FTC Staff Comment Before the Food and Drug Administration: In the Matter of Draft Guidance for Industry and FDA Staff: Whole Grains Label Statements

______________________________
BEFORE THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
In the Matter of
Draft Guidance for Industry and FDA Staff:
Whole Grains Label Statements
Docket No. 2006-0066
Comments of the Staff of
the Bureau of Consumer Protection,
the Bureau of Economics,
and the Office of Policy Planning
of the Federal Trade Commission
April 18, 2006*
* These comments represent the views of the staff of the Bureau of Consumer Protection,
the Bureau of Economics, and the Office of Policy Planning of the Federal Trade
Commission. They are not necessarily the views of the Federal Trade Commission or any
individual Commissioner. The Commission has, however, voted to authorize the staff to
submit these comments.

I. INTRODUCTION
Adequate consumption of whole grains is an important part of a healthy diet. The 2005
Dietary Guidelines for Americans identify whole grains as a significant source of fiber and other
nutrients and encourage increased consumption as a way to reduce the risk of several chronic
diseases and to help with weight maintenance.1 Specifically, the Guidelines recommend that
people “consume 3 or more ounce-equivalents of whole grain products per day, with the rest of
the recommended grains coming from enriched or whole-grain products,” and that, “in general at
least half the grains should come from whole grains.”2 To help ensure that consumers receive
consistent and reliable information about the whole grain content of food products, the Food and
Drug Administration (“FDA”) has issued draft guidance for industry. The FDA guidance
document clarifies what the agency considers to be “whole grain” and identifies permissible label
statements that food manufacturers may use to describe the whole grain content of their
products.3 FDA is seeking public comment on this guidance document.
The staff of the Federal Trade Commission’s Bureau of Consumer Protection, Bureau of
Economics, and Office of Policy Planning (“FTC staff”) generally supports FDA’s guidance on
whole grain label statements. The FTC staff believes that the guidance will help manufacturers
1 “Dietary Guidelines for Americans, 2005,” (HHS/USDA 2005) at Chapter 5,
available at http://www.healthierus.gov/dieatryguidelines.
2 Id.
3 “Draft Guidance for Industry and FDA Staff: Whole Grains Label Statements,”
Docket No. 2006D-0066, 71 Fed. Reg. 8597 (Feb. 17, 2006) (“Whole Grain Guidance”). The
draft guidance document is available at http://www.cfsan.fda.gov/~dms/flgragui.html. FDA has
indicated that the guidance is non-binding and does not impose legally enforceable
responsibilities on industry.
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who make whole grain claims to use consistent terms, will help inform consumers about the
importance of whole grains to diet and health, and will make it easier for consumers to choose
foods rich in whole grains. The FTC staff comment provides specific suggestions concerning
how FDA could expand and clarify its guidance to give consumers additional tools to make
informed choices about whole grain products and to establish additional safeguards against
misleading label claims.
The FTC, through enforcement of the Federal Trade Commission Act, has developed
considerable expertise in food advertising and labeling issues.4 The FTC staff also has
experience studying the effects of regulation on market performance, including the performance
in markets for foods,5 and has done substantial research on how consumers interpret nutrition and
health claims in food advertising.6 FTC staff research suggests government regulations and
policies on labeling and advertising have a strong effect on the type and amount of health and
4 The Federal Trade Commission Act, 15 U.S.C. § 45 et seq., prohibits deceptive or
unfair acts or practices in or affecting commerce, including deceptive marketing of food
products. The FTC and the FDA have overlapping jurisdiction to regulate advertising, labeling
and promotion of foods. Under a longstanding liaison agreement between the agencies, the FDA
exercises primary responsibility for ensuring that food advertising is truthful and not misleading.
Working Agreement between FTC and Food and Drug Administration, 4 Trade Reg. Rep. (CCH)
¶ 9,850.01 (1971).
5 See, e.g., P. Ippolito & J. Pappalardo, Advertising Nutrition & Health: Evidence
from Food Advertising 1977-1997 (2002), available at
http://www.ftc.gov/opa/2002/10/foodads.htm.
6 See, e.g., D. Murphy, Consumer Perceptions of Qualified Health Claims in
Advertising (Federal Trade Commission, Working Paper No. 277, 2005), available at
http://www.ftc.gov/be/workpapers/wp277.pdf; D. Murphy et al., A Generic Copy Test of Food
Health Claims in Advertising, Federal Trade Commission (1998), available at
http://www.ftc.gov/opa/1998/11/food.htm
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nutrition information that consumers receive. 	Labeling and advertising regulations and policies
that permit manufacturers to disseminate truthful and non-misleading information about diet and
health are likely to lead to better informed consumers, more competition on the health attributes
of food, and formulation of healthier products.
For that reason, the FTC staff encourages FDA to consider the following three issues as it
finalizes its draft guidance:
• 	FDA should consider expanding its guidance to allow label statements that provide
greater dietary context to the factual, quantitative statements on whole grain currently
permitted. Consumers need simple, easy tools to help them decide how a food fits into
their diet. It is important to give consumers sufficient context for whole grain statements
so that they can more easily choose foods that will help them reach the recommended
consumption of 3 or more servings of whole grain daily. Because it could be an effective
way to provide context, FDA should consider allowing “good source” and “excellent
source” claims, such as those already in widespread use. In addition, or as an alternative,
the FDA should consider providing examples of other permissible ways that food
companies could provide context to their whole grain claims.
• 	As FDA’s draft guidance recognizes, there is potential for consumers to be misled or
confused by unqualified “whole grain” claims for products that contain a mixture of
whole grain and refined grain. Many consumers may interpret such unqualified claims to
mean that all or nearly all of the grain in the product is whole grain. Additional guidance
from FDA on the appropriate use of “100% whole grain,” “whole grain,” “made with
whole grain,” and other similar terms could reduce the risk that consumers will be misled
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or confused. One possible approach would be for FDA to provide guidance setting
specific percentage and minimum content standards for the amount of whole grain in
products bearing such unqualified claims.
• 	Because consumer awareness of the new dietary recommendations and whole grain label
statements may be still evolving, the FTC staff also recommends that FDA solicit
relevant consumer perception data and consider conducting its own copy testing to
determine the most effective way to give consumers context for their whole grain food
choices and to set standards for unqualified whole grain claims.
II. BACKGROUND
FDA’s “Guidance for Industry and FDA Staff: Whole Grain Label Statements,” published
in draft form on February 17, 2006 (“Whole Grain Guidance”), clarifies which types of grain
FDA considers qualify as “whole grain.” It also provides guidance on what claims food
manufacturers can make in labeling about the whole grain content of their products. The Whole
Grain Guidance indicates that manufacturers can make factual statements about the amount of
whole grain in a product, including claims such as “10 grams of whole grains,” and “½ ounce of
whole grains,” and percentage claims such as “100% whole grain,” as long as the statements are
neither false nor misleading and do not imply a particular level of the ingredient.7
7 Whole Grain Guidance at Section II and Question 10. In addition to permitting
factual statements about whole grain content, the draft Whole Grain Guidance reiterates existing
FDA policy permitting manufacturers to make health claims relating whole grains to reduced risk
of heart disease and certain cancers on food products that qualify for the claim. FDA approved
these whole grain health claims pursuant to the FDA Modernization Act of 1997 (FDAMA), as
claims based on an authoritative statement of a scientific body. The approved claims are
permitted in labeling for foods that meet certain nutritional criteria. For example, FDA permits
the claim, “Diets rich in whole grain foods and other plant foods, and low in saturated fat and
cholesterol, may help reduce the risk of heart disease,” for foods that contain 51% or more whole
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The draft Whole Grain Guidance, however, does not permit claims that state or imply that
a product is “high” in whole grain or is a “good source” or “excellent source” of whole grain.8
The draft guidance also does not give examples of permissible alternative ways to give
consumers some context for evaluating whole grain label information.
The draft Whole Grain Guidance also cautions against the use of certain unqualified
whole grain statements in labeling for products that also contain some refined grain ingredients.
Specifically, FDA indicates that the statement “100% whole grain” should not be used for such
products. It also advises that, depending on context, a simple statement such as “whole grain”
may be construed as meaning the product is “100% whole grain.”9
III. DIETARY CONTEXT FOR WHOLE GRAIN CLAIMS
The FTC staff believes that whole grain label statements would be more helpful to
consumers if they provided sufficient context to allow consumers to evaluate how a food fits
within their dietary needs. The staff therefore urges FDA to reconsider its position that
grains by weight and fall below specified limits for total fat, saturated fat, cholesterol, and trans
fat. See FDA/CFSAN/Office of Nutritional Products, Labeling, and Dietary Supplements,
“Health Claim Notification for Whole Grain Foods with Moderate Fat Content,” (Dec. 9, 2003),
available at http://ww.cfsan.fda.gov/~dms/flgrain2.html.
8 Id. On November 8, 2005, the FDA denied a citizen petition by General Mills,
Inc., requesting that the agency develop definitions for “excellent source,” “good source,” and
“made with” as descriptors for the whole grain content of foods. In denying the petition, FDA
explained that it considered such claims to be implied claims about fiber that could be potentially
misleading for a whole grain product that was not high in dietary fiber. The agency also
indicated that the terms “excellent source” and “good source” have been defined under FDA
labeling regulations for use with specific nutrients for which a reference daily intake (RDI) or
daily reference value (DRV) has been established, and that there is no such RDI or DRV for
whole grains. Letter from Margaret Glavin, Associate Commissioner for Regulatory Affairs,
FDA to Stuart M. Pape, Docket No. 2004P-0223/CP1 (Nov. 8, 2005).
9 Whole Grain Guidance at Question 7.
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manufacturers should not make label statements identifying foods as a “good source” or
“excellent source” of whole grain or any other claim that states or implies a particular level of
whole grain. In addition, or in the the alternative, the staff suggests that FDA consider expanding
its draft guidance to provide examples of permissible ways for manufacturers to give consumers
information that puts factual, quantitative statements about whole grain content on labels into
context.
The FTC staff believes that context is especially important given that many consumers
may not yet be fully aware of the new dietary recommendations on whole grain or able to
translate quantitative statements into food choices that will meet those recommendations. The
new Dietary Guidelines for Americans were issued in 2005 and differ from previous guidelines
in their greater emphasis on the importance of whole grains to health. For the first time, the 2005
Dietary Guidelines make specific recommendations that Americans “consume 3 or more ounce-
equivalents of whole grain products per day” and that “at least half the grains should come from
whole grains.”10 Many American diets fall far short of these dietary recommendations. Analysis
of food consumption patterns by the United States Department of Agriculture indicates that in
2003 Americans were consuming on average 10 servings of grain a day, but only just over one
serving of those was whole grain.11 In addition, food intake surveys from 1999-2000 show that
10 “Dietary Guidelines for Americans, 2005,” (HHS/USDA 2005), at Chapter 5,
available at http://www.healthierus.gov/dieatryguidelines.
11 See L. Mancino & J. Buzby, “Americans’ Whole Grain Consumption Below
Guidelines,” Amber Waves, USDA/ERS (April 2005), available at
http://www.ers.usda.gov/AmberWaves/April05/Findings/WholeGrainConsumption.htm.
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nearly 40 percent of Americans reported not eating any whole grains in an entire day.12
The food label is an important tool to help consumers increase their whole grain
consumption consistent with the new dietary recommendations. Giving consumers a simple and
easy way to identify foods with substantial whole grain content can make the label a more
effective tool. The factual label statements currently permitted by FDA’s draft Whole Grain
Guidance are useful points of reference and can help consumers compare the whole grain content
of different products.13 They may not, however, give consumers enough context to determine
easily how much of their recommended daily amount of whole grain they are getting from a
serving of a food. The FTC staff believes that many consumers may find it difficult, if not
impossible, to translate a quantitative statement such as “10 grams whole grain” into meaningful
information about how much of their recommended daily amount of whole grain they will
receive from a serving of a food.14
It would be more helpful to allow food manufacturers to put the amount of whole grains
into dietary context for consumers. Ideally, a claim would simply and clearly indicate how the
12 Id.
13 For example, consumers would be able to compare a product labeled “10 grams
whole grain” to one labeled “6 grams whole grain.”
14 The FTC staff has seen evidence of the difficulty consumers have with
quantitative statements in other contexts. In early 1996, when the staff conducted copy tests of
food advertising that presented various formats for nutrient content information, for example, it
found that “most participants in the test failed to interpret such measurements correctly, whether
they were expressed as absolute numbers of grams or milligrams, or as a percentage of the
relevant Daily Recommended Values.” The staff also found that advertising disclosures
concerning high levels of risk-increasing nutrients were “most effective if framed in plain
English.” D. Murphy et al., A Generic Copy Test of Food Health Claims in Advertising, Federal
Trade Commission (1998) at E8-9, available at http://www.ftc.gov/opa/1998/11/food.htm.
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amount of whole grain in a food fits with consumers’ recommended dietary needs. This approach
would provide enough information so that consumers would not need to look up the 2005
Dietary Guidelines for Americans or perform calculations to translate quantitative statements into
number of servings.
Seals, icons, or simple claims that identify foods as either a “good source” or “excellent
source” of whole grain are examples of methods for giving consumers quick and simple tools to
choose among whole grain products. Prior to FDA’s recent decision to deny a citizen petition
requesting that the agency develop standard definitions for these terms,15 they were being widely
used in the marketplace by several major manufacturers and by the Whole Grains Council, an
industry trade association, and its members.16 Given that these seals, icons, and claims appear to
be in widespread use, the FTC staff believes that these terms may already be familiar to many
consumers and may provide a basis for a useful framework for giving consumers the dietary
context they need.
The FTC staff suggests, therefore, that FDA consider amending its draft Whole Grain
Guidance to allow expressly the continued use of the label statements “good source” and
“excellent source” to describe the level of whole grain in a food. If FDA permits these claims, it
15 See Letter from Margaret Glavin, Associate Commissioner for Regulatory Affairs,
FDA to Stuart M. Pape, Docket No. 2004P-0223/CP1 (Nov. 8, 2005).
16 See Letter from Whole Grains Council to FDA, Docket No. 2004P-0223 (Oct. 12,
2005) (supporting the “Whole Grain Descriptive Claims Citizen Petition” filed by General
Mills). The Whole Grains Council is a consortium of industry and other groups, including 93
American grain companies. According to the Council, both its members, and several large food
companies, including General Mills, Kellogg, Kraft, and Pepperidge Farm (Campbell Soup) are
all using the descriptors “good” and “excellent” source of whole grain, standardized to the same
levels: 8-15g grams for “good,” and 16 or more grams for “excellent.”
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should also establish standards describing the appropriate qualifying levels of whole grain for
these claims. The FTC staff believes that allowing these claims is one way to simplify
consumers’ task in making whole grain food choices, and may also spur companies to
reformulate or introduce new products with higher whole grain content in order to qualify for
these claims.
The FTC staff recognizes that terms such as “good source” and “excellent source” have
typically been defined pursuant to FDA regulations for use as nutrient content claims, for
nutrients that have an established RDI or DRV (for example, “good source of fiber”) and that
whole grain is not a “nutrient” and does not have a formal RDI or DRV. However, the FTC staff
suggests that FDA could develop voluntary standards for the use of these terms through informal
agency guidance, using the 2005 Dietary Guidelines for Americans recommendations for 3 one-
ounce equivalent servings of whole grain daily as a reference amount.
In addition, or as an alternative approach, the FTC staff suggests that FDA consider
expanding its draft Whole Grain Guidance to provide some specific examples of other simple
ways that food companies can provide dietary context to their whole grain claims. For instance,
the guidance could give examples of how a manufacturer could refer to the 2005 Dietary
Guidelines in a whole grain label statement. There may be many permissible approaches, under
current FDA policy and regulation, for providing dietary context to whole grain claims. The FTC
staff believes it would benefit both industry and consumers if FDA were to illustrate some of
these approaches in its guidance.17
17 As one possible model, USDA’s Food Safety and Inspection Service (FSIS) has
issued a Statement of Interim Policy Guidance for meat and poultry labeling that includes
specific illustrations of how companies can give dietary context to their whole grain claims. The
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Consumer awareness of dietary recommendations and whole grain label statements may
be new and still evolving. The FTC staff, therefore, further recommends that, as FDA develops
and refines its policy and guidance on whole grain label statements, the agency should consider
relevant consumer perception data on existing whole grain claims, including “good source” and
“excellent source.” FDA should also consider conducting its own copy testing to determine the
most effective way to give consumers the dietary context they need to make good whole grain
food choices.
IV. UNQUALIFIED WHOLE GRAIN CLAIMS
The FTC staff generally supports FDA’s guidance on unqualified whole grain statements.
The draft Whole Grain Guidance indicates that products labeled as “100 percent whole grain”
should not contain any grain ingredients other than whole grain. It further indicates that,
“depending on the context in which a ‘whole grain’ statement appears on the label, it could be
construed as meaning that the product is 100 percent whole grain.”18 In an example, FDA
indicates that pizza and bagels labeled as “whole grain” or “whole wheat” should only be labeled
as such when the flour ingredients are made entirely from whole grain or whole wheat flours.19
guidance covers claims made for meat and poultry food products that include a grain component,
such as rice, pasta or breading. The examples present the whole grain information in terms of
servings and cite to the Food Guide Pyramid recommendation for three servings a day. FSIS
indicates, for instance, that it would approve such statements as, “One whole grain ounce
equivalent per serving, MyPyramid recommends at least 3-one ounce equivalents of whole grains
per day.” USDA/FSIS Statement of Interim Policy Guidance: Use of the USDA MyPyramid
Reference on Meat and Poultry Labeling and Whole Grain Claims. (Oct. 14, 2005), available at
http://www.fsis.usda.gov/OPPDE/larc/Claims/Food_Guide_MYPyramid_Policy.pdf.
18 Whole Grain Guidance at Q.7.
19 Id.
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FDA does not, however, provide definitive standards for either the percentage or amount of
whole grain that should be in products labeled with unqualified claims. Nor does it address other
common variations of these claims that are in widespread use in the marketplace, such as “made
with whole grain.”
There appear to be many variations of unqualified whole grain claims currently in the
marketplace. Some product labels simply claim “whole grain,” others more explicitly claim
“100% whole grain,” while others use somewhat more ambiguous phrases like “made with whole
grain.” 	It is not clear that companies are using these terms consistently or that consumers are
interpreting them correctly. Depending on the context of the claim and other elements of the
product label, a claim such as “made with whole grain” may convey widely discrepant
messages.20
In fact, even within the government, there are discrepancies in how these terms are
defined. The U.S. Department of Agriculture, for instance, in guidance to the meat and poultry
industry, has indicated that it will allow whole grain claims, such as “whole wheat pasta,” and
“pasta made with whole wheat,” as long as 51% of the grain components are whole grain and the
product contains at least one-half ounce equivalent (8 grams) of whole grain per serving.21 The
USDA guidance is thus a less rigorous standard than proposed in FDA’s current draft guidance
20 On some food labels, for instance, the words “whole grain” appear in large,
banner type on the front label while the words “made with,” presumably meant to qualify the
“whole grain” banner, are in substantially smaller type. This may be a method that companies
use to imply that their products are 100% whole grain, when they are not.
21 USDA/FSIS Statement of Interim Policy Guidance: Use of the USDA MyPyramid
Reference on Meat and Poultry Labeling and Whole Grain Claims. (Oct. 14, 2005), available at
http://www.fsis.usda.gov/OPPDE/larc/Claims/Food_Guide_MYPyramid_Policy.pdf.
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that products, such as bagels or pizza, labeled “whole grain” or “whole wheat” be made entirely
from whole grain or whole wheat flour.
The FTC staff suggests that FDA consider establishing definitive percentage and
minimum content standards for companies to use when they choose to make “100% whole
grain,” “whole grain,” “made with whole grain,” and similar unqualified claims. Such specific
standards would provide even greater clarity for food manufacturers and consumers and ensure
the claims are being used consistently in the marketplace. The guidance should also clarify that
such standards would apply to unqualified claims only, and would not restrict companies from
making truthful, nonmisleading whole grain claims that are appropriately qualified to specify the
amount or percentage of whole grain in the product.
A. Percentage Standards for Unqualified Whole Grain Claims
The FTC staff agrees with FDA’s draft guidance position that, in addition to the express
“100% whole grain” statement, other variations of general, unqualified claims are also likely to
convey that all or nearly all of the grain in the product is whole grain. Although the Commission
has not done consumer research directly on this issue, studies on other types of unqualified
claims, including “Made in USA” and “recycled,” suggest that many reasonable consumers
interpret an unqualified claim about a product’s content to mean that it refers to the entire
product. In a 1991 copy test on “Made in USA,” approximately 77% of respondents indicated
that the statement meant that all or almost all of the product was made in the USA.22 Similarly,
22 See FTC Enforcement Policy Statement on U.S. Origin Claims, 62 Fed. Reg.
63,757 (Dec. 2, 1997) at 63,763-34 (discussing the 1991 FTC Copy Test, Document No.
B213001 of the public record, and other relevant consumer perception research). A 1995 FTC-
commissioned survey of consumer attitudes provided additional confirmation, finding that the
percentage of consumers agreeing with a “Made in USA” label fell dramatically as the amount of
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consumer research on “recycled content” claims has shown that a majority of consumers interpret
the statement as referring to all or most of the product or package. 23 The FTC staff believes that
the consumer evidence on these unqualified claims is indicative of how consumers are likely to
interpret an unqualified “whole grain” statement. Many reasonable consumers will likely
understand “whole grain” to mean that all, or virtually all, of the food product is whole grain, or
that all of the grain ingredients in the product are whole grains. The FTC staff suggests that
setting definitive percentage standards for food companies to use when they make a hierarchy of
claims, ranging from “100% whole grain” to “whole grain” to “made with whole grain,” would
provide certainty in the marketplace while still allowing some leeway for claims on products that
are not 100% whole grain.24
production costs incurred abroad increased. Id. at 63,764 (discussing the 1995 FTC Attitude
Survey, Document No. B212883 of the public record). Based in part on this and other consumer
perception evidence, and on the record as a whole, the Commission’s 1997 Enforcement Policy
Statement on U.S. Origin Claims provides that “unqualified U.S. origin claims should be
substantiated by evidence that the product is all or virtually all made in the United States.” Id. at
63,767.
23 See, e.g., L. Morris, M. Hastak & M. Mazis, Consumer Comprehension of
Environmental Advertising and Labeling Claims, The Journal of Consumer Affairs 328, 340
(Winter 1995) (54.7% of respondents expected a “recycled” claim to mean that “all” or “most” of
the materials used to make the product were recycled). Based on that research and other
consumer evidence, the Commission established a standard for unqualified claims of “recycled
content,” requiring that such claims only be made if the “entire product or package, excluding
minor, incidental components, is made from recycled material.” FTC Guides for the Use of
Environmental Marketing Claims, 16 C.F.R. § 260.7(e) (1998).
24 An example of a statutory and regulatory scheme that sets similar percentage
standards is the USDA’s National Organic Program. Under that Program, 1) products labeled as
“100 percent Organic,” must contain 100% organically produced ingredients; 2) products labeled
simply “organic” must contain at least 95% organic ingredients; and 3) multi-ingredient products
labeled as “made with organic ingredients” must contain at least 70% organic ingredients and
satisfy additional labeling requirements. USDA/Agricultural Marketing Services National
Organic Program, 7 C.F.R. §§ 205.301(c) and 205.304 (2002), available at
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B. Minimum Content Standards
In addition to establishing explicit percentage standards for foods labeled as “100%
whole grain,” “whole grain,” and “made with whole grain,” the FTC staff believes that FDA
should also require that these foods contain a sufficient amount of whole grain, in an absolute
sense, to make a meaningful contribution to the daily diet. This requirement is especially
important for multiple-ingredient foods in which the grain is only one of many ingredients, for
example, a product that combines pasta or rice with vegetables or meat. Without a minimum
standard for the absolute amount of whole grain, a company could accurately state that its
product was “100% whole grain,” even if the grain ingredients represented a small portion of the
overall ingredients and the absolute amount of whole grain were insignificant.25
USDA has imposed such a standard in its Interim Policy Guidance for the meat and
poultry industry. Its guidance indicates that there should be a significant amount of the whole
grain component in foods making “whole grain ” or “made with whole grain” claims to ensure
that statements are not misleading. USDA suggests that foods labeled with these phrases contain
at least a one-half ounce equivalent of whole grain ingredients (8 grams of dry whole wheat).26
This amount represents half of one of the three servings daily recommended by the 2005 Dietary
http://www.ams.usda.gov/nop/NOP/standards.html. An assessment of this scheme may provide
some useful guidance as to the costs and benefits of articulating definitive percentages in the
context of whole grain claims.
25 For example, many entree dishes contain rice or pasta combined with vegetables,
dairy, or meat ingredients. Even if the pasta or rice component is 100% whole grain, the dish
may provide an amount of whole grain that is insignificant in the context of an entire diet.
26 The absolute standard for minimum whole grain content is in addition to USDA’s
requirement that at least 51% of the grain ingredients be whole grains.
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Guidelines.
The FTC staff believes that additional guidance, in the form of percentage and minimum
content standards, will ensure that when consumers choose products labeled as “whole grain” or
“made with whole grain,” or similar claims, they will be getting a meaningful amount of whole
grain. FDA guidance standardizing these and similar terms could also provide the foundation for
consumer education that ties the dietary recommendations for whole grain consumption to real
world food choices at the grocery store.
As FDA considers whether to expand its guidance on unqualified whole grain claims to
provide specific percentage thresholds and/or minimum content standards, the FTC staff again
believes that it would be helpful for FDA to solicit relevant consumer perception data from the
industry and others and, if possible, to conduct copy testing of how consumers interpret phrases
such as “whole grain,” “made with whole grain,” and other similar terms. Understanding better
how consumers view these claims would help inform the agency about how best to define them
to minimize confusion.
V. CONCLUSION
The FTC staff generally supports the FDA’s efforts to provide guidance on whole grain
label statements. The draft guidance is an important step toward helping consumers evaluate
whole grain food products and make better-informed choices concerning their whole grain
consumption. As FDA finalizes its guidance, the FTC staff suggests that it consider giving more
specific guidance on two issues. First, the staff recommends that FDA reconsider allowing the
“good source” and “excellent source” claims that have already become widespread in the
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marketplace, as a way to provide consumers with a simple tool for identifying foods rich in
whole grains. In addition, or as an alternative approach, the staff suggests that FDA expressly
identify other permissible ways that manufacturers can give dietary context to whole grain label
statements. Second, the staff recommends that FDA expand on its guidance governing
unqualified whole grain claims to provide specific percentage and minimum whole grain content
standards for foods bearing these claims.
Adequate consumption of whole grain is important to consumer health, and many
Americans are falling far short of their dietary needs. Giving consumers easy ways to choose
products that provide meaningful amounts of whole grain could help them to reduce their risk of
several chronic diseases as well as help them maintain a healthy weight. More specific guidance
could also provide the consistency and clarity that food companies need to motivate them to
introduce products with higher whole grain content.
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__________________________
__________________________
__________________________
Respectfully submitted,
Lydia B. Parnes, Director
Mary K. Engle, Associate Director, Division of Advertising Practices
Thomas B. Pahl, Assistant Director, Division of Advertising Practices
Michelle K. Rusk, Attorney, Division of Advertising Practices
Bureau of Consumer Protection
Michael A. Salinger, Director
Pauline M. Ippolito, Associate Director for Special Projects
R. Dennis Murphy, Economist, Division of Consumer Protection
Bureau of Economics
Maureen K. Ohlhausen, Director
Office of Policy Planning
17