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, 17300-17307 [2022-06419]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 87, Number 59 (Monday, March 28, 2022)]
[Notices]
[Pages 17300-17307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, [email protected].

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 AsPredicted.org or 
ClinicalTrials.gov 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

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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 https://www.regulations.gov 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]
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