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Notice2022-06419

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim “Healthy” on Packaged Foods

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Published

March 28, 2022

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

Full Text

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[Federal Register Volume 87, Number 59 (Monday, March 28, 2022)]
[Notices]
[Pages 17300-17307]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-06419]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0336]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Quantitative Research
on a Voluntary Symbol Depicting the Nutrient Content Claim ``Healthy''
on Packaged Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995 (PRA).

DATES: Submit written comments (including recommendations) on the
collection of information by April 27, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Quantitative Research on a Voluntary Symbol
Depicting the Nutrient Content Claim `Healthy' on Packaged Foods.''
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White

[[Page 17301]]

Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852,
301-796-7726, <a href="/cdn-cgi/l/email-protection#66363427351207000026000207480e0e1548010910"><span class="__cf_email__" data-cfemail="b3e3e1f2e0c7d2d5d5f3d5d7d29ddbdbc09dd4dcc5">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Quantitative Research on a Voluntary Symbol Depicting the Nutrient
Content Claim ``Healthy'' on Packaged Foods

OMB Control Number 0910-NEW

I. Background

Section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 343(r)(1)(A)) permits the use of label and
labeling claims that characterize the level of a nutrient in a food
when the claims are made in accordance with FDA's regulations. Such
claims are referred to as ``nutrient content claims.'' We have issued
regulations under section 403(r)(1)(A) of the FD&C Act describing
``implied nutrient content claims'' as those that, among other things,
suggest that a food, because of its nutrient content, may help
consumers maintain healthy dietary practices (21 CFR 101.65(d)(1)(i).
The rule finalizing these claims also describes implied claims, in
part, as those that imply that a food, because of its nutrient content,
may be useful in achieving a total diet that conforms to current
dietary recommendations (``Food Labeling: Nutrient Content Claims,
General Principles, Petitions, Definition of Terms,'' 58 FR 2302 at
2374, January 6, 1993)). We have determined that a claim that a food,
because of its nutrient content, may be useful in maintaining healthy
dietary practices is clearly a claim that characterizes the level of
nutrients in that food. The claim is essentially saying that the level
of nutrients in the food is such that the food will contribute to good
health (58 FR 2302 at 2375). In 1994, we issued a definition of
``healthy'' as an implied nutrient content claim (59 FR 24232, May 10,
1994); the regulation is codified at 21 CFR 101.65(d)(2).
FDA seeks to improve dietary patterns in the United States to help
reduce the burden of diet-related chronic diseases and advance health
equity. We are committed to accomplishing this by, in part, empowering
consumers with information to make more informed dietary choices. To
help advance these goals, we are exploring the development of a graphic
symbol to help companies communicate and consumers identify packaged
food products that meet FDA's definition of ``healthy.'' The symbol
would be a graphic representation of the nutrient content claim
``healthy'' and, like the implied nutrient content claim ``healthy''
itself, would be voluntary for packaged food companies. Companies could
voluntarily use the symbol on food products that meet FDA's definition
of ``healthy.''
In 2019 and 2020, FDA conducted a review of the literature on
front-of-package (FOP) nutrition-related symbols and conducted a series
of focus groups to test symbol concepts and draft FOP symbols (see
Docket No. FDA-2021-N-0336 for the literature review and a table of
draft FOP symbols).
As part of our efforts to promote public health, we intend to
conduct two consecutive quantitative research studies--a survey (Study
1) and an experimental study (Study 2) to explore consumer responses to
the draft FOP symbols that companies could voluntarily use on a food
product as a graphic representation of the nutrient content claim
``healthy.'' If research results suggest the need, the symbols will be
fine-tuned following the survey and again following the experimental
study. Study 1 will use non-probability survey methods, using a web-
based panel to draw a sample of 2,000 U.S. adults ages 18 and older who
self-identify as primary food shoppers. The sample will be balanced to
the demographics of the U.S. population. The survey instrument will
focus on clarity, relevance, and appeal of a set of symbols.
Study 2 will be a controlled, randomized experiment that will use a
15-minute web-based questionnaire to collect information from 5,000
U.S. adult members of an online consumer panel. Conditions for Study 2
will be: (1) A set of draft FOP symbols, including ``no-symbol''
controls; (2) three types of mock food products (i.e., a breakfast
cereal, a frozen meal, and a canned soup); (3) a ``no-information''
condition where no explanation of the symbol is provided; and; (4) a
Uniform Resource Locator (URL) condition, in which a URL is tested
alongside the symbol. Each participant in Study 2 will be randomly
assigned to a condition, which will include viewing a label image and
responding to various measures of the symbol's effectiveness. Measures
of response in the experiment will include product perceptions (e.g.,
healthfulness and contribution to a healthy diet), label perceptions
(e.g., believability, trustworthiness, message effects), and purchase/
choice questions. The instrument will also collect information from
participants about their history of purchasing or consuming similar
products; nutrition knowledge; dietary interests; motivation regarding
label use; health status; and demographic characteristics.
The studies are part of our continuing effort to enable consumers
to make informed dietary choices and construct healthful diets. We
intend to use the results to inform our continued exploration of a
symbol manufacturers could voluntarily use to represent the nutrient
content claim ``healthy'' on the food label. We will not use the
results to develop population estimates.
Description of Respondents: Respondents to this collection of
information include members of the general public.
In the Federal Register of May 7, 2021 (86 FR 24629), FDA published
a 60-day notice requesting public comment on the proposed collection of
information (``60-day notice''). We received 43 comments, 27 of which
were PRA-related. The remaining comments were non-responsive to the
four PRA topics, and so we will not address them in this document.

A. Comments Regarding the Necessity and Practical Utility of the
Information Being Collected and FDA Response

Several comments addressed the necessity and practical utility of
collecting information on a voluntary symbol depicting the nutrient
content claim ``healthy'' on packaged foods.
(Comment 1) Some comments supported FDA's proposed collection of
information through the three proposed quantitative consumer research
studies. Some comments expressly supported FDA's end research goal of
enabling consumers to make informed dietary choices and construct
healthful diets. Some supported FDA's intention to understand consumer
responses to draft FOP symbols and gather data and other information to
inform our thinking on a ``healthy'' symbol. Many comments indicated
the importance of conducting this research before taking regulatory
action on any symbol. Some comments supported conducting the research
in conjunction with development of a proposed rule that would update
the definition of ``healthy'' on food packages.
Other comments opposed FDA research on a ``healthy'' symbol. Some
of these comments suggested the research is unnecessary, claiming that
a single food is not ``healthy'' or ``unhealthy,'' that overall diet
matters more than individual foods, or that symbols are industry
marketing. A few comments suggested a ``healthy'' symbol could be
particularly misleading to, or misinterpreted by, people who are

[[Page 17302]]

experiencing eating disorders. Some comments also questioned whether a
``healthy'' symbol would: (1) Have a positive and meaningful impact on
improving health or (2) lead consumers to overconsume foods bearing the
symbol.
(Response 1) We intend to conduct this research now, in conjunction
with further work on updating our definition of the claim ``healthy''
and before taking regulatory action on any symbol. Our intended
research will help us better understand how consumers might respond to
and use a graphic symbol to identify packaged food products that meet
our definition of ``healthy.'' This research will help address many
points raised in the comments, such as how consumers might react to and
understand a ``healthy'' symbol and misinterpretations they may have.
While we agree that there are some symbols that may be used
exclusively for industry marketing, companies could use any FDA
``healthy'' symbol we develop and finalize only when the product
displaying the symbol meets FDA's regulatory definition of ``healthy.''
This could help consumers make more informed dietary choices and
construct healthful diets. The comments claiming that a single food is
not ``healthy'' or ``unhealthy'' and that overall diet matters more
than individual foods are commenting on the ``healthy'' claim itself,
which we do not intend to test in this research. Rather, we intend to
test consumer reactions to symbols that could be a graphic
representation of the claim. Nonetheless, we note that a ``healthy''
symbol, such as the ones FDA is exploring in our research, could help
consumers choose food products, as part of their overall diet, that
meet FDA's regulatory definition of ``healthy.'' The research is not
designed to study long-term health effects or consumer consumption
patterns. We reiterate that this research is about graphical
representations of the nutrient content claim ``healthy''--in other
words, we intend to study only the symbol, not the claim itself.
Depending on the results of this data collection, we may decide to test
additional symbols or revise our current symbols.
(Comment 2) Many comments expressed a preference for conducting the
research after we revise our regulatory definition of ``healthy,'' as
they wondered whether the definition of the claim could influence both
the design and consumer understanding of the symbol. Some expressed
concern that testing a symbol without clearly communicating what the
symbol means could lead to ambiguous results. One comment expressed
concern that, by conducting testing only on the symbols in the notice,
we would not consider testing any other symbols in the future. A few
comments contended that FDA's testing would be invalid if the mock
products used in testing do not meet FDA's updated ``healthy''
definition.
(Response 2) FDA has an existing definition for the claim
``healthy,'' and in the Federal Register of September 28, 2016, we
announced our intent to exercise enforcement discretion around some
criteria for the claim (see ``Use of the Term `Healthy' in the Labeling
of Human Food Products: Guidance for Industry,'' 81 FR 66527). However,
as part of this data collection, we have included experimental
conditions in which participants will read general information
outlining the use of the claim ``healthy'' only for purposes of this
study. This will help us better understand how consumers might respond
to the symbols we are proposing to test if participants understand a
``healthy'' definition, even if not necessarily an updated definition.
While the symbol is intended to represent the nutrient content claim
``healthy,'' our research on the symbol is not dependent on specific
criteria for ``healthy.'' We are researching general consumer
perceptions and impressions of the symbols themselves, not the
definition that may underly those symbols, and as such, we do not need
to wait until we have a final, updated regulatory definition of
``healthy'' before conducting this research. Moreover, the symbols
being tested would not need to be modified with a changing definition
of ``healthy;'' the symbol would remain a simple graphic representation
of the ``healthy'' claim.
Regarding the claim that our testing would be invalid if the mock
products used in testing do not meet FDA's updated ``healthy''
definition, our mock products represent broad and basic food
categories. They include foods such as vegetables and whole grains with
limited nutrients of concern (e.g., sodium or saturated fat) that would
meet our current definition of ``healthy'' and would help consumers
build a diet consistent with the Dietary Guidelines for Americans,
2020-2025.

B. Comments Regarding the Accuracy of Our Burden Estimates, Including
the Validity of the Methodology and Assumptions Used, and FDA Response

Many comments discussed the accuracy of FDA's estimate of the
burden for this information collection, including the validity of FDA's
methodology and the assumptions used.
(Comment 3) Several comments alleged that we provided limited
details about our proposed research studies and encouraged us to
publish additional information on the proposed scope and methodology of
our consumer research to allow for more comprehensive input from
experts in the field of consumer research. One comment suggested we
``pre-register'' details of the proposed studies on <a href="http://AsPredicted.org">AsPredicted.org</a> or
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> so that stakeholders could better understand the
primary outcome of the research, hypotheses, analytic plan, and power
analysis used.
(Response 3) We described the research in the 60-day notice,
providing information on research design, measures, sampling, and
sample size. Many comments substantively addressed these issues, and so
we believe there was enough information about the studies in the 60-day
notice for the public--including consumer researchers--to comment on
the research.
We specified in the 60-day notice that we intend to use the results
to inform our continued exploration of a symbol manufacturers could
voluntarily use to represent the nutrient content claim ``healthy'' on
the food label (86 FR 24629 at 24631). The comment did not provide
sufficient information regarding additional details that it believed
necessary for stakeholders to better understand this primary outcome,
hypotheses, analytic plan, and power analysis used, and it did not
explain what additional details might be available via pre-registration
that would not be available in our Federal Register notices. Therefore,
we are unable to provide those details here, and we also decline to
pre-register our studies.
(Comment 4) One comment questioned the ordering of the quantitative
research, asking why the experimental studies come before the surveys.
Other comments suggested we use the two surveys to test draft symbols
first to narrow down options and test the ``final'' symbols in the
experiment, or to conduct preliminary research to narrow the options
for the experiment.
(Response 4) We conducted several phases of qualitative research to
solicit input from consumers, allowing us to evaluate symbol prototypes
and design elements to learn what resonated with consumers. Through
that process we narrowed our draft symbol options. After considering
public comments, we have reconsidered the order of the research, and
plan to conduct one survey with a larger sample size (instead of two
surveys with smaller sample sizes each) before the experimental study.
In other words, we will reorder

[[Page 17303]]

the studies and combine the two surveys into one, which will allow us
to test all symbols in a single survey. While our proposed information
collection is intended to help us better understand how consumers might
respond to and use a graphic symbol that indicates packaged food
products meet FDA's definition of ``healthy,'' and all the draft
symbols we proposed to test would allow us to do that, we expect
conducting a single survey first will help us further revise and narrow
down the set of symbols.
(Comment 5) One comment suggested we use a more naturalistic study
environment, such as an online store setting, instead of using images.
(Response 5) Online store settings and other naturalistic study
environments have been successfully employed in some studies on food
labeling effects. One advantage of employing such naturalistic study
environments is that they more closely reflect participants' actual
shopping experience. However, there are substantial additional costs
associated with using such research settings, and results in these
settings generally do not differ appreciably from results garnered
through the simple random-assignment-to-condition design that we
proposed. Therefore, we decline to change our study environment.
(Comment 6) One comment suggested that FDA separate different
aspects of the symbols to isolate consumer perceptions of the word
``healthy,'' the graphic itself, and the graphic accompanied by the
word ``FDA.'' One comment suggested that FDA should test each symbol
with and without ``FDA.''
(Response 6) Separating each aspect of the symbols for our testing
would increase the number of conditions exponentially, making the
design impractical. We instead elected to use a full factorial design
with simple random assignment to condition, to give us results on the
performance of the various symbol designs. Using random assignment to
condition, we may be able to eliminate some symbols without needing to
test particular attributes in any one symbol. We may consider alternate
study designs when we have a narrower set of symbols.
One finding of our literature review was that institutional
endorsement may be related to greater confidence in the symbol. Our
focus group research affirmed that participants regarded symbols with
``FDA'' as more trustworthy than symbols without ``FDA.'' Therefore,
for the intended research, we are testing draft symbols with ``FDA.''
We may consider additional research on this point depending on the
results.
(Comment 7) One comment recommended using images of real food
products in the experimental studies instead of using mock product
images.
(Response 7) FDA does not agree with the recommendation to use
images of real products in the experimental studies. Mock images remove
the potential for brand biases, a source of response error that has
been demonstrated to affect the way individuals answer survey
questions. Mock food product labels psychologically remove the salience
of branded product informational cues present in the retrieval stage of
the response process (Refs. 1 and 2). Additionally, the mock product
labels we designed are visually similar to labels consumers could
expect to see in stores for each given product category. We confirmed
this assertion in our qualitative testing by noting that participants
perceived the mock product labels as ones with which they were
unfamiliar, but which were plausible for the food product depicted.
(Comment 8) One comment suggested that we should assess ``multi-
tier symbols'' in addition to the symbols we intend to test. The
comment suggested that multi-tier symbols are those that use, for
example, an increasing number of stars to indicate to the consumer that
a choice is ``good,'' ``better,'' or ``best.'' The comment argued that
a multi-tiered approach could encourage consumers to make incremental
improvements in their diets, enable manufacturers to reformulate
products to meet the initial tier of the system, and increase the
number of foods with at least some healthful benefits that could carry
a symbol.
Another comment suggested that FDA consider a symbol that warns
consumers about high levels of unhealthy nutrients. Another comment
asserted that we should also test what it suggested were more neutral
FOP labels, such as traffic lights, nutrition scoring symbols, and
warning symbols, to better assist consumers in making healthy choices
and motivate manufacturers to make healthier foods.
(Response 8) For the purpose of this study, we are testing only
symbols that would be a graphic representation of the nutrient content
claim ``healthy''--a food that could bear that claim could also bear
the symbol. FDA's systematic literature review suggested that a summary
indicator--the type we are proposing to test--would have the greatest
utility to depict the ``healthy'' claim to a broad array of consumers,
especially those with lower education or lower health literacy. As
such, we disagree that we should test other kinds of symbols to depict
the nutrient content claim ``healthy.'' We are testing different draft
symbol designs based on our literature review and the feedback we
collected through our focus group research. Our current study plans are
limited to testing summary symbols depicting the nutrient content claim
``healthy'' to get reactions to design elements and to reduce the
current number of symbols under consideration. Because there are no
``healthy'' tiers in the nutrient content claim, we decline to test a
tiered symbol.
(Comment 9) One comment encouraged us to consider testing the
``healthy'' symbol alongside other current voluntary FOP labels--rather
than as the only symbol on a package--to determine the effect of other
FOP labels on the efficacy of the ``healthy'' symbol.
(Response 9) Our studies are designed to test general consumer
responses to the symbols presented. Testing additional variables, such
as the effect of other packaging elements on the symbols, is outside
the scope of this research. We may decide to test ``healthy'' symbols
alongside other FOP symbols in later research depending on the results
from this data collection.
(Comment 10) One comment recommended randomizing participants to
see subgroups of symbols, claiming it would be an efficient use of
resources.
(Response 10) FDA agrees with the recommendation that participants
be randomly assigned; however, we disagree with the recommendation to
have participants view subgroups of symbols. We plan to randomly assign
participants to see a single symbol condition, including product type,
information on the definition of healthy, URL/no-URL, and set of
symbols. Viewing a single symbol condition precludes the effects of
biases that may result from having viewed and responded to questions
about one symbol affecting responses about another symbol (Ref. 1).
Therefore, even if we might use fewer resources by assigning
participants to see subgroups of symbols, the practice would introduce
biases and confounds that could make interpreting the results very
difficult.
(Comment 11) One comment recommended incorporating time limits for
a choice task to better mimic real-life scenarios where consumers have
only limited time to shop.
(Response 11) The current experimental study design is random
assignment to condition with no ``choice task.'' While time-constraint

[[Page 17304]]

studies can be useful to test certain variables, our research goal is
for the participants to provide thoughtful responses, unaffected by the
stress that a time limit could impose.
(Comment 12) A few comments recommended that the studies be
adequately powered to enable FDA to do appropriate statistical
analysis.
(Response 12) Our studies are designed to have the appropriate
statistical power to conduct all necessary statistical analysis. We
will test hypotheses related to between-label differences. We will
impose no a priori direction of differences, if any (i.e., we assume
all tests are two-tailed). The target sample size (5,000 for the
experimental study and 2,000 for the survey) will yield enough
observations to provide adequate power to identify 4-way interactions
of a medium size (Ref. 3).
(Comment 13) One comment recommended that we test the draft
``healthy'' symbols in the context of restaurants.
(Response 13) Our research plans include testing symbols solely on
packaged foods. Testing ``healthy'' on a packaged food label versus in
a restaurant minimizes the many confounding factors inherent in
studying claims in a restaurant environment, such as the enormous
variance in size and content of materials used to sell restaurant food.
Keeping the studies limited to packaged food labels allows FDA to
better isolate various effects of the symbols to strictly test consumer
perceptions about the symbols. Additionally, as we noted in response to
another comment, we have no reason to believe that adding additional
test product categories would change the study outcomes given our goal
of testing consumer responses to the symbols.
(Comment 14) Some comments recommended that FDA include more than
three mock product types in the experimental studies because of the
potential that consumer perceptions of a ``healthy'' symbol might be
different on different products. One comment suggested including a
variety of food categories in the studies, while a few other comments
recommended including specific product categories, including beverages
and fresh produce, so FDA could assess consumer reactions to, or
preferences for placement of, a symbol on those products.
(Response 14) FDA disagrees with the recommendation to add more
product types to the studies. We are proposing to test ``healthy''
symbols on a set of mock products that belong to large food categories,
with many product types within each category. The broad product
categories for those mock products are likely to contain multiple
products that currently meet FDA's regulatory definition of
``healthy.''
For our research, we chose three packaged foods that are commonly
consumed and that are clearly distinct food types. The selected
products will give us sufficient information on general consumer
responses to the symbols to continue development of a proposed
``healthy'' symbol. We also note that adding any products would
increase the scope and cost of the studies while providing limited new
information and that the comments provided no evidence that additional
test products from other food categories would impact our study
outcome.
We decline to include a beverage as one of the mock products. While
beverages that meet FDA's definition of ``healthy'' could bear any
``healthy'' symbol we finalize, the same is true of any packaged food,
and as we explained above, we have no reason to believe that adding
additional test product categories would change the study outcomes. We
decline to add fresh produce to the studies for the same reasons.
(Comment 15) A few comments recommend comparing foods with a
``healthy'' symbol and foods that may have healthful attributes but do
not meet the regulatory definition of ``healthy,'' to evaluate whether
use of the symbol might result in discouraging purchase of foods that
have important nutrients but that do not meet the definition of
``healthy.'' Another comment suggested testing a variety of products
(``healthier'' and ``less healthy'') for each food product category
included in the studies.
(Response 15) The studies are not designed to test purchasing
behavior, and so we decline to add mock products for that purpose.
Rather, this research is designed to test general consumer responses to
the symbols themselves. Additionally, a product could only bear the
symbol if it qualified to bear the ``healthy'' claim itself--the symbol
is a graphic representation of the claim--and we are not testing the
claim definition or its effects here.
One of the study assumptions is that, like the nutrient content
claim ``healthy,'' any food bearing a ``healthy'' symbol on its label
must meet the regulatory definition of ``healthy.'' Therefore, to test
consumer responses to the symbols, we do not need to test the ancillary
effects of a ``healthy'' symbol on foods that do not bear the claim.
Moreover, FDA intends to test ``healthy'' symbols on a set of mock
products whose product categories are likely to contain multiple
products that currently meet FDA's regulatory definition of
``healthy''--we are making no claims about the relative healthfulness
of any product. Using these mock products in our research will provide
us with sufficient information to understand how consumers might
respond to a ``healthy'' symbol on food packaging, and that information
is our goal with these studies. Testing the selected products will give
us sufficient information to continue development of a proposed
``healthy'' symbol.
The comment did not provide an explanation for its recommendation
to test ``healthier'' and ``less healthy'' products for each food
product category. We are not testing ``healthier'' and ``less healthy''
versions of a given product in this research effort, as the goal of the
research is to gauge participants' reactions to a symbol. Additionally,
we are working on updating our definition of ``healthy'' and will
describe our proposed updated definition in any related rulemaking. It
would be inappropriate to assign relative ``healthfulness'' to
comparator products. Products bearing the ``healthy'' symbol, which
would be a graphic version of the nutrient content claim ``healthy,''
would have to meet the criteria for using the claim.
(Comment 16) One comment noted a symbol with the term ``FDA'' may
cause confusion if that symbol is used on any products regulated by the
U.S. Department of Agriculture (USDA) and urged us to consider the
potential for such confusion in our research. Another suggested that we
engage with the Food Safety and Inspection Service during our proposed
consumer research on the ``healthy'' symbol to develop a symbol that
could apply to all products that meet the ``healthy'' claim criteria.
(Response 16) We cannot comment on whether or how USDA might allow
an FDA ``healthy'' symbol on the products it regulates that meet FDA's
definition of ``healthy.'' However, we intend to coordinate with our
federal partners, including USDA, as appropriate, as we continue our
work on a ``healthy'' symbol.
(Comment 17) A few comments asserted it was important to consider
the symbols' placement on packaging and noted that food packaging size,
type, and appearance vary, suggesting that FDA should study how
consumers may respond to a ``healthy'' symbol on a wider variety of
packaging formats than are currently proposed for the studies. One
comment suggested testing the symbol on different locations on the
package and with varying prominence.

[[Page 17305]]

Another encouraged flexibility in specified requirements (e.g.,
placement, type size, color format, scannable images) surrounding the
FOP symbol.
(Response 17) We anticipate that any ``healthy'' symbol we propose
would be standardized in certain ways. However, the purpose of this
research is to gauge consumer responses to the symbols we are testing,
not to decide on a single symbol, its potential placement on packaging,
or what aspects we would require, should a company choose to use the
symbol.
(Comment 18) A few comments suggested we include questions or
conduct additional research to assess the potential for consumer
misunderstanding of the symbols. Some comments suggested that we
investigate whether consumer perceptions of some symbols might imply
messages other than ``healthy'' (such as ``organic,'' ``natural,''
``plant-based,'' and ``minimally processed'') or whether the symbols we
are testing may appear similar to other existing or abandoned symbols
(such as the USDA Organic Seal, Smart Choices, or any of USDA's
bioengineered food symbols). One comment claimed that a lack of
legibility of the text in the symbol could cause consumer confusion.
Another comment recommended that FDA avoid leaf or nature imagery in
the symbol because it could imply that the product is plant-based,
``natural,'' or unprocessed. One comment encouraged us to examine how
appealing the symbols are to consumers, and another comment described
the proposed symbols as too simplistic.
(Response 18) We have selected study designs and draft symbols that
we expect, when used together, will reveal how consumers will react
when they see such symbols on a food label. We included questions in
our studies on what the symbols lead participants to believe about the
products bearing them. We also expect to hear from participants whether
the symbols we are testing are perceived as too complex, too
simplistic, or invoke concepts other than ``healthy.''
We agree that any symbol we propose should be legible and minimize
imagery that our research indicates could widely lead consumers to
think the symbol means something unintended. As such, we will add an
open-ended question to the experimental study asking what the symbol
brings to mind to help determine if any symbols should be removed from
consideration or revised on this basis. Moreover, we agree that the FDA
symbol design for ``healthy'' should not be easily confused with other
existing symbols and should be viewed as professional and credible by
consumers. We expect to get some data on these points through this
round of testing and may undertake further research before we make any
formal regulatory decision on a symbol.
(Comment 19) One comment suggested that FDA test other terms
besides ``healthy,'' such as ``nourishing'' or ``nutrient-dense.''
(Response 19) We are not testing the nutrient content claim
``healthy;'' rather, we are testing consumer responses to graphic
representations of the claim. We similarly do not intend to test other
terms.
(Comment 20) Several comments supported conducting research on the
use of an accompanying URL with the ``healthy'' symbol; however, others
stated the purpose for including a URL was unclear, and one comment
expressed concern that a URL would not work as well in a brick-and-
mortar retail setting. Another comment stated that future labeling
could include the use of other technologies, such as a quick response
(QR) code or digital watermark, to provide consumers access to all the
labeling information included on the package and suggested that we
incorporate digital disclosure flexibility into our labeling
regulations because technology continues to evolve. Other comments
suggested that consumers may not have internet access in stores or may
not know how to use QR codes, while another comment suggested that
researchers could develop unique QR codes for each condition and track
participant use.
(Response 20) Our research efforts on the ``healthy'' symbol are
intended to collect sufficient data for the development and
finalization of a ``healthy'' symbol. We are studying several
dimensions of a proposed symbol, including the inclusion of a URL as
part of the symbol. This research will help us better understand study
participants' reactions to and understanding of those different
elements.
Our preliminary research indicated that participants are interested
in learning more about the symbols, and a URL can serve as a
representation to participants that more information is available. The
current study design proposes to test a URL alongside some of the
symbols to gauge the ability of the URL to indicate that information
about the symbol is available and to assess the degree to which a URL
improves confidence and trust in the symbol. We are not studying
participants' actual ability to access the URL in stores or elsewhere.
We are also not considering inclusion of other technologies, such as a
QR code or digital watermark, in this information collection because a
URL will help us gauge whether participants want a way to access
additional information about the symbol. Further, a QR code or digital
watermark would not indicate government involvement in the way a URL
ending ``.gov'' may, and we are interested in how participants will
respond to a ``.gov'' URL.
While we agree that technology changes over time, we are only
studying consumer responses to the symbols in this research. It would
be premature to comment on any requirements surrounding any symbol we
might propose. However, we could consider other digital elements, such
as QR codes or digital watermarks, in future research depending on our
future research goals.
(Comment 21) Some comments raised concerns that the use of FDA's
name as part of the ``healthy'' symbol. The comments said that the use
of FDA's name could create the appearance of an FDA endorsement of a
given food.
(Response 21) We are testing draft symbols with ``FDA.'' We note
that we are studying several dimensions of a proposed symbol to help us
better understand study participants' reactions to and understanding of
those different elements, including any impression of an FDA
endorsement.
(Comment 22) A few comments expressed uncertainty as to whether FDA
research participants would come from a nationally representative
sample and recommended paying particular attention to or using quota
samples similar to the demographic breakdown of the U.S. population
regarding sex, age, race/ethnicity, income, and education. Some
comments also stated that FDA should consider oversampling from certain
groups at highest risk for dietary-related disparities, asserting that
it is important to ensure that any proposed healthy symbol works well
among all populations. One comment noted this is especially important
for lower-education groups who, the comment asserted, may be less
likely to use or understand the package's nutrition label. Some
comments also requested that FDA screen participants to ensure a sample
large enough to collect responses from food-allergic individuals,
caregivers to food-allergic individuals, and parents.
(Response 22) We designed our studies to test consumer responses to
draft symbols in a randomized controlled setting, with participants
drawn from a general population. Our research collection is not
intended to produce population estimates. However, we intend to select
the samples in each study to be reflective of the general U.S.

[[Page 17306]]

population (e.g., sex, race/ethnicity). We believe our approach is
reasonable because any ``healthy'' symbol we finalize will be available
to the general U.S. population.
(Comment 23) One comment suggested that we test a Spanish language
version of the symbol and consider whether including ``FDA'' as part of
the symbol would resonate with consumers of products sold in other
countries.
(Response 23) Our regulations, at 21 CFR 101.15(c), generally
require that the labeling of all food offered for sale in the United
States be in English, and outline requirements for manufacturers that
also choose to label their products in additional languages. Because we
generally require only English labeling, and manufacturers may choose
whether to use or include foreign-language labeling, we are testing
only an English-language version of the symbol in this set of studies.
As for products sold in other countries, the nutrient content claim
``healthy,'' and any related symbol we finalize, are specifically for
products marketed and sold in the United States. We decline to comment
on marketing and sales in, or the food labeling requirements of, other
countries.
(Comment 24) One comment argued that we should not generalize the
results from this study to all FOP label systems.
(Response 24) We agree that findings from this research should not
be generalized to all FOP label systems.

C. Comments Regarding Ways To Enhance the Quality, Utility, and Clarity
of the Information To Be Collected, and FDA Response

Several comments suggested ways to enhance the quality, utility,
and clarity of the information about ``healthy'' symbols to be
collected.
(Comment 25) Some comments stated FDA should conduct thorough
research regarding the development and finalization of a symbol for
``healthy,'' and should collect comprehensive data so that FDA's final
decision promotes health.
(Response 25) FDA agrees with the comments. Our research goal is to
explore consumer responses to draft symbols that could represent the
nutrient content claim ``healthy.'' The goal of the symbol is to help
consumers make more informed dietary choices.
(Comment 26) Several comments recommended we change certain aspects
of the questions we include in the experimental study. Some comments
suggested that we select specific outcome measures, such as purchase
intent, sales data, ability of the symbols to attract consumer
attention, long-term behavior change, consumer perceptions of the taste
and cost of products bearing the ``healthy'' symbol, the healthfulness
of the products consumers purchased, the number of ``healthier''
products purchased in a shopping setting, and any unintended
consequences of the symbol.
One comment recommended adding covariates, such as health status,
particularly for conditions that are related to nutrition, such as
diabetes, weight status, and hypertension, to help us understand
responses. Regarding the interpretation of measurements, one comment
suggested we avoid ``believability'' or ``trustworthiness'' as
indicators of which symbol can help people make more informed dietary
choices, claiming that these are not strong predictors of behavior. The
comment cited a study on cigarette pack warning messages that found
that measures on the effects of the warning message resulted more in
intended behavior change than did measures on attitude perceptions
(Ref. 4).
Another comment recommended FDA provide an option for open-ended
responses to gauge consumers' perceptions of ``healthy.''
(Response 26) The intended studies cover the key measurements and
covariates that will help us understand consumer perceptions of the
symbols. The comments did not provide, and we are not aware of,
evidence that adding covariates or measurements would enhance the
quality, utility, or clarity of the information we intend to collect.
We will evaluate our draft symbols based on our analysis of all--not
just a subset--of these measurements. We acknowledge that there are
measurements we are not including in this research effort (e.g., long-
term behavior changes). These studies are designed to explore consumer
responses to the draft symbols, and inclusion of variables such as
long-term behavior changes would be premature.
We plan to use a variety of measures to help understand the
potential impact of a voluntary FOP symbol for ``healthy,'' and intend
to use ``believability'' and ``trustworthiness'' as outcome measures
because well-established scientific literature has shown that
consumers' attitudes and perceptions affect their behavior (Refs. 5 to
7). Additionally, we note that the cigarette-pack study one comment
cited qualified its findings as unsure if the same would be found in
other message or product scenarios (Ref. 4). Because the published
literature does not indicate that ``effects perception measures'' have
been tested in the food label domain, we will add some questions to the
experimental study to evaluate their use as outcome measures compared
to ``message effects measures.''
We disagree with the suggestion to query consumers on their
perception of ``healthy.'' Our research is designed to test consumer
responses to the draft symbols, not determine consumer perceptions of
``healthy.''

D. Comment Regarding Ways To Minimize the Burden of the Collection of
Information on Respondents, Including Through the Use of Automated
Collection Techniques, When Appropriate, and Other Forms of Information
Technology, and FDA Response

One comment discussed minimizing the information collection burden
on respondents to our proposed ``healthy'' symbol research.
(Comment 27) One comment supported the proposed research and noted
that the use of online surveys will help alleviate participant and
administrative burden while ensuring that the research reaches
sufficient participants.
(Response 27) We agree with the comment for the purposes of this
research.

E. Nonresponsive Comments to the PRA

Some comments addressed aspects of ``healthy'' symbols that are
outside the scope of this information collection or addressed issues
other than the ``healthy'' symbol research. These discussed, for
example, the definition of ``healthy,'' potential impacts of the
``healthy'' nutrient content claim generally, whether the symbols
should be voluntary or mandatory, and whether we should develop an
accompanying consumer education campaign. These are outside the scope
of this information collection, and we will not address them here.
Interested parties will have an opportunity to comment on any
``healthy'' symbol we propose and any proposed updated definition of
the nutrient content claim ``healthy'' in response to their respective
Federal Register notices.
FDA estimates the burden of this collection of information as
follows:

[[Page 17307]]

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 1 (Survey) Cognitive interview screener 75 1 75 0.083 (5 minutes)........................ 6
Study 2 (Experiment) Cognitive interview 75 1 75 0.083 (5 minutes)........................ 6
screener \2\.
Study 1 (Survey) Cognitive interview......... 5 1 5 1........................................ 5
Study 2 (Experiment) Cognitive interview..... 9 1 9 1........................................ 9
Study 1 (Survey) Pretest..................... 60 1 60 0.17 (10 minutes)........................ 10
Study 2 (Experiment) Pretest................. 180 1 180 0.25 (15 minutes)........................ 45
Study 1 (Survey)............................. 2,000 1 2,000 0.17 (10 minutes)........................ 340
Study 2 (Experiment)......................... 5,000 1 5,000 0.25 (15 minutes)........................ 1,250
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 1,671
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Since Study 3 is identical to Study 2, only one set of cognitive interviews and pre-tests are needed.

II. References

The following references are on display with the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a> as these
references are copyright protected. Some may be available at the
website address, if listed. FDA has verified the website addresses, as
of the date this document publishes in the Federal Register, but
websites are subject to change over time.

1. Odsakoff, P.M., S.B. MacKenzie, N.P. Podsakoff, 2012. ``Sources
of Method Biases in Social Science Research and Recommendations on
How to Control It.'' Annual Review of Psychology, 63, pp. 539-569.
2. Sheff, J.N., 2011. ``Biasing Brands.'' Cardozo Law Review, 32(4),
pp. 1245-1314.
3. Cohen, J., 1992. ``A Power Primer.'' Psychology Bulletin, 112(1),
pp. 155-159.
4. Baig, S.A., S.M. Noar, N.C. Gottfredson, et al., 2021.
``Incremental Criterion Validity of Message Perceptions and Effects
Perceptions in the Context of Anti-smoking Messages.'' Journal of
Behavioral Medicine, 44, pp. 74-83.
5. Azjen, I., 2011. ``The Theory of Planned Behaviour: Reactions and
Reflections.'' Psychology and Health, 26(9), pp. 1113-1127.
6. Azjen, I., 2014. ``The Theory of Planned Behaviour is Alive and
Well, and Not Ready to Retire: A Commentary on Sniehotta, Presseau,
and Araujo-Soares.'' Healthy Psychology Review, 9(2), pp. 131-137.
7. Ajzen, I., 2016. ``Consumer Attitudes and Behavior: The Theory of
Planned Behavior Applied to Food Consumption Decisions.'' Italian
Review of Agricultural Economics, 70(2), pp. 121-138.

Dated: March 21, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs,
U.S. Food and Drug Administration.
[FR Doc. 2022-06419 Filed 3-25-22; 8:45 am]
BILLING CODE 4164-01-P

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