even in the absence of any express
reference to a disease or health-related condition, conveys an
implied health message to consumers.
64 21 C.F.R. section 101.14 et seq. (1993)
65 21 C.F.R. section 101.14(c) (1993).
66 21 C.F.R. section 101.14(a)(5) (1993).
67 21 C.F.R. section 101.14(d)(2)(vi)-(vii) (1993).
68 21 C.F.R. section 101.14(e)(6) (1993).
69 21 C.F.R. section 101.14(d)(2)(iii) (1993).
70 21 C.F.R. section 101.70 (1993). This regulation requires that
FDA take final action within 190 days of the receipt of a
petition, either to deny the petition or to publish a proposal to
amend the regulations to allow the use of the requested health
claim.
71 21 U.S.C. section 343(r)(3)(B)(i). This standard is also set
forth in FDA's regulations at 21 C.F.R. section 101.14(c) (1993).
72 NLEA, section 3(b).
73 See, e.g., Pacific Rice, FTC Dkt. No. C-3395 (Aug. 17, 1992)
(consent order) (claims about health benefits of consuming rice
bran cereal challenged as unsubstantiated); see also Thompson
Medical, 104 F.T.C. at 822 (claims involving health or safety
issues require a "relatively high level of substantiation,
typically scientific tests").
74 Gracewood Fruit Co., FTC Dkt. No. C-3470 (Oct. 29, 1993)
(consent order); see also Pompeian, Inc., FTC Dkt. No. C-3402
(Oct. 27, 1992) (consent order).
75 58 Fed. Reg. 2505 (1993).
76 See Pfizer, Inc., supra note 34. See also Substantiation
Statement, 104 F.T.C. at 840; Thompson Medical, 104 F.T.C. at
821.
77 Unqualified as used in this discussion of substantiation
refers to health claims that do not include specific disclosures
concerning the extent of supporting scientific evidence.
78 This approach is consistent with the Commission's approach to
evaluating the substantiation for claims made for drug products
and medical devices regulated by FDA. See, e.g., Removatron, 111
F.T.C. at 305 (FDA's determination of efficacy of hair removal
device given substantial weight); Thompson Medical, 104 F.T.C. at
826 (recognizing importance of applying standard consistent with
FDA's in evaluating safety and efficacy of a drug product subject
to jurisdiction of both agencies).
79 Food marketers should not expect to circumvent FDA's petition
process for health claims simply by limiting the assertion of
unapproved or unreviewed claims to advertising.
80 See, e.g., National Comm'n on Egg Nutrition (NCEN), 517 F.2d
485 (7th Cir. 1975), appeal after remand, 570 F.2d 157 (7th Cir.
1977), cert. denied, 483 U.S.C. 921 (1978). The final Commission
order in NCEN, as modified by the court, required that the
advertiser, if it made any claims regarding the relationship
between dietary cholesterol and heart disease, disclose that
there was a controversy among experts about the scientific basis
for the link between egg consumption and heart disease, and that
NCEN was presenting its side of that controversy. Where NCEN
characterized the level of scientific evidence, the order further
required a disclosure that many medical experts believed that
increasing egg consumption might increase the risk of heart
disease.
81 In order to be effective, qualifications or disclosures should
be sufficiently clear and prominent to prevent deception. See
Deception Statement, 103 F.T.C. at 180; Thompson Medical, 104
F.T.C. at 789 n.9, 842-43; see also Guides for the Use of
Environmental Marketing Claims, 16 C.F.R. section 260.6(a)
(1993). Clarity of language, relative type size and proximity to
the claim being qualified, and an absence of contrary claims that
could undercut effectiveness, will maximize the likelihood that
the qualifications and disclosures are appropriately clear and
prominent. See, e.g., Figgie Int'l, Inc., 107 F.T.C. 313, 401
(1986), aff'd, 817 F.2d 102 (4th Cir. 1987). For example, the
Commission is unlikely to find a video superscript, without
accompanying audio, to be an effective method of disclosure in a
television ad. See, e.g., Kraft, slip. op. at 10. As always, the
Commission will also consider any extrinsic evidence of the
effectiveness of qualifications and disclosures in its
determination of whether a claim is deceptive. In making this
determination, the Commission will consider all reasonable
interpretations of the advertisement. The Commission will find an
advertisement to be deceptive if it can reasonably be interpreted
in a misleading way, even though other, nonmisleading
interpretations may be equally possible. See Kraft, slip. op. at
6 n.8.
82 These specific disqualifying levels are set forth at 21 C.F.R.
section 101.14(a)(5) (1993).
83 58 Fed. Reg. 2489 (1993).
84 The Commission has routinely accorded great weight to FDA
determinations of the safety and efficacy of food and drug
products. See, e.g., Removatron, 111 F.T.C. at 305; Thompson
Medical, 104 F.T.C. at 826; see also Sterling Drug, Inc., 102
F.T.C. 395, 768-69, aff'd, 741 F.2d 1146 (9th Cir. 1984), cert.
denied, 470 U.S. 1084 (1985).
85 For example, USDA has stated its "intention to publish a
proposed rule on health claims in line with FDA's proposal." See
58 Fed. Reg. 632, 664 (Jan. 6, 1993). If so, the regulation's
disqualifying level for cholesterol will preclude health claims
on the labels of virtually all meat and poultry products.
Notwithstanding the regulations, however, the Commission would
not prohibit a truthful advertising claim that explains in a
nondeceptive manner the health advantages of substituting meat or
poultry items that are relatively low in fat and saturated fat
for higher fat alternatives (e.g., a claim suggesting the merit
of substituting skinless breast of turkey for hamburger). Such
claims would assist consumers who are trying to improve their
diets but who are unwilling to forgo all meat and poultry.
86 See, e.g., Campbell, FTC Dkt. No. 9223 (Aug. 18, 1992)
(consent order required disclosure of sodium content and
recommended maximum daily sodium intake in advertisements making
claims about heart disease for soups with more than 500 mg. of
sodium per 8-oz. serving).
87 The Commission has traditionally required that material
information be disclosed if its absence could mislead reasonable
consumers. See Deception Statement, 103 F.T.C. at 182; see also
International Harvester, 104 F.T.C. at 1057; North American
Philips, 111 F.T.C. at 175, 195 (failure to disclose the fact
that a water filter could introduce a harmful chemical into the
water was misleading).
88 In Campbell, the Commission charged that claims that the
company's soups contained little fat or cholesterol, and were
heart-healthy, were deceptive because the company had failed to
disclose that the soups were high in sodium. Specifically, the
complaint alleged that the high level of sodium was a material
fact given that a diet high in sodium can contribute to
hypertension, a risk factor associated with heart disease. FTC
Dkt. No. 9223 (Aug. 18, 1992) (consent order).
89 A statement indicating both the amount of the risk-increasing
nutrient and the recommended maximum daily intake of that
nutrient, as determined by FDA, would be one example of an
acceptable disclosure, provided such information adequately
conveys the health implications of the risk-increasing nutrient.
See, e.g., Campbell, supra.
90 Further, the FDA's treatment of health claims in labeling for
any food containing a risk-increasing level of a nutrient, as
well as the NLEA-mandated educational effort, could well increase
consumers' expectations concerning the scope of unqualified
health claims, including expectations that the foods do not
present any significant health risks.
91 21 C.F.R. section 101.14(d)(2)(vi) (1993).
92 21 C.F.R. section 101.14(d)(2)(vii) (1993).
93 58 Fed. Reg. 2514 (1993).
94 56 Fed. Reg. 60,553 (1992) (discussion of proposed
regulations).
95 See, e.g., Gracewood Fruit Co., FTC Dkt. No. C-3470 (Oct. 29,
1993) (consent order). The complaint accompanying the Gracewood
consent agreement challenged claims that eating grapefruit could
reduce serum cholesterol levels, in part because there was no
evidence that the small amount of pectin (the relevant nutrient)
in grapefruit was sufficient to cause any meaningful reduction in
serum cholesterol. See also Lorillard, 186 F.2d at 57
(advertising claiming that cigarettes were lowest in nicotine,
tars, and resins challenged in part because the difference was so
small as to be insignificant). Similarly, the Commission's Guides
for the Use of Environmental Marketing Claims include the general
principle that claims should not be presented in a manner that
overstates the attribute or benefit of a product, and that
"[m]arketers should avoid implications of significant
environmental benefits if the benefit is in fact negligible." 16
C.F.R. section 260.6(c) (1993).
96 See discussion supra at Part III, Section A.2., (comparative
nutrient claims).
97 21 C.F.R. section 101.14(e)(6) (1993).
98 58 Fed. Reg. 2522 (1994).
99 See discussion supra at Part IV, Section C.
100 For example, a qualified comparative health claim suggesting
that consumers switch from a high fat to a fat-free salad
dressing, and indicating that diets low in total fat may
contribute to a reduced risk of some forms of cancer, could
encourage a dietary choice resulting in a significant health
benefit, even if the fat-free salad dressing did not contain
sufficient levels of any of the six nutrients or substances
specified by FDA.
101 FDA has stated that model health claim language can be
paraphrased as long as all mandatory elements of the model
statements are addressed. 58 Fed. Reg. 2510 (1993).
102 21 C.F.R. section 101.72(e) (1993). In authorizing other
health claims, FDA provides alternative approaches of either
expressly enumerating the relevant factors, or stating more
simply that the development of the disease depends on many
factors. See, e.g., 21 C.F.R. section 101.73 (1993) (governing
claims about dietary fat and cancer).
103 58 Fed. Reg. 2511 (1993); see also 21 U.S.C. section
343(r)(3)(B)(iii).
104 Deception Statement, 103 F.T.C. at 176. In J.B. Williams Co.
v. FTC, for example, the Commission challenged as deceptive
advertising claims that a vitamin and iron supplement would
reduce tiredness because the advertiser failed to disclose that
those symptoms are usually caused by factors other than vitamin
and iron deficiency. 381 F.2d 884, 890 (6th Cir. 1967). See also
Keele Hair & Scalp Specialists, 55 F.T.C. 1840 (1959), aff'd, 275
F.2d 18 (5th Cir. 1960) (baldness cure claims challenged for
failure to disclose significance of male heredity as cause of
baldness, for which cure was ineffective).