Enforcement
Policy Statement on
Food Advertising
May 1994
I. Introduction
II. Legal Framework for Commission Action
III. Nutrient Content Claims
- Claims Describing the Absolute and Comparative Nutrient Content of Foods
- Absolute Nutrient Content Claims
- Comparative Nutrient Content Claims
- Synonyms for Nutrient Content Claims
- Implied Nutrient Content Claims
- Nutrient Content Claim Disclosures
IV. Health Claims
- Standard for Substantiation of Health Claims
- Health Claims for Foods That Contain a Nutrient at a Level That Increases the Risk of a
Disease
- Nutrient/Substance Levels Sufficient to Ensure Meaningful Health Benefits
- Minimum Nutritional Value for Foods Bearing Health Claims
- Relevance of Dietary Factors to Claimed Health Benefit
Footnotes
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),1 and the Food and Drug Administration's (FDA) January 6,
1993, issuance of food labeling regulations implementing the NLEA.2
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."3 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."4 Since 1954, the
FTC and the FDA have operated under a Memorandum of Understanding,5 under
which the Commission has assumed primary responsibility for regulating food advertising,
while FDA has taken primary responsibility for regulating food labeling.6 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.7 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.8 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.9 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.10
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.
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 Statement11 and its
Statement on Advertising Substantiation.12 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.13
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.14
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,15 including the juxtaposition of phrases, images, and the
nature of the claim and the transaction.16 In other words,
in ascertaining the meaning of an advertisement, the Commission will focus on the ad's
overall net impression.17
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.18 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."19 However, "[n]ot all omissions are deceptive, even if
providing the information would benefit consumers."20 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.21
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.22 Finally, a
representation must be material, i.e., likely to affect a consumer's choice or
use of a product or service.23 Express claims and claims involving health or safety are
presumptively material.24
In addition, objective claims carry with them the
implication that they 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.25 A reasonable basis consists of competent and reliable
evidence. In the context of nutrient content or health claims, substantiation will usually
require competent and reliable scientific evidence sufficient to support the claim that is
made.26 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.27 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.
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.28
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.29
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.30 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.31
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 5.32 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.33 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.34 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.35 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.
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 5.36 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 implications37 may comply with
Section 5, even if the nutrient difference does not meet FDA's prescribed differences for
purposes of labeling.38
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.39 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. For example, 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.40 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.41
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.42 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.43
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.44 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,45 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.
4. Implied Nutrient Content Claims
As defined in FDA's regulations, an implied
nutrient content claim is a claim that:
- 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
- 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").46
Under this definition, statements about
ingredients may or may not be nutrient content claims.47 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.48
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.49 If the net impression produced by an ad is likely to mislead
reasonable consumers, the ad is deceptive and violates Section 5.
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.50 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.51
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.
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;52 (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;53 and (3) "triggered" disclosures of the amount
of certain related nutrients when claims concerning fiber, saturated fat, and cholesterol
appear.54
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.55 For example, it is misleading to fail to disclose
qualifying information necessary to prevent an affirmative statement from creating a
misleading impression.56 However, a seller's silence in circumstances that do not
give a particular meaning to the silence is not deceptive.57 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 5.58 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.59 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.60 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.61
Second, the Commission will also scrutinize
nutrient content claims for cholesterol, saturated fat, and fiber. Congress enacted
"special rules"62 requiring that claims for these nutrients trigger
disclosure of other nutrients.63 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 Claims64
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.65 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;66 (2)
establishing disqualifying levels for total fat, saturated fat, cholesterol, and sodium,
above which foods are disqualified from bearing any health claims;67 (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;68 (4) requiring
that foods bearing health claims have some minimal nutritional value;69 and
(5) requiring that health claims identify those factors, other than dietary intake of the
substance, that affect the diet-disease relationship.70 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.71
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.
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.72
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.73 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.74 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.75
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
substantiation 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."76
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.77 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 unqualified78 health claim.79 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.80
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.81 In the absence of adequate qualification, the Commission
will find such claims deceptive.82
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.83 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."84
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 condition85 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.86 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.87 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.88
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.89 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.90
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.91
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.
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."92 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."93 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,94 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."95
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.96 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.97
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.98 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.99
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.100 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.101
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.
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.102 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.103 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.104
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.105
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
1 Nutrition Labeling and
Education Act of 1990, Pub. L. No. 101-535, 104 Stat. 2353 (codified in part at 21 U.S.C. § 343(i), (q) and (r)).
2 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.
3 15 U.S.C. §§ 45, 52, 55 (1980).
4 21 U.S.C. § 343(a). USDA's authority is derived from the Federal Meat
Inspection Act, 21 U.S.C. § 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. § 453(h)(1) (prohibiting labeling of poultry products that
is "false or misleading in any particular").
5 Working Agreement Between FTC
and Food and Drug Administration, 4 Trade Reg. Rep. (CCH) ¶ 9,850.01 (1971)
(hereinafter "Memorandum of Understanding").
6 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.
7 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. § 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. § 343(r)(1)(B) (Supp. 1990).
8 "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).
9 NLEA, § 2(c).
10 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.
11 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. House of Representatives ("Deception Statement").
12 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.C. Cir. 1986), cert.
denied, 479 U.S. 1086 (1987) ("Substantiation Statement").
13 See, e.g., cases
cited infra notes 26, 29, 32, 36, 50, 51, 74, 75, 81, 87, 96.
14 Deception Statement, 103
F.T.C. at 183.
15 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. at 789, 799; Cliffdale Associates, 103 F.T.C. at 164; Deception
Statement, 103 F.T.C. at 176).
16 Deception Statement, 103
F.T.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.
17 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.
18 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).
19 International Harvester,
104 F.T.C. at 1058.
20 Deception Statement, 103
F.T.C. at 175 n.4; International Harvester, 104 F.T.C. at 1059.
21 Deception Statement, 103
F.T.C. at 175 n.4.
22 Deception Statement, 103
F.T.C. at 177.
23 Id. at 182.
24 Kraft, slip op. at
22-23, Thompson Medical, 104 F.T.C. at 816-17; Deception Statement, 103 F.T.C. at
182-83.
25 Substantiation Statement, 104
F.T.C. at 839.
26 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.
27 See Bertolli; Pacific
Rice.
28 21 C.F.R. §
101.69(b) (1993).
29 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).
30 See Thompson Medical,
104 F.T.C. at 826.
31 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.C. 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.
32 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).
33 Substantiation Statement, 104
F.T.C. at 839.
34 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.
35 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. §
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. § 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.
36 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).
37 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. § 14.15 (1979) (comparative advertising regarding objective
measurable attributes must have sufficient clarity or disclosures to ensure that such
comparisons are not deceptive).
38 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.
39 See Policy Statement
in Regard to Comparative Advertising, 16 C.F.R. § 14.15 (1979). The Commission's Guides
for the Use of Environmental Marketing Claims also include this requirement. 16 C.F.R. §
260.6(d) (1993).
40 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).
41 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.
42 21 C.F.R. § 101.13(b)
(1993). Interested parties may petition FDA to authorize additional synonyms. 21 C.F.R. §
101.69(b)(2) (1993).
43 58 Fed. Reg. 2319-20 (1993). See
Nutrition Labeling and Education Act of 1990, § 403(4)(2)(A)(i).
44 Chrysler Corp. v. FTC,
561 F.2d 357, 363 (D.C. Cir. 1977); Kraft, slip. op. at 6 n.8. See also Deception
Statement, 103 F.T.C at 178 n.21 ("A secondary message understood by reasonable
consumers is actionable if deceptive even though the primary message is accurate").
45 21 C.F.R. § 101.54(b) and
(c) (1993).
46 21 C.F.R. § 101.13(b)(2)
(1993).
47 58 Fed. Reg. 2371 (1993).
48 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. § 101.65(c)(3) (1993).
49 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").
50 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).
51 See Estee Corp., 102
F.T.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).
52 21 C.F.R. § 101.13(g)
(1993).
53 21 C.F.R. § 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. § 101.14(a)(5)
(1993).
54 See 21 C.F.R. §
101.54(d) (requirements for fiber claims); 21 C.F.R. § 101.62(c) (requirements for
saturated fat claims); 21 C.F.R. § 101.62(d) (requirements for cholesterol claims).
55 Deception Statement, 103
F.T.C. at 176.
56 International Harvester,
104 F.T.C. at 1057.
57 Id. at 1059.
58 Id. at 1058
("[n]ot all omissions are deceptive, even if providing the information would benefit
consumers").
59 21 C.F.R. §
101.13(g) (1993).
60 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).
61 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).
62 House Committee on Energy and
Commerce, Nutrition Labeling and Education Act of 1990, H.R. Rep. No. 538, 101st Cong., 2d
Sess. 20 (1990).
63 21 U.S.C. §
343(r)(2)(A)(iii)-(v).
64 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. § 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.
65 21 C.F.R. §
101.14 et seq. (1993).
66 21 C.F.R. §
101.14(c) (1993).
67 21 C.F.R. §
101.14(a)(5) (1993).
68 21 C.F.R. §
101.14(d)(2)(vi)-(vii) (1993).
69 21 C.F.R. §
101.14(e)(6) (1993).
70 21 C.F.R. §
101.14(d)(2)(iii) (1993).
71 21 C.F.R. § 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.
72 21 U.S.C. § 343(r)(3)(B)(i).
This standard is also set forth in FDA's regulations at 21 C.F.R. § 101.14(c) (1993).
73 NLEA, § 3(b).
74 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").
75 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).
76 58 Fed. Reg. 2505 (1993).
77 See Pfizer, Inc., supra
note 34. See also Substantiation Statement, 104 F.T.C. at 840; Thompson
Medical, 104 F.T.C. at 821.
78 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.
79 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).
80 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.
81 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. 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.
82 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. § 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.
83 These specific disqualifying
levels are set forth at 21 C.F.R. § 101.14(a)(5) (1993).
84 58 Fed. Reg. 2489 (1993).
85 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).
86 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.
87 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).
88 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).
89 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).
90 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.
91 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.
92 21 C.F.R. § 101.14(d)(2)(vi)
(1993).
93 21 C.F.R. §
101.14(d)(2)(vii) (1993).
94 58 Fed. Reg. 2514 (1993).
95 56 Fed. Reg. 60,553 (1992)
(discussion of proposed regulations).
96 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. § 260.6(c)
(1993).
97 See discussion supra
at Part III, Section A.2., (comparative nutrient claims).
98 21 C.F.R. §
101.14(e)(6) (1993).
99 58 Fed. Reg. 2522 (1994).
100 See discussion supra
at Part IV, Section C.
101 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.
102 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).
103 21 C.F.R. §
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. §
101.73 (1993) (governing claims about dietary fat and cancer).
104 58 Fed. Reg. 2511 (1993); see
also 21 U.S.C. § 343(r)(3)(B)(iii).
105 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). |
