Expansion of Use of the Term “Healthy”
| Published date | 19 March 2020 |
| Citation | 85 FR 15759 |
| Record Number | 2020-05738 |
| Section | Notices |
| Court | Food Safety And Inspection Service |
Federal Register, Volume 85 Issue 54 (Thursday, March 19, 2020)
[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15759-15761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05738]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2019-0008]
Expansion of Use of the Term ``Healthy''
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice and request for comments.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
that it will allow establishments to use the implied nutrient content
claim ``healthy'' on their labels which: (1) Are not low in total fat,
but have a fat profile makeup of predominantly mono and polyunsaturated
fats; or (2) contain at least ten percent of the Daily Value (DV) per
reference amount customarily consumed (RACC) of potassium or vitamin D.
FSIS is making this announcement to maintain consistent requirements
for food labels by allowing the same uses of the claim ``healthy'' for
meat and poultry products as are currently allowed for food products
under the Food and Drug Administration's (FDA's) jurisdiction.
DATES: This notice is applicable March 19, 2020. Submit comments on or
before May 18, 2020.
ADDRESSES: FSIS invites interested persons to submit comments on this
notice. Comments may be submitted by one of the following methods:
Federal eRulemaking Portal: This website provides the ability to
type short comments directly into the comment field on this web page or
attach a file for lengthier comments. Go to http://www.regulations.gov.
Follow the on-line instructions at that site for submitting comments.
Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety and Inspection Service, 1400
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
3700.
Hand- or Courier-Delivered Items: Deliver to 1400 Independence
Avenue SW, Room 6065, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2019-0008. Written
comments received in response to this docket will be made available for
public inspection and posted without change, including any personal
information, to http://www.regulations.gov.
Docket: For access to background documents or comments received,
call
[[Page 15760]]
(202) 720-5627 to schedule a time to visit the FSIS Docket Room at 1400
Independence Avenue SW, Room 6065, Washington, DC 20250-3700.
FOR FURTHER INFORMATION CONTACT: Jeff Canavan, Deputy Director,
Labeling and Program Delivery Staff, Office of Policy and Program
Development, Food Safety and Inspection Service, U.S. Department of
Agriculture, Stop Code 3784, Patriots Plaza 3, 9-146, 1400 Independence
Avenue SW, Washington, DC 20250-3700; Telephone (301) 504-0879; Fax
(202) 245-4792.
SUPPLEMENTARY INFORMATION:
Background
FSIS is the public health regulatory agency in the USDA that is
responsible for ensuring that the nation's commercial supply of meat
and poultry products is safe, wholesome, and accurately labeled and
packaged. Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601-
695, at 607) and the Poultry Products Inspection Act (PPIA) (21 U.S.C.
451-470, at 457), the labels of meat and poultry products must be
approved by the Secretary of Agriculture, who has delegated this
authority to FSIS, before these products can enter commerce. The FMIA
and PPIA also prohibit the sale or offer for sale by any person, firm,
or corporation of any article in commerce under any name or other
marking or labeling that is false or misleading (21 U.S.C. 601(n) and
607(d); 21 U.S.C. 453(h) and 457(c)).
FSIS Regulations for ``Healthy'' Claims
FSIS regulations (9 CFR 317.363(b) and 381.463(b) define the
parameters for the use of the implied nutrient content claim
``healthy'' or any other derivative of the term ``health'' and similar
terms on meat and poultry product labeling. The definitions establish
specific criteria for nutrients to limit in the diet, such as total
fat, saturated fat, cholesterol, and sodium; and requirements for
nutrients to encourage in the diet, including vitamin A, vitamin C,
calcium, iron, protein, and fiber.
On May 10, 1994, FSIS published a final rule defining the term
``healthy'' that included new standards for sodium (59 FR 24220). FSIS
created initial ``first-tier'' sodium standards, and ``second-tier''
sodium standards that would become more rigorous after a 24-month time
period. After extending the first-tier sodium standards in the Federal
Register (63 FR 7279, 64 FR 72490, and 68 FR 460), FSIS decided, in
2006, to indefinitely defer to the first-tier sodium standards (71 FR
1683). Consequently, FSIS continues to apply the original (first-tier)
levels of sodium established in the 1994 regulation when approving
labels for ``healthy.''
Recent Changes to Regulations and Policy
In December 2015, USDA and the U.S. Department of Health and Human
Services (HHS) published the 2015-2020 Dietary Guidelines for
Americans.\1\ The Dietary Guidelines were designed for professionals to
help all individuals consume a healthy and nutritionally-adequate diet.
Specific recommendations in the Dietary Guidelines have evolved over
time, as nutrition science has advanced. For example, scientific
understanding and nutrition guidance has shifted from recommending
diets low in total fat to recommending keeping overall fat intake
within the age-appropriate acceptable macronutrient distribution ranges
(AMDR), and instead prioritizing replacing saturated fats with
polyunsaturated and monounsaturated fats and keeping trans fat intake
as low as possible.
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\1\ https://health.gov/dietaryguidelines/2015/resources/2015-2020_Dietary_Guidelines.pdf.
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On May 27, 2016, FDA issued two final rules updating the Nutrition
Facts label and serving size information for packaged foods (81 FR
33742 and 81 FR 34000). The above-mentioned 2015-2020 Dietary
Guidelines for Americans served as the scientific basis for these two
FDA final rules that included changes in the individual nutrients that
must be declared on the Nutrition Facts label and changes to the DV of
other individual nutrients. The changes reflected the most recent
nutrition and public health research and recent dietary recommendations
from expert groups. These rules also improved the presentation of
nutrition information on the Nutrition Facts label to help consumers
make more informed choices and maintain healthy dietary practices.
Consistent with FDA's final rules, FSIS has proposed to change its
nutrition labeling regulations (82 FR 6732). In November 2016, FSIS
published a Federal Register notice allowing FSIS products to
voluntarily adopt the FDA Nutrition Facts label format (81 FR 80631).
The notice explained that at least one label sketch with the FDA
nutrition format must be submitted to FSIS before that format could be
generically approved for other products.
On September 28, 2016, FDA announced in the Federal Register that
it was requesting comments on the use of the term ``healthy'' in the
labeling of human food products (81 FR 66562). According to this
Federal Register notice, FDA published the notice in accordance with
the FDA Foods and Veterinary Medicine Program's 2016-2025 Strategic
Plan and in response to a citizen petition requesting that FDA update
the nutrient content claim regulations to be consistent with current
Federal dietary guidance. Specifically, FDA's notice stated that the
petitioner requested that the Agency amend the regulation defining
``healthy'' as it relates to total fat intake and to emphasize whole
food and dietary patterns rather than specific nutrients.
Additionally, in the same Federal Register publication, FDA
announced the availability of a guidance document for industry entitled
``Use of the Term `Healthy' in the Labeling of Human Food Products:
Guidance for Industry'' (81 FR 66527). According to FDA, the science
supporting public health recommendations for the intake of various
nutrients had evolved, as evidenced in the 2015-2020 Dietary
Guidelines. FDA also announced the Agency's intention to temporarily
exercise enforcement discretion with respect to some of the criteria
for bearing the implied nutrient content claim ``healthy'' until 21 CFR
101.65(d)(2) is amended through rulemaking.
In the Federal Register notice, FDA explained that it intended 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 of
mono- and polyunsaturated fats declared constitute most of the fat
content.
FDA also stated, in the notice, that it intends to exercise
enforcement discretion with respect to the current requirement that any
food bearing the nutrient content claim ``healthy'' contain at least
ten percent of the DV per RACC of vitamin A, vitamin C, calcium, iron,
protein, or fiber, if the food instead contains at least ten percent of
the DV per RACC of potassium or vitamin D. FDA's guidance document is
available at https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM521692.pdf.
FSIS's Policy
To maintain consistent requirements for food labels, FSIS has used
its enforcement discretion to allow the same uses of the claim
``healthy'' for meat and poultry products as are
[[Page 15761]]
allowed for food products under FDA jurisdiction under FDA's 2016
guidance. There are few labels that qualify for the ``healthy'' claim
under the allowances in this notice that wouldn't qualify otherwise.
According to FSIS's Label Submission and Approval System (LSAS) \2\
data, the types of products utilizing FDA's guidance for the claim
``healthy'' are mostly products that meet the definition of meal-type
in 317.313(l)/381.413(l). Egg product labels are not affected by this
policy because FSIS inspected egg products are required by regulation
to use the FDA nutrition requirements in 21 CFR part 101 in compliance
with 9 CFR 590.411(e)--as such, egg product labeling follows the FDA
nutrition panel and the FDA enforcement discretion even though FSIS's
Labeling and Program Delivery Staff (LPDS) reviews and approves FSIS
inspected egg product label applications. Because FSIS has received
multiple questions from industry about our policy, FSIS is announcing
in this Federal Register notice that it will continue to recognize
FDA's 2016 guidance to alleviate consumer confusion and promote
uniformity in the marketplace.
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\2\ FSIS's Label Submission and Approval System (LSAS) is a web-
based software application that integrates and implements an
electronic label application process for establishments to submit
label applications to FSIS.
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Specifically, FSIS has allowed and will continue to allow the
implied nutrient content claim ``healthy'' on foods that have a fat
profile of predominantly mono and polyunsaturated fats (i.e. sum of
monounsaturated fats and polyunsaturated fats are greater than the
total saturated fat content of food), but do not meet the regulatory
definition of ``low fat,'' as specified in 9 CFR 317.363(b)(1)/
381.463(b)(1) or that contain at least ten percent of the DV per RACC
of potassium or vitamin D as one of the options in 9 CFR 317.363(b)(4)
and 381.463(b)(4), provided the remaining criteria for healthy in 9 CFR
317.363 and 381.463 have been met.
FSIS's LPDS has reviewed many proposed labels referencing FDA's
``healthy'' notice, and most have contained errors and needed
correction. If a company wishes to use FDA's ``healthy'' claim, they
will first need to submit at least one label sketch to LPDS for
approval.
A corporation's parent-company only needs to submit one label
application for a product produced in multiple establishments that are
owned by the corporation. Subsequent similar labels for other products
that use FDA's ``healthy'' claim can be generically approved.
Submitting one label and receiving approval helps ensure that the rest
of the labels are in compliance with FDA and FSIS regulations. Labels
using the modified ``healthy'' claim must be submitted to LPDS in the
new FDA nutrition panel format.
FSIS will continue to allow the use of implied nutrient content
claim ``healthy'' on foods that have a fat profile of predominantly
mono and polyunsaturated fats (i.e., sum of monounsaturated fats and
polyunsaturated fats are greater than the total saturated fat content
of food), but do not meet the regulatory definition of ``low fat,'' as
specified in 9 CFR 317.363(b)(1) and 381.463(b)(1) or that contain at
least ten percent of the DV per RACC of potassium or vitamin D as one
of the options in 9 CFR 317.363(b)(4) and 381.463(b)(4), provided the
remaining criteria for healthy in 9 CFR 317.363 and 381.463 have been
met until FSIS's ``healthy'' regulations (9 CFR 317.363(b) and
381.463(b)) are amended through rulemaking. FSIS will continue to
coordinate with FDA on any changes to these regulations.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this Federal
Register publication on-line through the FSIS web page located at:
http://www.fsis.usda.gov/federal-register. FSIS will also announce and
provide a link to it through the FSIS Constituent Update, which is used
to provide information regarding FSIS policies, procedures,
regulations, Federal Register notices, FSIS public meetings, and other
types of information that could affect or would be of interest to our
constituents and stakeholders. The Constituent Update is available on
the FSIS web page. Through the web page, FSIS is able to provide
information to a much broader, more diverse audience. In addition, FSIS
offers an email subscription service which provides automatic and
customized access to selected food safety news and information. This
service is available at: http://www.fsis.usda.gov/subscribe. Options
range from recalls to export information, regulations, directives, and
notices. Customers can add or delete subscriptions themselves and have
the option to password protect their accounts.
Congressional Review Act
Pursuant to the Congressional Review Act at 5 U.S.C. 801 et seq.,
the Office of Information and Regulatory Affairs has determined that
this notice is not a ``major rule,'' as defined by 5 U.S.C. 804(2).
USDA Nondiscrimination Statement
No agency, officer, or employee of the USDA shall, on the grounds
of race, color, national origin, religion, sex, gender identity, sexual
orientation, disability, age, marital status, family/parental status,
income derived from a public assistance program, or political beliefs,
exclude from participation in, deny the benefits of, or subject to
discrimination, any person in the United States under any program or
activity conducted by the USDA.
How To File a Complaint of Discrimination
To file a complaint of discrimination, complete the USDA Program
Discrimination Complaint Form, which may be accessed online at: http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your
authorized representative.
Send your completed complaint form or letter to USDA by mail, fax,
or email:
Mail: U.S. Department of Agriculture, Director, Office of
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
Fax: (202) 690-7442.
Email: [email protected].
Persons with disabilities who require alternative means for
communication (Braille, large print, audiotape, etc.) should contact
USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Done at Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2020-05738 Filed 3-18-20; 8:45 am]
BILLING CODE 3410-DM-P
