[Federal Register Volume 85, Number 98 (Wednesday, May 20, 2020)]
[Notices]
[Pages 30711-30713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10824]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1155]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Labeling
Regulations
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 June 19, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. All comments should be
identified with the OMB control number 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, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
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 Regulations
OMB Control Number 0910-0381--Revision
This information collection supports our food labeling regulations
and associated Agency guidance. Under the authority of 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), we have issued regulations
regarding the labeling of food. The regulations are codified in parts
101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105) and
implement statutory provisions 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. While part 101 sets 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 disclosure requirements, along with the reporting and
recordkeeping provisions, are necessary 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. 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.
Specifically, the regulations set forth the general content and
format requirements for food packaging, including nutrition and
ingredient information. Additional regulations provide for nutrient
content claims. To assist respondents in this regard, we developed the
document entitled ``Guidance for Industry: Notification of a Health
Claim or Nutrient Content Claim Based on an Authoritative Statement of
a Scientific Body.'' The guidance is available from our website at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-notification-health-claim-or-nutrient-content-claim-based-authoritative-statement. The guidance communicates
our recommendations regarding food labeling claims associated with
regulations found in Sec. Sec. 101.13, 101.14, 101.54, 101.69, and
101.70. It was developed to assist respondents in satisfying criteria
found or discussed in these regulations regarding the submission of
notifications for certain health claims and identifies information to
include and information we will evaluate in determining compliance with
statutory requirements (e.g., supporting literature; discussion of
analytical methodology or methodologies used in support of a particular
claim).
The regulations also include provisions applicable to the labeling
of dietary supplements. To assist respondents in this regard and in
understanding provisions under the Dietary Supplement and
Nonprescription Drug Consumer Protection Act (Pub. L. 109-462), we
developed the guidance entitled ``Questions and Answers: Labeling of
Dietary Supplements as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act.'' The guidance is
available from our website at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-labeling-dietary-supplements-required-dietary.
The guidance communicates the following information: (1) What
``domestic address'' means for purposes of the dietary supplement
labeling requirements in section 403(y) of the FD&C Act; (2) FDA's
recommendation for the use of an introductory statement
[[Page 30712]]
before the domestic address or phone number that is required to appear
on the product label under section 403(y); and (3) when FDA intends to
begin enforcing the labeling requirements of section 403(y).
The guidance entitled ``Substantiation for Dietary Supplement
Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and
Cosmetic Act'' has also been developed to assist respondents to the
information collection. The guidance is available from our website at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food. The guidance discusses the
requirement that a manufacturer of a dietary supplement making a
nutritional deficiency, structure/function, or general well-being claim
have substantiation that the claim is truthful and not misleading. The
guidance is intended to describe the amount, type, and quality of
evidence FDA recommends that a manufacturer have to substantiate a
claim under section 403(r)(6) of the FD&C Act.
Finally, we are revising the information collection by
consolidating elements associated with revised Nutrition Facts and
Supplement Facts labels regulations. Requirements included among the
food labeling regulations found in part 101 govern both format and
content of the Nutrition Facts (Sec. 101.9) and Supplement Facts
(Sec. 101.36) labels. Currently, the information collection associated
with food labeling under Sec. Sec. 101.9 (including petitions filed
under 101.9(c)) and 101.36 (disclosures associated with serving size)
is approved under OMB control number 0910-0813. These provisions were
established by rulemaking (RIN 0910-AF22) and have now been
incorporated into the regulations in part 101.
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.
In the Federal Register of February 5, 2020 (85 FR 6551), we
published a notice inviting public comment on the proposed collection
of information. One comment was received suggesting FDA consider
including labeling requirements pertaining to folic acid, while a
second comment was received that was not responsive to the information
collection topics solicited. Neither comment suggested we revise our
burden estimates, which are as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Number of responses Total Average
21 CFR section; activity respondents per annual burden per Total hours
respondent responses response
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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); procedure for 10,000 1 10,000 8 80,000
small business nutrition labeling exemption
notice using Form FDA 3570....................
101.12(h); petitions to establish or amend 5 1 5 80 400
referenced amounts customarily consumed (RACC)
101.69; petitions for nutrient content claims.. 3 1 3 25 75
101.70; petitions for health claims............ 5 1 5 80 400
101.108; written proposal for requesting 1 1 1 40 40
temporary exemptions from certain regulations
for the purpose of conducting food labeling
experiments...................................
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Total...................................... ........... ........... 10,042 ........... 80,943
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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 Total
21 CFR section; activity Number of records per annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping
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101.9(c)(6)(iii) \2\; added 31,283 1 31,283 1....................... 31,283
sugars.
101.9(c)(6)(i) \2\; dietary 31,283 1 31,283 1....................... 31,283
fiber.
101.9(c)(6)(i)(A) \2\; soluble 31,283 1 31,283 1....................... 31,283
fiber.
101.9(c)(6)(i)(B) \2\; 31,283 1 31,283 1....................... 31,283
insoluble fiber.
101.9(c)(8) \3\; vitamin E..... 31,283 1 31,283 1....................... 31,283
101.9(c)(8) \3\; folate/folic 31,283 1 31,283 1....................... 31,283
acid.
New products................... 216 1 216 1....................... 216
101.12(e); recordkeeping to 25 1 25 1....................... 25
document the basis for density-
adjusted RACC.
101.13(q)(5); recordkeeping to 300,000 1.5 450,000 0.75 (45 minutes)....... 337,500
document the basis for
nutrient content claims.
101.14(d)(2); recordkeeping to 300,000 1.5 450,000 0.75 (45 minutes)....... 337,500
document nutrition information
related to health claims for
food products.
101.22(i)(4); recordkeeping to 25 1 25 1....................... 25
document supplier
certifications for flavors
designated as containing no
artificial flavors.
101.100(d)(2); recordkeeping 1,000 1 1,000 1....................... 1,000
pertaining to 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 100 1 100 1....................... 100
pertaining to disclosure
requirements for food not
accurately labeled for quality
of contents.
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Total...................... ............. ............ 1,089,064 ........................ 864,064
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\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.
[[Page 30713]]
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Number of disclosures Total Average burden per
21 CFR section; activity respondents per annual disclosure Total hours
respondent disclosures
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101.3, 101.22, parts 102 and 104; 25,000 1.03 25,750 0.5 (30 minutes)......... 12,875
statement of identity 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 the 25,000 1.03 25,750 0.25 (15 minutes)........ 6,438
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.
101.9, 101.13(n), 101.14(d)(3), 25,000 1.03 25,750 4........................ 103,000
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 minutes)........ 112,500
nutrition labeling of 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 RACC 25 1 25 1........................ 25
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 that 300,000 1.5 450,000 0.75 (45 minutes)........ 337,500
restaurants disclose the basis
for nutrient content claims made
for their food.
101.14(d)(2); general 300,000 1.5 450,000 0.75 (45 minutes)........ 337,500
requirements for disclosure of
nutrition information related to
health claims for food products.
101.15; requirements pertaining 160 10 1,600 8........................ 12,800
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 minutes)......... 500
labeling of raw fruits,
vegetables, and fish.
101.45(c); databases of nutrient 5 4 20 4........................ 80
values for raw fruits,
vegetables, and fish.
101.79(c)(2)(i)(D); disclosure 1,000 1 1,000 0.25 (15 minutes)........ 250
requirements for food labels
that contain a folate/neural
tube defect health claim.
101.79(c)(2)(iv); disclosure of 100 1 100 0.25 (15 minutes)........ 25
amount of folate for food 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)-(i), (k), and (q) of
the FD&C Act.
101.7 and 101.100(h); disclosure 25,000 1.03 25,750 0.5 (30 minutes)......... 12,875
requirements for 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.
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Total........................ ........... ........... 1,513,799 ......................... 1,030,258
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Because of the consolidation of OMB control number 0910-0813, our
estimate reflects an annual increase of 188,442 responses and 188,282
hours. These estimates are based on our experience with food labeling,
related submissions of petitions, and informal communications with
industry.
Dated: May 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10824 Filed 5-19-20; 8:45 am]
BILLING CODE 4164-01-P