0381 Food labeling SSA 2020 REV

0381 Food labeling SSA 2020 REV.pdf

Food Labeling Regulations

OMB: 0910-0381

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UNITED STATES FOOD AND DRUG ADMINISTRATION
Food Labeling Regulations
OMB Control No. 0910-0381 – Revision

SUPPORTING STATEMENT – Part A: Justification
Terms of Clearance:
In accordance with the terms of clearance established December 5, 2017 upon OMB approval for
the information collection, FDA has discontinued OMB control nos. 0910-0374, 0910-0626, and
0910-0642.
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (“FDA” or “we”) food
labeling regulations, programs, and guidance. Food labeling regulations require food producers
to disclose to consumers and others specific information about themselves or their products on
the label or labeling of their products. Related regulations require that food producers retain
records establishing the basis for the information contained in the label or labeling of their
products and provide those records to regulatory officials (21 CFR part 1 – General Enforcement
Regulations). Finally, certain regulations provide for the submission of food labeling petitions to
FDA. Regulations governing food labeling may be found in parts 101, 102, 104, and 105 (21
CFR parts 101, 102, 104, and 105), and are issued under the authority of sections 4, 5, and 6 of
the Fair Packaging and Labeling Act (the 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 (the
FD&C Act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e). Most of the regulations
derive from section 403 of the FD&C Act, which provides that 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. The disclosure requirements and other collections of information
in the regulations in parts 101, 102, 104, and 105 are necessary to ensure that food products
produced or sold in the United States are in compliance with the labeling provisions of the
FD&C Act and the FPLA.
We are revising the information collection to include requirements found in part 101 that govern
the format and content of the Nutrition Facts (§ 101.9 (21 CFR 101.9)) and Supplement Facts
(§ 101.36 (21 CFR 101.36)) labels (currently approved under OMB control number 0910-0813).
The associated information collection was established in support of rulemaking (RIN 0910AF22) for which the resulting regulations have now become effective.
To assist respondents with the information collection, we have developed the following agency
guidance documents:

Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on
an Authoritative Statement of a Scientific Body (https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/guidance-industry-notification-health-claim-ornutrient-content-claim-based-authoritative-statement);
Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section
403(r)(6) of the Federal Food, Drug, and Cosmetic Act (https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/guidance-industry-substantiation-dietarysupplement-claims-made-under-section-403r-6-federal-food); and
Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary
Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act (https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/guidance-industry-questions-and-answers-regarding-labeling-dietarysupplements-required-dietary).
We have also developed Form FDA 3570 - Model Small Business Nutrition Labeling Exemption
Notice, which enables small entities to request certain exemptions from the labeling
requirements.
Accordingly, we are requesting OMB approval of the information collection provisions in 21
CFR parts 101, 102, 104, and 105; Form FDA 3570; and the agency guidance documents
identified and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The purpose of our food labeling requirements is to ensure that products offered to consumers
includes specific disclosures and is not misbranded. Consumers need to be knowledgeable about
foods they purchase. Nutrition labeling provides information for use by consumers in selecting a
nutritious diet. 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. Products not in compliance with section 403 of the
FD&C Act and parts 101, 102, 104, and 105 of our implementing food labeling regulations may
be rendered misbranded under the FD&C Act and the manufacturer and the product subject to
regulatory action. We use information submitted in nutrient content claim or health claim
petitions to verify nutrient and health claims. The requirements in §§ 101.69 and 101.70 are
those that we believe are necessary to fulfill the requirements of the FD&C Act. We also use
information submitted to verify that a Scientific Body of the United States Government or the
National Academy of Sciences has published an authoritative statement which is currently in
effect about the level of the nutrient to which the nutrient content claim refers, or about the
relationship between the nutrient and the disease or health related condition to which the health
claim refers, and that the claim is an accurate representation of that statement.

We use information reported under the provisions of §§ 101.9(j)(18) and 101.36(h)(2) to
determine whether and, if appropriate, to grant small businesses exemption requests regarding
nutrition labeling for low-volume food products. Under section 403(q)(5)(E) of the FD&C Act,
a low-volume food product is exempt from the requirements for nutrition labeling if it is the
subject of a notice from a small business claiming the exemption provided by the Nutrition
Labeling and Education Act Amendments of 1993. Those food products that are not the subject
of such a notice are not exempt from the mandatory nutrition labeling requirements of section
403(q) of the FD&C Act unless the food qualifies for another exemption. Section 403(q)(5)(E)
of the FD&C Act does not require that the information in a notice claiming exemption be
reviewed by FDA for the exemption to be in effect. However, we do review the information in
each notice to determine whether it meets the requirements for the notice established in section
403(q)(5)(E)(iii) of the FD&C Act. We provide the information on the identity of firms
submitting notices claiming exemption to our field personnel and to State enforcement agencies
by posting the names and addresses of the firms on a website maintained by the agency.
We use information in petitions submitted under the provisions of § 101.12(h) to determine
whether a new reference amount should be established, or an existing reference amount should
be amended. The consequence of not having this information is that we would be restricted in
obtaining the information necessary to amend or add to the regulation on reference amounts
customarily consumed (RACCs).
We use information submitted in response to the provisions for alternative approaches contained
in §§ 101.9(g)(9) and 101.36(f)(2) to determine whether such alternative approaches would be
consistent with the requirements for nutrition labeling in section 403(q) of the FD&C Act. The
consequences of not having this information would be a reduced flexibility of the manufacturer
to use alternative approaches for complying with the requirements of section 403(q) of the
FD&C Act for the nutrition labeling of food products.
Data generated by the food labeling experiments permitted under § 101.108 may form the basis
for a citizen’s petition to amend the existing food labeling regulations. The data could also be
useful to FDA for evaluating whether changes in current food labeling requirements are
warranted, and for developing alternative labeling formats that may be useful to consumers and
manufacturers. The extent of the collection of information is determined by the firm proposing
the labeling experiment and is of benefit to this firm. However, the labeling changes proposed
by a firm could not be implemented without supporting information favoring the proposed
changes.
Description of Respondents: Respondents to this information collection are manufacturers,
packers, and distributors of food products. Because of the existence of exemptions and
exceptions, not all of the requirements apply to all food producers or to all of their products.
Some of the regulations affect food retailers, such as supermarkets and restaurants. Respondents
include the private sector (including for-profit businesses, not-for-profit institutions and farms).
3. Use of Improved Information Technology and Burden Reduction
The regulations in parts 101, 102, 104, and 105 do not specifically prescribe the use of
automated, electronic, mechanical, or other technological techniques or other forms of
information technology as necessary for use by firms. Companies are free to use whatever forms

of information technology may best assist them in developing notifications or meeting labeling
requirements for food. We have developed a web-based data entry system so small business may
electronically claim exemption from the requirements for nutrition labeling. Information
regarding this system is available from our website at:
https://www.fda.gov/food/labeling-nutrition-guidance-documents-regulatory-information/smallbusiness-nutrition-labeling-exemption
We estimate that ninety percent (90%) of the respondents will use electronic means to submit the
request for exemption.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
We estimate that approximately ten percent (10%) of the respondents are small businesses,
however we believe the information collection poses no undue burden on small entities. The
requirements are the minimum requirements for complying with the provisions of the FD&C
Act, however our regulations provide for certain exemptions. In most cases, the information that
is required to be disclosed or submitted to the agency is information that is available to a firm,
including a small business, as a normal course of its doing business. Small businesses may claim
exemption from the requirements for nutrition labeling under the provisions of 21 CFR
101.9(j)(18) and 101.36(h)(2). We aid small businesses in dealing with the requirements of the
FD&C Act through the agency’s Regional Small Business Representatives and through the
scientific and administrative staffs within the agency. We have provided a Small Business Guide
on our website at https://www.fda.gov/industry/small-business-assistance.
6. Consequences of Collecting the Information Less Frequently
Data collection is consistent with statutory and regulatory requirements, and established at
intervals that facilitate efficient agency review.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
We published a 60-day notice for public comment in the Federal Register of February 5, 2020
(85 FR 6551). One comment was received suggesting we consider including labeling
requirements pertaining to folic acid. We appreciate this comment. A second comment was
received but was not responsive to the information collection topics solicited. Neither comment
suggested we revise our burden estimates, and we therefore retain those estimates provided in
our 60-notice and included in this supporting statement.

9. Explanation of Any Payment or Gift to Respondents
This information collection does not provide for payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
In preparing this supporting statement, we consulted with our Privacy Office to ensure
appropriate handling of information collected. Information submitted to FDA under the food
labeling regulations may contain trade secret and commercial confidential information. Only
information that is releasable under the agency’s regulations in 21 CFR part 20 would be
released to the public. This information is also safeguarded by Section 301(j) of the FD&C Act
and would be protected from disclosure under the Freedom of Information Act (FOIA) under
sections 552(a) and (b) (5 U.S.C. 552(a) and (b)).
Privacy Act
This ICR does not collect personally identifiable information (PII) or information of a personal
nature. PII collected via Form FDA 3570 (Small Business Nutrition Labeling Exemption Notice
Model Form) includes the respondent’s name and telephone number. The information collected
is for business contact purposes only. In addition, the information collected and stored is not
subject to the Privacy Act of 1974 and the particular notice and other requirements of the Privacy
Act do not apply. Specifically, FDA (including vendors or service providers acting on behalf of
FDA) does not use name or any other personal identifier to retrieve records from the information
collected.
11. Justification for Sensitive Questions
This information collection does not involve questions that are of a personally sensitive nature.
12. Estimates of Annualized Burden Hours and Cost
12a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden1
21 CFR Section; Activity

101.9(c)(6)(i); dietary fiber
101.9(j)(18) and 101.36(h)(2);
procedure for small business
nutrition labeling exemption
notice using Form FDA 3570
101.12(h); petitions to establish
or amend a RACC

No. of
Respondents

No. of
Responses
per
Respondent

Total Annual
Responses

Average
Burden per
Response

Total
Hours

10,000

80,000

400

101.69; petitions for nutrient
content claims

101.70; petitions for health
claims

400

101.108; written proposal for
requesting temporary exemptions
from certain regulations for the
purpose of conducting food
labeling experiments

TOTAL
1

10,042

80,943

There are no capital costs or operating and maintenance costs associated with this collection of information.

Manufacturers of food products that contain an isolated or synthetic non-digestible
carbohydrate that is not listed in the definition of dietary fiber have the option of submitting a
citizen petition to FDA requesting us to amend the definition of "dietary fiber" to include the
carbohydrate as a listed dietary fiber, by demonstrating the physiological benefits of the
isolated or synthetic non-digestible carbohydrate to human health.
We estimate that there are approximately 28 isolated or synthetic non-digestible carbohydrates
that do not meet the definition of dietary fiber. Once a citizen petition filed by a manufacturer
related to a particular isolated or synthetic non-digestible carbohydrate is granted or denied, or
the carbohydrate is the subject of an authorized health claim, and the dietary fiber is listed in the
definition of dietary fiber, the use of the dietary fiber as an ingredient in any food product must
be included in the total amount of dietary fiber declared in nutrition labeling for such product.
Thus, we estimate that 28 manufacturers would incur burden associated with filing a citizen
petition to amend the listing of dietary fiber related to an isolated and synthetic non-digestible
carbohydrate that is not currently listed in the definition of dietary fiber and that the required
reporting burden is 1 hour per manufacturer. This calculation is shown in Table 1, row 1.
Also, while § 101.108 was promulgated to provide a petition procedure for certain food
labeling exemptions, no such petitions have been received in the recent past, and we therefore
provide an estimate of 1 to reserve approval of any future collection under this part.
Table 2.--Estimated Annual Recordkeeping Burden1
21 CFR Section; Activity
No. of
No. of
Total
Recordkeepers Records per
Annual
Recordkeeper Records

Average
Burden per
Recordkeeping

Total
Hours

101.9(c)(6)(iii); added sugars2

31,283

101.9(c)(6)(i); dietary fiber2

31,283

101.9(c)(6)(i)(A); soluble fiber2

31,283

101.9(c)(6)(i)(B); insoluble fiber2

31,283

101.9(c)(8); vitamin E3

31,283

101.9(c)(8); folate/folic acid3

31,283

New Products

216

101.7(t); recordkeeping pertaining to
disclosure requirements for food not
accurately labeled for quantity of
contents

100

101.12(e); recordkeeping to document
the basis for density-adjusted RACC

300,000

1.5

450,000

0.75

337,500

300,000

1.5

450,000

0.75

337,500

101.13(q)(5); recordkeeping to
document the basis for nutrient
content claims
101.14(d)(2); recordkeeping to
document nutrition information
related to health claims for
food products
101.22(i)(4); recordkeeping to
document supplier certifications for
flavors designated as containing no
artificial flavors

1,000
1
1,000
1
1,000
101.100(d)(2); recordkeeping
pertaining to agreements that form the
basis for an exemption from the
labeling requirements of section
403(c), (e), (g), (h), (i), (k), and (q) of
the FD&C Act
TOTAL
1,089,064
864,064
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
2
These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for
added sugars, dietary fiber, and soluble and insoluble fiber. Manufacturers will only need to keep records for
products with both added and naturally occurring sugars, added sugars that undergo fermentation in certain
fermented foods, and products with non- digestible carbohydrates (soluble or insoluble) that do and do not meet
the definition of dietary fiber.
3
These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for
vitamin E and folate/folic acid. The declaration of vitamin E and folate/folic acid is not mandatory unless a
health or nutrient content claim is being made or these nutrients are directly added to the food for enrichment
purposes.

Based on our experience with food labeling regulations, records that are required to be retained
are records that a prudent and responsible manufacturer uses and retains as a normal part of
doing business, e.g., analyses of nutrient databases, recipes or formulations, batch records, or
other records. Thus, the recordkeeping burden of this collection of information consists of the
time required to identify and assemble the records for copying and retention.
The declarations for added sugars, dietary fiber, soluble fiber, and insoluble fiber are mandatory,
and we conservatively estimate roughly 31,283 food manufacturers would incur this
recordkeeping burden and the required recordkeeping would be 1 hour per manufacturer. These
calculations are reflected in Table 2, rows 1 to 4. The declaration of vitamin E and folate/folic
acid is not mandatory unless a health or nutrient content claim is being made or these nutrients

are directly added to the food for enrichment purposes. However, we conservatively estimate
that 31,283 respondents would incur this recordkeeping burden and that the required
recordkeeping would be 1 hour per manufacturer. These calculations are reflected in Table 2,
rows 5 and 6.
We estimate that the number of newly introduced products that are covered under this collection
of information is 216. We assume the required recordkeeping is 1 hour per product, for an
annual recurring recordkeeping burden of 216 hours, as reflected in Table 2, row 7. Adding all
of the burden from OMB Control Numbers 0910-0381 and 0910-0813 results in a total of
864,064 annual recordkeeping burden hours.
Table 3.--Estimated Annual Third-Party Disclosure Burden1
21 CFR Section; Activity

No. of
Respondents

No. of
Disclosures per
Respondent

Total Annual
Disclosures

Avg.
Burden per
Disclosure

Total
Hours

101.3, 101.22, 102 and 104;
statement of identity labeling
requirements
101.4, 101.22, 101.100, 102, 104
and 105; ingredient labeling
requirements

25,000

1.03

25,750

0.5

12,875

25,000

1.03

25,750

101.5; requirement to specify the
name and place of 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

25,000

1.03

25,750

0.25

6,438

101.9, 101.13(n), 101.14(d)(3),
101.62, and 104; labeling
requirements for disclosure of
nutrition information
101.9(g)(9) and 101.36(f)(2);
alternative means of compliance
permitted

25,000

1.03

25,750

103,000

300,000

1.5

450,000

0.25

112,500

101.12(b); RACC for baking powder,
baking soda and pectin

2.3

101.12(e); adjustment to the RACC
of an aerated food permitted

5,000

101.10; requirements for nutrition
labeling of restaurant foods

101.12(g); requirement to 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;
requirements to disclose nutrition
information for any food product for
which a nutrient content claim is
made

200

101.13(j)(2), 101.13(k), 101.54,
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

5,000

101.13(q)(5); requirement that
restaurants disclose the basis for
nutrient content claims made for
their food

300,000

1.5

450,000

0.75

337,500

101.14(d)(2); general requirements
for disclosure of nutrition
information related to health claims
for food products

300,000

1.5

450,000

0.75

337,500

101.15; requirements pertaining to
prominence of required statements
and use of foreign language

160

1,600

12,800

101.22(i)(4); supplier certifications
for flavors designated as containing
no artificial flavors

1,500

7,500

300

12,000

4.025

48,300

1,000

0.5

500

1,000

0.25

250

100

0.25

101.30 and 102.33; labeling
requirements for fruit or vegetable
juice beverages
101.36; nutrition labeling of dietary
supplements
101.42 and 101.45; nutrition
labeling of raw fruits, vegetables, and
fish
101.45(c); databases of nutrient
values for raw fruits, vegetables,
and fish
101.79(c)(2)(i)(D); disclosure
requirements for food labels that
contain a folate/neural tube defect
health claim
101.79(c)(2)(iv); disclosure of
amount of folate for food labels that
contain a folate/neural tube defect
health claim

101.100(d); disclosure of 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

1,000

101.7 and 101.100(h); disclosure
requirements for food not accurately
labeled for quantity of contents and
for claiming certain labeling
exemptions

25,000

1.03

25,750

0.5

12,875

Nutritional labeling for new products

500

1,000

TOTAL
1

1,513,799

1,030,258

There are no capital costs or operating and maintenance costs associated with this collection of information.

Under §§ 101.9 and 101.12, some manufacturers of retail food products make labeling changes
to modify the serving sizes and other nutrition information based on changes to what products
may be or are required to be labeled as a single serving, or based on updated, modified, or
established RACCs. We estimate that about 500 new products will be affected by these
requirements each year and that the associated disclosure burden is 2 hours per product, for an
annual burden of 1,000 hours. The estimated annual reporting, recordkeeping, and third-party
disclosure burdens are based on our communications with industry and our knowledge of and
experience with food labeling and the submission of petitions and requests to us.
12b. Annualized Cost Burden Estimate
We estimate that the total annualized cost burden to respondents associated with the
requirements of part 101 of the regulations to be approximately $194,326,570.70. We
estimate a respondent’s average wage to be commensurate to that of a Federal
government employee at the GS-13/Step-1 rate for the Washington-Baltimore locality
pay area for the year 2020, $49.19 per hour. To account for overhead, this cost is
increased by 100 percent, making the estimated cost burden to the respondent $98.38 per
hour. Using these figures, the agency estimates the cost burden for reporting to be
$7,963,172.34 (80,943 hours x $98.38 per hour), the burden hour cost for recordkeeping
to be $85,006,616.32 (864,064 hours x $98.38 per hour); and, the cost burden for thirdparty disclosure to be $101,356,782.04 (1,030,258 hours x $98.38 per hour), for a total
annualized burden hour cost of $194,326,570.70.
Activity

Hourly Wage Rate

Reporting

Total Burden
Hours
80,943

$98.38

Total Respondent
Costs
$7,963,172.34

Recordkeeping

864,064

$98.38

$85,006,616.32

Third-Party
Disclosure
Total

1,030,258

$98.38

$101,356,782.04
$194,326,570.70

13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs
There are no capital, start-up, operating, or maintenance costs associated with this collection.
14. Annualized Cost to the Federal Government
Our total cost to the Federal government estimate is $5,900,498. We assume collecting and
analyzing samples to determine compliance with requirements for dietary supplements to require
14.2 FTEs annually. Using a fully-loaded salary cost of $180,000 annually, we calculate that
$2,556,000 will be allocated for this activity. Based on our experience, we also estimate that we
will utilize annually 14.7 FTEs to inspect firms and collect and analyze samples of conventional
foods to determine compliance with the various food labeling provisions. Similarly, we use a
fully-loaded salary cost of $180,000 annually to calculate a cost of $2,646,000 per year. Finally,
we estimate that 7,100 hours is expended in the review of petition and notice submissions.
Assuming agency FTEs at a wage rate for a GS-13, Step 1 in the Washington-Baltimore area will
review and evaluate the submissions at a rate of $98.38 per hour, we calculate a cost of
$698,498 annually.
15. Explanation for Program Changes or Adjustments
The information collection reflects adjustment. As a result of consolidating burden applicable to
provisions associated with the Nutrition Facts and Supplemental Facts labels (previously
included under OMB control no. 0910-0813), we have increased the number of annual responses
by 188,442 and associated burden hours by 188,942.
16. Plans for Tabulation and Publication and Project Time Schedule
The information from this collection will not be published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of OMB expiration date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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