0813 NFL SSA 2019 Ext

UNITED STATES FOOD AND DRUG ADMINISTRATION
Food Labeling:
Nutrition Facts Label and Supplement Facts Label
OMB Control No. 0910-0813
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports requirements for the Nutrition Facts and Supplemental
Facts labels. Section 403(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 343(q)) specifies certain nutrients to be declared in nutrition labeling and authorizes
the Secretary of Health and Human Services (Secretary) to require other nutrients to be
declared if the Secretary determines that provide such information will assist consumers in
maintaining healthy dietary practices. The Secretary also has discretion under section
403(q) of the FD&C Act to remove, by regulation and under certain circumstances, nutrient
information that is otherwise explicitly required in food labeling under this section. We
have also taken these actions consistent with current data on the associations between
nutrients and chronic diseases, health-related conditions, physiological endpoints, and/or
maintaining a healthy dietary pattern that reflects current public health conditions in the
United States.
Regulations in § 101.9 (21 CFR 101.9) establish standards defining serving size and
requiring that certain products provide additional information within the Nutrition Facts
label that conveys that information to consumers. The regulations are based on current
scientific evidence and dietary recommendations of most recent consensus reports.
Regulations at 21 CFR 101.9, 101.12, and 101.36 provide the list of nutrients that are
required or permitted to be declared; provide Daily Reference Values and Reference Daily
Intake values that are based on current dietary recommendations from consensus reports;
provide requirements for foods represented or purported to be specifically for children
under the age of 4 years and pregnant and lactating women and establish nutrient reference
values specifically for these population subgroups; and provide the format and appearance
of the Nutrition Facts label.
Section 101.12 defines a single-serving container; requires dual-column labeling for
certain containers; establishes several reference amounts customarily consumed (RACCs);
and provides the label serving size for breath mints.
We therefore request extension of OMB approval for the information collection provisions
found in the applicable regulations and discussed in this supporting statement.

2. Purpose and Use of the Information Collection
We believe that the information collection provisions are necessary because analytical
methods are not available that would allow us to verify labeling declarations. Consumers
rely on this information to make healthy dietary choices. Because of the increased
prevalence of obesity and diabetes and high rates of chronic diseases such as heart disease
and stroke in the United States, treatment and prevention of these diseases continue to be a
major public health concern and a national priority.
We believe that the regulations associated with this collection of information better align the
information provided in the Nutrition Facts label with data on consumption, dietary
recommendations, and scientific evidence on the relationship between nutrition and chronic
disease; improve the design and content of the Nutrition Facts label to make relevant label
information more salient and easy to understand so that consumers may make more
informed decisions; and potentially prompt industry to reformulate products to maintain
health and nutrient content claims. We also believe that the information collection
provisions associated with RACCs and breath mints better inform consumers who purchase
these food products.
Description of Respondents: Respondents to the collection of information are manufacturers
of food products sold in the United States.
3. Use of Improved Information Technology and Burden Reduction
While this collection of information does not require the use of electronic reporting or
recordkeeping, we encourage this approach and believe respondents currently utilize
information technology to satisfy information collection provisions required under other
Federal regulations regarding the labeling and manufacture of food and its delivery or
introduction for delivery into interstate commerce. Similarly, we expect that third-party
disclosure provisions imposed by the collection of information will be addressed through
automated labeling processes currently employed by respondents to the collection of
information. Therefore, we estimate that one-hundred percent (100%) of the notifications
will be submitted electronically over next three years.
4. Efforts to Identify Duplication and Use of Similar Information
Information about the nutrient content of foods is mandated under the Nutrition Labeling
and Education Act (NLEA) of 1990 and the Dietary Supplement Health and Education Act
of 1994 (DSHEA). We believe these information collection requirements are consistent
with these statutory authorities in conjunction with authority under the FD&C Act, and we
are unaware of any duplicative collection requirements.
5. Impact on Small Businesses or Other Small Entities
We estimate approximately 98 percent of respondents are small businesses, however the
regulations do provide for certain exemptions. Specifically, we allow certain small

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businesses whose products do not sell more than 100,000 units to apply for a labeling
exemption for that particular product. Such an exemption is granted for 12 months (on a per
product basis) and the business has the option to re-apply for a continuation of this
exemption.
6. Consequences of Collecting the Information Less Frequently
Information collection occurs on an occasional basis and is consistent with statutory and
regulatory requirements.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice inviting public comment
in the Federal Register of April 19, 2019 (84 FR 16513). We received one comment that
suggested increasing font size for the number of servings and supported the overall goals of
food labeling and making information available to consumers. As explained in our 30-day
publication of July 22, 2019 (84 FR 35119), because the Nutrition Facts label has limited
space to inform consumers of the nutritional content of the product, increasing the font size
for the number of servings would impact other nutritional information that is included and
we decline to adopt the suggestion.
9. Explanation of Any Payment or Gift to Respondents
This information collection does not provide for payment or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
Records that may be reviewed during FDA inspections are subject to FDA regulations in 21
CFR part 20. Confidential commercial information is protected from disclosure under FOIA
in accordance with section 552(a) and (b) (5 U.S.C. 552(a) and (b)) and by part 20. To the
extent that § 20.64 applies, we will honor the confidentiality of any data in investigation
records compiled for law enforcement purposes.
Privacy Act
This ICR request does not contain any personally identifiable information and does not
include a form that requires a Privacy Act Statement under 5 U.S.C. § 552a(e)(3).
11. Justification for Sensitive Questions
The information collection does not contain questions of a sensitive nature.

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12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:
Table 1.--Estimated Annual Recordkeeping Burden1
Type of Declaration; 21
CFR Section

No. of
Recordkeepers

No. of Records
per
Recordkeeper

Total
Annual
Records

Average
Burden per
Recordkeeping

Total
Hours

Added Sugars;
101.9(c)(6)(iii)2
Dietary Fiber;
101.9(c)(6)(i)2
Soluble Fiber;
101.9(c)(6)(i)(A)2
Insoluble Fiber;
101.9(c)(6)(i)(B)2
Vitamin E; 101.9(c)(8)3
Folate/Folic Acid;
101.9(c)(8)3
New Products
Total

31,283

1

31,283

1

31,283

31,283

1

31,283

1

31,283

31,283

1

31,283

1

31,283

31,283

1

31,283

1

31,283

31,283
31,283

1
1

31,283
31,283

1
1

31,283
31,283

216

1

216

1

216
187,914

1

There are no capital costs or operating and maintenance costs associated with this collection of information.
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 nondigestible carbohydrates (soluble or insoluble) that do and do not meet the definition of dietary fiber.
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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.
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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.
Based on our previous experience with similar information collections, we estimate the
recordkeeping burden to be 1 hour per product as estimated in table 1.
The declarations for added sugars, dietary fiber, soluble fiber, and insoluble fiber are
mandatory, and we conservatively estimate all of the 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 1, 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 all 31,283 respondents would incur this

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recordkeeping burden and that the required recordkeeping would be 1 hour per
manufacturer. These calculations are reflected in table 1, 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 1,
row 7. Adding the burden from new products to the burden for existing products results in a
total of 187,914 annual recordkeeping burden hours.
Table 2.--Estimated Annual Reporting Burden1
Filing of citizen petition
regarding a particular isolated or
synthetic non-digestible
carbohydrate
Dietary Fiber; 101.9(c)(6)(i)
1

No. of
Respondents
28

No. of
Total
Responses
Annual
per
Responses
Respondent
1
28

Total
Average
Hours
Burden
per
Response
1
28

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 nondigestible carbohydrate that is not currently listed in the definition of dietary fiber and that
the required recordkeeping would be 1 hour per manufacturer. This calculation is shown in
table 2.
Table 3.--Estimated Annual Third-Party Disclosure Burden

21 CFR 101.9
Nutritional labeling for new
products
1

No. of
Respondents
500

No. of
Total
Disclosures per
Annual
Respondent
Disclosures
1
500

Average
Burden per
Disclosure
2

Total
Hours
1,000

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,
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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.
12b. Annualized Cost Burden Estimate
The mean hourly wage of an operations manager in the food manufacturing industry
is $59.37 (Bureau of Labor Statistics. May 2018 National Industry-Specific Occupational
Employment and Wage Estimates; NAICS 31100 – Food Manufacturing). We increase this
cost by 100 percent to account for benefits and overhead, for a total of $118.74 ($59.37 x 2).
We therefore estimate the annualized cost incurred by respondents to be $22,434,973.08
(188,942 burden hours x $118.74/hr).
Table 4. -- Estimated Respondent Burden Cost
Activity
Total
Hourly Wage
Total Respondent
Burden
Rate
Costs
Hours
Recordkeeping
187,914
$118.74
$22,312,908.36
Reporting
28
$118.74
$3,324.72
3rd Party
1,000
$118.74
$118,740
Disclosure
Total
$22,434,973.08
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating or maintenance costs associated with this
information collection.
14. Annualized Cost to the Federal Government
FDA’s review of the retained records would generally occur as part of its routine inspection
activities. We estimate that our review of the retained records would take five hours per
inspection. We estimate the hourly cost for review and evaluation to be $18.19 to $61.77
per hour, the GS 5/Step 1 rate to the GS 13/Step 10 rate for the Washington-Baltimore
locality pay area for the year 2019. To account for overhead, this cost is increased by 100
percent, making the total cost $36.38 to $123.54 per hour. The midpoint of this range is
$79.96 per hour. Thus, we estimate the cost to the Federal Government for the review of
records to be $399.80 per review ($79.96/hour x 5 hours). We estimate that it will review
records for an average of 500 inspections per year. Thus, we estimate that the total annual
cost to the Federal Government for reviewing records during inspections would be $199,900
($399.80 x 500 inspections) in 2019 dollars.

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15. Explanation for Program Changes or Adjustments
This information collection reflects adjustments resulting from regulations that have become
effective since last OMB review (RIN 0910-AF22). Accordingly, we have lowered our
third-party disclosure estimate to reflect that burden associated with changes in labeling
resulting from the new requirements has since been realized by respondents. This results in
a decrease of 1,149,158 annual disclosures and 2,299,816 burden hours attributable to those
labeling changes. We have also made corresponding cost adjustments.
16. Plans for Tabulation and Publication and Project Time Schedule
These information collection requirements will not be published, tabulated or manipulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not seeking approval not to display the expiration date. We will display the OMB
expiration date as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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