81 FR 84465 - Food Labeling
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 226 (November 23, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 226 (November 23, 2016)
| Page Range | 84465-84465 | |
| FR Document | 2016-28364 |
[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)] [Rules and Regulations] [Page 84465] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28364] ----------------------------------------------------------------------- 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 page 50, Sec. 101.10 is revised to read as follows:. Sec. 101.10 Nutrition labeling of restaurant foods whose labels or labeling bear nutrient content claims or health claims. Nutrition labeling in accordance with Sec. 101.9 shall be provided upon request for any restaurant food or meal for which a nutrient content claim (as defined in Sec. 101.13 or in subpart D of this part) or a health claim (as defined in Sec. 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 Sec. 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 Sec. 101.11(a)), the information in the written nutrition information required by Sec. 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 requirements for the claim. Presentation of nutrition labeling may be in various forms, including those provided in Sec. 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
![Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Rules and Regulations 84465
meet the definition of electronic Provided, That the food bears no requirements for the claim. Presentation
signatures in § 11.3(b)(7) of this chapter nutrition claims or other nutrition of nutrition labeling may be in various
are exempt from the requirements of information in any context on the label forms, including those provided in
part 11 of this chapter. or in labeling or advertising. * * * § 101.45 and other reasonable means.
(f) Misbranding. A standard menu * * * * * [79 FR 71253, Dec. 1, 2014]
item offered for sale in a covered [FR Doc. 2016–28363 Filed 11–22–16; 8:45 am]
[FR Doc. 2016–28364 Filed 11–22–16; 8:45 am]
establishment shall be deemed BILLING CODE 1301–00–D
BILLING CODE 1301–00–D
misbranded under sections 201(n),
403(a), 403(f) and/or 403(q) of the
Federal Food, Drug, and Cosmetic Act if DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
its label or labeling is not in conformity HUMAN SERVICES HUMAN SERVICES
with paragraph (b) or (c) of this section.
[79 FR 71253, Dec. 1, 2014]
Food and Drug Administration Food and Drug Administration
[FR Doc. 2016–28367 Filed 11–22–16; 8:45 am] 21 CFR Part 101
BILLING CODE 1301–00–D
21 CFR Part 330
Food Labeling [Docket No. FDA–2016–N–0543]
DEPARTMENT OF HEALTH AND CFR Correction RIN 0910–AH30
HUMAN SERVICES ■ In Title 21 of the Code of Federal Food and Drug Administration Review
Regulations, parts 100 to 169, revised as and Action on Over-the-Counter Time
Food and Drug Administration
of April 1, 2016, on page 50, § 101.10 is and Extent Applications
revised to read as follows:.
21 CFR Part 101
AGENCY: Food and Drug Administration,
§ 101.10 Nutrition labeling of restaurant HHS.
Food Labeling foods whose labels or labeling bear nutrient
content claims or health claims. ACTION: Final rule.
CFR Correction
Nutrition labeling in accordance with SUMMARY: The Food and Drug
■ In Title 21 of the Code of Federal § 101.9 shall be provided upon request Administration (FDA or Agency) is
Regulations, parts 100 to 169, revised as for any restaurant food or meal for amending its nonprescription (over-the-
of April 1, 2016, on pages 43 and 44, in which a nutrient content claim (as counter or OTC) drug regulations. This
§ 101.9, paragraphs (j)(1)(i), (2) defined in § 101.13 or in subpart D of final rule supplements the time and
introductory text, (3) introductory text, this part) or a health claim (as defined extent application (TEA) process for
and the first sentence of (j)(4) are in § 101.14 and permitted by a OTC drugs by establishing timelines and
revised to read as follows. And, on page regulation in subpart E of this part) is performance metrics for FDA’s review of
50, the effective date note at the end of made, except that information on the non-sunscreen TEAs, as required by the
§ 101.9 is removed. nutrient amounts that are the basis for Sunscreen Innovation Act (SIA). It also
the claim (e.g., ‘‘low fat, this meal amends the existing TEA process to
§ 101.9 Nutrition labeling of food.
provides less than 10 grams of fat’’) may include filing determination and
* * * * * serve as the functional equivalent of
(j) * * * withdrawal provisions to make the TEA
complete nutrition information as process more efficient.
(1)(i) Food offered for sale by a person described in § 101.9. For the purposes of
who makes direct sales to consumers this section, restaurant food includes DATES: This rule is effective December
(e.g., a retailer) who has annual gross two categories of food. It includes food 23, 2016.
sales made or business done in sales to which is served in restaurants or other ADDRESSES: For access to the docket to
consumers that is not more than establishments in which food is served read background documents or the
$500,000 or has annual gross sales made for immediate human consumption or electronic and written/paper comments
or business done in sales of food to which is sold for sale or use in such received, go to https://
consumers of not more than $50,000, establishments. It also includes food www.regulations.gov and insert the
Provided, That the food bears no which is processed and prepared docket number, found in brackets in the
nutrition claims or other nutrition primarily in a retail establishment, heading of this final rule, into the
information in any context on the label which is ready for human consumption, ‘‘Search’’ box and follow the prompts
or in labeling or advertising. Claims or which is of the type described in the and/or go to the Division of Dockets
other nutrition information subject the previous sentence, and which is offered Management, 5630 Fishers Lane, Rm.
food to the provisions of this section, for sale to consumers but not for 1061, Rockville, MD 20852.
§ 101.10, or § 101.11, as applicable. immediate human consumption in such FOR FURTHER INFORMATION CONTACT:
* * * * * establishment and which is not offered Kristen Hardin, Center for Drug
(2) Except as provided in § 101.11, for sale outside such establishment. For Evaluation and Research (CDER), Food
food products that are: standard menu items that are offered for and Drug Administration, 10903 New
* * * * * sale in covered establishments (as Hampshire Ave., Silver Spring, MD
(3) Except as provided in § 101.11, defined in § 101.11(a)), the information 20993, 240–402–4246, Kristen.Hardin@
food products that are: in the written nutrition information fda.hhs.gov.
mstockstill on DSK3G9T082PROD with RULES
* * * * * required by § 101.11(b)(2)(ii)(A) will SUPPLEMENTARY INFORMATION:
(4) Except as provided in § 101.11, serve to meet the requirements of this
foods that contain insignificant amounts section. Nutrient levels may be Table of Contents
of all of the nutrients and food determined by nutrient databases, I. Executive Summary
components required to be included in cookbooks, or analyses or by other A. Purpose and Coverage of the Final Rule
the declaration of nutrition information reasonable bases that provide assurance B. Summary of the Major Provisions of the
under paragraph (c) of this section, that the food or meal meets the nutrient Final Rule
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Document Created: 2016-11-23 05:29:59
Document Modified: 2016-11-23 05:29:59
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| FR Citation | 81 FR 84465 |
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