Food Labeling, 84465 [2016-28363]
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Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Rules and Regulations
meet the definition of electronic
signatures in § 11.3(b)(7) of this chapter
are exempt from the requirements of
part 11 of this chapter.
(f) Misbranding. A standard menu
item offered for sale in a covered
establishment shall be deemed
misbranded under sections 201(n),
403(a), 403(f) and/or 403(q) of the
Federal Food, Drug, and Cosmetic Act if
its label or labeling is not in conformity
with paragraph (b) or (c) of this section.
Provided, That the food bears no
nutrition claims or other nutrition
information in any context on the label
or in labeling or advertising. * * *
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[FR Doc. 2016–28363 Filed 11–22–16; 8:45 am]
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84465
requirements for the claim. Presentation
of nutrition labeling may be in various
forms, including those provided in
§ 101.45 and other reasonable means.
[79 FR 71253, Dec. 1, 2014]
[FR Doc. 2016–28364 Filed 11–22–16; 8:45 am]
BILLING CODE 1301–00–D
[FR Doc. 2016–28367 Filed 11–22–16; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
21 CFR Part 101
[79 FR 71253, Dec. 1, 2014]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Part 330
BILLING CODE 1301–00–D
Food Labeling
21 CFR Part 101
§ 101.10 Nutrition labeling of restaurant
foods whose labels or labeling bear nutrient
content claims or health claims.
Food Labeling
CFR Correction
In Title 21 of the Code of Federal
Regulations, parts 100 to 169, revised as
of April 1, 2016, on pages 43 and 44, in
§ 101.9, paragraphs (j)(1)(i), (2)
introductory text, (3) introductory text,
and the first sentence of (j)(4) are
revised to read as follows. And, on page
50, the effective date note at the end of
§ 101.9 is removed.
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Nutrition labeling of food.
mstockstill on DSK3G9T082PROD with RULES
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(j) * * *
(1)(i) Food offered for sale by a person
who makes direct sales to consumers
(e.g., a retailer) who has annual gross
sales made or business done in sales to
consumers that is not more than
$500,000 or has annual gross sales made
or business done in sales of food to
consumers of not more than $50,000,
Provided, That the food bears no
nutrition claims or other nutrition
information in any context on the label
or in labeling or advertising. Claims or
other nutrition information subject the
food to the provisions of this section,
§ 101.10, or § 101.11, as applicable.
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(2) Except as provided in § 101.11,
food products that are:
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(3) Except as provided in § 101.11,
food products that are:
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(4) Except as provided in § 101.11,
foods that contain insignificant amounts
of all of the nutrients and food
components required to be included in
the declaration of nutrition information
under paragraph (c) of this section,
VerDate Sep<11>2014
16:26 Nov 22, 2016
Food and Drug Administration Review
and Action on Over-the-Counter Time
and Extent Applications
■
Food and Drug Administration
§ 101.9
RIN 0910–AH30
In Title 21 of the Code of Federal
Regulations, parts 100 to 169, revised as
of April 1, 2016, on page 50, § 101.10 is
revised to read as follows:.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2016–N–0543]
CFR Correction
Jkt 241001
Nutrition labeling in accordance with
§ 101.9 shall be provided upon request
for any restaurant food or meal for
which a nutrient content claim (as
defined in § 101.13 or in subpart D of
this part) or a health claim (as defined
in § 101.14 and permitted by a
regulation in subpart E of this part) is
made, except that information on the
nutrient amounts that are the basis for
the claim (e.g., ‘‘low fat, this meal
provides less than 10 grams of fat’’) may
serve as the functional equivalent of
complete nutrition information as
described in § 101.9. For the purposes of
this section, restaurant food includes
two categories of food. It includes food
which is served in restaurants or other
establishments in which food is served
for immediate human consumption or
which is sold for sale or use in such
establishments. It also includes food
which is processed and prepared
primarily in a retail establishment,
which is ready for human consumption,
which is of the type described in the
previous sentence, and which is offered
for sale to consumers but not for
immediate human consumption in such
establishment and which is not offered
for sale outside such establishment. For
standard menu items that are offered for
sale in covered establishments (as
defined in § 101.11(a)), the information
in the written nutrition information
required by § 101.11(b)(2)(ii)(A) will
serve to meet the requirements of this
section. Nutrient levels may be
determined by nutrient databases,
cookbooks, or analyses or by other
reasonable bases that provide assurance
that the food or meal meets the nutrient
PO 00000
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or Agency) is
amending its nonprescription (over-thecounter or OTC) drug regulations. This
final rule supplements the time and
extent application (TEA) process for
OTC drugs by establishing timelines and
performance metrics for FDA’s review of
non-sunscreen TEAs, as required by the
Sunscreen Innovation Act (SIA). It also
amends the existing TEA process to
include filing determination and
withdrawal provisions to make the TEA
process more efficient.
DATES: This rule is effective December
23, 2016.
ADDRESSES: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this final rule, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kristen Hardin, Center for Drug
Evaluation and Research (CDER), Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 240–402–4246, Kristen.Hardin@
fda.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose and Coverage of the Final Rule
B. Summary of the Major Provisions of the
Final Rule
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[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Rules and Regulations]
[Page 84465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28363]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
Food Labeling
CFR Correction
0
In Title 21 of the Code of Federal Regulations, parts 100 to 169,
revised as of April 1, 2016, on pages 43 and 44, in Sec. 101.9,
paragraphs (j)(1)(i), (2) introductory text, (3) introductory text, and
the first sentence of (j)(4) are revised to read as follows. And, on
page 50, the effective date note at the end of Sec. 101.9 is removed.
Sec. 101.9 Nutrition labeling of food.
* * * * *
(j) * * *
(1)(i) Food offered for sale by a person who makes direct sales to
consumers (e.g., a retailer) who has annual gross sales made or
business done in sales to consumers that is not more than $500,000 or
has annual gross sales made or business done in sales of food to
consumers of not more than $50,000, Provided, That the food bears no
nutrition claims or other nutrition information in any context on the
label or in labeling or advertising. Claims or other nutrition
information subject the food to the provisions of this section, Sec.
101.10, or Sec. 101.11, as applicable.
* * * * *
(2) Except as provided in Sec. 101.11, food products that are:
* * * * *
(3) Except as provided in Sec. 101.11, food products that are:
* * * * *
(4) Except as provided in Sec. 101.11, foods that contain
insignificant amounts of all of the nutrients and food components
required to be included in the declaration of nutrition information
under paragraph (c) of this section, Provided, That the food bears no
nutrition claims or other nutrition information in any context on the
label or in labeling or advertising. * * *
* * * * *
[FR Doc. 2016-28363 Filed 11-22-16; 8:45 am]
BILLING CODE 1301-00-D
