[Federal Register Volume 59, Number 104 (Wednesday, June 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13284]


[[Page Unknown]]

[Federal Register: June 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \7\3NLEA, 3(b).
---------------------------------------------------------------------------

    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'').
---------------------------------------------------------------------------

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).
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \83\These specific disqualifying levels are set forth at 21 CFR 
101.14(a)(5) (1993).
    \84\58 FR 2489, Jan. 6, 1993.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    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