Nutrition Facts and Supplemental Facts Label Supporting Statement for PR

Food Labeling: Revision of the Nutrition Facts and Supplement Facts Label
RIN 0910-AF22
OMB Control No. 0910-NEW
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
Following the passage of the Nutrition Labeling and Education Act of 1990, which added section
403(q) of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 343(q)), FDA issued
various regulations related to nutrition information on food labels, including the declaration of
nutrients, the format for nutrition labeling, reference values for use in declaring the nutrient
content, and allowances for certain specified products to be exempt from nutrition labeling (21
CFR 101.9). In addition, following the passage of the Dietary Supplement Health and Education
Act of 1994, FDA amended its food labeling regulations to establish requirements for nutrition
labeling of dietary supplements (21 CFR 101.9(j)(6) and 21 CFR 101.36). Section 403(q) of the
Federal Food, Drug, and Cosmetic Act specifies certain nutrients to be declared in nutrition
labeling, and authorizes the Secretary of Health and Human Services to require other nutrients to
be declared if the Secretary determines that a nutrient will provide information regarding the
nutritional value of such food that will assist consumers in maintaining healthy dietary practices.
The Secretary also has discretion under section 403(q) of the FFDCA to remove, by regulation
and under certain circumstances, nutrient information that is otherwise explicitly required in food
labeling under this section. In the proposed rule “Food Labeling: Revision of the Nutrition and
Supplement Facts Labels,” FDA is proposing to revise its regulations to provide updated
nutrition information on the label and improve how the nutrition information is presented to
consumers, in light of current scientific evidence, dietary recommendations of most recent
consensus reports, and public comments received in response to advance notices of proposed
rulemaking.
This information collection is being requested to support FDA regulations at 21 CFR Part 101.
2. Purpose and Use of the Information Collection
Federal Government: Under the NFL proposed rule, FDA is requiring that manufacturers make
and keep records to verify declarations in their food labeling regarding certain nutrients. We
believe these requirements are necessary because analytical methods are not available that would
allow us to verify labeling declarations and consumers rely on this information. The information
collection requirements of the proposed rule allow the agency to determine whether products
comply with FDA regulations.
Individuals/Households: The Nutrition Facts label contains nutrient content information on
which consumers rely 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 has become a major public health

concern and a national priority. FDA believes that provisions of the proposed rule (i) better
aligns the information provided in the Nutrition Facts label with new data on consumption,
dietary recommendations, and scientific evidence on the relationship between nutrition and
chronic disease, (ii) improves 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 (iii) potentially prompts industry to reformulate products to maintain
health and nutrient content claims.
3. Use of Improved Information Technology and Burden Reduction
While the proposed rule does not require the use of electronic reporting or recordkeeping, we
encourage this approach. Records must be made available to FDA upon request. We expect
most all facilities will utilize electronic means to satisfy the information collection requirements
of the proposed rule.
4. Efforts to Identify Duplication and Use of Similar Information
Disclosure of information about the nutrient content of foods is mandated under the Nutrition
Labeling and Education Act of 1990. We believe the information collection requirements under
the proposed rule are consistent with this statutory authority and we are unaware of any
duplicative collection requirements.
5. Impact on Small Businesses or Other Small Entities
We estimate the proposed rule will affect approximately 59,872 manufacturers, of which 98
percent are small businesses. The targeted exemption from labeling that currently exists for
some small businesses will continue to be available under the proposed rule. Currently, we
allow certain small 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. Currently, there are about 3,000 small businesses registered with FDA for a small
business nutrition labeling exemption. On average we grant labeling exemptions to
approximately 10,000 products per year.
6. Consequences of Collecting the Information Less Frequently
Under the proposed rule, we are requiring that manufacturers make and keep records to verify
the following declarations: added sugars, when a food product contains both naturally-occurring
sugars and added sugars, and for specific foods containing added sugars, alone or in combination
with naturally-occurring sugars, where the added sugars are subject to fermentation; isolated or
synthetic non-digestible carbohydrates that do not meet the proposed definition of dietary fiber;
different forms of vitamin E; and, folate/folic acid. Manufacturers would be required to maintain
the records to verify the label declaration of the aforementioned nutrients for a period of two
years after introduction or delivery for introduction of the food into interstate commerce. In
addition, we are proposing to require that such records be provided to FDA upon request, during
an inspection, for official review and photocopying or other means of reproduction, and that
records required may be retained either as original records, true copies (such as photocopies,
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pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original
records) or electronic records. Where reduction techniques such as microfilming are used,
suitable reader and photocopying equipment would need to be readily available.
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
A proposed rule entitled, “Food Labeling: Revision of the Nutrition and Supplement Facts
Labels,” was published in the Federal Register on March 3, 2014 (79 FR 11879).
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
Under the proposed rule, records required by part 101 will be protected from public disclosure to
the extent allowable under 21 CFR part 20. Our general policies, procedures, and practices
relating to the protection of confidential or otherwise protected information received from third
parties would apply to information received under this rule.
11. Justification for Sensitive Questions
The information collection does not contain questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
Description of Respondents: Respondents to the information collection are
manufacturers of retail food products marketed in the United States.
We estimate the burden of this collection of information as follows:
If the rule is finalized, the declarations for added sugars, dietary fiber, soluble fiber, and
insoluble fiber would be mandatory and we estimate that all respondents would incur
recordkeeping burden. We estimate 1 hour per recordkeeping provision, as shown in Table 1.
We estimate that there are fewer than 20 isolated and synthetic non-digestible carbohydrates that
do not meet the definition of dietary fiber. Once a citizen or health claim petition filed by a
manufacturer related to a particular isolated and synthetic non-digestible carbohydrate is granted
or denied, it applies to all food products that contain said non-digestible carbohydrate. Thus, we
estimate that, at most, 20 manufacturers would incur a recordkeeping burden associated with
filing a citizen or health claim petition related to an isolated and synthetic non-digestible
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carbohydrate that does not meet the definition of dietary fiber and that the required
recordkeeping would be 1 hour per manufacturer. 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 believe all estimated
respondents would incur this recordkeeping burden.
Table 1 – Estimated Annual Recordkeeping Burden1
Type of Declaration;
Proposed 21 CFR
Section

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
Dietary Fiber;
101.9(c)(6)(i) (filing
a claim)
Vitamin E ;
101.9(c)(8)3
Folate/Folic
Acid/101.9(c)(8)3
Total

No. of
Recordkeepers

No. of Records
per
Recordkeeper

Total
Annual
Records

Avg. Burden per
Recordkeeping

Total
Hours

59,872

1

59,872

1

59,872

59,872

1

59,872

1

59,872

59,872

1

59,872

1

59,872

59,872

1

59,872

1

59,872

20

1

20

1

20

59,872

1

59,872

1

59,872

59,872

1

59,872

1

59,872
359,252

1

There are no capital costs or operating and maintenance costs associated with this collection of information. Hours are
annualized over 3 years.
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 nondigestible 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.

12b. Annualized Cost Burden Estimate
The mean hourly wage of an operations manager in the food manufacturing industry is $53.56
(Bureau of Labor Statistics. May 2012 National Industry-Specific Occupational Employment and
Wage Estimates; NAICS 311000 - Food Manufacturing). We increase this cost by 50 percent to
account for benefits and overhead, for a total of $80.34 (= $53.56*1.5). We therefore estimate
the annualized cost incurred by respondents to be $28,862,305.68 (359,252 burden hours x
$80.34/hr).
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital costs associated with the information collection.
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14. Annualized Cost to the Federal Government
FDA’s review of the retained records would generally occur as part of its routine inspection
activities. FDA estimates that its review of the retained records would take five hours per
inspection. FDA estimates the hourly cost for review and evaluation to be $16.33 to $55.46 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 2012. To account for overhead, this cost is increased by 50 percent, making the
total cost $24.50 to $83.19 per hour. The midpoint of this range is $53.85 per hour. Thus, FDA
estimates the cost to the Federal Government for the review of records to be $269.25 per review
($53.85/hour x 5 hours). FDA estimates that it will review records for an average of 500
inspections per year. Thus, FDA estimates that the total annual cost to the Federal Government
for reviewing records during inspections would be $134,625 ($269.25 x 500 inspections) in 2012
dollars.
15. Explanation for Program Changes or Adjustments
This is a new information collection.
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 for OMB approval of the
information collection.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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