80_FR_45611 80 FR 45465 - The Food and Drug Administration's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Draft Guidance for Industry; Availability

80 FR 45465 - The Food and Drug Administration's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 146 (July 30, 2015)

Page Range45465-45466
FR Document2015-18655

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled ``FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels: Guidance for Industry.'' The draft guidance, when finalized, will explain to manufacturers of conventional foods and dietary supplements our policy on determining the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount.

Federal Register, Volume 80 Issue 146 (Thursday, July 30, 2015) 
[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Proposed Rules]
[Pages 45465-45466]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18655]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2015-D-1839]


The Food and Drug Administration's Policy on Declaring Small 
Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 45466]]


ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is 
announcing the availability of a draft guidance for industry entitled 
``FDA's Policy on Declaring Small Amounts of Nutrients and Dietary 
Ingredients on Nutrition Labels: Guidance for Industry.'' The draft 
guidance, when finalized, will explain to manufacturers of conventional 
foods and dietary supplements our policy on determining the amount to 
declare on the nutrition label for certain nutrients and dietary 
ingredients that are present in a small amount.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on the 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 28, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Nutrition, Labeling, and Dietary Supplements, 
Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
two self-addressed adhesive labels to assist the office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Carole Adler, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``FDA's Policy on Declaring Small Amounts of Nutrients and 
Dietary Ingredients on Nutrition Labels: Guidance for Industry.'' We 
are issuing the draft guidance consistent with our good guidance 
practices regulation (21 CFR 10.115). The draft guidance represents the 
current thinking of FDA on our policy on declaring small amounts of 
nutrients and dietary ingredients on nutrition labels. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.
    The draft guidance, when finalized, will explain our nutrition 
labeling policy on declaring the nutrient values in conventional foods 
and dietary ingredient values in dietary supplements in certain cases. 
Specifically, declaring small amounts of nutrients and dietary 
ingredients in the nutrition labeling may result in a conflict between 
21 CFR 101.9(c)(1) through (8) and 21 CFR 101.9(g)(4)(ii) and 21 CFR 
101.9(g)(5). In such cases, we are recommending manufacturers declare 
nutrients and dietary ingredients in accordance with Sec.  101.9(c)(1) 
through (8). If the draft guidance is finalized, we intend to consider 
the use of our enforcement discretion with respect to the compliance 
requirements in Sec.  101.9(g)(4)(ii)) and Sec.  101.9(g)(5) when a 
conflict exists with Sec.  101.9(c)(1) through (8).
    We also are considering whether changes to our nutrition labeling 
regulations are needed, including changes to Sec.  101.9(c) or (g), or 
both. If we determine that rulemaking is needed, we will consider 
whether to revise or withdraw the draft guidance.

II. Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in Sec.  101.9 have been approved under OMB 
control number 0910-0381.

III. Comments

    Interested persons may submit either electronic comments regarding 
the draft guidance to http://www.regulations.gov or written comments 
regarding the draft guidance to the Division of Dockets Management (see 
ADDRESSES). It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday, and will 
be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
document at http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: July 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18655 Filed 7-29-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Proposed Rules 45465 FIGURE 1 TO PARAGRAPHS (h) AND (j) FIGURE 2 TO PARAGRAPH (i) OF THIS procedures and tests must be done to comply with this AD; any procedures or tests that are OF THIS AD—PART NUMBERS AND AD—AIRPLANE MANUFACTURER SE- not identified as RC are recommended. Those SERIAL NUMBERS OF AFFECTED RIAL NUMBERS—Continued procedures and tests that are not identified FORWARD ENGINE MOUNTS AND AT- as RC may be deviated from using accepted TACHMENT PINS—Continued Airplane manufacturer serial Nos. methods in accordance with the operator’s maintenance or inspection program without 4753 obtaining approval of an AMOC, provided Serial No. 4754 the procedures and tests identified as RC can Forward Engine 4755 be done and the airplane can be put back in Attachment Pin 4757 Mount a serviceable condition. Any substitutions or (P/N 740–2022–501) 4761 (P/N 745–2010–503) changes to procedures or tests identified as 4762 RC require approval of an AMOC. 1467SC 13813001 4772 1445SC 13755001 4773 (l) Special Flight Permits Prohibited 1462SC 13789001 4774 Special flight permits, as described in 1464SC 13793001 4775 Section 21.197 and Section 21.199 of the 1466SC 13811001 4779 Federal Aviation Regulations (14 CFR 21.197 1470SC 13819001 4782 and 21.199), are not allowed. 1459SC 13783001 4783 1463SC 13791001 4784 (m) Related Information 1475SC 13829001 4786 (1) Refer to Mandatory Continuing 1458SC 13781001 4788 Airworthiness Information (MCAI) EASA 1477SC 13833001 4790 Airworthiness Directive 2015–0004, dated 1474SC 13827001 4791 January 13, 2015, for related information. 1478SC 13835001 4798 This MCAI may be found in the AD docket 1479SC 13837001 4804 on the Internet at http://www.regulations.gov 1472SC 13823001 4813 by searching for and locating Docket No. FAA–2015–2963. (i) Exception to Paragraph (g) of This AD (j) Parts Installation Prohibition (2) For Airbus service information For airplanes with manufacturer serial As of the effective date of this AD, no identified in this AD, contact Airbus, numbers identified in figure 2 to paragraph person may install on any airplane any Airworthiness Office—EIAS, 1 Rond Point (i) of this AD: If it can be conclusively engine mount attachment pin having P/N Maurice Bellonte, 31707 Blagnac Cedex, determined that an engine has not been 740–2022–501 with a serial number France; telephone +33 5 61 93 36 96; fax +33 replaced after March 1, 2011 (the date of identified in figure 1 to paragraphs (h) and 5 61 93 44 51; email account.airworth-eas@ manufacture of the first airplane with (j) of this AD. airbus.com; Internet http://www.airbus.com. affected engine mounts), the airplane is not For Goodrich Aerostructures service (k) Other FAA AD Provisions information identified in this AD, contact affected by the requirements of paragraphs (g) and (h) of this AD. The following provisions also apply to this UTC Aerospace Systems, ATTN: Christopher AD: Newth—V2500 A1/A5 Project Engineer, (1) Alternative Methods of Compliance Aftermarket—Aerostructures; 850 Lagoon FIGURE 2 TO PARAGRAPH (i) OF THIS (AMOCs): The Manager, International Drive, Chula Vista, CA; telephone 619–498– AD—AIRPLANE MANUFACTURER SE- Branch, ANM–116, Transport Airplane 7505; email christopher.newth@utas.utc.com. RIAL NUMBERS Directorate, FAA, has the authority to You may view this service information at the approve AMOCs for this AD, if requested FAA, Transport Airplane Directorate, 1601 Airplane manufacturer serial Nos. using the procedures found in 14 CFR 39.19. Lind Avenue SW., Renton, WA. For In accordance with 14 CFR 39.19, send your information on the availability of this 4593 request to your principal inspector or local material at the FAA, call 425–227–1221. 4602 Flight Standards District Office, as Issued in Renton, Washington, on July 17, 4620 appropriate. If sending information directly 2015. 4637 to the International Branch, send it to ATTN: 4638 Sanjay Ralhan, Aerospace Engineer, Michael Kaszycki, 4642 International Branch, ANM–116, Transport Acting Manager, Transport Airplane 4643 Airplane Directorate, FAA, 1601 Lind Directorate, Aircraft Certification Service. 4644 Avenue SW., Renton, WA 98057–3356; [FR Doc. 2015–18533 Filed 7–29–15; 8:45 am] 4660 telephone 425–227–1405; fax 425–227–1149. BILLING CODE 4910–13–P 4677 Information may be emailed to: 9-ANM-116- 4690 AMOC-REQUESTS@faa.gov. Before using 4696 any approved AMOC, notify your appropriate 4700 principal inspector, or lacking a principal DEPARTMENT OF HEALTH AND 4701 inspector, the manager of the local flight HUMAN SERVICES 4703 standards district office/certificate holding 4706 district office. The AMOC approval letter Food and Drug Administration 4707 must specifically reference this AD. 4710 (2) Contacting the Manufacturer: For any 21 CFR Part 101 4716 requirement in this AD to obtain corrective 4719 actions from a manufacturer, the action must [Docket No. FDA–2015–D–1839] 4725 be accomplished using a method approved Lhorne on DSK7TPTVN1PROD with PROPOSALS 4726 by the Manager, International Branch, ANM– The Food and Drug Administration’s 4731 116, Transport Airplane Directorate, FAA; or Policy on Declaring Small Amounts of 4736 the EASA; or Airbus’s EASA DOA. If Nutrients and Dietary Ingredients on 4737 approved by the DOA, the approval must Nutrition Labels; Draft Guidance for 4741 include the DOA-authorized signature. Industry; Availability 4746 (3) Required for Compliance (RC): If any 4751 service information contains procedures or AGENCY: Food and Drug Administration, 4752 tests that are identified as RC, those HHS. 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45466 Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Proposed Rules ACTION: Notification of availability. not establish any rights for any person at http://www.fda.gov/FoodGuidances and is not binding on FDA or the public. or http://www.regulations.gov. Use the SUMMARY: The Food and Drug You can use an alternative approach if FDA Web site listed in the previous Administration (FDA, we, or the it satisfies the requirements of the sentence to find the most current Agency) is announcing the availability applicable statutes and regulations. version of the guidance. of a draft guidance for industry entitled The draft guidance, when finalized, ‘‘FDA’s Policy on Declaring Small Dated: July 24, 2015. will explain our nutrition labeling Amounts of Nutrients and Dietary Leslie Kux, policy on declaring the nutrient values Ingredients on Nutrition Labels: in conventional foods and dietary Associate Commissioner for Policy. Guidance for Industry.’’ The draft ingredient values in dietary [FR Doc. 2015–18655 Filed 7–29–15; 8:45 am] guidance, when finalized, will explain supplements in certain cases. BILLING CODE 4164–01–P to manufacturers of conventional foods Specifically, declaring small amounts of and dietary supplements our policy on nutrients and dietary ingredients in the determining the amount to declare on nutrition labeling may result in a DEPARTMENT OF THE TREASURY the nutrition label for certain nutrients conflict between 21 CFR 101.9(c)(1) and dietary ingredients that are present through (8) and 21 CFR 101.9(g)(4)(ii) Internal Revenue Service in a small amount. and 21 CFR 101.9(g)(5). In such cases, DATES: Although you can comment on we are recommending manufacturers 26 CFR Part 1 any guidance at any time (see 21 CFR declare nutrients and dietary [REG–138526–14] 10.115(g)(5)), to ensure that the Agency ingredients in accordance with considers your comment on the draft RIN 1545–BM46 § 101.9(c)(1) through (8). If the draft guidance before it begins work on the guidance is finalized, we intend to Issue Price Definition for Tax-Exempt final version of the guidance, submit consider the use of our enforcement Bonds; Correction either electronic or written comments discretion with respect to the on the draft guidance by September 28, compliance requirements in AGENCY: Internal Revenue Service (IRS), 2015. § 101.9(g)(4)(ii)) and § 101.9(g)(5) when Treasury. ADDRESSES: Submit written requests for a conflict exists with § 101.9(c)(1) ACTION: Partial withdrawal of notice of single copies of the draft guidance to the through (8). proposed rulemaking, notice of Office of Nutrition, Labeling, and We also are considering whether proposed rulemaking, and notice of Dietary Supplements, Center for Food changes to our nutrition labeling public hearing; correction. Safety and Applied Nutrition (HFS– regulations are needed, including 820), Food and Drug Administration, changes to § 101.9(c) or (g), or both. If SUMMARY: This document contains 5100 Paint Branch Pkwy., College Park, we determine that rulemaking is corrections to partial withdrawal of MD 20740. Send two self-addressed needed, we will consider whether to notice of proposed rulemaking, notice of adhesive labels to assist the office in revise or withdraw the draft guidance. proposed rulemaking, and notice of processing your request. See the public hearing; correction (REG– II. Paperwork Reduction Act of 1995 SUPPLEMENTARY INFORMATION section for 138526–14) that were published in the electronic access to the draft guidance. The draft guidance refers to Federal Register on Wednesday, June Submit electronic comments on the previously approved collections of 24, 2015 (80 FR 36301). The partial draft guidance to http:// information found in FDA regulations. withdrawal of notice of proposed www.regulations.gov. Submit written These collections of information are rulemaking, notice of proposed comments on the draft guidance to the subject to review by the Office of rulemaking, and notice of public Division of Dockets Management (HFA– Management and Budget (OMB) under hearing are relating to the definition of 305), Food and Drug Administration, the Paperwork Reduction Act of 1995 issue price for purposes of the arbitrage 5630 Fishers Lane, Rm. 1061, Rockville, (44 U.S.C. 3501–3520). The collections restrictions under section 148 of the MD 20852. of information in § 101.9 have been Internal Revenue Code (Code). approved under OMB control number DATES: Written or electronic comments FOR FURTHER INFORMATION CONTACT: 0910–0381. and requests for a public hearing for the Carole Adler, Center for Food Safety and Applied Nutrition (HFS–820), Food and III. Comments notice of proposed rulemaking Drug Administration, 5100 Paint Branch Interested persons may submit either published at 80 FR 36301, June 24, Pkwy., College Park, MD 20740, 240– electronic comments regarding the draft 2015, are still being accepted and must 402–2371. guidance to http://www.regulations.gov be received by September 22, 2015. SUPPLEMENTARY INFORMATION: or written comments regarding the draft FOR FURTHER INFORMATION CONTACT: guidance to the Division of Dockets Lewis Bell at (202) 317–6980 (not a toll- I. Background free number). Management (see ADDRESSES). It is only We are announcing the availability of necessary to send one set of comments. SUPPLEMENTARY INFORMATION: a draft guidance for industry entitled Identify comments with the docket ‘‘FDA’s Policy on Declaring Small Background number found in brackets in the Amounts of Nutrients and Dietary heading of this document. Received The notice of proposed rulemaking Ingredients on Nutrition Labels: comments may be seen in the Division that is the subject of this correction is Lhorne on DSK7TPTVN1PROD with PROPOSALS Guidance for Industry.’’ We are issuing of Dockets Management between 9 a.m. under section 148 of the Internal the draft guidance consistent with our and 4 p.m., Monday through Friday, and Revenue Code. good guidance practices regulation (21 will be posted to the docket at http:// CFR 10.115). The draft guidance Need for Correction www.regulations.gov. represents the current thinking of FDA As published in the Wednesday, June on our policy on declaring small IV. Electronic Access 24, 2015 (80 FR 36301) partial amounts of nutrients and dietary Persons with access to the Internet withdrawal of notice of proposed ingredients on nutrition labels. It does may obtain the draft guidance document rulemaking, notice of proposed VerDate Sep<11>2014 13:52 Jul 29, 2015 Jkt 235001 PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 E:\FR\FM\30JYP1.SGM 30JYP1


Document Created: 2018-02-23 09:29:53
Document Modified: 2018-02-23 09:29:53
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotification of availability.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 28, 2015.
ContactCarole Adler, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371.
FR Citation80 FR 45465 
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