[Federal Register Volume 88, Number 115 (Thursday, June 15, 2023)]
[Notices]
[Pages 39257-39264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12820]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0155]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Quantitative Research 
on Front of Package Labeling 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 July 17, 2023.

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 Front of Package 
Labeling on Packaged Foods.'' Also include the FDA docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[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 Front of Package Labeling on Packaged Foods

OMB Control Number 0910-NEW

I. Background

    The United States continues to face an epidemic of diet-related 
chronic diseases, many of which are experienced disproportionately by 
racial and ethnic minority groups, those with lower socioeconomic 
status, and those living in rural areas (Ref. 1). To help address this 
problem, FDA has continued to prioritize its nutrition activities (Ref. 
2) to help empower consumers with nutrition information to make 
healthier choices more easily and encourage industry innovation by 
providing flexibility to facilitate the production of healthier foods. 
FDA is focused on: (1) creating a healthier food supply for all; (2) 
establishing a healthy start to set the foundation for a long, healthy 
life; and (3) empowering consumers through informative labeling and 
tailored education (Ref. 2; see also Ref. 3).
    FDA is exploring the development of a front of package system to 
help consumers interpret the nutrient information on food products. 
Front of package (FOP) labeling is intended to complement the Nutrition 
Facts label by giving consumers a simple aid to provide additional 
context for making healthy food selections. As part of our food-
labeling efforts, we are exploring the establishment of a standardized, 
science-based FOP scheme that helps consumers, particularly those with 
lower nutrition literacy, quickly and easily identify foods that are 
part of a healthy dietary pattern.
    The increased attention in recent years to FOP and the experiences 
of countries that have adopted FOP labeling suggest that FOP labeling 
may aid nutrition comprehension and the ability to make healthier 
choices, especially for those with lower nutrition literacy. FOP 
schemes adopted in countries throughout the world include both 
mandatory and voluntary labeling schemes and noninterpretative, 
interpretative, nutrient specific, and summary schemes.
    In 2022, FDA conducted a review of the literature on FOP nutrition-
related labels and conducted a set of focus groups to test FOP concepts 
and draft FOP schemes (see Docket No. FDA-2023-N-0155 for the 
literature review). These focus group results provided insights into 
the varying ways that consumers interpret FOP nutrition information. As 
part of our efforts to promote public health, we intend to conduct an 
experimental study, informed by results of the focus group testing, to 
further explore consumer responses to various FOP schemes. In the 
experimental study, we will test a smaller subset of FOP schemes from 
the focus group testing, with additional variations informed by, among 
other things, focus group results (see https://www.reginfo.gov/public/do/PRAViewIC?ref_nbr=202008-0910-021&icID=253321 for information about 
FDA's front of package focus groups, including graphic FOP schemes 
tested). The study will be a controlled, randomized experiment that 
will use a 15-minute web-based questionnaire to collect information 
from 9,000 U.S. adult members of an online consumer panel maintained by 
a contractor. The sample will be balanced to reflect the U.S. Census on 
gender, education, age, and ethnicity/race. A measure of nutrition 
literacy will also be used to balance the sample to ensure a variety of 
literacy levels for each condition.
    Conditions for the study will be: (1) a set of draft FOP schemes, 
including ``no-scheme'' controls; (2) three types of mock food products 
(i.e., a breakfast cereal, a frozen meal, and a canned soup); and (3) a 
``no-information'' condition where no explanation of the FOP scheme is 
provided. The experiment will have two main parts: (1) a within-scheme 
comparison and identification of healthfulness profile and (2) a 
single-product (and scheme) evaluation. In part 1, participants will 
see three levels of healthfulness (most healthful, middle, and least 
healthful) on a single scheme and be asked to identify the most and 
least healthful profile. Participants will be timed and will be 
provided with a link to a Nutrition Facts label in case they want more 
information to answer the question. Each participant in part 1 will 
evaluate three different sets of schemes. In part 2, each participant 
will be randomly assigned to a single condition (food product, scheme 
type, or level of healthfulness). In this section, participants will be 
asked to use the label image to respond to various measures of the 
label's effectiveness. Product perceptions (e.g., healthfulness and 
contribution to a healthy diet) and label perceptions (e.g., 
believability and trustworthiness) will constitute the

[[Page 39258]]

measures of response in the experiment. 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 help enable 
consumers to make informed dietary choices and construct healthful 
diets. We intend to use the results to inform our continued exploration 
of an FOP labeling scheme. 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 January 26, 2023 (88 FR 5005), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information (60-day notice). We received 26 comments, 2 
of which were duplicates. Of the other 24, 20 were related to the PRA. 
The remaining comments were nonresponsive to the four PRA topics, so we 
will not address them in this document. We have numbered each comment 
to help distinguish among different topics. The number assigned is for 
organizational purposes only and does not signify the comment's value, 
importance, or the order in which it was received.

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 an FOP scheme that would provide information 
to consumers to help them make more informed food choices.
    (Comment 1) Many comments supported FDA's proposed collection of 
information through an experimental study. Many supported our consumer 
research, including the study design, goals, and research on schemes. 
Several other comments suggested that the study has limitations because 
it only assesses purchase intention and how consumers say they will 
behave, and not actual purchase or consumption behaviors.
    (Response 1) As is common with research in the scientific 
literature, our study design mimics, as much as possible, how consumers 
will respond to a FOP nutrition label scheme (Refs. 4 and 5). Assessing 
actual purchase or consumption behavior is not possible because the 
schemes to be tested are not currently available in the marketplace. 
Additionally, the overall focus of this research is to assess consumer 
understanding of FOP schemes that may help consumers interpret certain 
nutrient information on food products; it is not meant to assess actual 
purchase or consumption behaviors.

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

    Some 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 2) Multiple comments encouraged FDA to increase 
transparency in our FOP research, with some expressing concern that the 
public has not had sufficient opportunity for input on the burdens of 
the information collection or the utility of the research due to a lack 
of information. Many comments urged us to provide more information on 
factors such as the specific objectives of the research; research and 
study design; methodologies; survey questions; visual product label 
mockups; the FOP schemes to be tested; FDA's basis for choosing the FOP 
schemes we have decided to test and excluding those we have excluded; 
nutritional criteria being tested, including the criteria for any color 
coding or ``High in'' schemes; the outcomes from our focus groups and 
any other past surveys and consumer research; an analysis of foreign 
FOP schemes; and the variables and conditions to be tested. One comment 
asked how we developed the schemes used in the focus groups, 
particularly those that contained the terms ``low,'' ``medium,'' and 
``high,'' given that FDA has not defined or applied these terms in the 
context used in the focus groups.
    A couple of comments suggested that FDA should collaborate with 
stakeholders when conducting studies or developing an FOP scheme in the 
future.
    (Response 2) Detailed information and all study materials are 
available at https://www.reginfo.gov. The literature review and FOP 
schemes are also available in the docket (Docket No. FDA-2023-N-0155). 
The schemes to be tested include variations on schemes that are 
currently available in the marketplace and others that attempt to 
interpret certain nutrition information. We developed schemes based on 
insights from our focus groups, analysis of the literature on FOP 
labeling, and review of schemes from other countries. We recognize that 
these schemes are a subset of the many possible schemes that could be 
tested, and we selected them for the reasons described above.
    Regarding nutritional criteria and the ``low,'' ``medium,'' and 
``high'' designations, for the purposes of the focus groups and 
experimental study, we have defined the nutritional criteria and the 
``low,'' ``medium,'' and ``high'' designations to be based on the 
percent Daily Value (see, e.g., https://www.fda.gov/food/new-nutrition-facts-label/lows-and-highs-percent-daily-value-new-nutrition-facts-label). The study refers to these criteria.
    FDA has collaborated with stakeholders on the exploration of the 
FOP schemes through our focus-group testing, 60-day notice, and this 
notice, and any regulatory action we take after our testing will be 
published in the Federal Register for public comment.
    (Comment 3) One comment said FDA did not provide enough information 
in our 60-day notice on our testing, including the number of label 
conditions, the number of food choices respondents will have, whether 
there will be a separate control group, and a primary study outcome, to 
allow the public to evaluate the suitability of our proposed sample 
size.
    (Response 3) The 60-day notice included information about the study 
to allow members of the public to provide comment. Detailed information 
and all study materials are available at https://www.reginfo.gov. The 
literature review and FOP schemes are also available in the docket 
(Docket No. FDA-2023-N-0155). There will be 10 total label conditions, 
3 food types, and a control group that will see a label with no scheme. 
Primary study outcomes include the ability to correctly interpret the 
nutritional profile of the product, the speed at which participants 
make their decisions, and their search for more information to answer 
the question (i.e., whether they want to view the Nutrition Facts 
label). The proposed sample size is 9,000 participants.

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

    Many comments suggested ways to enhance the quality, utility, and 
clarity of the information about the FOP schemes to be collected.
    (Comment 4) One comment said we should avoid color coding or 
``low,'' ``medium,'' or ``high'' markers in our scheme because it is 
unwise to base a food's healthfulness on one factor alone. Another 
comment said that color-coding nutrients to limit and nutrients to 
encourage in the same scheme would

[[Page 39259]]

confuse consumers and that we should include an option that does not 
color code nutrients to encourage. A few comments said that we should 
present some schemes in black and white and others with color to 
identify if color should be used. Several comments said that we should 
only test schemes that industry could implement without excess cost or 
burden.
    (Response 4) Color-coding and interpretational aids such as 
``high,'' ``medium,'' and ``low'' are being tested because prior 
research has found such interpretive components helpful to consumers 
when evaluating the nutritional profile of products (Refs. 6 and 7). We 
disagree that testing these interpretational aids bases a food's 
healthfulness on one factor alone; rather, the schemes we are testing 
are intended to complement the Nutrition Facts label by giving 
consumers a simple aid to provide additional context for making healthy 
food selections.
    The study will test both color and black-and-white schemes (see 
Docket No. FDA-2023-N-0155). We are not currently planning to test 
schemes that include both nutrients to limit and nutrients to 
encourage, so there will be no options in the study that cover 
nutrients to encourage.
    Regarding the cost of implementation, this quantitative study 
focuses on gathering information. Should we move forward with a 
regulatory action, we will consider potential economic impacts of any 
proposed scheme.
    (Comment 5) One comment recommended that FDA conduct indepth 
interviews with diverse stakeholders because such interviews facilitate 
better understanding and add nuance to findings.
    (Response 5) We have incorporated a variety of qualitative research 
methods, including the use of interviews, as part of our research. The 
study will employ cognitive interviews before we conduct the proposed 
experiment to test whether and how participants understand the study 
questions and whether the design will reach our research goals. The 
study instrument will include an open-ended question, providing 
participants an opportunity to express top-of-mind reactions to the 
study and schemes. FDA also conducted focus groups on FOP nutrition 
labels in 2022, which have informed the proposed experimental study. We 
note that the quantitative nature of experimental studies allows for 
statistical generalizability of effects while qualitative designs do 
not.
    (Comment 6) Some comments advocated testing consumption in the home 
or testing in real-world or simulated shopping environments. One 
comment advocated that the FOP schemes appear alongside other commonly 
found symbols on food labels.
    (Response 6) 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.
    Participants will view the schemes on mock food labels that closely 
match those found in grocery stores. The study will not assess the 
schemes alongside other commonly found symbols on the food label. Our 
studies are designed to test general consumer responses to the schemes 
presented. Testing additional variables, such as the effect of other 
packaging elements on the schemes, is outside the scope of this 
research. We are not testing consumption in the home because, again, 
our studies are designed to test general consumer responses to the 
schemes presented. We are not studying consumption behavior.
    (Comment 7) A couple of comments said that mockups of product 
labels should accurately represent products in the marketplace, and 
that the mockups we used in the focus-group testing included 
unrealistic elements, such as fewer competing claims, small type size 
for voluntary claims, and fonts not commonly used on product labels. 
Several comments asserted that we should ensure label mockups are 
realistic, and a few comments maintained that the mockups should not 
introduce bias.
    (Response 7) FDA disagrees with the comment that its mock food 
packages contain unrealistic elements, and the comment provides no 
support for the claim that our chosen type size and fonts are not 
commonly used on product labels. While we recognize that our mockups 
contain fewer competing claims than might be on some real packages, the 
mock packages represent products that might be found in the actual 
marketplace and reflect a real-world food product scenario without the 
introduction of bias that may come with including competing symbols or 
claims.
    (Comment 8) One comment urged us to develop research objectives 
that pair with our policy objectives. The comment recommended that we 
add the following goal of FOP labels: ``To help people quickly and 
easily identify foods that, when consumed, may lead people to exceed 
daily nutritional recommendations for nutrients of concern (sodium, 
added sugar, and saturated fat).'' The comment also recommended that 
FDA establish more specific research objectives relating to encouraging 
healthier food selections, enabling consumers to identify foods that 
are part of a healthy eating pattern, and identifying foods associated 
with nutrients of concern. A few comments said we need to clearly 
define the quantitative consumer research's primary outcome so that we 
can develop questions and research designs that will address the 
intended goal. One comment said that, before conducting the 
quantitative study, FDA should identify the metrics for consumer 
understanding to guide the study design and interpretation of results.
    (Response 8) The goal of our research is to assess which FOP scheme 
best enables consumers to identify foods that can help them build a 
healthy eating pattern. We decline to add any other research objectives 
because we believe that our stated research goal most closely 
corresponds to our policy objectives.
    Regarding the research's primary outcome, we noted earlier that our 
primary study outcomes include the ability to correctly interpret the 
nutritional profile of the product, the speed at which participants 
make their decisions, and their search for more information to answer 
the question (i.e., want to view the Nutrition Facts label). We believe 
we have developed questions and research designs that will address our 
intended goal.
    We agree that we should identify the metrics for consumer 
understanding to guide the study design and interpretation of results. 
An element of the study design process includes identifying appropriate 
metrics for measuring consumer understanding. These metrics will help 
FDA interpret the study results.
    (Comment 9) Many comments urged FDA to research how FOP schemes 
would impact consumer behavior, including purchase or consumption 
decisions. One comment encouraged us to study consumers' selection of 
calories and nutrients, foods that meet our proposed definition of 
``healthy,'' and foods high in added sugars, sodium, or saturated fat. 
A few comments said we should measure whether, and why, the schemes 
would affect intended purchase or consumption frequency. A couple of 
comments recommended

[[Page 39260]]

testing whether the presence of an FOP scheme makes consumers more 
likely to read and understand the Nutrition Facts label. Some comments 
suggested specific methods for studying and evaluating consumer 
behavior.
    A few comments asserted that research on consumer behavior and how 
consumers use and understand FOP labeling is necessary to avoid 
consumer confusion, misleading consumers, and unintended consequences. 
Another comment recommended that FDA's research assess whether 
consumers interpret the label to have the same meaning that FDA 
intends.
    (Response 9) We acknowledge that there are measurements we are not 
including in this research effort (e.g., behavior changes). These 
studies are designed to explore consumer responses to the schemes, and 
inclusion of variables such as behavior changes would be outside of the 
scope of our research.
    The study will measure whether participants can understand the 
scheme when trying to identify certain nutrient profiles. The study 
will also include an option for participants to view the Nutrition 
Facts label if they so choose, but the study will not evaluate reading 
and understanding of the Nutrition Facts label because this is not the 
goal of the study.
    (Comment 10) One comment encouraged us to assess consumer 
understanding of product healthfulness using objective measures (i.e., 
questions with factual answers). Some comments urged FDA to include 
open-ended questions in our survey.
    (Response 10) One of the goals of the research is to assess 
consumers' ability to use the schemes to determine product 
healthfulness. In one part of the study, participants will see three 
versions of a scheme and will be asked to identify the scheme with the 
most healthful nutritional profile and the scheme with the least 
healthful nutritional profile. The profiles are based on FDA's 
characterization of levels of the percent Daily Value as either 
``high'' or ``low'' (see https://www.fda.gov/food/new-nutrition-facts-label/lows-and-highs-percent-daily-value-new-nutrition-facts-label). 
The questionnaire will have at least one open-ended question seeking 
general feedback on the study and schemes.
    (Comment 11) One comment encouraged us to assess the 
trustworthiness of the schemes. Conversely, another comment opposed 
factoring in participants' ratings of believability and trustworthiness 
because, according to the comment, those factors are not strong 
predictors of real-world responses. Another comment said we should 
evaluate the reliability of respondents' answers versus real-life 
consumer behavior by considering the statistical significance of the 
study.
    (Response 11) The study will include measures of trustworthiness 
and believability of the schemes, and these will be considered along 
with the other outcome measures. With respect to factoring in 
participants' ratings of believability and trustworthiness, many 
factors contribute to how people respond in the real world; thus, it is 
important for the study to include a variety of outcome measures while 
also limiting the scope to just the pertinent factors. We plan to 
conduct tests of statistical significance to evaluate the probability 
that the study findings are true patterned responses.
    (Comment 12) One comment argued that our research design should 
consider the limitations of FOP schemes. Another comment encouraged FDA 
to expand our research plans to include more settings and to consider 
approaches that mitigate hypothetical bias.
    (Response 12) The research will take into account the many factors 
that may limit consumers' ability and motivation to use FOP nutrition 
labels, such as nutrition literacy, Nutrition Facts label usage, time 
limitations, and health considerations. FDA disagrees with the comment 
encouraging us to expand the research to include more settings. FDA is 
designing the study so that the questions or tasks mirror how consumers 
typically approach food label reading. Additionally, as we noted above, 
results in naturalistic 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. However, cognitive interviews and pretests will help to 
improve the ``real-world'' feel of the questionnaire.
    FDA's study is designed to mitigate hypothetical bias because it 
focuses on perceptions and understanding of the FOP schemes rather than 
on trying to assess behaviors associated with them.
    (Comment 13) Multiple comments recommended FDA use industry 
materials or schemes in our testing, such as Facts Up Front and 
Consumer Brands' FOP nutrition labeling principles. Several comments 
urged us to test variations of the Facts Up Front scheme, with some 
reasoning that Facts Up Front has widespread adoption and that 
consumers are already familiar with the program and understand how to 
use it.
    (Response 13) FDA is planning to test a scheme that includes 
attributes of the U.S. industry-established FOP schemes.
    (Comment 14) Some comments said we should consider flexibility and 
exemptions to address space limitations regarding font size, style, and 
placement in our quantitative research.
    (Response 14) The research will test placement on the food label 
but will not test font size and style. Contemplating flexibility and 
exemptions relating to issues such as font size and style on packages 
with space limitations is not the purpose of this study, which is to 
gauge consumer responses to the schemes we are testing.
    (Comment 15) One comment said FDA should test how digital 
disclosure could replace an FOP scheme on the package.
    (Response 15) The goal of our current research focuses on exploring 
FOP schemes that help consumers quickly and easily identify foods that 
can help them build a healthy eating pattern. We are not currently 
testing digital disclosures because that approach does not align with 
our research goals relating to the speed and ease with which consumers 
can assess foods.
    (Comment 16) A few comments cautioned against using schemes that 
overlook, or mislead consumers about, a food's whole contribution to 
the diet or subjectively characterize a food (for instance, as ``High 
in,'' ``medium,'' or ``low in'') based on just three nutrients.
    (Response 16) FDA is interested in learning how the different 
schemes to be tested help consumers put a food, as a whole, into the 
context of their daily (or longer-term) diets. The schemes included in 
the experimental study do not subjectively characterize a food based on 
three nutrients. The ``high,'' ``medium,'' and ``low'' designations 
included in the study are based on established criteria for 
interpreting the percent Daily Value of a nutrient (see, e.g., https://www.fda.gov/food/new-nutrition-facts-label/lows-and-highs-percent-daily-value-new-nutrition-facts-label) and the study refers to these 
criteria.
    (Comment 17) One comment said that our research should maximize 
opportunities to include nutritious foods that are widely available and 
within the purchase reach of most consumers.
    (Response 17) The mock food product categories to be included in 
the experiment are those that are highly consumed by many consumers of 
all economic levels (breakfast cereal, frozen meals, and canned soup). 
There are a variety of foods in these categories,

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which in turn can vary widely in terms of healthfulness.
    (Comment 18) One comment recommended that FDA test a label that 
states: ``WARNING: HIGH IN [sodium/added sugars/saturated fat]'' 
accompanied by a warning icon.
    (Response 18) Our research goal focuses on exploring ways that FOP 
labels can complement the Nutrition Facts label on packaged foods by 
giving consumers additional context to quickly and easily identify 
foods that can help them build a healthy dietary pattern. Our research 
will test schemes that include a ``high'' designation or a ``High in'' 
statement as part of that goal. However, we will not test the word 
``warning'' or a warning icon because doing so would not align with our 
research goals of learning how to provide consumers with additional 
factual context for food choices.
    (Comment 19) One comment urged FDA to include low- and no-calorie 
sweeteners in the tested schemes because, according to the comment, the 
public wants to know if products contain such sweeteners.
    (Response 19) Information relating to low- and no-calorie 
sweeteners is available to consumers in the ingredient list of a 
product. The focus of our study is to explore how to help consumers 
quickly and easily identify foods that can help them build a healthy 
eating pattern, with a focus on the nutrients that the Dietary 
Guidelines for Americans (Dietary Guidelines) have identified as 
nutrients to limit (Ref. 8).
    (Comment 20) One comment said we could improve our schemes by 
limiting numerical information, emphasizing interpretive components 
(e.g., a prominently placed ``High in'' designation), and adding 
attention-grabbing features. The comment also recommended against 
testing labels that highlight nutrients to encourage, because, 
according to the comment, companies already promote the healthy aspects 
of their products, and labels that combine both nutrients to limit and 
nutrients to encourage would create a challenge for consumer education.
    However, other comments supported testing schemes with nutrients to 
encourage, arguing that the schemes must accurately reflect the full 
nutrient profile of a food; that the public should have tools to 
construct a healthy diet; and that, for instance, a product with some 
added sugar may be viewed as negative by the consumer if ``High in'' or 
``red'' is marked on the FOP even if the product provides positive 
nutrition overall. A couple of comments claimed that many of the 
proposed schemes tested in the original focus groups reduced a food to 
its negative nutrients rather than recognizing its overall contribution 
to the diet and its positive nutrient and food group content.
    Other comments advocated testing at least one scheme with a 
``positive'' approach that would, for instance, award food stars 
depending on the food's nutrient content. A couple of comments said 
that we should also do consumer research on summary-based systems.
    A couple of comments suggested that tested FOP schemes should align 
with the Dietary Guidelines to focus on overall dietary patterns rather 
than on individual nutrients.
    (Response 20) The study will test a variety of schemes reflecting 
those currently found in the marketplace; some of them will contain 
limited numerical information and some will contain interpretive 
components. The study will assess consumers' ability to use the schemes 
to make decisions to support a healthful overall dietary pattern. As we 
noted earlier, the schemes we are testing are intended to complement 
the Nutrition Facts label by giving consumers a simple aid to provide 
additional context for making healthy food selections.
    With respect to comments that urged FDA to test a ``positive'' 
approach or a summary-based system, we are testing different schemes 
based on our literature review and the feedback we collected through 
our focus group research, which indicate that simpler schemes are 
easier for consumers to understand and that consumers often already 
have access to information about nutrients to encourage on the front of 
food packages. As such, our current study plans do not include testing 
nutrients to encourage.
    (Comment 21) One comment said it is important to understand whether 
consumers viewing an FOP scheme view the foods as ones that should be 
avoided, particularly for products that are healthful food choices 
recommended by the Dietary Guidelines or MyPlate.
    (Response 21) The research will evaluate whether the FOP scheme 
assists consumers in identifying the healthfulness of a product or 
whether the scheme encourages them to avoid the product.
    (Comment 22) One comment recommended against testing Guideline 
Daily Amount (GDA) labels with numeric information (e.g., amount per 
serving or percent Daily Value) without an additional interpretive 
component. Conversely, a couple of comments requested that we also 
include GDA schemes without interpretive elements to help us understand 
the benefits and limitations of the schemes, with one comment 
suggesting that fact-based FOP schemes used by industry could be our 
control.
    (Response 22) FDA is testing the effects of different kinds of 
schemes, including GDA-type schemes. Some of the schemes being tested 
have interpretational aids and some do not. Statistical analysis will 
allow FDA to use each of the tested schemes as a control for other 
schemes.
    (Comment 23) One comment said that FDA should consider testing the 
effects of different FOP label designs both with and without additional 
information to aid in label interpretation.
    (Response 23) FDA is testing the effects of different kinds of 
schemes, some that have interpretational aids and some that do not.
    (Comment 24) One comment encouraged us to use survey measures with 
strong psychometric properties. For example, the comment said FDA 
should consider using the UNC Perceived Message Effectiveness Scale to 
assess effects perceptions.
    (Response 24) FDA acknowledges the value of using measures that are 
reliable, have been validated, and that have strong psychometric 
properties. However, we do not believe that the UNC Perceived Message 
Effectiveness Scale is appropriate for this study because this study 
deals with the provision of nutritional information via food labeling.
    (Comment 25) One comment recommended that we pre-register a 
protocol for the proposed experiment, including the primary outcome and 
all secondary outcomes, any hypotheses or predictions, the analytic 
plan, and the power calculations used to arrive at the target sample 
size.
    (Response 25) FDA declines to preregister the research protocol, as 
described in the comment. The comment did not explain what additional 
details might be available via preregistration that would not be 
available in our Federal Register notices, in the docket (Docket No. 
FDA-2023-N-0155), and on https://www.reginfo.gov.
    (Comment 26) A few comments said the foods tested should reflect 
more product categories, varieties, package sizes, and nutrient 
profiles that would be subject to an FDA FOP scheme. For example, some 
of these comments recommended that we test single-ingredient products, 
individual foods, and foods that are known to be higher in sugar, 
sodium, or saturated fat. Some comments said that without doing so, the 
research setting would be

[[Page 39262]]

unrealistic, and we may not be able to apply the study findings to all 
types of packaged foods, including beverages, available to consumers. 
One comment said that we should compare consumer reactions to FOP 
schemes across multiple food categories so that we can assess whether 
reactions to standardized FOP schemes might shift perception, 
purchasing, or consumption of certain products.
    (Response 26) FDA declines to add more product types to the 
studies. We are proposing to test schemes on a set of mock products 
that belong to large food categories, with many product types within 
each category. The mock food product categories to be included in the 
experiment (breakfast cereal, frozen meals, and canned soup) are those 
that are highly consumed by many consumers of all economic levels. 
There are a variety of foods in these categories, which can vary widely 
in terms of healthfulness and the nutrients included in the schemes.
    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 schemes. We also note that adding any products would 
increase the scope and cost of the studies while providing limited new 
information, and the comments provided no evidence that additional test 
products from other food categories, varieties, package sizes, and 
nutrient profiles would impact our study outcome.
    (Comment 27) One comment encouraged us to search for and consider 
the design of previously conducted research on FOP schemes when 
designing our own consumer research.
    (Response 27) FDA has conducted a thorough review of the scientific 
literature on FOP schemes and continues to monitor the emerging 
science.
    (Comment 28) One comment recommended we test additional variables, 
including health status, whether respondents have nutrition-related 
conditions, caregiver status, English language literacy, and method of 
administration of the test, to assess how consumers understand and use 
FOP schemes. The comment also said that respondents should be primary 
shoppers and should span socioeconomic status. A couple of comments 
said we should include demographic data, such as racial and ethnic 
minority groups, those with lower socioeconomic status, those living in 
rural areas, and parents of minors, to improve understanding of 
behavior changes across demographic groups.
    (Response 28) The study is designed to assess how consumers 
understand and use FOP schemes. Most of the variables mentioned are 
included in the study, including a measure of whether the participant 
is the primary grocery shopper in the household. FDA agrees that a 
measure of caregiver status could be useful. Therefore, we have added 
this variable to the study instrument.
    (Comment 29) A few comments said our research must include diverse 
populations, including race, ethnicity, education status, nutrition 
literacy, and income level. The comment continued that our research 
should address the needs of the most vulnerable populations. A few 
comments said we could consider over-indexing or oversampling on key 
consumer constituencies, such as the populations the FOP schemes are 
meant to target and caregivers. A couple of comments expressed concern 
that those in underserved communities and those most at risk for diet-
related disease may not have computers and may have unreliable or no 
access to the internet, making participation in the study difficult.
    (Response 29) Our study will ensure that members of underserved 
communities and those most at risk for diet-related disease are 
adequately represented. Participants recruited for the study will 
include diverse populations, considering race, ethnicity, education 
status, nutrition literacy, rural residency, and other sociodemographic 
factors. The study will also oversample consumers with lower nutrition 
literacy levels to ensure that we can evaluate the findings against 
levels of nutrition literacy. The Pew Research Center reports that 93 
percent of American adults use the internet (Ref. 9). The Institute of 
Museum and Library Services reports that approximately 312 million 
Americans (out of the total U.S. population of approximately 330 
million, according to the 2020 U.S. Census) live in a public library 
service area (Ref. 10). Virtually all public libraries provide free 
internet access (Ref. 11). There is no requirement that participants 
have a computer, laptop, or tablet at home to participate in this 
study. In the past, participants in FDA-funded studies who did not have 
a computer at home have completed studies using outside resources; for 
example, a computer at the public library.
    (Comment 30) Several comments said that we may need a larger sample 
size than 3,000 given the information provided and that the results of 
the quantitative study will impact the entire U.S. population.
    (Response 30) FDA agrees with the comment, and we plan to increase 
the sample size to 9,000.
    (Comment 31) One comment said we may need to include additional 
schemes in the testing to understand category-specific, pack size-
specific considerations, such as the ``calories-only'' scheme sometimes 
used on foods in small packages. Another comment urged us to include 
some very small package mockups to ensure fit and readability of the 
FOP scheme. Similarly, another comment urged FDA to test a beverage 
option with a small or very small label to determine what nutritional 
information to include and whether a beverage container with a small 
label can bear an FOP scheme of readable size. Another comment stated 
that FDA's research should include various beverages among the products 
tested to ensure that FDA identifies differences in consumers' views 
between FOP labels on food versus beverages.
    (Response 31) We are testing different schemes based on our 
literature review and the feedback we collected through our focus group 
research. The comments provided no evidence that including additional 
schemes in our testing would help us understand category-specific, 
package size-specific considerations. As such, FDA declines to add 
additional schemes to our testing.
    FDA disagrees with the recommendation to add more product sizes or 
types, including beverages, to the study. 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 schemes to inform any 
future action we may take on the schemes. 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, 
including beverages, would impact our study outcome.
    (Comment 32) One comment stated that calories should be included on 
most of the tested schemes. The comment asserted that energy is the 
most important component in diet planning and said that FDA must 
explain why we were not including calories. Another comment recommended 
that FDA include a calories-only icon in our research, while another 
comment wondered if the public would consume more overall

[[Page 39263]]

calories if FOP does not contain information on calories.
    (Response 32) We decline to add calories to the schemes we are 
testing or test a calories-only scheme. Our regulations, at 21 CFR 
101.9(d)(1)(iii), require the Nutrition Facts label to display calorie 
information with increased prominence, relative to other information, 
in order to draw consumer attention (see 81 FR 33741 at 33939, May 27, 
2016). At this point, for the purposes of the experimental study, we 
believe that consumers have adequate access to calorie information, 
while the purpose of our research on FOP is to determine the usefulness 
of providing consumers with additional factual context for making 
healthy food selections. Regarding whether the public would consume 
more calories if FOP does not contain information on calories, this 
comment falls outside of the scope of our current research, which 
explores which schemes will provide consumers with additional 
information rather than shape consumer behavior.
    (Comment 33) A couple of comments said FDA must consider how a 
standardized FOP scheme would interact with the voluntary ``healthy'' 
symbol FDA is studying. One of these comments encouraged us to evaluate 
whether having multiple FOP information systems could confuse 
consumers.
    (Response 33) The purpose of this study is to evaluate how 
consumers understand a FOP labeling scheme. We are not considering the 
intersection of hypothetical label claims at this time, as we seek to 
conduct our study in a manner that minimizes bias. It is also outside 
the scope of our current quantitative research to test the effect of 
multiple FOP labeling systems. Rather, we are assessing how consumers 
understand the schemes that we are testing.
    (Comment 34) A few comments encouraged us to update our literature 
review because, for example, schemes presented to respondents should 
reflect the latest science.
    (Response 34) FDA agrees with the comment and has updated the 
literature review and continues to monitor the emerging scientific 
literature.
    (Comment 35) One comment said we should review the results of 
studies on the long-term impacts and utility of FOP schemes, and not 
rely only on very recent studies.
    (Response 35) FDA has been monitoring the scientific literature on 
FOP since 2006 and continues to monitor the literature, including any 
studies on long-term impacts and utility of FOP schemes.
    (Comment 36) A couple of comments said we need to identify key 
metrics for success on label effectiveness, including how product 
perception, label perceptions, and nutritional qualities questions will 
be presented to the respondents, before conducting the study.
    (Response 36) FDA plans to use product, label, and nutrition 
perception measures and will test these in cognitive interviews prior 
to conducting the pretests and the experiment.
    (Comment 37) One comment recommended that we include readable 
samples of category users for each of the categories being presented 
(e.g., cereal, frozen meals) and evaluate results among each relevant 
category user base.
    (Response 37) FDA will include questions to assess whether 
participants use the product and will take this into account when 
evaluating the results.

D. Comments 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

    No comments discussed minimizing the information collection burden 
on respondents to our proposed FOP scheme research.

E. Nonresponsive Comments to the PRA

    Some comments addressed aspects of FOP schemes that are outside the 
scope of this information collection or addressed issues other than the 
FOP scheme research. These discussed, for example, whether the schemes 
should be voluntary or mandatory, specific ways to update the 
literature review, food allergies, requirements of any proposed FOP 
scheme, and constitutional and other legal issues with FOP 
requirements. 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 FOP scheme we propose in response 
to its Federal Register notice.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                  Number of
           Activity               Number of     responses per   Total  annual   Average  burden    Total  hours
                                 respondents     respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
Pretest 1 Screener...........             800               1             800               0.05              40
                                                                                     (3 minutes)
Pretest 1....................             200               1             200               0.25              50
                                                                                    (15 minutes)
Pretest 2 Screener...........             800               1             800               0.05              40
                                                                                     (3 minutes)
Pretest 2....................             200               1             200               0.25              50
                                                                                    (15 minutes)
Experiment Screener..........          40,000               1          40,000               0.05           2,000
                                                                                     (3 minutes)
Experiment...................           9,000               1           9,000               0.25           2,250
                                                                                    (15 minutes)
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ..............  ..............  .................           4,430
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The number of participants in the study was increased from the 
3,000 respondents estimated in the 60-day Federal Register notice to 
41,600 with this publication. Therefore, the total burden has been 
increased from 3,205 responses and 801 hours to 51,000 responses and 
4,430 hours because of the increase in the sample size for the pretests 
and the full experiment and screener. The reason for the increase in 
burden hours is because of a decision to

[[Page 39264]]

target consumers with higher and lower nutrition literacy levels, rural 
residence, and to ensure that the sample mirrors the demographic 
distribution of the U.S. population.

II. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500 and are available for viewing by interested persons between 9 
a.m. and 4 p.m., Monday through Friday; they also are available 
electronically at https://www.regulations.gov. References without 
asterisks are not on public display at https://www.regulations.gov 
because they have copyright restriction. Some may be available at the 
website address, if listed. References without asterisks are available 
for viewing only at the Dockets Management Staff. 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. Centers for Disease Control and Prevention. Overweight & 
Obesity, Available at: https://www.cdc.gov/obesity/index.html. 
Accessed on April 20, 2023.
* 2. FDA, FDA's Nutrition Initiatives. Available at: https://www.fda.gov/food/food-labeling-nutrition/fdas-nutrition-initiatives. 
Accessed on April 20, 2023.
* 3. The White House, ``Biden-Harris Administration National 
Strategy on Hunger, Nutrition, and Health.'' Available at: https://www.whitehouse.gov/wp-content/uploads/2022/09/White-House-National-Strategy-on-Hunger-Nutrition-and-Health-FINAL.pdf. Accessed on April 
20, 2023.
4. Talati, Z., M. Egnell, S. Hercberg, et al. ``Food Choice Under 
Five Front-of-Package Nutrition Label Conditions: An Experimental 
Study Across 12 Countries,'' American Journal of Public Health, 
109(12), 1770-1775, 2019.
5. Vargas-Meza, J., A. J[aacute]uregui, A. Contreras-Manzano, et al. 
``Acceptability and Understanding of Front-of-Pack Nutritional 
Labels: An Experimental Study in Mexican Consumers,'' BMC Public 
Health, 19, 1751, 2019.
6. Pettigrew, S., L.M. Dana, Z. Talati, et al. ``The Role of Colour 
and Summary Indicators in Influencing Front-of-Pack Food Label 
Effectiveness Across Seven Countries,'' Public Health Nutrition, 
24(11), 3566-3570, 2021.
7. Song, J., M.K. Brown, M. Tan, et al. ``Impact of Color-Coded and 
Warning Nutrition Labelling Schemes: A Systematic Review and Network 
Meta-Analysis,'' PLoS Med, 18(10), e1003765, 2021.
8. U.S. Department of Agriculture and U.S. Department of Health and 
Human Services. Dietary Guidelines for Americans, 2020-2025. 9th 
Edition. December 2020. Available at https://www.dietaryguidelines.gov/resources/2020-2025-dietary-guidelines-online-materials. Accessed on May 9, 2023.
9. Pew Research Center. Internet/Broadband Fact Sheet. April 7, 
2021. Available at: https://www.pewresearch.org/internet/fact-sheet/internet-broadband/. Accessed on April 19, 2023.
* 10. Institute of Museum and Library Services. ``Public Libraries 
in the United States: Fiscal Year 2017,'' vol. 1, p. 2. June 2020. 
Available at https://www.imls.gov/publications/public-libraries-united-states-survey-fiscal-year-2017-volume-1. Accessed on April 
27, 2023.
* 11. Samantha, B., M. Crandall, K. Fisher, et al. ``Opportunity for 
All: How the American Public Benefits From internet Access at U.S. 
Libraries,'' Institute of Museum and Library Services, March 2010, 
p. 32. Available at https://www.imls.gov/sites/default/files/publications/documents/opportunityforall_0.pdf. Accessed on April 
27, 2023.

    Dated: June 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12820 Filed 6-14-23; 8:45 am]
BILLING CODE 4164-01-P


