Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages, 11547-11550 [2012-4423]
Download as PDF
<![CDATA[
Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices
Kimberly Lane,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2012–4549 Filed 2–24–12; 8:45 am]
Food and Drug Administration
BILLING CODE 4163–18–P
[Docket No. FDA–2011–N–0320]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study on Consumer Responses to
Whole Grain Labeling Statements on
Food Packages
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
Advisory Board on Radiation and
Worker Health (ABRWH or Advisory
Board), National Institute for
Occupational Safety and Health
(NIOSH)
AGENCY:
ACTION:
CONTACT PERSON FOR MORE INFORMATION:
Theodore Katz, M.P.A., Executive
Secretary, NIOSH, CDC, 1600 Clifton
Road, NE., MS E–20, Atlanta, Georgia
30333, Telephone: (513) 533–6800, toll
free: 1–800–CDC–INFO, email:
dcas@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: February 17, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
srobinson on DSK4SPTVN1PROD with NOTICES
BILLING CODE 4163–18–P
Notice.
The Food and Drug
Administration (FDA) 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.
DATES: Fax written comments on the
collection of information by March 28,
2012.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–New and
title ‘‘Experimental Study on Consumer
Responses to Whole Grain Labeling
Statements on Food Packages.’’ Please
also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, II, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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.
SUMMARY:
The meeting scheduled to convene on
February 28–29, 2012 was published in
the Federal Register on February 16,
2012, Volume 77, Number 32, Pages
9254–9255. This notice was put on
display for 12 days in advance of the
meeting instead of the 15 calendar days
required in accordance with section
10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92–463), and
pursuant to the requirements of 42 CFR
83.15(a).
[FR Doc. 2012–4569 Filed 2–24–12; 8:45 am]
Food and Drug Administration,
HHS
Experimental Study on Consumer
Responses to Whole Grain Labeling
Statements on Food Packages—(OMB
Control Number 0910–New)
I. Background
The Nutrition Labeling and Education
Act, which amended the Federal Food,
Drug, and Cosmetic Act, requires most
foods to bear nutrition labeling (i.e., the
Nutrition Facts) and requires food labels
that bear nutrient content claims and
certain health messages to comply with
VerDate Mar<15>2010
18:10 Feb 24, 2012
Jkt 226001
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
11547
specific requirements. There are three
different types of claims (health claims,
nutrient content claims, and structure/
function claims) that the food industry
can voluntarily use on food labels.
Although they are regulated differently,
they all must be truthful and not
misleading (Ref. 1).
In the past 30 years, whole-grain
consumption has been greatly promoted
by government agencies and scientific
communities as an important part of a
healthy diet (Refs. 2 and 3). For
example, the newly released ‘‘Dietary
Guidelines for Americans 2010’’
recommends Americans eat fewer
refined grains and consume more
nutrient-dense whole grains instead
(Ref. 4). At the same time, whole grain
labeling statements, such as ‘‘Made
With Whole Grain’’, on food products
have also become more prevalent in
recent years (Ref. 5). Given the variety
of whole-grain statements on food
products and the importance of whole
grains in maintaining a healthy diet, it
is important for policy makers to gain a
better understanding of how consumers
interpret these statements.
Several studies indicate that
consumers may have difficulties in
understanding the meaning of whole
grains or recognizing whole-grain foods
(Refs. 6 to 8). Research also suggests
consumer product perceptions and
purchase decisions can be influenced by
labeling statements, and different
labeling statements may have different
influences (Refs. 9 and 10). The majority
of existing studies focus on whole grain
intake or the relationships between
whole grain and disease prevention.
There is a lack of systematic
investigation of consumers’
understanding of different whole-grain
labeling statements. We are aware of at
least one existing study related to the
statements (Ref. 11). However, the study
did not compare consumer reactions to
various whole-grain statements.
Therefore, FDA, as part of its effort to
promote public health, plans to use the
proposed study to explore and compare
consumer responses to food labels that
use whole-grain labeling statements.
Specifically, the study plans to
examine: (1) Consumer judgments about
a food product including its nutritional
attributes, overall healthiness, and
health benefits; (2) consumer judgments
about a labeling statement in terms of its
credibility, helpfulness, and other
attributes; (3) consumer interpretations
of different terms and statements, such
as ‘‘Made with Whole Grain’’, ‘‘MultiGrain’’, and ‘‘100% Whole Wheat’’; (4)
consumer extrapolation of whole grain
statements beyond the scope of the
statements themselves (i.e., halo effects);
E:\FR\FM\27FEN1.SGM
27FEN1
srobinson on DSK4SPTVN1PROD with NOTICES
11548
Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices
and (5) how whole grain statements
influence consumer use of the Nutrition
Facts.
The proposed collection of
information is a controlled randomized
experimental study. The study will use
a 15-minute Web-based survey to collect
information from 2,700 Englishspeaking adult members of an online
consumer panel maintained by a
contractor. The study will aim to
produce a sample that reflects the U.S.
Census on gender, education, age, and
ethnicity/race.
The study will randomly assign each
participant to view one label image from
a set of food labels that will be created
for the study and systematically varied
in the (1) whole grain labeling
statement; (2) featured product (e.g.,
bread, salty snacks, and breakfast bars);
(3) access to the Nutrition Facts label;
and (4) nutritional profile (differing by
the amount of fiber and the ranking
order of whole grain products on the
ingredient list). With regard to claims,
the study will focus on examples of
whole grain statements that can be
found on food packages. All label
images will be mock-ups resembling
food labels that may be found in the
marketplace. Images will show product
identity (e.g., bread) but not any real or
fictitious brand name. The study will
provide half of the participants access to
the Nutrition Facts but not together with
a product image (i.e., these participants
can look at the Nutrition Facts if they
choose to). The study will show the
other half of the respondents a label in
which the Nutrition Facts is located
next to the product image.
The survey will ask its participants to
view label images and answer questions
about their perceptions and reactions
related to the product and claim.
Product perceptions (e.g., healthiness,
potential health benefits, levels of whole
grains, and fiber amount) and label
perceptions (e.g., helpfulness and
credibility) will constitute the measures
of response in the experiment. To help
understand the data, the survey will
also collect information about
participants’ backgrounds, such as
consumption and purchase patterns,
awareness and knowledge of nutrients
and substances, and health status and
demographic characteristics.
The study is part of the Agency’s
continuing effort to enable consumers to
make informed dietary choices and
construct healthful diets. Results of the
study will be used primarily to enhance
the Agency’s understanding of how
whole grains claims and other related
labeling statements on food packages
may affect how consumers perceive a
product or a label, which may in turn
VerDate Mar<15>2010
18:10 Feb 24, 2012
Jkt 226001
affect their dietary choices. Results of
the study will not be used to develop
population estimates.
In the Federal Register of May 26,
2011 (76 FR 30725), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received eight letters
in response to the notice, each
containing multiple comments. Several
comments were generally supportive of
FDA’s study. Additional comments
were outside the scope of the four
collection of information topics on
which the notice solicits comments and
will not be discussed in this document.
The comments on the four collection of
information topics, and the Agency’s
responses, are discussed in the
following paragraphs.
(Comment 1) One comment
questioned the necessity of the study
given FDA’s many pressing
responsibilities. The comment suggested
that the ‘‘Dietary Guidelines for
Americans 2005’’ and the prevalence of
Whole Grain Stamps on products have
increased consumer ability to
understand the benefits of whole grains
and to find and purchase them in stores.
(Response) FDA disagrees with this
comment. Research suggests that
although consumers may be aware of
the benefits of whole grain foods, they
still have difficulties in understanding
the meaning of whole grains or
recognizing whole grain foods (Refs. 6
through 8). Given the multitude of
whole grain statements appearing in the
marketplace and the importance of
whole grains in maintaining a healthy
diet, there is a genuine need for
systematic investigation of how
consumers interpret various whole-grain
statements.
(Comment 2) Several comments
suggested improvements to the
proposed survey instrument. One
comment questioned whether the terms
‘‘healthiness’’ and ‘‘nutritional
qualities’’ should be equated to one
another as in a proposed response item
‘‘healthiness or nutritional qualities.’’ A
few comments noted that the scales of
the ranking questions need to be revised
from a four or six point scale to a five
point scale with a ‘‘neutral position’’
(e.g., neither agree nor disagree). Several
comments questioned whether a ‘‘don’t
know’’ choice should be included or
omitted in several places. One comment
suggested that the section on general
knowledge of whole grains should be
asked before questions on specific
labels. One comment stated that the
questions on evaluating the
trustworthiness and helpfulness of the
whole grain statement may be biased or
leading because all the negative terms
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
are placed on the left-hand side of the
scale. Another comment stated that the
perceptions of the claim statement may
be confounded by product cues such as
color and graphics.
(Response) FDA has carefully
reviewed the survey instrument and has
incorporated all necessary clarifications
and improvements in response to the
comments. In terms of the perceived
connection between ‘‘healthiness’’ and
‘‘nutritional qualities,’’ FDA found in
previous cognitive testing that some
respondents understood nutritional
qualities as an element of healthiness
and equated the two concepts, as in
‘‘healthiness or nutritional qualities.’’
The testing also found that this
expression performed best in
respondent comprehension and in
conveying the intent of the item, which
is the nutritional aspect of health.
Therefore, we have decided to retain the
expression ‘‘healthiness or nutritional
qualities.’’ Regarding inclusion of a
‘‘neutral’’ (neither agree nor disagree)
response in the rating scales, research
(e.g., Ref. 12) has suggested that such a
response can be interpreted as a ‘‘don’t
know’’ response by some respondents.
Therefore, we have kept the six point
rating scale and added a ‘‘don’t know’’
option. Questions whose response
options purposefully omit a ‘‘don’t
know’’ option will be further evaluated
in the cognitive interviews to confirm
that participants are able to select one
of the provided choices. Regarding the
order of the general knowledge and
label response sections, we disagree
with the suggestion and believe the
suggested change would create more
biases than the current order. We also
disagree that claim perceptions may be
biased because negative terms are
placed on the left-hand side of the scale.
Existing research has not produced
consensus about whether placing
negative or positive terms at the
beginning of a scale is more likely to
cause biases. More importantly, because
this is an experimental study that
employs random assignment, bias is
irrelevant as we are mainly interested in
quantitative differences in dependent
measures between tested stimuli (e.g.,
claims). We agree that product cues may
make it difficult to isolate the impact of
whole grain claims. For this reason, the
study has created mock-up labels that
do not include real or fictitious brand
names and only resemble, but are not
identical to, real packages. Moreover,
the study will compare responses to
labels that differ only in the presence or
absence of a claim, and in the claim
language, but not in any other respect.
(Comment 3) One comment suggested
that FDA should clearly define in the
E:\FR\FM\27FEN1.SGM
27FEN1
srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices
study concepts such as ‘‘whole grains’’,
‘‘foods made from whole grains’’, and
‘‘whole grain food’’ when asking about
whole grain consumption.
(Response) We disagree with this
suggestion. How consumers interpret
these labeling statements is the core
question that FDA is interested in
answering and clear definitions would
defeat this purpose. In the modified
version of our questionnaire, we have
provided specific examples of whole
grain products (such as cereal or bread,
pasta that are made with whole grains)
when we ask participants about their
whole grain consumption patterns.
(Comment 4) One comment proposed
revising a question in the survey that is
intended to assess potential consumer
confusion about the meaning of organic
versus whole grain. The question we
proposed asked participants to judge the
likelihood that a product is organic
based on the information shown on the
experimental label stimuli.
(Response) The question FDA
originally proposed (how likely a
product shown in the survey is organic)
has been removed from the revised
questionnaire. Instead, we have added a
new question that asks whether
respondents think the statement ‘‘All
whole grain foods are organic’’ is true or
false.
(Comment 5) One comment stated
that consumers do not understand
‘‘ounce-equivalents’’ when trying to
answer the whole grain consumption
questions. The comment suggested
using grams or servings as a
measurement of whole grain, or other
basic descriptions of amounts as
included in the ‘‘Dietary Guidelines for
Americans’’ or MyPlate (e.g., half of the
grains you consume, half of a plate).
(Response) We agree that consumers
are probably more familiar with
measurements expressed in servings or
grams than with measurements
expressed in ounce-equivalents and
have replaced ounce-equivalents with
servings or grams in the study. Also, we
have removed the question about
whether consumers are aware of the
recommended amount of whole grains
they should consume according to the
Dietary Guidelines for Americans
because respondents may not know
details in the ‘‘Dietary Guidelines for
Americans’’ or MyPlate.
(Comment 6) One comment suggested
that FDA should incorporate the three
standards listed in the ‘‘Dietary
Guidelines for Americans 2010’’ (‘‘look
for 100% whole grain foods’’; ‘‘look for
products using the FDA whole grain
health claim’’; ‘‘look for products with
at least 8 grams of whole grain’’) into the
VerDate Mar<15>2010
18:10 Feb 24, 2012
Jkt 226001
study to see whether consumers can use
them to seek out whole grains.
(Response) We agree that this
information is useful and have included
these standards in the study. We will
examine how well respondents
understand them and whether they can
evaluate the amount of whole grain in
a certain food based on the claim on the
front of the food package and the
Nutrition Facts and the ingredient list
on the back.
(Comment 7) One comment suggested
that FDA add a variety of grains and
more non-wheat-based foods (e.g.,
brown rice, oatmeal, and popcorn) to
see if consumers understand these are
whole grain foods. The same comment
also suggested FDA include more foods
lower in overall grain content than the
three planned (bread, cereal, breakfast
bars), as these are likely to be high in
grain content.
(Response) We agree with the
comment and have included bread, salty
snacks (instead of cereal), and breakfast
bars in the study.
(Comment 8) One comment suggested
that FDA add more questions on
participants’ consumption, purchases of
the food categories studied, and health
and nutrition attitude questions. The
comment also suggested that FDA
explore consumers’ understanding of
whole grains relative to consumers’
understanding of other aspects of a
healthy diet, such as consumption of
leafy green vegetables or legumes. The
comment stated that the information can
help reveal whether consumer
knowledge about dietary practices other
than whole grain consumption might
require greater Agency resources and
attention.
(Response) We have added questions
on participants’ consumption and
purchase of the food categories that will
be studied (bread, breakfast bars, and
salty snacks). Due to resource
limitations, we will not be able to ask
additional questions about participants’
understanding of other aspects of a
healthy diet or expand the study to
include a larger group of foods.
(Comment 9) One comment suggested
that, in addition to testing two
nutritional profiles for a given product
(one high in fiber amount and one low
in fiber amount), the study should
include at least one product that
provides a good source of fiber.
(Response) We agree that the
suggested addition will increase our
understanding of consumer reactions to
products with various fiber contents.
We have included three types of foods:
Bread, breakfast bars, and salty snacks
(instead of cereal), each with two
nutritional profiles (one high in fiber
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
11549
amount and one low in fiber amount) in
the study. Bread usually provides a
good source of fiber.
(Comment 10) One comment
suggested that, because the focus of the
proposed research is on interpretation of
whole grain label statements, the data
analysis should treat the label
statements as fixed effects and the
product categories and nutrition profiles
as random effects.
(Response) We will consider the need
and appropriateness of the suggested
analytic approach during data analysis.
(Comment 11) Several comments
urged FDA to provide graphics and
revised instruments in the 30-day notice
for public comment.
(Response) We agree and have
included these materials in the
information collection request.
(Comment 12) One comment
encouraged FDA to revise its draft
guidance to provide clear guidance to
industry as to the types of claims that
may be made about whole grains and
also to limit whole grain claims to foods
that provide at least a good source of
fiber (10% Daily Value) for foods with
a mid to large size Reference Amount
Customarily Consumed (RACC), such as
those associated with ready-to-eat
cereals.
(Response) The comment is outside of
the scope of the proposed collection of
information described in the 60-day
notice and therefore is not addressed
here. Nonetheless, the comment has
been forwarded to the docket for the
whole grain draft guidance.
FDA estimates the burden of this
collection of information as follows
(Table 1). FDA plans to conduct
cognitive interviews by screening 72
panelists in order to obtain 9
individuals for cognitive interviews.
Each screening is expected to take
5 minutes (0.083 hour), and each
cognitive interview is expected to take
1 hour. The total for cognitive interview
activities is 15 hours (6 hours + 9
hours). Subsequently, we plan to screen
1,152 individuals for pretest, each
taking 2 minutes (0.033 hours), in order
to have 576 of them complete a 15minute (0.25 hours) pretest. The 576
target responses are 376 more than the
200 target responses described in the 60day notice. The change is because we
increased the number of our
experimental conditions from 156 to
288, and we wanted to ensure two
responses per experimental condition
(288 * 2). Thus, the total for the pretest
activities is 182 hours (38 hours + 144
hours). For the survey, we estimate that
5,400 invitations, each taking 2 minutes
(0.033 hours), will need to be sent to
adult members of an online consumer
E:\FR\FM\27FEN1.SGM
27FEN1
11550
Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices
the 60-day notice and reflects 15 fewer
hours for pretest invitation, 533 fewer
hours for survey invitation, and 94 more
hours for the pretest, respectively.
Recent experience by our contractor
suggests that the Agency will not need
to send as many invitations as originally
panel to have 2,700 of them complete a
15-minute (0.25 hours) questionnaire.
The total for the survey activities is 855
hours (180 hours + 675 hours).
Therefore, the total estimated burden is
1,052 hours. This estimate is 454 hours
lower than the 1,506 hours described in
estimated to achieve its target sample
sizes in pretest and survey. FDA’s
burden estimate is based on prior
experience with research that is similar
to this proposed study.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average burden per response
Total hours
Cognitive interview screener ....
Cognitive interview ...................
Pretest invitation .......................
Pretest ......................................
Survey invitation .......................
Survey .......................................
72
9
1,152
576
5,400
2,700
1
1
1
1
1
1
72
9
1,152
576
5,400
2,700
0.083 (5 minutes) .....................
1 hour .......................................
0.033 (2 minutes) .....................
0.25 (15 minutes) .....................
0.033 (2 minutes) .....................
0.25 (15 minutes) .....................
6
9
38
144
180
675
Total ...................................
............................
............................
............................
...................................................
1,052
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
srobinson on DSK4SPTVN1PROD with NOTICES
II. References
The following references are on
display in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20857, under
Docket No. FDA–2011–N–0320 and may
be seen by interested persons between 9
a.m. and 4 p.m., Monday through
Friday. We have verified all Web site
addresses, but we are not responsible for
any subsequent changes to the Web sites
after this document publishes in the
Federal Register.
1. U.S. Food and Drug Administration,
‘‘Claims That Can Be Made for Conventional
Foods and Dietary Supplements,’’ September
2003, available at https://www.fda.gov/Food/
LabelingNutrition/LabelClaims/
ucm111447.htm.
2. Cleveland, L.E., A.J. Moshfegh, A.M.
Albertson, et al., ‘‘Dietary Intake of Whole
Grains,’’ Journal of the American College of
Nutrition, vol. 19, pp. 331S–338S, 2000.
3. Kantor, L.S., J.N. Variyam, J.E.
Allshouse, et al., ‘‘Choose a Variety of Grains
Daily, Especially Whole Grains: A Challenge
for Consumers,’’ Journal of Nutrition, vol.
131, pp. 473S–486S, 2001.
4. U.S. Department of Agriculture and U.S.
Department of Health and Human Services,
‘‘Executive Summary of Dietary Guidelines
for Americans, 2010,’’ January 2011,
available at https://www.cnpp.usda.gov/
Publications/DietaryGuidelines/2010/
PolicyDoc/ExecSumm.pdf.
5. Supermarket News, ‘‘Report: Whole
Grains Gain Momentum,’’ September 17,
2010, available at https://supermarketnews.
com/news/whole_grains_0917/#.
¨
¨
6. Arvola, A., L. Lahteenmaki, M. Dean, et
al., ‘‘Consumers’ Beliefs About Whole and
Refined Grain Products in the UK, Italy and
Finland,’’ Journal of Cereal Science, vol. 46,
pp. 197–206, 2007.
7. Kantor, L.S., J.N. Variyam, J.E.
Allshouse, et al., ‘‘Choose a Variety of Grains
Daily, Especially Whole Grains: A Challenge
VerDate Mar<15>2010
18:10 Feb 24, 2012
Jkt 226001
for Consumers,’’ Journal of Nutrition, vol.
131, pp. 473S–486S, 2001.
8. Marquart, L., K.L. Wiemer, J.M. Jones, et
al., ‘‘Whole Grain Health Claims in the USA
and Other Efforts to Increase Whole-Grain
Consumption,’’ Proceedings of the Nutrition
Society, vol. 62, pp. 151–160, 2003.
9. Drichoutis, A.C., P. Lazaridis, and R.M.
Nayga, ‘‘Consumers’ Use of Nutritional
Labels: A Review of Research Studies and
Issues,’’ Academy of Marketing Science
Review, vol. 10.9, 2006.
10. Grunert, K.G. and J.M. Willis, ‘‘A
Review of European Research on Consumer
Response to Nutrition Information on Food
Labels,’’ Journal of Public Health, vol. 15,
pp. 384–399, 2007.
11. Kellogg Company. ‘‘A Survey of
Consumers’ Whole Grain & Fiber
Consumption Behaviors, and the Perception
of Whole Grain Foods as a Source of Dietary
Fiber,’’ 2010. FDA Docket No. 2006–D–0298.
July 2010, available at https://
www.regulations.gov/#!document
Detail;D=FDA–2006–D–0298–0016.
12. Clark, L.A. and D. Watson,
‘‘Constructing Validity: Basic Issues in
Objective Scale Development,’’ Psychological
Assessment, vol. 7(3), pp. 309–319, 1995.
Dated: February 21, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–4423 Filed 2–24–12; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0140]
Draft Guidance for Industry on
Notification to Food and Drug
Administration of Issues That May
Result in a Prescription Drug
Shortage; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Notification to FDA
of Issues that May Result in a
Prescription Drug or Biological Product
Shortage.’’ This draft guidance relates to
the Federal Food, Drug, and Cosmetic
Act (FD&C Act), which requires sole
manufacturers to notify FDA of a
discontinuance of certain drug products
and to the President’s Executive Order
13588 of October 31, 2011, directing
FDA to use all available administrative
tools to expand the Agency’s efforts to
combat the problem of drug shortages.
We are also requesting responsive
comments from interested stakeholders
on a specific question posed in this
Federal Register document related to
the draft guidance.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 29, 2012.
SUMMARY:
E:\FR\FM\27FEN1.SGM
27FEN1
]]>Agencies
[Federal Register Volume 77, Number 38 (Monday, February 27, 2012)]
[Notices]
[Pages 11547-11550]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4423]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0320]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study on
Consumer Responses to Whole Grain Labeling Statements on Food Packages
AGENCY: Food and Drug Administration, HHS
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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.
DATES: Fax written comments on the collection of information by March
28, 2012.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title ``Experimental Study on Consumer Responses to Whole Grain
Labeling Statements on Food Packages.'' Please also include the FDA
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, II, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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.
Experimental Study on Consumer Responses to Whole Grain Labeling
Statements on Food Packages--(OMB Control Number 0910-New)
I. Background
The Nutrition Labeling and Education Act, which amended the Federal
Food, Drug, and Cosmetic Act, requires most foods to bear nutrition
labeling (i.e., the Nutrition Facts) and requires food labels that bear
nutrient content claims and certain health messages to comply with
specific requirements. There are three different types of claims
(health claims, nutrient content claims, and structure/function claims)
that the food industry can voluntarily use on food labels. Although
they are regulated differently, they all must be truthful and not
misleading (Ref. 1).
In the past 30 years, whole-grain consumption has been greatly
promoted by government agencies and scientific communities as an
important part of a healthy diet (Refs. 2 and 3). For example, the
newly released ``Dietary Guidelines for Americans 2010'' recommends
Americans eat fewer refined grains and consume more nutrient-dense
whole grains instead (Ref. 4). At the same time, whole grain labeling
statements, such as ``Made With Whole Grain'', on food products have
also become more prevalent in recent years (Ref. 5). Given the variety
of whole-grain statements on food products and the importance of whole
grains in maintaining a healthy diet, it is important for policy makers
to gain a better understanding of how consumers interpret these
statements.
Several studies indicate that consumers may have difficulties in
understanding the meaning of whole grains or recognizing whole-grain
foods (Refs. 6 to 8). Research also suggests consumer product
perceptions and purchase decisions can be influenced by labeling
statements, and different labeling statements may have different
influences (Refs. 9 and 10). The majority of existing studies focus on
whole grain intake or the relationships between whole grain and disease
prevention. There is a lack of systematic investigation of consumers'
understanding of different whole-grain labeling statements. We are
aware of at least one existing study related to the statements (Ref.
11). However, the study did not compare consumer reactions to various
whole-grain statements. Therefore, FDA, as part of its effort to
promote public health, plans to use the proposed study to explore and
compare consumer responses to food labels that use whole-grain labeling
statements.
Specifically, the study plans to examine: (1) Consumer judgments
about a food product including its nutritional attributes, overall
healthiness, and health benefits; (2) consumer judgments about a
labeling statement in terms of its credibility, helpfulness, and other
attributes; (3) consumer interpretations of different terms and
statements, such as ``Made with Whole Grain'', ``Multi-Grain'', and
``100% Whole Wheat''; (4) consumer extrapolation of whole grain
statements beyond the scope of the statements themselves (i.e., halo
effects);
[[Page 11548]]
and (5) how whole grain statements influence consumer use of the
Nutrition Facts.
The proposed collection of information is a controlled randomized
experimental study. The study will use a 15-minute Web-based survey to
collect information from 2,700 English-speaking adult members of an
online consumer panel maintained by a contractor. The study will aim to
produce a sample that reflects the U.S. Census on gender, education,
age, and ethnicity/race.
The study will randomly assign each participant to view one label
image from a set of food labels that will be created for the study and
systematically varied in the (1) whole grain labeling statement; (2)
featured product (e.g., bread, salty snacks, and breakfast bars); (3)
access to the Nutrition Facts label; and (4) nutritional profile
(differing by the amount of fiber and the ranking order of whole grain
products on the ingredient list). With regard to claims, the study will
focus on examples of whole grain statements that can be found on food
packages. All label images will be mock-ups resembling food labels that
may be found in the marketplace. Images will show product identity
(e.g., bread) but not any real or fictitious brand name. The study will
provide half of the participants access to the Nutrition Facts but not
together with a product image (i.e., these participants can look at the
Nutrition Facts if they choose to). The study will show the other half
of the respondents a label in which the Nutrition Facts is located next
to the product image.
The survey will ask its participants to view label images and
answer questions about their perceptions and reactions related to the
product and claim. Product perceptions (e.g., healthiness, potential
health benefits, levels of whole grains, and fiber amount) and label
perceptions (e.g., helpfulness and credibility) will constitute the
measures of response in the experiment. To help understand the data,
the survey will also collect information about participants'
backgrounds, such as consumption and purchase patterns, awareness and
knowledge of nutrients and substances, and health status and
demographic characteristics.
The study is part of the Agency's continuing effort to enable
consumers to make informed dietary choices and construct healthful
diets. Results of the study will be used primarily to enhance the
Agency's understanding of how whole grains claims and other related
labeling statements on food packages may affect how consumers perceive
a product or a label, which may in turn affect their dietary choices.
Results of the study will not be used to develop population estimates.
In the Federal Register of May 26, 2011 (76 FR 30725), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received eight letters in response to
the notice, each containing multiple comments. Several comments were
generally supportive of FDA's study. Additional comments were outside
the scope of the four collection of information topics on which the
notice solicits comments and will not be discussed in this document.
The comments on the four collection of information topics, and the
Agency's responses, are discussed in the following paragraphs.
(Comment 1) One comment questioned the necessity of the study given
FDA's many pressing responsibilities. The comment suggested that the
``Dietary Guidelines for Americans 2005'' and the prevalence of Whole
Grain Stamps on products have increased consumer ability to understand
the benefits of whole grains and to find and purchase them in stores.
(Response) FDA disagrees with this comment. Research suggests that
although consumers may be aware of the benefits of whole grain foods,
they still have difficulties in understanding the meaning of whole
grains or recognizing whole grain foods (Refs. 6 through 8). Given the
multitude of whole grain statements appearing in the marketplace and
the importance of whole grains in maintaining a healthy diet, there is
a genuine need for systematic investigation of how consumers interpret
various whole-grain statements.
(Comment 2) Several comments suggested improvements to the proposed
survey instrument. One comment questioned whether the terms
``healthiness'' and ``nutritional qualities'' should be equated to one
another as in a proposed response item ``healthiness or nutritional
qualities.'' A few comments noted that the scales of the ranking
questions need to be revised from a four or six point scale to a five
point scale with a ``neutral position'' (e.g., neither agree nor
disagree). Several comments questioned whether a ``don't know'' choice
should be included or omitted in several places. One comment suggested
that the section on general knowledge of whole grains should be asked
before questions on specific labels. One comment stated that the
questions on evaluating the trustworthiness and helpfulness of the
whole grain statement may be biased or leading because all the negative
terms are placed on the left-hand side of the scale. Another comment
stated that the perceptions of the claim statement may be confounded by
product cues such as color and graphics.
(Response) FDA has carefully reviewed the survey instrument and has
incorporated all necessary clarifications and improvements in response
to the comments. In terms of the perceived connection between
``healthiness'' and ``nutritional qualities,'' FDA found in previous
cognitive testing that some respondents understood nutritional
qualities as an element of healthiness and equated the two concepts, as
in ``healthiness or nutritional qualities.'' The testing also found
that this expression performed best in respondent comprehension and in
conveying the intent of the item, which is the nutritional aspect of
health. Therefore, we have decided to retain the expression
``healthiness or nutritional qualities.'' Regarding inclusion of a
``neutral'' (neither agree nor disagree) response in the rating scales,
research (e.g., Ref. 12) has suggested that such a response can be
interpreted as a ``don't know'' response by some respondents.
Therefore, we have kept the six point rating scale and added a ``don't
know'' option. Questions whose response options purposefully omit a
``don't know'' option will be further evaluated in the cognitive
interviews to confirm that participants are able to select one of the
provided choices. Regarding the order of the general knowledge and
label response sections, we disagree with the suggestion and believe
the suggested change would create more biases than the current order.
We also disagree that claim perceptions may be biased because negative
terms are placed on the left-hand side of the scale. Existing research
has not produced consensus about whether placing negative or positive
terms at the beginning of a scale is more likely to cause biases. More
importantly, because this is an experimental study that employs random
assignment, bias is irrelevant as we are mainly interested in
quantitative differences in dependent measures between tested stimuli
(e.g., claims). We agree that product cues may make it difficult to
isolate the impact of whole grain claims. For this reason, the study
has created mock-up labels that do not include real or fictitious brand
names and only resemble, but are not identical to, real packages.
Moreover, the study will compare responses to labels that differ only
in the presence or absence of a claim, and in the claim language, but
not in any other respect.
(Comment 3) One comment suggested that FDA should clearly define in
the
[[Page 11549]]
study concepts such as ``whole grains'', ``foods made from whole
grains'', and ``whole grain food'' when asking about whole grain
consumption.
(Response) We disagree with this suggestion. How consumers
interpret these labeling statements is the core question that FDA is
interested in answering and clear definitions would defeat this
purpose. In the modified version of our questionnaire, we have provided
specific examples of whole grain products (such as cereal or bread,
pasta that are made with whole grains) when we ask participants about
their whole grain consumption patterns.
(Comment 4) One comment proposed revising a question in the survey
that is intended to assess potential consumer confusion about the
meaning of organic versus whole grain. The question we proposed asked
participants to judge the likelihood that a product is organic based on
the information shown on the experimental label stimuli.
(Response) The question FDA originally proposed (how likely a
product shown in the survey is organic) has been removed from the
revised questionnaire. Instead, we have added a new question that asks
whether respondents think the statement ``All whole grain foods are
organic'' is true or false.
(Comment 5) One comment stated that consumers do not understand
``ounce-equivalents'' when trying to answer the whole grain consumption
questions. The comment suggested using grams or servings as a
measurement of whole grain, or other basic descriptions of amounts as
included in the ``Dietary Guidelines for Americans'' or MyPlate (e.g.,
half of the grains you consume, half of a plate).
(Response) We agree that consumers are probably more familiar with
measurements expressed in servings or grams than with measurements
expressed in ounce-equivalents and have replaced ounce-equivalents with
servings or grams in the study. Also, we have removed the question
about whether consumers are aware of the recommended amount of whole
grains they should consume according to the Dietary Guidelines for
Americans because respondents may not know details in the ``Dietary
Guidelines for Americans'' or MyPlate.
(Comment 6) One comment suggested that FDA should incorporate the
three standards listed in the ``Dietary Guidelines for Americans 2010''
(``look for 100% whole grain foods''; ``look for products using the FDA
whole grain health claim''; ``look for products with at least 8 grams
of whole grain'') into the study to see whether consumers can use them
to seek out whole grains.
(Response) We agree that this information is useful and have
included these standards in the study. We will examine how well
respondents understand them and whether they can evaluate the amount of
whole grain in a certain food based on the claim on the front of the
food package and the Nutrition Facts and the ingredient list on the
back.
(Comment 7) One comment suggested that FDA add a variety of grains
and more non-wheat-based foods (e.g., brown rice, oatmeal, and popcorn)
to see if consumers understand these are whole grain foods. The same
comment also suggested FDA include more foods lower in overall grain
content than the three planned (bread, cereal, breakfast bars), as
these are likely to be high in grain content.
(Response) We agree with the comment and have included bread, salty
snacks (instead of cereal), and breakfast bars in the study.
(Comment 8) One comment suggested that FDA add more questions on
participants' consumption, purchases of the food categories studied,
and health and nutrition attitude questions. The comment also suggested
that FDA explore consumers' understanding of whole grains relative to
consumers' understanding of other aspects of a healthy diet, such as
consumption of leafy green vegetables or legumes. The comment stated
that the information can help reveal whether consumer knowledge about
dietary practices other than whole grain consumption might require
greater Agency resources and attention.
(Response) We have added questions on participants' consumption and
purchase of the food categories that will be studied (bread, breakfast
bars, and salty snacks). Due to resource limitations, we will not be
able to ask additional questions about participants' understanding of
other aspects of a healthy diet or expand the study to include a larger
group of foods.
(Comment 9) One comment suggested that, in addition to testing two
nutritional profiles for a given product (one high in fiber amount and
one low in fiber amount), the study should include at least one product
that provides a good source of fiber.
(Response) We agree that the suggested addition will increase our
understanding of consumer reactions to products with various fiber
contents. We have included three types of foods: Bread, breakfast bars,
and salty snacks (instead of cereal), each with two nutritional
profiles (one high in fiber amount and one low in fiber amount) in the
study. Bread usually provides a good source of fiber.
(Comment 10) One comment suggested that, because the focus of the
proposed research is on interpretation of whole grain label statements,
the data analysis should treat the label statements as fixed effects
and the product categories and nutrition profiles as random effects.
(Response) We will consider the need and appropriateness of the
suggested analytic approach during data analysis.
(Comment 11) Several comments urged FDA to provide graphics and
revised instruments in the 30-day notice for public comment.
(Response) We agree and have included these materials in the
information collection request.
(Comment 12) One comment encouraged FDA to revise its draft
guidance to provide clear guidance to industry as to the types of
claims that may be made about whole grains and also to limit whole
grain claims to foods that provide at least a good source of fiber (10%
Daily Value) for foods with a mid to large size Reference Amount
Customarily Consumed (RACC), such as those associated with ready-to-eat
cereals.
(Response) The comment is outside of the scope of the proposed
collection of information described in the 60-day notice and therefore
is not addressed here. Nonetheless, the comment has been forwarded to
the docket for the whole grain draft guidance.
FDA estimates the burden of this collection of information as
follows (Table 1). FDA plans to conduct cognitive interviews by
screening 72 panelists in order to obtain 9 individuals for cognitive
interviews. Each screening is expected to take 5 minutes (0.083 hour),
and each cognitive interview is expected to take 1 hour. The total for
cognitive interview activities is 15 hours (6 hours + 9 hours).
Subsequently, we plan to screen 1,152 individuals for pretest, each
taking 2 minutes (0.033 hours), in order to have 576 of them complete a
15-minute (0.25 hours) pretest. The 576 target responses are 376 more
than the 200 target responses described in the 60-day notice. The
change is because we increased the number of our experimental
conditions from 156 to 288, and we wanted to ensure two responses per
experimental condition (288 * 2). Thus, the total for the pretest
activities is 182 hours (38 hours + 144 hours). For the survey, we
estimate that 5,400 invitations, each taking 2 minutes (0.033 hours),
will need to be sent to adult members of an online consumer
[[Page 11550]]
panel to have 2,700 of them complete a 15-minute (0.25 hours)
questionnaire. The total for the survey activities is 855 hours (180
hours + 675 hours). Therefore, the total estimated burden is 1,052
hours. This estimate is 454 hours lower than the 1,506 hours described
in the 60-day notice and reflects 15 fewer hours for pretest
invitation, 533 fewer hours for survey invitation, and 94 more hours
for the pretest, respectively. Recent experience by our contractor
suggests that the Agency will not need to send as many invitations as
originally estimated to achieve its target sample sizes in pretest and
survey. FDA's burden estimate is based on prior experience with
research that is similar to this proposed study.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive interview screener.................. 72 1 72 0.083 (5 minutes)............... 6
Cognitive interview........................... 9 1 9 1 hour.......................... 9
Pretest invitation............................ 1,152 1 1,152 0.033 (2 minutes)............... 38
Pretest....................................... 576 1 576 0.25 (15 minutes)............... 144
Survey invitation............................. 5,400 1 5,400 0.033 (2 minutes)............... 180
Survey........................................ 2,700 1 2,700 0.25 (15 minutes)............... 675
-----------------
Total..................................... ................ ................ ................ ................................ 1,052
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20857, under Docket No. FDA-2011-N-0320 and may
be seen by interested persons between 9 a.m. and 4 p.m., Monday through
Friday. We have verified all Web site addresses, but we are not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.
1. U.S. Food and Drug Administration, ``Claims That Can Be Made
for Conventional Foods and Dietary Supplements,'' September 2003,
available at https://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm.
2. Cleveland, L.E., A.J. Moshfegh, A.M. Albertson, et al.,
``Dietary Intake of Whole Grains,'' Journal of the American College
of Nutrition, vol. 19, pp. 331S-338S, 2000.
3. Kantor, L.S., J.N. Variyam, J.E. Allshouse, et al., ``Choose
a Variety of Grains Daily, Especially Whole Grains: A Challenge for
Consumers,'' Journal of Nutrition, vol. 131, pp. 473S-486S, 2001.
4. U.S. Department of Agriculture and U.S. Department of Health
and Human Services, ``Executive Summary of Dietary Guidelines for
Americans, 2010,'' January 2011, available at https://www.cnpp.usda.gov/Publications/DietaryGuidelines/2010/PolicyDoc/ExecSumm.pdf.
5. Supermarket News, ``Report: Whole Grains Gain Momentum,''
September 17, 2010, available at https://supermarketnews.com/news/whole_grains_0917/#.
6. Arvola, A., L. L[auml]hteenm[auml]ki, M. Dean, et al.,
``Consumers' Beliefs About Whole and Refined Grain Products in the
UK, Italy and Finland,'' Journal of Cereal Science, vol. 46, pp.
197-206, 2007.
7. Kantor, L.S., J.N. Variyam, J.E. Allshouse, et al., ``Choose
a Variety of Grains Daily, Especially Whole Grains: A Challenge for
Consumers,'' Journal of Nutrition, vol. 131, pp. 473S-486S, 2001.
8. Marquart, L., K.L. Wiemer, J.M. Jones, et al., ``Whole Grain
Health Claims in the USA and Other Efforts to Increase Whole-Grain
Consumption,'' Proceedings of the Nutrition Society, vol. 62, pp.
151-160, 2003.
9. Drichoutis, A.C., P. Lazaridis, and R.M. Nayga, ``Consumers'
Use of Nutritional Labels: A Review of Research Studies and
Issues,'' Academy of Marketing Science Review, vol. 10.9, 2006.
10. Grunert, K.G. and J.M. Willis, ``A Review of European
Research on Consumer Response to Nutrition Information on Food
Labels,'' Journal of Public Health, vol. 15, pp. 384-399, 2007.
11. Kellogg Company. ``A Survey of Consumers' Whole Grain &
Fiber Consumption Behaviors, and the Perception of Whole Grain Foods
as a Source of Dietary Fiber,'' 2010. FDA Docket No. 2006-D-0298.
July 2010, available at https://www.regulations.gov/#!documentDetail;D=FDA-2006-D-0298-0016.
12. Clark, L.A. and D. Watson, ``Constructing Validity: Basic
Issues in Objective Scale Development,'' Psychological Assessment,
vol. 7(3), pp. 309-319, 1995.
Dated: February 21, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4423 Filed 2-24-12; 8:45 am]
BILLING CODE 4160-01-P
