Enforcement policy statement On Food Advertising
Federal RegisterJun 1, 1994
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FEDERAL TRADE COMMISSION
Enforcement policy statement On Food Advertising
AGENCY: Federal Trade Commission.
ACTION: Enforcement policy statement.
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SUMMARY: On May 13, 1994, the Federal Trade Commission (``the
Commission'') placed on the public record an enforcement policy
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), and the Food and Drug Administration's issuance of food
labeling regulations implementing the NLEA. The NLEA applies only to
labeling and did not change the FTC's statutory authority to prohibit
deceptive acts or practices under sections 5 and 12 of the Federal
Trade Commission Act. Nevertheless, in light of the comprehensive
regulatory scheme established for food labeling by the NLEA, the
Commission is issuing this statement to clarify how it will enforce its
own statutes in the food advertising area in light of issues raised by
FDA's food labeling regulations.
EFFECTIVE DATE: May 13, 1994.
FOR FURTHER INFORMATION CONTACT: Anne V. Maher, (202) 326-2987,
Michelle Rusk, (202) 326-5148, or Maureen Enright, (202) 326-3160,
Division of Advertising Practices, Federal Trade Commission, 6th &
Pennsylvania Ave. NW, Washington, DC 20580.
SUPPLEMENTARY INFORMATION:
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),1 and the Food and Drug Administration's (FDA) January 6,
1993, issuance of food labeling regulations implementing the
NLEA.2
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\1\Nutrition Labeling and Education Act of 1990, Public Law No.
101-535, 104 Stat. 2353 (codified in part at 21 U.S.C. 343(i), (q)
and (r)).
\2\Food labeling regulations implementing the Nutrition Labeling
and Education Act of 1990: opportunity for comments (58 FR 2066,
January 6, 1993), codified in part in sections of 21 CFR parts 5,
20, 104, 105, and 130. 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.
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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
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\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.
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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.
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\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).
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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
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\1\0The 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.
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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
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
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\1\1See 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'').
\1\2FTC 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'').
\1\3See, e.g., cases cited infra notes 26, 29, 32, 36, 50, 51,
74, 75, 81, 87, 96.
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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
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\1\4Deception Statement, 103 F.T.C. at 183.
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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
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\1\5Kraft, 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).
\1\6Deception 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.
\1\7Kraft, 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.
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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
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\1\8Deception 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).
\1\9International Harvester, 104 F.T.C. at 1058.
\2\0Deception Statement, 103 F.T.C. at 175 n.4; International
Harvester, 104 F.T.C. at 1059.
\2\1Deception Statement, 103 F.T.C. at 175 n.4.
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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
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\2\2Deception Statement, 103 F.T.C. at 177.
\2\3Id. at 182.
\2\4Kraft, slip op. at 22-23, Thompson Medical, 104 F.T.C. at
816-17; Deception Statement, 103 F.T.C. at 182-83.
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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.
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\2\5Substantiation Statement, 104 F.T.C. at 839.
\2\6See, 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.
\2\7See Bertolli; Pacific Rice.
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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.28
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\2\821 CFR 101.69(b) (1993).
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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
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\2\9See, 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).
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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
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\3\0See Thompson Medical, 104 F.T.C. at 826.
\3\1In 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.
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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.
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\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.
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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.
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\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 CFR 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 CFR 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.
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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 implications\37\ may comply with section 5,
even if the nutrient difference does not meet FDA's prescribed
differences for purposes of labeling.\38\
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\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 CFR 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.
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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 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.
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\39\See Policy Statement in Regard to Comparative Advertising,
16 CFR 14.15 (1979). The Commission's Guides for the Use of
Environmental Marketing Claims also include this requirement. 16 CFR
260.6(d) (1993).
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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.'').
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\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).
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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
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\4\1Although 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 FR 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.
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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
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\4\221 CFR 101.13(b) (1993). Interested parties may petition FDA
to authorize additional synonyms. 21 CFR 101.69(b)(2) (1993).
\4\358 FR 2319-20, Jan. 6, 1993. See Nutrition Labeling and
Education Act of 1990, section 403(4)(2)(A)(i).
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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.
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\4\4Chrysler Corp. v. FTC, 561 F.2d 357, 363 (DC 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'').
\4\521 CFR 101.54(b) and (c) (1993).
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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'').46
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\4\621 CFR 101.13(b)(2) (1993).
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
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\4\758 FR 2371, Jan. 6, 1993.
\4\8For 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 CFR 101.65(c)(3) (1993).
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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.
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\4\9Kraft, 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'').
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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
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\5\0Kraft, 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).
\5\1See 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).
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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
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\5\221 CFR Sec. 101.13(g) (1993).
\5\321 CFR 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 CFR 101.14(a)(5) (1993).
\5\4See 21 CFR 101.54(d) (requirements for fiber claims); 21 CFR
101.62(c) (requirements for saturated fat claims); 21 CFR 101.62(d)
(requirements for cholesterol claims).
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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.
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\5\5Deception Statement, 103 F.T.C. at 176.
\5\6International Harvester, 104 F.T.C. at 1057.
\5\7Id. at 1059.
\5\8Id. at 1058 (``[n]ot all omissions are deceptive, even if
providing the information would benefit consumers'').
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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.
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\5\921 CFR Sec. 101.13(g) (1993).
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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
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\6\0See 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).
\6\1Id. 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).
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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.
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\6\2House Committee on Energy and Commerce, Nutrition Labeling
and Education Act of 1990, H.R. Rep. No. 538, 101st Cong., 2d Sess.
20 (1990).
\6\321 U.S.C. 343(r)(2)(A)(iii)-(v).
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IV. Health Claims64
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\6\4FDA'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 CFR 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 FR 2483, Jan. 6,
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.
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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
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\6\521 CFR 101.14 et seq. (1993).
\6\621 CFR 101.14(c) (1993).
\6\721 CFR 101.14(a)(5) (1993).
\6\821 CFR 101.14(d)(2)(vi)-(vii) (1993).
\6\921 CFR 101.14(e)(6) (1993).
\7\021 CFR 101.14(d)(2)(iii) (1993).
\7\121 CFR 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.
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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
\7\221 U.S.C. 343(r)(3)(B)(i). This standard is also set forth
in FDA's regulations at 21 CFR Sec. 101.14(c) (1993).
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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.
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\7\3NLEA, 3(b).
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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:
\7\4See, 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'').
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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
\7\5Gracewood 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).
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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
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\7\658 FR 2505, Jan. 6, 1993.
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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.
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\7\7See Pfizer, Inc., supra note 34. See also Substantiation
Statement, 104 F.T.C. at 840; Thompson Medical, 104 F.T.C. at 821.
\7\8Unqualified as used in this discussion of substantiation
refers to health claims that do not include specific disclosures
concerning the extent of supporting scientific evidence.
\7\9This 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).
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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
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\8\0Food 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.
---------------------------------------------------------------------------
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
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\8\1See, 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.
\8\2In 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. Sec. 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.
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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\
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\83\These specific disqualifying levels are set forth at 21 CFR
101.14(a)(5) (1993).
\84\58 FR 2489, Jan. 6, 1993.
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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
condition\85\ and, while not necessarily prohibiting all health claims
in advertising for 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.
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\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
FR 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.
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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\
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\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).
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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\
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\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.
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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\
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\91\Further, 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.
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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\
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\92\21 CFR 101.14(d)(2)(vi) (1993).
\93\21 CFR 101.14(d)(2)(vii) (1993).
\94\58 FR 2514, Jan. 6, 1993.
\95\56 FR 60,553 (1992) (discussion of proposed regulations).
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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.
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\9\6See, 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 CFR 260.6(c) (1993).
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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
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\9\7See discussion supra at Part III, Section A.2., (comparative
nutrient claims).
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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
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\9\821 CFR 101.14(e)(6) (1993).
\9\958 FR 2522 (1994).
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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.
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\1\00See discussion supra at part IV, section C.
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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
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\1\01For 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.
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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
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\1\02FDA has stated that model health claim language can be
paraphrased as long as all mandatory elements of the model
statements are addressed. 58 FR 2510, Jan. 6, 1993.
\1\0321 CFR 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
CFR 101.73 (1993) (governing claims about dietary fat and cancer).
\1\0458 FR 2511, Jan. 6, 1993; 21 U.S.C. 343(r)(3)(B)(iii).
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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
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\1\05Deception 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).
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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.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 94-13284 Filed 5-31-94; 8:45 am]
BILLING CODE 6750-01-P
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