81 FR 66527 - Use of the Term “Healthy” in the Labeling of Human Food Products: Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 188 (September 28, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 188 (September 28, 2016)
| Page Range | 66527-66529 | |
| FR Document | 2016-23367 |
[Federal Register Volume 81, Number 188 (Wednesday, September 28, 2016)] [Rules and Regulations] [Pages 66527-66529] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-23367] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2016-D-2335] Use of the Term ``Healthy'' in the Labeling of Human Food Products: Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance for Industry.'' The guidance advises manufacturers who wish to use the implied nutrient content claim ``healthy'' to label their food products as provided by our regulations. More specifically, the guidance advises food manufacturers of our intent to exercise enforcement discretion with respect to the implied nutrient content claim ``healthy'' on foods that have a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of ``low fat'', or that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D. DATES: Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food [[Page 66528]] and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-D-2335 for ``Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, 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. Submit written requests for single copies of the guidance to the Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1450. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a guidance for industry entitled ``Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance for Industry.'' We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. 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. Under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(r)(1)(A)), a food is misbranded if it bears claims, either express or implied, that characterize the level of a nutrient which is of a type required to be declared in nutrition labeling unless the claim is made in accordance with a regulatory definition established by FDA (see section 403(r)(2) of the FD&C Act). Our food labeling regulations at Sec. 101.65(d) (21 CFR 101.65(d)) provide the regulatory definition for use of the term ``healthy'' or related terms (such as ``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,'' ``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'') as an implied nutrient content claim on the label or in labeling of a food. This definition establishes the following nutrient conditions for bearing a ``healthy'' claim: (1) Specific criteria for nutrients to limit in the diet, such as total fat, saturated fat, cholesterol, and sodium; and (2) requirements for nutrients to encourage in the diet, including vitamin A, vitamin C, calcium, iron, protein, and fiber. The criteria are linked to elements in the Nutrition Facts label and serving size regulations (see Sec. Sec. 101.9 and 101.12). The nutrient criteria to use the claim can vary for different food categories (e.g., fruits and vegetables, or seafood and game meat) (Sec. 101.65(d)(2)). In the Federal Register of May 27, 2016, we issued final rules updating the Nutrition Facts label and serving size information for packaged foods to reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart disease (see 81 FR 33742, ``Food Labeling: Revision of the Nutrition and Supplement Facts Labels''; 81 FR 34000 ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments''). Updates to the Nutrition Facts label include changes in the individual nutrients that must be declared and also changes to the DV of other individual nutrients, reflecting changes in recommended intake levels, based on current science. Because the science supporting public health recommendations for intake of various nutrients has evolved, as reflected in the updated Nutrition Facts Label, FDA intends to exercise enforcement discretion with respect to some of the criteria for bearing the implied nutrient content claim ``healthy.'' In particular, we intend to exercise enforcement discretion with respect to the current requirement that any food bearing the nutrient content claim ``healthy'' meet the low fat requirement provided that: (1) The amounts of mono- and polyunsaturated fats are declared on the label; and (2) the amounts declared constitute the majority of the fat content. Similarly, we intend to exercise enforcement discretion with respect to the current requirement that any food bearing the nutrient content claim ``healthy'' contain at least 10 percent of the DV per RACC of vitamin A, vitamin C, calcium, iron, protein, or fiber, if the food instead contains at least 10 percent of the DV per RACC of potassium or vitamin D. We are issuing this guidance without prior public comment under 21 CFR 10.115(g)(2) because we have determined that prior public participation is not feasible or appropriate, as this guidance implements a temporary enforcement policy while we update our regulations to be consistent with the final Nutrition Facts Label rule. However, as with all Agency guidances, the public may comment on the guidance at any time. [[Page 66529]] II. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web sites listed in the previous sentence to find the most current version of the guidance. Dated: September 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-23367 Filed 9-27-16; 8:45 am] BILLING CODE 4164-01-P
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equivalent or more stringent restrictions On December 16, 2015, the MSRB ACTION: Notification of availability.
on municipal advisors than rule 206(4)– filed with the Commission proposed
5 (the ‘‘SEC Pay to Play Rule) under the amendments to the MSRB Pay to Play SUMMARY: The Food and Drug
Investment Advisers Act of 1940 (the Rule to extend its application to Administration (FDA or we) is
‘‘Advisers Act’’) imposes on investment municipal advisors, which the announcing the availability of a
advisers and is consistent with the Commission published for notice and guidance for industry entitled ‘‘Use of
objectives of the SEC Pay to Play Rule. comment on December 23, 2015 the Term ‘Healthy’ in the Labeling of
pursuant to section 19(b)(1) of the Human Food Products: Guidance for
DATES: This Order was issued by the Industry.’’ The guidance advises
Commission on September 20, 2016. Securities Exchange Act of 1934 (the
‘‘Exchange Act’’) and rule 19b–4 manufacturers who wish to use the
ADDRESSES: Secretary, Securities and implied nutrient content claim
thereunder (Exchange Act Rel. No.
Exchange Commission, 100 F Street NE., 76763 (Dec. 23, 2015) [80 FR 81710 ‘‘healthy’’ to label their food products as
Washington, DC 20549–1090. (Dec. 30, 2015)]). On February 17, 2016, provided by our regulations. More
FOR FURTHER INFORMATION CONTACT: the MSRB published a regulatory notice specifically, the guidance advises food
Sirimal R. Mukerjee, Senior Counsel, announcing that the proposed manufacturers of our intent to exercise
Melissa Roverts Harke, Senior Special amendments to the MSRB Pay to Play enforcement discretion with respect to
Counsel, or Sara Cortes, Assistant Rule were deemed approved by the the implied nutrient content claim
Director, at (202) 551–6787 or IArules@ Commission under section 19(b)(2)(D) of ‘‘healthy’’ on foods that have a fat
sec.gov, Investment Adviser Regulation the Exchange Act on February 13, 2016 profile of predominantly mono and
Office, Division of Investment and that the effective date of the rule polyunsaturated fats, but do not meet
Management, Securities and Exchange was August 17, 2016. the regulatory definition of ‘‘low fat’’, or
Commission, 100 F Street NE., On August 25, 2016, the Commission that contain at least 10 percent of the
Washington, DC 20549–8549. issued a notice of intent to issue an Daily Value (DV) per reference amount
order (Investment Advisers Act Rel. No. customarily consumed (RACC) of
SUPPLEMENTARY INFORMATION: The SEC
4512 (Aug. 25, 2016) [81 FR 60651 potassium or vitamin D.
Pay to Play Rule [17 CFR 275.206(4)–5]
(Sept. 2, 2016)]) finding that the MSRB DATES: Submit either electronic or
under the Advisers Act [15 U.S.C. 80b]
Pay to Play Rule imposes substantially written comments on FDA guidances at
prohibits an investment adviser from
equivalent or more stringent restrictions any time.
providing advisory services for
compensation to a government client for on municipal advisors than the SEC Pay ADDRESSES: You may submit comments
two years after the adviser or certain of to Play Rule imposes on investment as follows:
its executives or employees (‘‘covered advisers and is consistent with the Electronic Submissions
associates’’) make a contribution to objectives of the SEC Pay to Play Rule.
The notice gave interested persons an Submit electronic comments in the
certain elected officials or candidates. following way:
Rule 206(4)–5 also prohibits an adviser opportunity to request a hearing and
stated that an order would be issued • Federal eRulemaking Portal: http://
and its covered associates from www.regulations.gov. Follow the
providing or agreeing to provide, unless a hearing was ordered. The
Commission has not received a request instructions for submitting comments.
directly or indirectly, payment to any Comments submitted electronically,
third-party for a solicitation of advisory for a hearing.
Accordingly, the Commission hereby including attachments, to http://
business from any government entity on www.regulations.gov will be posted to
behalf of such adviser, unless such finds that the MSRB Pay to Play Rule
imposes substantially equivalent or the docket unchanged. Because your
third-party is a ‘‘regulated person’’ comment will be made public, you are
(‘‘third-party solicitor ban’’). Rule more stringent restrictions on municipal
advisors than the SEC Pay to Play Rule solely responsible for ensuring that your
206(4)–5 defines a ‘‘regulated person’’ as comment does not include any
an SEC-registered investment adviser, a imposes on investment advisers and is
consistent with the objectives of the SEC confidential information that you or a
registered broker or dealer subject to pay third party may not wish to be posted,
to play restrictions adopted by a Pay to Play Rule.
such as medical information, your or
registered national securities association By the Commission.
anyone else’s Social Security number, or
that prohibit members from engaging in Dated: September 20, 2016. confidential business information, such
distribution or solicitation activities if Brent J. Fields, as a manufacturing process. Please note
certain political contributions have been Secretary. that if you include your name, contact
made, or a registered municipal advisor [FR Doc. 2016–23224 Filed 9–27–16; 8:45 am] information, or other information that
subject to pay to play restrictions BILLING CODE 8011–01–P identifies you in the body of your
adopted by the Municipal Securities comments, that information will be
Rulemaking Board (the ‘‘MSRB’’) that posted on http://www.regulations.gov.
prohibit members from engaging in • If you want to submit a comment
DEPARTMENT OF HEALTH AND
distribution or solicitation activities if with confidential information that you
HUMAN SERVICES
certain political contributions have been do not wish to be made available to the
made. In addition, in order for a broker- Food and Drug Administration public, submit the comment as a
dealer or municipal advisor to be a written/paper submission and in the
regulated person under rule 206(4)–5, 21 CFR Part 101 manner detailed (see ‘‘Written/Paper
the Commission must find, by order, Submissions’’ and ‘‘Instructions’’).
sradovich on DSK3GMQ082PROD with RULES
that these pay to play rules impose [Docket No. FDA–2016–D–2335]
substantially equivalent or more Written/Paper Submissions
Use of the Term ‘‘Healthy’’ in the
stringent restrictions on broker-dealers Submit written/paper submissions as
Labeling of Human Food Products:
or municipal advisors than the SEC Pay follows:
Guidance for Industry; Availability
to Play Rule imposes on investment • Mail/Hand delivery/Courier (for
advisers and are consistent with the AGENCY: Food and Drug Administration, written/paper submissions): Division of
objectives of the SEC Pay to Play Rule. HHS. Dockets Management (HFA–305), Food
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II. Electronic Access without change, including any business ecosystems, fisheries, marine and
Persons with access to the Internet or personal information provided, such wildlife habitats, beaches, and coastal
may obtain the guidance at either http:// as names, addresses, email addresses, or wetlands of the Gulf Coast region. To
www.fda.gov/FoodGuidances or http:// telephone numbers. Treasury also will carry out the Comprehensive Plan, the
www.regulations.gov. Use the FDA Web make such comments available for Act makes available to the Council, 30
sites listed in the previous sentence to public inspection and copying in percent of penalties deposited into the
find the most current version of the Treasury’s Library, Department of the trust fund plus one half of interest
guidance. Treasury, 1500 Pennsylvania Avenue earned on trust fund investments.
NW., Washington, DC 20220, on official The Act provides that ‘‘[o]f the
Dated: September 23, 2016. amounts received by the Council . . . ,
business days between the hours of
Leslie Kux, 10:00 a.m. and 5:00 p.m. Eastern Time. not more than 3 percent may be used for
Associate Commissioner for Policy. All comments received, including administrative expenses, including
[FR Doc. 2016–23367 Filed 9–27–16; 8:45 am] attachments and other supporting staff,’’ to carry out the Comprehensive
BILLING CODE 4164–01–P materials, will be part of the public Plan. 33 U.S.C. 1321(t)(2)(B)(iii).
record and subject to public disclosure. The Act does not specify when the
You should submit only information statutory three percent cap on
DEPARTMENT OF THE TREASURY that you wish to make publicly administrative expenses is applied to
available. the Council.1 In its final regulations,
31 CFR Part 34 Treasury specified that ‘‘the three
FOR FURTHER INFORMATION CONTACT: percent limit is applied to the total
RIN 1505–AC52 Janet Vail, Office of Gulf Coast amount of funds received by the
Restoration, restoreact@treasury.gov or Council, beginning with the first fiscal
Gulf Coast Restoration Trust Fund 202–622–6873. year the Council receives funds through
AGENCY: Office of the Fiscal Assistant SUPPLEMENTARY INFORMATION: the end of the fourth, or most recent
Secretary, Treasury. fiscal year, whichever is later.’’ 31 CFR
I. Background
ACTION: Interim Final Rule. 34.204(b). The final regulations
The Act makes funds available for the recognized that as a new independent
SUMMARY: The Department of the restoration and protection of the Gulf Federal entity, the Council’s startup
Treasury is issuing this Interim Final Coast region, and certain programs with administrative expenses would be
Rule to change when the statutory three respect to the Gulf of Mexico, through greater in its initial years, and as a result
percent cap on administrative expenses a trust fund in the Treasury of the the final regulations apply the three
is applied to the Gulf Coast Ecosystem United States known as the Gulf Coast percent cap for administrative expenses
Restoration Council (Council) under the Restoration Trust Fund (trust fund). The at the end of the fourth fiscal year, and
Resources and Ecosystem Sustainability, trust fund holds 80 percent of the at the end of each fiscal year thereafter.
Tourist Opportunities, and Revived administrative and civil penalties paid However, in the Supplementary
Economies of the Gulf Coast States Act after July 6, 2012, under the Federal Information section of the final
of 2012 (RESTORE Act or Act). Water Pollution Control Act in regulations, Treasury stated that it ‘‘will
DATES: Effective date for the Interim connection with the Deepwater Horizon propose to cap the Council’s
Final Rule: September 28, 2016. Written Oil Spill. The Act gives Treasury several administrative expenses at three percent
comments on the Interim Final Rule roles in administering the trust fund. of amounts the Council receives under
must be received on or before: One role is to establish procedures, in the Comprehensive Plan Component
November 14, 2016. consultation with the Departments of before the termination of the Trust
ADDRESSES: Treasury invites comments the Interior and Commerce, concerning Fund,’’ and open this proposal for a 45
on the topic addressed in this Interim the expenditure of amounts from the day comment period.2 Under this
Final Rule. Comments may be submitted trust fund and compliance measures for formulation, the application of the three
by any of the following methods: the programs and activities carried out percent limit to the Council’s
Electronic Submission of Comments: under the Act. On December 14, 2015, administrative expenses would be
Interested persons may submit Treasury promulgated final regulations extended from the end of the fourth
comments electronically through the on the RESTORE Act, 80 FR 77239, fiscal year to the date that the trust fund
Federal eRulemaking Portal at http:// which became effective on February 12, terminates. Treasury expects that the
www.regulations.gov. Electronic 2016. trust fund will terminate after 2032.
submission of comments allows the The Act established an independent Treasury included this language because
commenter maximum time to prepare Federal entity, the Gulf Coast Ecosystem the Council expressed a need for more
and submit a comment, ensures timely Restoration Council (Council), to flexibility on when the statutory three
receipt, and enables the Department to administer certain components of the
make them available to the public. Act, including the Comprehensive Plan 1 Treasury considered whether the three percent
Comments submitted electronically Component. The Council is comprised limitation applies at any time, but determined that
Congress did not provide for such a requirement.
through the http://www.regulations.gov of members from six Federal agencies or Specifically, the Act was enacted as part of Moving
Web site can be viewed by other departments and the five Gulf Coast Ahead for Progress in the 21st Century Act (MAP–
commenters and interested members of States. One of the Federal members, 21). MAP–21 contains non-RESTORE Act sections
the public. currently the Secretary of Agriculture, that include limitations that apply ‘‘at any time.’’
See MAP–21 § 100121. Treasury believes that if
Mail: Send to Department of the serves as Chairperson of the Council.
sradovich on DSK3GMQ082PROD with RULES
Congress had intended the three percent limitation
Treasury, Attention Janet Vail, Office of The authority for the Council terminates on administrative expenses to apply ‘‘at any time,’’
Gulf Coast Restoration, Office of the on the date all funds in the trust fund Congress would have included those words in the
Fiscal Assistant Secretary, Room 2112; have been expended. RESTORE Act just as it did elsewhere in MAP–21.
The Council is responsible for Moreover, such a requirement would undermine
1500 Pennsylvania Avenue NW., the RESTORE Act’s purpose of ensuring effective
Washington, DC 20220. developing and implementing a and long-term planning in the restoration of the
In general, Treasury will post all Comprehensive Plan to restore and Gulf Coast.
comments to http://www.regulations.gov protect the natural resources, 2 80 FR 77239, 77241.
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Document Created: 2016-09-28 01:07:23
Document Modified: 2016-09-28 01:07:23
| 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 | |
| Action | Notification of availability. | |
| Dates | Submit either electronic or written comments on FDA guidances at any time. | |
| Contact | Vincent de Jesus, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1450. | |
| FR Citation | 81 FR 66527 |
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