Notice2023-17145
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Requirements
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Published
August 10, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 153 (Thursday, August 10, 2023)</title>
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[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54326-54329]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17145]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0918]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Labeling
Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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: Submit written comments (including recommendations) on the
collection of information by September 11, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0381. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#dd8d8f9c8ea9bcbbbb9dbbb9bcf3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="c292908391b6a3a4a482a4a6a3ecaaaab1eca5adb4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Food Labeling Requirements
OMB Control Number 0910-0381--Revision
This information collection supports statutory and regulatory
requirements that govern food labeling, and information collection
recommendations discussed in associated Agency guidance. Sections 4, 5,
and 6 of the Fair Packaging and Labeling Act (FPLA) (15 U.S.C. 1453,
1454, and 1455) and sections 201, 301, 402, 403, 409, 411, 701, and 721
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321,
331, 342, 343, 348, 350, 371, and 379e), establish provisions under
which a food product shall be deemed to be misbranded if, among other
things, its label or labeling fails to bear certain required
information concerning the food product, is false or misleading in any
particular, or bears certain types of unauthorized claims. Implementing
regulations are codified in parts 101, 102, 104, and 105 (21 CFR parts
101, 102, 104, and 105). While regulations in part 101 set forth
general food labeling provisions, requirements pertaining to the common
or usual name for nonstandardized foods; guidelines for nutritional
quality to prescribe the minimum level or range of nutrient composition
appropriate for a given class of food; and requirements for foods for
special dietary use are found in parts 102, 104, and 105, respectively.
The requirements are intended to ensure the safety of food products
produced or sold in the United States and enable consumers to be
knowledgeable about the foods they purchase and include corresponding
information disclosure requirements, along with the reporting and
recordkeeping provisions, subject to enforcement by FDA.
We provide information resources regarding food labeling under the
FD&C Act and its amendments on our website at <a href="https://www.fda.gov/food/food-labeling-nutrition">https://www.fda.gov/food/food-labeling-nutrition</a>. Food labeling is required for most prepared
foods, such as breads, cereals, canned and frozen foods, snacks,
desserts, drinks, etc. Nutrition labeling for raw produce (fruits and
vegetables) and fish is voluntary. We refer to these products as
``conventional'' foods. For detailed information on dietary supplement
labeling requirements visit our website at <a href="https://www.fda.gov/food/dietary-supplements">https://www.fda.gov/food/dietary-supplements</a>. Nutrition labeling provides information for use by
consumers in selecting a nutritious diet. Other information enables
consumers to comparison shop. Ingredient information also enables
consumers to avoid substances to which they may be sensitive. Petitions
or other requests submitted to us provide the basis for us to permit
new labeling statements or to grant exemptions from certain labeling
requirements. Recordkeeping requirements enable us to monitor the basis
upon which certain label statements are made for food products and
whether those statements are in compliance with the requirements of the
FD&C Act or the FPLA. Requirements include general content and format
for the labeling of food packaging, including nutrition and ingredient
information. Additional regulations provide for specific nutrient
content claims.
The information collection includes Form FDA 3570 entitled, ``Small
Business Nutrition Labeling Exemption Notice,'' for use as applicable
and available for download from our website at <a href="https://www.fda.gov/food/labeling-nutrition-guidance-documents-regulatory-information/small-business-nutrition-labeling-exemption-notice-model-form">https://www.fda.gov/food/labeling-nutrition-guidance-documents-regulatory-information/small-business-nutrition-labeling-exemption-notice-model-form</a>. We have
also developed the following guidance documents to assist respondents
with various aspects of the information collection:
<bullet> ``Guidance for Industry: Notification of a Health Claim or
Nutrient Content Claim Based on an Authoritative Statement of a
Scientific Body'' (June 1998). The guidance document is available from
our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-notification-health-claim-or-nutrient-content-claim-based-authoritative-statement">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-notification-health-claim-or-nutrient-content-claim-based-authoritative-statement</a>. The guidance
document
[[Page 54327]]
discusses section 403(r)(2) and (r)(3) (21 U.S.C. 343(r)(2) and (3)) of
the FD&C Act and was issued to provide instruction on the submission of
information to FDA during the initial phase of implementing these new
provisions.
<bullet> ``Questions and Answers: Labeling of Dietary Supplements
as Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act'' (September 2009). The guidance document is available
from our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-labeling-dietary-supplements-required-dietary">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-labeling-dietary-supplements-required-dietary</a>. The guidance
document communicates content elements and FDA enforcement of labeling
requirements in section 403(y) of the FD&C Act.
<bullet> ``Substantiation for Dietary Supplement Claims Made Under
Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act''
(January 2009). The guidance document is available from our website at
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food</a>. The guidance document discusses
FDA recommendations regarding claims under section 403(r)(6) of the
FD&C Act.
For operational efficiency, we are revising the information
collection to account for burden that may result from activities
associated with the labeling of certain beers, currently approved in
OMB Control No. 0910-0728. The Tobacco Tax and Trade Bureau is
responsible for the dissemination and enforcement of regulations with
respect to the labeling of distilled spirits, certain wines, and malt
beverages issued in the Federal Alcohol Administration Act. However,
and as discussed in the guidance document ``Labeling of Certain Beers
Subject to the Labeling Jurisdiction of the Food and Drug
Administration'' (December 2014), certain bottled or otherwise packaged
beers are subject to section 403 of the FD&C Act. The guidance document
is available for download from our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-labeling-certain-beers-subject-labeling-jurisdiction-food-and-drug-administration">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-labeling-certain-beers-subject-labeling-jurisdiction-food-and-drug-administration</a> and provides recommendations regarding applicable
labeling requirements for products under FDA's jurisdiction.
We are also revising the information collection to include new
requirements applicable to the gluten-free labeling of fermented or
hydrolyzed foods established through rulemaking (RIN 0910-AH00) and
approved in OMB Control No. 0910-0817.
Description of Respondents: Respondents to this information
collection are manufacturers, packers, and distributors of food
products, as well as certain food retailers, such as supermarkets and
restaurants, subject to statutory and regulatory food labeling
requirements.
In the Federal Register of April 12, 2023 (88 FR 22045), we
published a 60-day notice soliciting comment on the proposed collection
of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section; activity Number of responses per Total annual Average burden Total
respondents respondent responses per response hours
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101.9(c)(6)(i); dietary fiber..... 28 1 28 1 28
101.9(j)(18) and 101.36(h)(2); 10,000 1 10,000 8 80,000
procedure for small business
nutrition labeling exemption
notice using Form FDA 3570.......
101.12(h); petitions to establish 1 1 1 80 80
or amend referenced amounts
customarily consumed (RACC)......
101.69; petitions for nutrient 3 1 3 25 75
content claims...................
101.70; petitions for health 5 1 5 80 400
claims...........................
101.108; written proposal for 1 1 1 40 40
requesting temporary exemptions
from certain regulations for the
purpose of conducting food
labeling experiments.............
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Total......................... ............... ............... 10,038 ............... 80,623
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden\1\
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Number of
21 CFR section; activity Number of records per Total annual Average burden per recordkeeping Total
recordkeepers recordkeeper records hours
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101.9(c)(6)(iii); added sugars \2\............. 31,283 1 31,283 1......................................... 31,283
101.9(c)(6)(i); dietary fiber \2\.............. 31,283 1 31,283 1......................................... 31,283
101.9(c)(6)(i)(A) \2\; soluble fiber........... 31,283 1 31,283 1......................................... 31,283
101.9(c)(6)(i)(B); insoluble fiber \2\......... 31,283 1 31,283 1......................................... 31,283
101.9(c)(8); vitamin E \3\..................... 31,283 1 31,283 1......................................... 31,283
101.9(c)(8); folate/folic acid \3\............. 31,283 1 31,283 1......................................... 31,283
New Products................................... 216 1 216 1......................................... 216
101.12(e); recordkeeping to document the basis 25 1 25 1......................................... 25
for density-adjusted RACC.
101.13(q)(5); recordkeeping to document the 300,000 1.5 450,000 0.75 (45 minutes)......................... 337,500
basis for nutrient content claims.
101.14(d)(2); recordkeeping to document 300,000 1.5 450,000 0.75 (45 minutes)......................... 337,500
nutrition information related to health claims
for food products.
101.22(i)(4); recordkeeping to document 25 1 25 1......................................... 25
supplier certifications for flavors designated
as containing no artificial flavors.
101.100(d)(2); recordkeeping pertaining to 1,000 1 1,000 1......................................... 1,000
agreements that form the basis for an
exemption from the labeling requirements of
section 403(c), (e), (g)-(i), (k), and (q) of
the FD&C Act.
101.7(t); recordkeeping pertaining to 100 1 100 1......................................... 100
disclosure requirements for food not
accurately labeled for quality of contents.
[[Page 54328]]
101.91; Documentation necessary to verify 5,000 56 280,000 0.45 (~27 minutes)........................ 126,000
compliance with gluten free labeling.
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Total...................................... ............... ............... 1,369,064 .......................................... 990,064
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate reflects the cumulative average burden we attribute to
the reporting and recordkeeping requirements found in the applicable
regulations; individual collection activities may not be evenly
distributed among respondents and/or the corresponding requirements.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
21 CFR section; activity Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
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101.3, 101.22, parts 102 and 25,000 1.03 25,750 0.5 (30 12,875
104; statement of identity minutes).
labeling requirements.
101.4, 101.22, 101.100, parts 25,000 1.03 25,750 1.............. 25,750
102, 104 and 105; ingredient
labeling requirements.
101.5; requirement to specify 25,000 1.03 25,750 0.25 (15 6,438
the name and place of minutes).
business of the
manufacturer, packer, or
distributor and, if the food
producer is not the
manufacturer of the food
product, its connection with
the food product.
101.9, 101.13(n), 25,000 1.03 25,750 4.............. 103,000
101.14(d)(3), 101.62, and
part 104; labeling
requirements for disclosure
of nutrition information.
101.9(g)(9) and 101.36(f)(2); 12 1 12 4.............. 48
alternative means of
compliance permitted.
101.10; requirements for 300,000 1.5 450,000 0.25 (15 112,500
nutrition labeling of minutes).
restaurant foods.
101.12(b); RACC for baking 29 2.3 67 1.............. 67
powder, baking soda, and
pectin.
101.12(e); adjustment to the 25 1 25 1.............. 25
RACC of an aerated food
permitted.
101.12(g); requirement to 5,000 1 5,000 1.............. 5,000
disclose the serving size
that is the basis for a
claim made for the product
if the serving size on which
the claim is based differs
from the RACC.
101.13(d)(1) and 101.67; 200 1 200 1.............. 200
requirements to disclose
nutrition information for
any food product for which a
nutrient content claim is
made.
101.13(j)(2) and (k), 101.54, 5,000 1 5,000 1.............. 5,000
101.56, 101.60, 101.61, and
101.62; additional
disclosure required if the
nutrient content claim
compares the level of a
nutrient in one food with
the level of the same
nutrient in another food..
101.13(q)(5); requirement 300,000 1.5 450,000 0.75 (45 337,500
that restaurants disclose minutes).
the basis for nutrient
content claims made for
their food.
101.14(d)(2); general 300,000 1.5 450,000 0.75 (45 337,500
requirements for disclosure minutes).
of nutrition information
related to health claims for
food products.
101.15; requirements 160 10 1,600 8.............. 12,800
pertaining to prominence of
required statements and use
of foreign language.
101.22(i)(4); supplier 25 1 25 1.............. 25
certifications for flavors
designated as containing no
artificial flavors.
101.30 and 102.33; labeling 1,500 5 7,500 1.............. 7,500
requirements for fruit or
vegetable juice beverages.
101.36; nutrition labeling of 300 40 12,000 4.025.......... 48,300
dietary supplements.
101.42 and 101.45; nutrition 1,000 1 1,000 0.5 (30 500
labeling of raw fruits, minutes).
vegetables, and fish.
101.45(c); databases of 5 4 20 4.............. 80
nutrient values for raw
fruits, vegetables, and fish.
101.79(c)(2)(i)(D); 1,000 1 1,000 0.25 (15 250
disclosure requirements for minutes).
food labels that contain a
folate/neural tube defect
health claim.
101.79(c)(2)(iv); disclosure 100 1 100 0.25 (15 25
of amount of folate for food minutes).
labels that contain a folate/
neural tube defect health
claim.
101.100(d); disclosure of 1,000 1 1,000 1.............. 1,000
agreements that form the
basis for exemption from the
labeling requirements of
section 403(c), (e), (g),
(h), (i), (k), and (q) of
the FD&C Act.
101.7 and 101.100(h); 25,000 1.03 25,750 0.5 (30 12,875
disclosure requirements for minutes).
food not accurately labeled
for quantity of contents and
for claiming certain
labeling exemptions.
Nutritional labeling for new 500 1 500 2.............. 1,000
products.
``Labeling of Certain Beers 12 1 12 1.............. 12
Subject to the Labeling
Jurisdiction of the Food and
Drug Administration''.
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Total.................... ............... ................. ............... ............... 1,030,270
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
These estimates reflect our continued experience with the
information collection. We have made nominal adjustments to reflect the
addition of burden associated with gluten and certain bottled or
otherwise packaged beer; petition submissions received since our last
evaluation of the information collection; and informal communications
with industry regarding food product labeling.
[[Page 54329]]
Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17145 Filed 8-9-23; 8:45 am]
BILLING CODE 4164-01-P
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