[Federal Register Volume 59, Number 89 (Tuesday, May 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11140]
[[Page Unknown]]
[Federal Register: May 10, 1994]
_______________________________________________________________________
Part II
Department of Agriculture
_______________________________________________________________________
Food Safety and Inspection Service
_______________________________________________________________________
9 CFR Part 317 et al.
Nutrition Labeling; Use of ``Healthy'' and Similar Terms on Meat and
Poultry Product Labeling; Final Rule
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 317 and 381
[Docket No. 91-006F-HLTH]
RIN 0583-AB34
Nutrition Labeling; Use of ``Healthy'' and Similar Terms on Meat
and Poultry Product Labeling
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
Federal meat and poultry products inspection regulations to permit the
use of the term ``healthy'' or any other derivative of the term
``health,'' such as ``healthful'' or ``healthier,'' on the labeling of
meat and poultry products. FSIS is taking this action to provide
consumers with accurate, informative labeling on meat and poultry
products that conforms with such labeling on other foods. This final
rule provides a definition for the implied nutrient content claim
``healthy'' for individual foods and meal-type products, and is
designed to parallel the definition issued by the Food and Drug
Administration (FDA) for other foods.
EFFECTIVE DATE: November 10, 1995.
FOR FURTHER INFORMATION CONTACT:
Charles Edwards, Director, Product Assessment Division, Regulatory
Programs, Food Safety and Inspection Service, U.S. Department of
Agriculture, Washington, DC 20250, (202) 254-2565.
SUPPLEMENTARY INFORMATION:
Executive Order 12866
FSIS has examined the economic implications of its final rule on
use of the term ``healthy'' and any other derivative of the term
``health'' on the labeling of meat and poultry products, as required by
Executive Order 12866. FSIS has determined that this final rule is
economically significant for purposes of Executive Order 12866.
Regulatory Options
1. No Definition. FSIS could choose not to define the term
``healthy.'' However, in its nutrition labeling final rule issued on
January 6, 1993, FSIS determined that the term ``healthy'' is an
implied nutrient content claim. If FSIS does not define the term
``healthy,'' its use on labeling, except on those products using the
claim in their brand name prior to November 27, 1991, or in a non-
nutritional context, would misbrand the food. This option would result
in large costs, including labeling costs, and a valuable signal used by
consumers to alert them to foods that may assist them in meeting
dietary goals would be lost.
FSIS could alternatively decide to propose to reverse its previous
determination that use of the term ``healthy'' is an implied nutrient
content claim. However, FSIS could only make such an amendment if it
were persuaded that its original determinations were in error. FSIS did
not receive any information that would support such a conclusion.
Furthermore, such an action would require separate rulemaking, and
would not take effect until well after the effective date of the
nutrition labeling regulations. Therefore, until FSIS published a final
rule, this alternative would have the same impact as not defining the
term ``healthy.''
2. Different Definition Than Proposed. FSIS could determine that an
alternative definition for the term ``healthy'' would be more
appropriate that that which was proposed. FSIS and FDA simultaneously
published proposals that would define the term ``healthy.'' However,
the definitions were different. FSIS proposed to link the definition of
the term ``healthy'' to the definition for the nutrient content claim
``lean'' with an added sodium restriction. Consequently, there would be
limits for fat, saturated fat, cholesterol, and sodium. FDA proposed a
definition that linked the term ``healthy'' to definitions for the
nutrient content claims ``low fat'' and ``low saturated fat'' with
restrictions on cholesterol and sodium.
There was overwhelming agreement among commenters that if
``healthy'' is defined, both FSIS and FDA should adopt uniform criteria
so as not to undermine the benefits consumers will ultimately realize
through application of the same definition.
Costs of the Final Regulations
FSIS has identified 27 uses of ``healthy'' or derivatives of the
term ``health'' in brand names, trade names, product lines, or
prominent displays on labeling of meat and poultry products. This
information was obtained by a search of the FSIS files from its prior
label approval system. The manufacturers of these products include five
large companies with annual sales of over $50 million and an estimated
20 medium-size companies with annual sales between $5 million and $50
million. FSIS has not identified usage of ``healthy'' on labeling by
small companies with annual sales of less than $5 million. However,
based on the percentage of medium-size companies using the term, FSIS
estimates that possibly 38 small companies might use ``healthy'' or
derivatives of the term ``health'' on product labeling. FSIS's Final
Regulatory Impact Analysis (FRIA) for nutrition labeling estimates that
large companies average 250 labels per company and 2.3 average labels
per product; medium companies average 80 labels per company and 2
average labels per product; and small companies average 30 labels per
company and 1.5 average labels per product. Based on this information,
FSIS found that at most a total of 3,990 labels and 2,100 products
could be affected by the final rule. However, FSIS expects that a much
lower number of labels will be influenced.
Manufacturers of products not meeting the definition of ``healthy''
have three options to bring their products into compliance with the
regulations: Reformulate, cease marketing, or relabel. Of these three
options, complete reformulation would be the most expensive. Assuming,
as an upper bound for total costs to the industry, all the estimated
2,100 products that might be affected had to be completely
reformulated, the total costs to companies based on initial analytical,
administrative, printing, and inventory costs for an 18-month
implementation period presented in the FRIA would be $33.1 million for
large companies, $18.9 million for medium companies, and $3.6 million
for small companies. Not all labeling will be affected and some
products could be reformulated with minimal cost.
FSIS examined data for 61 meals from a leading brand name producer.
These meals weighed between 7 and 13.5 ounces. Of these, 49 (80
percent) are FSIS-regulated products, and 12 are regulated by FDA.
Nutrient values were compared to criteria for maximum fat, saturated
fat, and cholesterol levels that meet the ``healthy'' definition for
meals. Only three meals failed to meet the lipid cutoff levels. The
three meals--meat loaf, chicken enchilada, and an FDA-regulated
manicotti--failed by exceeding the saturated fat cutoff level. Meal
sodium contents ranged from 220 to 580 milligrams in the 61 meals so
that all could meet the 1994 maximum level of 600 milligrams per
serving. When compared to the 1997 phase-in criterion of 480
milligrams, 17 meals (28 percent) failed the sodium test. On the other
hand, 72 percent did meet the level.
FSIS staff went to grocery stores to record current label values
for other FSIS meal products labeled ``healthy'' and obtained
information on 16 additional meals beyond those of the leading brand.
When these 16 meals were compared to the cutoff level for fat
components, four failed by only small amounts. The majority did not
meet the 1994 sodium limit of 600 milligrams.
Based on the data reviewed, FSIS believes many meals can easily
meet the ``healthy'' definition for fat, saturated fat, and cholesterol
levels. FSIS also believes all meals can be formulated to meet the 1994
sodium criterion of 600 milligrams per serving. Regarding the 1997
phase-in criterion of 480 milligrams, 72 percent of the leading brand
meals meet that criterion now. This indicates that it is
technologically feasible to formulate products acceptable to current
consumer taste.
Individual processed meat and poultry products, such as luncheon
meats and frankfurters, will have more difficulty meeting the criteria.
Generally, individual processed meat and poultry products can meet the
fat, saturated fat, and cholesterol levels when the reference amounts
are less than 2 ounces or if they do not contain too much meat or
poultry when the reference amounts are over 8 ounces.
Of about 100 individual food product types for which minimum meat
and/or poultry contents are established by FSIS's ``Standards and
Labeling Policy Book,'' FSIS estimates that approximately one-half
could not be labeled as ``healthy'' if made with lean meat or poultry
to meet the minimum meat or poultry content. However, this still leaves
many individual food product types with the potential to be labeled
``healthy.'' Furthermore, more foods could be so labeled if made with
extra-lean meat or made as nonstandardized versions with less meat or
poultry content.
FSIS also examined current labeling values for individual food
products now carrying the term ``healthy'' in the brand name. All
luncheon meats met the fat criteria; most did not meet the 1994 sodium
criterion of 480 milligrams per reference amount and labeled serving,
although they were not far off. None of the products were close to the
360 milligram criterion for 1997. Most soups met the fat criteria, but
would need some reformulation to meet the current sodium standard, and
would require major reformulation to meet the 1997 sodium criterion of
360 milligrams. Overall, the sodium level will cause the most problem
for this food category. Nonetheless, FSIS believes that the market can
reach the 480 milligrams and 360 milligrams levels within the
timeframes allowed as consumer sodium tastes continue to change.
Under the extra-lean criterion for raw, unprocessed meat and
poultry cuts, a limited number of raw meat and poultry cuts will be
able to meet the cutoff level for fat, saturated fat, and cholesterol.
FSIS is not aware that any of the cuts of meat and poultry that can
meet the definition currently are labeled ``healthy'' in brand names.
FSIS believes that the use of the extra-lean criteria for these foods
and the resulting healthy status of the very leanest of these products
enforce the fact that these foods can be part of a healthy diet. FSIS
also notes that the lean meats can be trimmed, prepared, and
incorporated into meals so that the resulting meal can be labeled
``healthy.'' Since all single-ingredient muscle meats and poultry are
low in sodium, at less than 100 milligrams per 100 grams on both a raw
and cooked basis, a maximum sodium restriction is unnecessary.
In conclusion, FSIS recognizes that the above information is not a
strict representation of the marketplace, but believes that it gives
some expectation of the reformulation problems that will be faced by
the industry. Many products, especially meals, will not face major
changes.
Some manufacturers might not be able to reformulate their products
or may determine that the costs of reformulation are prohibitive. The
manufacturers may choose to market their products under a different
brand name. New resources must also be expended in marketing the
product and in informing consumers that the product has a new name. A
brand name is an intangible asset representing capital just as a
tangible asset is capital. Brand names act as signals that help
consumers identify quality differences and shop more efficiently.
Manufacturers invest real resources in developing and maintaining their
brand identities.
FSIS acknowledges that it could be a cost to the individual
manufacturers of products currently branded ``healthy'' if the brand
names were, in fact, removed from the market. The loss of a brand name
could be a societal loss, as is the loss of any productive asset. The
price consumers are willing to pay for the product may have been due to
consumer misperception about the nutritional profile of the product
bearing the term ``healthy.'' Although most of these products are
nutritionally labeled, some consumers use the term ``healthy'' as a
signal to buy the product and do not read the information on the
nutrition panel on the back of the product.
Manufacturers of those products that make ``healthy'' claims on
products that are not sold under ``healthy'' brand names may choose to
relabel products without the claim when reformulation is either too
costly or not technologically feasible. In its FRIA for the nutrition
labeling regulations, FSIS determined that average costs of redesigning
and printing new labels and inventory losses fell significantly as the
compliance period increased. Costs approach zero when the compliance
period is long enough so that mandated changes can be accomplished in
conjunction with planned labeling changes. FSIS has no information
regarding the number of products that make ``healthy'' claims but do
not use the term in the brand name, but assumes this number is not very
large for meat and poultry products.
Benefits of the Final Rule
In its cost-benefit analysis for the nutrition labeling
regulations, FSIS noted many significant benefits of improved nutrition
labeling, including decreased rates of three types of cancer and
coronary heart disease. The Agency concluded that, as consumers are
given more informative labeling, uncertainty concerning the nutritional
value of the foods they eat will decrease, and many consumers will
select more nutritious, healthier foods. The improved health status of
Americans expected to result from the nutrition labeling rule
pertaining to meat and poultry products was estimated to be about $1.6
billion over a period of 20 years.
It is possible that some products that are currently marketed as
``healthy'' but do not fit the definition may be misleading consumers.
Removal of these products from the marketplace may actually increase
health benefits to consumers. It is also possible that a small number
of products that could assist some consumers in reducing their
consumption of fat, saturated fat, cholesterol, or sodium will be
unable to bear the claim ``healthy,'' thus potentially reducing
benefits. Some products may be reformulated to meet the requirements
for the claim, but may lose sales from lack of consumer taste
satisfaction. It is expected, however, given the selling power of the
term ``healthy'' and the technological advances present in the food
industry, that this rule will increase the number of products bearing
the term ``healthy.''
Executive Order 12778
This final rule has been reviewed under Executive Order 12778,
Civil Justice Reform. States and local jurisdictions are preempted
under the Federal Meat Inspection Act (FMIA) and the Poultry Products
Inspection Act (PPIA) from imposing any marking, labeling, packaging,
or ingredient requirements on federally inspected meat and poultry
products that are in addition to, or different than, those imposed
under the FMIA or PPIA. States and local jurisdictions may, however,
exercise concurrent jurisdiction over meat and poultry products that
are outside official establishments for the purpose of preventing the
distribution of meat and poultry products that are misbranded or
adulterated under the FMIA or PPIA, or, in the case of imported
articles, which are not at such an establishment, after their entry
into the United States. Under the FMIA and PPIA, States that maintain
meat and poultry inspection programs must impose requirements that are
at least equal to those required under the FMIA and PPIA. The States
may, however, impose more stringent requirements on such State
inspected products and establishments.
No retroactive effect will be given to this final rule. The
administrative procedures specified in 9 CFR 306.5 and 381.35 must be
exhausted prior to any judicial challenge of the application of the
provisions of this final rule, if the challenge involves any decision
of an inspector relating to inspection services provided under the FMIA
or PPIA. The administrative procedures specified in 9 CFR parts 335 and
381, subpart W, must be exhausted prior to any judicial challenge of
the application of the provisions of this final rule with respect to
labeling decisions.
Effect on Small Entities
The Administrator has determined that this final rule will not have
a significant economic impact on a substantial number of small
entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601).
The final rule provides a definition for the implied nutrient content
claim ``healthy'' and its derivatives and provides for its use on the
labeling of meat and poultry products. Small meat and poultry
establishments are exempt from nutrition labeling, provided the
labeling of their products bears no nutrition claims or nutrition
information.
However, small entities with products that currently bear labeling
that FSIS is regulating as a defined implied nutrient content claim,
i.e., labeling bearing the term ``healthy'' or its derivatives that is
an implied nutrient content claim under FSIS's regulatory definition of
an implied nutrient content claim, may be impacted by this regulation.
If such products do not conform to the regulatory definition of
``healthy,'' the labeling would need to be changed so as not to
misbrand the product, or the product would need to be reformulated to
meet the criteria for the definition. While the term ``healthy'' has
been widely used on labeling, FSIS believes that the number of small
entities with products bearing such labeling is not substantial because
most of the firms using such labeling are large.
Small manufacturers opting to use the term ``healthy'' or its
derivatives as an implied claim on their labeling, as defined by these
regulations, would be required to comply with the nutrition labeling
requirements, thereby, incurring the costs associated with such
compliance. However, the use of the defined implied nutrient content
claim on the labeling would be voluntary. Decisions by individual
manufacturers on whether to use the claim on their product labeling
would be based on their conclusions that the benefits would outweigh
the costs of including such a claim on the labeling. To minimize the
impact on firms with products that do not conform to the regulations,
FSIS is allowing an 18-month implementation period, with an additional
24 months to achieve a further reduction in sodium levels.
Paperwork Requirements
The final rule specifies the regulations permitting the use of the
term ``healthy,'' or any other derivative of the term ``health'' on the
labeling of meat and poultry products. The final rule requires those
manufacturers opting to use the term ``healthy'' or its derivatives as
an implied claim on their labeling, as defined by this regulation, to
revise their labeling and submit such labeling to FSIS for approval.
The paperwork requirements contained in this final rule have been
submitted to the Office of Management and Budget for review.
Background
On January 6, 1993, FSIS published in the Federal Register (58 FR
632) final regulations on nutrition labeling for meat and poultry
products. These regulations contain, in part, provisions governing use
of implied nutrient content claims on product labeling. At 9 CFR
317.313(b) and 381.413(b), FSIS cross-referenced provisions pertaining
to nutrient content claims at 21 CFR 101.13(b) to define an implied
nutrient content claim as one that either describes a food or
ingredient in a manner suggesting a nutrient is absent or present in a
certain amount, or suggests the food, because of its nutrient content,
may be useful in maintaining healthy dietary practices and is made in
association with an explicit claim or statement about a nutrient. FSIS
did not provide a regulatory provision covering the use of the term
``healthy'' in its final nutrition labeling regulations.
In that same issue of the Federal Register (58 FR 688), FSIS
published a proposed rule to solicit comments from the public on
regulatory provisions for the definition and use of the term
``healthy'' or any other derivative of the term ``health.'' FSIS
proposed that the implied nutrient content claim ``healthy'' or any
other derivative of the term ``health'' be permitted on the labeling of
meat and poultry products that meet the following criteria: Contain
less than 10 grams (g) of fat, less than 4 g of saturated fatty acids,
less than 95 milligrams (mg) of cholesterol, and less than 480 mg of
sodium per 100 g and Reference Amount Customarily Consumed for
individual foods, and per 100 g and labeled serving for meal-type
products, as defined in 9 CFR 317.313(l) and 381.413(l). FSIS stated
that the proposed rule would apply the criteria for ``healthy'' to any
term used anywhere on the label that includes the term ``health.'' FSIS
proposed to include the ``healthy'' provisions contained in the
proposed rule (58 FR 688) in 9 CFR 317.309(j) and 381.409(j). FSIS now
believes that the proposed ``healthy'' provisions were inappropriately
placed in a section of the regulations that do not relate to general or
specific requirements for nutrient content claims. Therefore, FSIS is
correcting that oversight in this final rule by promulgating those
provisions at 9 CFR 317.363 and 381.463, which are reserved for
nutrient content claim requirements.
On January 6, 1993, FDA also published a proposal (58 FR 2944) that
would establish a definition for the implied nutrient content claim
``healthy'' for foods under its jurisdiction. FDA proposed to permit
the term ``healthy'' to be used on foods that meet regulatory
definitions for ``low fat'' and ``low saturated fat,'' and that do not
exceed disclosure levels for cholesterol and sodium. In their final
nutrition labeling regulations, FSIS and FDA adopted identical
definitions for the express nutrient content claims of ``low fat'' and
``low saturated fat.'' As defined in 9 CFR 317.362 and 381.462, ``low
fat'' claims may only be made on products containing 3 g or less total
fat per reference amount when they are individual foods and per 100 g
when they are meal-type products. ``Low saturated fat'' claims may only
be made on products containing 1 g or less saturated fat per reference
amount when they are individual foods and per 100 grams when they are
meal-type products. As defined in 21 CFR 101.13(h), FDA's disclosure
levels for cholesterol are 60 mg per reference amount and labeled
serving for individual foods, 90 mg per labeled serving for main
dishes, and 120 mg per labeled serving for meal products. Sodium
disclosure levels are 480 mg per reference amount and labeled serving
for individual foods, 720 mg per labeled serving for main dishes, and
960 mg per labeled serving for meal products.
Discussion of Comments and Final Rule
FSIS received 47 comments in response to the January 6, 1993,
proposed rule (58 FR 688). The majority of the comments (31) were
submitted by food manufacturers, while 5 were received from consumer
groups; 3 from academia; 2 from professional organizations; 2 from
trade associations; 1 from a foreign government; 1 from a State
government; 1 from a food retailer; and 1 from a consumer. All comments
submitted with respect to the proposed rule were given due
consideration. A summary of the comments and FSIS's responses follow.
Use of the Term ``Healthy''
Some commenters questioned FSIS's authority to regulate use of the
word ``healthy.'' These commenters argued that the term is an adjective
which does not characterize the quantity of nutrients in food products.
Other commenters wanted use of ``health'' banned altogether because the
term offers shoppers no substantial information on which to base food
choices, and is only a marketing tool. A foreign government stated that
any differences in nutrition labeling requirements between the U.S. and
other countries will create significant trade barriers. A few
commenters contended that if ``healthy'' is not defined, it should not
be grandfathered, i.e., used as an implied nutrient content claim as
part of brand names in use prior to November 27, 1991, as long as such
use is not false or otherwise misleading, but it should be available
for use by all companies.
The majority of responses supported defining the term because of
current inconsistent usage in the marketplace that serves to confuse
and mislead consumers. Several commenters cited the 1992 National
Consumers League opinion poll, and another cited internal market
research to show that consumers often expect products labeled as
``healthy'' to be low in nutrients of public health concern, such as
fat and sodium. A few manufacturers or products with brand names, trade
names, or product lines now containing the term ``healthy'' advised
that their products were specially formulated to be ``good for you''
and/or control nutrients that health authorities recommend be consumed
at decreased dietary levels in order to lessen the risk of diet-related
diseases or health conditions. There was overwhelming agreement among
commenters that if ``healthy'' is defined, both FSIS and FDA should
adopt uniform criteria so as not to undermine the benefits consumers
will ultimately realize through application of the same definition.
FSIS has authority to require nutrition labeling and to regulate
the labeling of meat and poultry products based upon the statutory
provisions concerning misbranding in the FMIA (21 U.S.C. 601(n)(1)) and
the PPIA (21 U.S.C. 453(h)(1)). Under these statutory provisions, an
article is misbranded if it is false or misleading in any particular.
FSIS agrees with the many commenters who concluded that use of the term
``healthy'' on the labeling of meat and poultry products conveys a
powerful message to consumers about the nutritional attributes of those
products. FSIS believes that in the absence of a regulatory definition
for the term, its use on product labeling has great potential to be
false or misleading to consumers. Accordingly, FSIS is establishing
regulatory provisions governing use of the term ``healthy'' as an
implied nutrient content claim. FSIS's intent is not to hamper free
trade by this action, but, rather, to eliminate misleading the American
consumer through inconsistent use of implied nutrient content claims.
The grandfathering provisions contained in 9 CFR 317.313(q)(1) and
381.413(q)(1) do not exempt defined implied nutrient content claims.
Therefore, upon the effective date of this final rule, the term
``healthy'' or any other derivative of the term ``health'' may no
longer appear as an implied nutrient content claims in brand names of
products that were initially marketed prior to November 27, 1991,
unless the product meets the regulatory requirements covering use of
nutrient content claims.
FSIS and FDA carefully reviewed and assessed their respective
comments regarding the need for a uniform definition for ``healthy.''
Both agencies agree with the comments that requested consistency in the
FSIS and FDA definition of ``healthy,'' and recognize that having
different definitions for the same nutrient content claim could likely
lead to consumer confusion and undermine the usefulness and credibility
of the claim. FSIS and FDA have jointly reached a decision to establish
a uniform definition of the term ``healthy'' as it applies to all foods
regulated by both agencies.
Derivatives and Synonyms
Commenters who addressed applying the criteria for ``healthy'' to
any term that includes the term ``health'' agreed with FSIS's proposed
position to include derivatives of ``health'' in the definition because
they are viewed by consumers as having the same general meaning.
Derivatives of ``health'' include, but are not limited to, the
following terms: Healthful, healthfully, healthfulness, healthier,
healthiest, healthily, and healthiness.
Several commenters asserted that products with labeling bearing
synonymous terms or phrases such as ``nutritious,'' ``wholesome,''
``smart choice,'' and ``foods for today's diets,'' all of which relay a
``good for you'' message, should be defined or required to meet the
``healthy'' definition. FSIS believes that such terms and phrases can
be implied nutrient content claims depending on the context in which
they are used. However, FSIS does not have sufficient information to
establish definitions for such terms or to determine that they are
synonyms for ``healthy.'' Therefore, such synonymous terms or phrases
are not included in this final rule.
Nutritional Context
Some commenters supported FSIS's proposed approach to treat the
term ``healthy'' as an implied nutrient content claim when it is used
in a brand name or elsewhere on the labeling of a product, except as it
pertains to general dietary guidance language. For example, one
commenter stated that when the term is used without context, either in
a brand name or standing alone, or when it is used on labeling that
bears other nutrient content claims, it should be presumed, based on
scores of examples on the market today, that consumers will believe the
term is used in reference to the nutritional properties of the labeled
food. Without context, the possible meaning is ambiguous, at a minimum,
which should be construed against the manufacturer, who has the
opportunity to provide clarifying language if a different meaning is
intended.
Other commenters urged FSIS to consider the textual use of the term
in determining whether it constitutes an implied nutrient claim,
contending that there will be circumstances where the term ``healthy''
neither explicitly nor implicitly characterizes the level of nutrients
in a food. Many were concerned that the vast bulk of published,
authoritative guidance material would be prohibited from use with any
USDA-regulated product under FSIS's proposed approach.
After careful review of all comments, FSIS has reconsidered usage
of ``healthy'' on labeling, and concludes that it would not be in the
best interest of consumers to preclude use of dietary guidance
statements, which frequently include the term ``healthy,'' on the
labeling of meat and poultry products. Also, FSIS recognizes that there
may be circumstances where the term ``healthy'' neither explicitly or
implicitly characterizes the level of a nutrient in a product, and
where it can be placed in proper context, for example, in advertising
copy on product labeling. FSIS is now convinced that it should evaluate
the term within the context of the entire labeling to determine if it
is used as an implied nutrient content claim as provided for in 9 CFR
317.313(b) and 381.413(b).
However, comments strongly suggest that use of the term ``healthy''
or any other derivative of the term ``health'' in the brand name of a
product or standing alone, including in a phrase, as in a banner or
flagged statement, and either with or without other nutrient content
claims, might lead consumers reasonably to believe that the labeled
product is useful in achieving a total diet conforming to dietary
guidelines by virtue of the nutritional attributes of the specific
product. While clarifying language might be used to identify non-
nutritional meaning, FSIS does not believe that such statements
standing alone, which might take the form of ``healthy, a big portion''
or ``healthy, no chemical preservatives,'' would necessarily negate a
nutritional meaning, and consumers might assume reasonably that
``healthy'' has a double meaning in those situations.
While FSIS agrees that use of the term ``healthy'' or any other
derivative of the term ``health'' in the brand name of a product or
standing alone is not inherently misleading, FSIS believes that such
use may be placed in a nutritional context in the absence of other
explicit or implied nutrient content claims on the labeling of the
product. Products bearing ``healthy'' in the brand name or standing
alone often are advertised and promoted to highlight the fact that they
are specially formulated to contain nutrients at levels that will
assist consumers to maintain healthy dietary practices. The product
lines frequently cover a wide variety of products, and the names are
recognized as characterizing products that can help consumers to meet
dietary recommendations.
FSIS believes that a nutritional context for a term may be
established by written statements, symbols, or vignettes on a product's
labeling, and by advertising, promotional materials, or other relevant
action. Therefore, FSIS views use of the term ``healthy'' or any other
derivative of the term ``health'' in a brand name or standing alone to
be in a nutritional context, even in the absence of other nutrient
claims, when such appearance implies that the product is useful in
maintaining healthy dietary practices. A nutritional context would not
be established when the term appears in a name listed only as part of
the identification of the manufacturer, packer, or distributor as
required in 9 CFR 317.2(c)(3) and 381.122 for meat and poultry
products, respectively, because associations would be to a company as
opposed to a specific product.
Individual Foods
Some commenters requested that FSIS restrict use of the term
``healthy'' to meal-type products. They argued that the term should be
limited to complete meals containing proper proportions of foods from
different food groups because the Food Guide Pyramid and other
traditional approaches to sound nutrition recommend certain numbers of
a variety of foods from several food groups for the average person.
Other commenters agreed with FSIS that the definition should not be
limited solely to meal-type products because many individual foods have
special nutritional attributes that contribute to a healthy diet. FSIS
is not persuaded that the definition should be confined to meal-type
products, and believes that both individual foods and meal-type
products can be used with a variety of foods to assist consumers to
achieve a total diet conforming to dietary guidelines.
Uniform Definition
FSIS received numerous comments that suggested definitions for use
of the term ``healthy'' on food labeling. As mentioned previously,
there was overwhelming agreement that FSIS and FDA adopt a uniform
definition. Both agencies conclude that because of the term's
widespread appeal and its potential usefulness in denoting foods than
can assist consumers in maintaining healthy dietary practices, the
definition should be reasonable and practical. The following discussion
addresses fat and saturated fat, cholesterol, sodium, and nutritive
value in turn.
1. Fat and Saturated Fat. Most commenters who maintained that the
term ``healthy'' should be defined by regulation supported limitations
on amounts of fat and saturated fat as prerequisites to use the term on
the labeling of meat and poultry products. Some agreed with the
proposed criteria of parallel levels for fat and saturated fat, as
required for use of the term ``lean'' without providing further grounds
for support other than those presented by FSIS in the preamble to its
proposal. The majority of commenters opposed the proposed criteria for
fat and saturated fat, on the basis that the levels were too high under
most conditions. Other commenters urged FSIS not to apply the same
criteria to individual foods as to meal-type products because the
latter generally contribute a larger fraction of total daily nutrients
and energy than most individual foods.
Some commenters who objected to the proposed definition voiced
concern that it might mislead consumers who purchase a product labeled
as ``healthy'' in an effort to minimize their intake of fat and
saturated fat. They argued that linking the definition of ``healthy''
to the definition of ``lean'' was not appropriate because foods labeled
as ``healthy'' are more than merely foods that can be incorporated into
a healthy diet. They asserted that the term ``healthy,'' as understood
by consumers and used by manufacturers, should be reserved for those
products that are the very best in helping consumers to limit their
intake of nutrients of public health concern, such as fat, cholesterol,
and sodium.
FSIS has carefully considered these comments, and concludes that
the criteria established for use of the term ``healthy'' on the
labeling of meat and poultry products should minimize intakes of fat
and saturated fat. FSIS is convinced that products low in fat and
saturated fat meet this goal. Accordingly, FSIS has modified the
proposed criteria of less than 10 g of fat and less that 4 g of
saturated fat to require that products meet the regulatory definitions
for ``low fat'' and ``low saturated fat.'' These new restrictions
recognize that a significant characteristic of the American diet is an
excess of fat and saturated fat, and will assure consumers that foods
labeled ``healthy'' are among the lowest in fat and saturated fat on
the market. Selection of ``low fat'' and ``low saturated fat'' criteria
for use of the term ``healthy'' is also responsive to the assertion
that individual foods and meal-type products should not be treated
uniformly because the latter, by definition, make a substantial
contribution to the diet.
One commenter suggested that the fat and saturated fat content of
meal-type products be capped at 10 g and 4 g per labeled serving,
respectively, to ensure that products labeled as ``healthy'' are lower
in these nutrients than meal-type products bearing competing claims
such as ``low fat'' and ``lean.'' FSIS rejects this suggestion because
the ``low'' criteria are designed to help consumers construct a diet
that is consistent with dietary guidelines, and FSIS believes they are
adequate to minimize fat intake.
A manufacturer of a line of meal-type products bearing the term
``healthy'' and exceeding the limit of 12 ounces per serving
(container) prescribed at 9 CFR 317.313(l) and 281.413(l) for meal-type
products for the purposes of making nutrient content claims requested
that limits on fat and saturated fat be indexed up for single-serving
meals that exceed 12 ounces in weight. In response, FSIS notes that the
``low fat'' and ``low saturated fat'' criteria are indexed on the per-
100-g basis. Therefore, FSIS does not perceive a need to evaluate meal-
type products that weigh more than 12 ounces on a case-by-case basis
for use of the implied nutrient content claim ``healthy.'' Accordingly,
FSIS is including meals that weigh more than 12 ounces in the
definition of a meal-type product for purposes of using the term
``healthy'' on the labeling of these products.
2. Cholesterol. Most of the commenters who supported limitations on
fat and saturated fat also supported limitations on cholesterol so that
products labeled as ``healthy'' would assist consumers to minimize
their intake of cholesterol. While some commenters argued for a strict
``low cholesterol'' criterion, a number agreed that the proposed levels
were appropriate because they were not overly restrictive and were
consistent with the cholesterol content of muscle meat.
Regarding comments favoring a ``low cholesterol'' criterion, FSIS
is not persuaded that a definition for ``healthy'' that requires a
product to be low in cholesterol is warranted. Such a definition would
virtually preclude use of the term on a large majority of food products
for the general public that are in the marketplace today--an outcome
that would be a disservice to both consumers and manufacturers alike.
Dietary guidelines advise consumers to eat a variety of foods, choosing
different foods from five major food groups that include vegetables;
fruits; grain products; dairy products; and meat, poultry, fish, dry
beans, eggs, and nuts. FSIS believes that the ``healthy'' definition
should encompass appropriate foods from all of these food groups in
order to be useful to consumers in selecting foods that can be used to
construct a healthy diet. Cholesterol is not ubiquitous in the food
supply but only found in foods of animal origin. Cholesterol is not
present in a number of foods, such as fruits and vegetables, that are
included in healthy diets, and dietary reductions in both total fat and
saturated fat facilitate reduction in dietary cholesterol. Because FSIS
is adopting in this final rule ``low fat'' and ``low saturated fat''
criteria for the definition of ``healthy,'' it concludes that a need to
require a ``low cholesterol'' criterion is not justified.
In view of concerns expressed by commenters that criteria for
``healthy'' should minimize intake of cholesterol, as well as fat and
saturated fat, FSIS has reconsidered its proposed criteria for
cholesterol. FSIS had proposed a limit of no more than 95 mg per 100 g
and per labeled serving (container) for meal-type products. Because
these products must weigh at least 6 ounces as defined in 9 CFR
317.313(l) and 381.413(l), they are restricted to less than 95 mg of
cholesterol in an entire serving. A commenter observed that it is
reasonable to expect meal-type products to contain no more than this
level. Even if meal-type products provided a third of a day's food
intake, their cholesterol content would have to fall under 100 mg for
an individual to consume less than the 300-mg recommended daily intake.
FSIS examined the disclosure level for cholesterol defined by FDA
at 21 CFR 101.13(h)(3) for a main dish product, as defined in 21 CFR
101.13(m) and that weighs at least 6 ounces. This level is 90 mg of
cholesterol per labeled serving and represents the lowest cholesterol
disclosure level for meal-type products of all weights. Because low fat
foods generally help individuals in reducing their intake of saturated
fat and cholesterol, and FSIS is adopting ``low fat'' and ``low
saturated fat'' criteria for use of the term ``healthy,'' FSIS
concludes that it is reasonable to apply a limitation of 90 mg of
cholesterol per labeled serving for use of the term ``healthy'' on
meal-type products. FSIS believes the 90 mg of cholesterol limit used
in conjunction with ``low fat'' and ``low saturated fat'' criteria
combine to set technologically feasible parameters that should
encourage manufacturers to design a broad range of these food products.
When cholesterol-containing foods such as meat, poultry, fish, eggs, or
cheese are components of meal-type products, manufacturers should be
able to meet the 90 mg of cholesterol limit by decreasing the amount of
cholesterol-containing foods in the products.
Commenters noted that most individual foods play a smaller role in
the daily diet than meal-type products so that it is anomalous to apply
the same disqualifying levels to both types of products. They stated
further that, as it was appropriate for FSIS to develop different
nutrient content claim criteria for individual foods and for meal-type
products, it is likewise appropriate that this same rationale be
applied in defining ``healthy.'' FSIS is now convinced that the
cholesterol criterion for individual foods should be lower than the
proposed 95-mg limit. FSIS believes that the limit of 60 mg of
cholesterol per reference amount customarily consumed and per labeled
serving size proposed by FDA for individual foods is a reasonable and
appropriate limit to minimize cholesterol intake from these products
when considering that the products must also meet ``low fat'' and ``low
saturated fat'' criteria. Accordingly, FSIS is adopting in this final
rule FDA's cholesterol criterion for the definition of ``healthy'' as
applied to individual food products.
3. Sodium. While a few commenters suggested that a limit on sodium
for a healthy food is unnecessary, most agreed that a limit is
appropriate, noting it is widely recognized that the average daily
sodium intake of Americans is higher than optimal under the Dietary
Guidelines for Americans, and that it is worth striving for the control
of sodium in food products. Although some commenters urged FSIS to
adopt FDA's proposed limits on sodium, the majority expressed the
opinion that FDA's sodium restrictions for meal products, main dishes,
and individual foods are too high. They further stated that while
FSIS's proposed limits may be reasonable for meal-type products, they
are too low for individual food products, in some cases, because they
must qualify on the per-100-g basis, as well as per reference amount. A
few commenters urged FSIS to adopt ``low sodium'' criteria for
individual foods and meal-type products. One commenter suggested a cap
of 480 mg of sodium per labeled serving for meal-type products if ``low
sodium'' criteria are adopted for this category of products.
After review and evaluation of the comments, FSIS concludes that
the concept of using disclosure levels as limits on the sodium content
in foods labeled as ``healthy'' does not minimize sodium intake from
such products. FSIS believes that a level above 480 mg of sodium per
labeled serving in meal-type products may not be helpful to consumers
who might choose products labeled as ``healthy'' as a means to achieve
the recommended daily intake of 2,400 mg of sodium per day. However,
FSIS maintains that ``low sodium'' criteria are overly restrictive
because a diet limited to ``low sodium'' products is not required to
meet dietary recommendations. FSIS is not persuaded by the comments to
change its proposed sodium criterion for meal-type products. FSIS is
convinced that a level of 480 mg of sodium per labeled serving is both
appropriate and technologically feasible. FSIS is deleting the per-100-
g basis on the sodium criterion for meal-type products because it is
superfluous for products that, by definition, weigh over 100 g.
Evidence supplied by commenters shows that many meal-type products
currently bearing the term ``healthy,'' or similar terms, on their
labeling average well below FDA's proposed cutoff levels of 720 mg of
sodium per labeled serving for main dishes and 960 mg for meal
products. While a number of the products are at or slightly below the
limit of 480 mg of sodium per labeled serving proposed by FSIS, there
are a number that exceed this level. A commenter suggested that a
sodium limit of 600 mg per labeled serving might be a reasonable level
for meal-type products that would provide room for consumption of
beverages and snacks throughout the day. Other commenters stressed that
it would be counterproductive to establish restrictions on sodium that
would diminish consumer acceptance of otherwise healthy products and
damage their marketability.
Based on information about the sodium content of meal-type products
on the market, FSIS believes that additional time should be afforded
manufacturers to reformulate products to meet the level FSIS is
adopting. This action minimizes compliance costs, ensures that products
will continue to meet consumer expectations, and is consistent with
FDA's approach. Accordingly, with regard to use of the term ``healthy''
on meat and poultry products, FSIS is establishing an interim criterion
of 600 mg of sodium per labeled serving for meal-type products.
Although this criterion must be met by the effective date of the
regulations, FSIS is allowing an additional 24 months for affected
parties to comply with the sodium criterion of 480 mg per labeled
serving.
Regarding individual foods, several commenters objected to FSIS's
proposed criterion of 480 mg of sodium per 100 g as too low in some
cases, contending that salt is a necessary addition to processed meats,
not a discretionary addition as with other processed food products. One
commenter stated that sodium is required for the production, shelf life
and safety of processed meats at some minimal level which exceeds 480
mg per 100 g. The commenter further argued that even though potassium
salt has been able to replace sodium salt to some degree (up to 40
percent), a level of 700 mg of sodium per 100 g of product could be
reached at best. A commenter also suggested that products reflecting a
meaningful reduction in a nutrient from a previous recipe should be
allowed to qualify for use of the term ``healthy.''
Based on information received in the comments and discussions with
FDA, FSIS concludes that, in order for the definition of ``healthy'' as
it applies to individual foods to be useful in assisting consumers to
achieve dietary goals, the amount of sodium permitted should be
significantly less than 20 percent of the recommended daily level of
2,400 mg per day, i.e., less than 480 mg per reference amount and
labeled serving. A significant reduction in a nutrient, as provided for
in 9 CFR 317.313(j) and 381.413(j) for relative claims, is at least 25
percent. However, for the definition of ``healthy,'' the reduction
cannot be applied to a particular food because the term ``healthy'' is
not defined as a relative claim, but as an implied nutrient content
claim. By applying the significant reduction principle to FDA's sodium
disclosure level for individual foods, FSIS arrives at a level of 360
mg (75 percent of 480 mg) per reference amount and labeled serving.
Accordingly, FSIS is establishing the sodium criterion for the
``healthy'' definition as it applies to individual foods at 360 mg per
reference amount and labeled serving.
For the same reasons discussed for meal-type products, FSIS
believes that additional time should be afforded manufacturers for
product reformulation to comply with the criterion of 360 mg of sodium
for the ``healthy'' definition as it applies to individual foods. As
with meal-type products, such action minimizes compliance costs,
ensures continued product acceptability, and is consistent with the
approach FDA is adopting. Accordingly, with regard to use of the term
``healthy'' on meat and poultry products, FSIS is establishing an
interim criterion of 480 mg of sodium per reference amount and labeled
serving for products that are individual foods. Although this criterion
must be met by the effective date of the regulations, FSIS is allowing
an additional 24 months for affected parties to comply with the sodium
criterion of 360 mg per reference amount and labeled serving.
Based on the comments submitted and other data it reviewed, FSIS is
aware that many meat and poultry products, which are individual foods,
exceed the 360 mg of sodium limit. Only a few products meet the limit
at this time, while somewhat more meet the interim limit of 480 mg of
sodium. Considering the 3\1/2\-year phase-in period allowed and the
information reviewed, FSIS believes the 360-mg level is a reasonable
and practical limit that both minimizes sodium intake and encourages
production of improved products. Furthermore, manufacturers have
options other than ``healthy'' to choose other claims such as ``light''
and ``reduced'' to describe products that fit into a healthy diet,
should their products fail to meet the sodium qualification for the
``healthy'' definition.
To ensure full compatibility with FDA's sodium criterion for
individual foods, FSIS is providing identical allowances for foods with
reference amounts of 30 g or less or 2 tablespoons or less, and for
dehydrated products that must be reconstituted with water or diluents
containing insignificant amounts of nutrients.
4. Nutritive Value. In its proposal on use of the term ``healthy,''
FSIS stated that it had solicited comments on use of the term in its
proposed rule entitled ``Nutrition Labeling of Meat and Poultry
Products'' published in the Federal Register on November 27, 1991 (56
FR 60302). Although FSIS did not propose requirements for essential
nutrients in its proposal on ``healthy'' issued on January 6, 1993,
FSIS noted that a few comments were received in response to the
November 27, 1991, proposal. Some commenters stated that the term
should not only be equated with controlled amounts of fat, saturated
fatty acids, cholesterol, and sodium, but that use of the term should
also meet the ``high'' definition for a certain number of
micronutrients.
In response to FSIS's proposal on ``healthy,'' some commenters
opposed additional definition requirements that a food labeled as
``healthy'' contain certain specified amounts of essential vitamins,
minerals, or other nutrients, on the basis that many nutritious foods
might fail to qualify, or that such a requirement might limit a
manufacturer's ability to formulate improved products. However, others
stated it would be absurd if foods without nutritional value could be
labeled as ``healthy'' while nutrient-dense lean meat products might
fail to qualify because of the inherent fat content of muscle tissue.
Most commenters favored an essential nutrient requirement because foods
labeled as ``healthy'' should make a nutritional contribution to the
diet, in addition to minimizing intake of nutrients of public health
concern. One commenter cited a recent survey by the American
Association of Retired Persons showing that 63 percent of respondents
said they expect a product labeled as ``healthy'' to be a good source
of some important vitamins and minerals.
Commenters suggested that requirements for six essential nutrients
for which labeling disclosure is mandatory, i.e., vitamin A, vitamin C,
calcium, iron, protein, and dietary fiber, be established at 10 percent
of the Reference Daily Intake or Daily Reference Value, i.e., an amount
consistent with the definition for good source of a nutrient, based on
the weight of the food product as follows: Meal products should provide
at least three of the six nutrients; main dishes should provide at
least two of the six nutrients; and individual foods should be a good
source of at least one of the six nutrients. Commenters also
recommended that requirements for essential nutrients be met prior to
nutrient addition to food products, so as to preclude addition solely
for the purpose of meeting the criteria for the claim ``healthy.''
FSIS has carefully considered these comments and suggested
requirements, and agrees that products labeled as ``healthy'' should
provide essential nutrients in the amounts recommended by commenters
prior to nutrient addition. Accordingly, FSIS is adopting the suggested
requirements of meal products, main dishes, and individual foods prior
to nutrient addition. To provide consistency with FDA's meal categories
on a weight basis, FSIS is applying the requirements per labeled
serving suggested for FDA's main dish products to FSIS-regulated meal
products weighing at least 6 ounces, but less than 10 ounces, and the
requirements per labeled serving suggested for FDA's meal products to
FSIS-regulated meal products weighing 10 ounces or more, including
those weighing more than 12 ounces.
FSIS interprets nutrient addition as an addition of nutrients
specifically to meet the requirements for ``healthy.'' For example, the
requirement does not preclude claims on products where a nutrient is
added to meet a standard of identity; a nutrient is added for
technological purposes, e.g., L-ascorbic acid (vitamin C) in curing
meats; a non-meat or non-poultry ingredient fortified in accordance
with FDA requirements and policy is used; or an ingredient is used that
is a source of a nutrient, such as textured vegetable protein.
Single-Ingredient, Raw Products
Several commenters suggested that FSIS establish a separate
category for muscle cuts of meat and poultry based on criteria for
``extra lean,'' which might also be appropriate for fish and game meats
under FDA jurisdiction. Based on information submitted by commenters
and otherwise available, FSIS believes that a number of meat and
poultry products that are individual foods comprised of more than one
ingredient readily can be formulated to meet the criteria for fat,
saturated fat, and cholesterol that FSIS is adopting. For example, many
soups that contain lesser amounts of meat or poultry and certain
luncheon products with added water or non-meat ingredients and that
have 55-g reference amounts currently meet the criteria.
However, FSIS realizes that single-ingredient, raw meat and poultry
products are severely impacted by the restrictions on fat, saturated
fat, and cholesterol. Information reported in USDA's Agriculture
Handbook No. 8 shows that no single cut of beef, pork, lamb, veal, or
chicken could meet all three requirements, and only skinless light meat
cuts of turkey could qualify to use the term.
A number of commenters stressed that ``healthy'' should be defined
in such a way that it is consistent with dietary guidelines. They
mentioned that many recommendations from public health organizations
and the Dietary Guidelines for Americans advise choosing lean meats,
fish, and poultry without skin as a means of achieving nutritious diets
low in fat, saturated fat, and cholesterol. They further stated that if
lean meats cannot be labeled as ``healthy'' because of the inherent fat
content of muscle tissue, there is little incentive for industry to
further its research and production of leaner red meat.
FSIS believes that products failing to meet the definition for
``healthy'' can also have a place in a healthy diet. Choosing lean
versus fattier cuts of meats makes it easier for Americans to meet
dietary guidelines. FSIS is fully aware that lean cuts of meat and
poultry, which of themselves do not meet definitions for ``low fat''
and ``low saturated fat,'' and do not contain 60 mg or less of
cholesterol per reference amount and labeled serving, can be
incorporated readily into meal-type products and individual food
mixtures that do meet the ``healthy'' definition. As stated in the
preamble to its proposal, FSIS believes that the criteria for
``healthy'' should not interfere with dietary guidance messages of
encouraging consumption of a variety of foods and increased use of lean
meats and poultry products.
FSIS is convinced that products labeled as ``healthy'' should both
assist consumers in meeting dietary guidelines, as well as minimize
intake of nutrients of public health concern. FSIS finds merit in those
comments suggesting that criteria for ``extra lean'' be considered for
use of the term ``healthy'' in connection with cuts of meat and
poultry. Accordingly, FSIS is providing in this final rule that single-
ingredient, raw meat and poultry products that meet the requirements
for ``extra lean'' may qualify to use the term ``healthy'' on the
labeling, provided they meet all other requirements to bear the claim.
Products qualify for the ``extra lean'' claim when they contain less
than 5 g of fat, less than 2 g of saturated fat, and less than 95 mg of
cholesterol per 100 g and per reference amount customarily consumed.
Single-ingredient, raw meat and poultry products may meet the ``extra
lean'' requirements in lieu of meeting definitions for ``low fat'' and
``low saturated fat'' and the limitation of
60 mg or less of cholesterol per reference amount and labeled serving.
Although ``extra lean'' criteria as applied to single-ingredient, raw
products are slightly less stringent than the criteria adopted for
processed, multi-ingredient individual food products, they both
recognize the inherent nutrient profile of muscle tissue and identify
the very leanest of meat and poultry products available to consumers in
the marketplace. Thus, ``extra lean'' criteria meet the goal of
minimizing fat intake from this important category of products that are
staples in the American diet.
FSIS is not specifying a sodium criterion for single-ingredient,
raw meat and poultry products because these products are inherently low
in sodium, containing amounts well below the limit established for
individual foods.
Implementation Date
In its proposed rule on use of the term ``healthy,'' FSIS advised
that it intended to make any final rule that derived from the
rulemaking effective the same effective date as the final rule entitled
``Nutrition Labeling of Meat and Poultry Products,'' which is July 6,
1994. FSIS further stated that, if, for some reason, a final rule on
``healthy'' and similar terms is not issued in time to meet the same
effective date as FSIS's final rule on nutrition labeling, the use of
``healthy'' and similar terms would be subject to the nutrient content
claim provisions set forth in the final rule on nutrition labeling.
In response to comments on the proposed rule, the provisions of
this final rule differ from the provisions contained in the proposed
rule. The differences are of a magnitude that will require the
relabeling, reformulation, and/or reanalysis of some products currently
on the market, i.e., those with labeling currently bearing the term
``healthy'' or any other derivative of ``health,'' and which do not
meet the requirements set forth in this final rule.
Therefore, FSIS has decided that sufficient time should be allotted
to make any changes necessary for manufacturers to comply with this
rule. FSIS has determined that this final rule will be implemented 18
months from the date of its promulgation, with an additional 24 months
to achieve further reductions in sodium levels. This 18-month period is
the same period as allowed for the nutrition labeling regulations based
on comments received from the public on issues related to its
implementation date. This timeframe is also consistent with FDA's
enforcement strategy as discussed in its companion rulemaking on use of
the term ``healthy.''
List of Subjects
9 CFR Part 317
Food labeling, Food packaging, Meat inspection.
9 CFR Part 381
Food labeling, Poultry and poultry products, Poultry inspection.
Final Rule
For the reasons discussed in the preamble, FSIS is amending 9 CFR
parts 317 and 381 of the Federal meat and poultry products inspection
regulations as follows:
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
1. The authority citation for part 317 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.
2. Section 317.363 is added to read as follows:
Sec. 317.363 Nutrient content claims for ``healthy.''
(a) The term ``healthy,'' or any other derivative of the term
``health,'' may be used on the labeling of any meat or meat food
product, provided that the product is labeled in accordance with
Sec. 317.309 and Sec. 317.313.
(b)(1) The product shall meet the requirements for ``low fat'' and
``low saturated fat,'' as defined in Sec. 317.362, except that single-
ingredient, raw products may meet the total fat and saturated fat
criteria for ``extra lean'' in Sec. 317.362.
(2) The product shall not contain more than 60 milligrams (mg) of
cholesterol per reference amount customarily consumed, per labeled
serving size, and, only for foods with reference amounts customarily
consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per
50 g, and, for dehydrated products that must be reconstituted with
water or a diluent containing an insignificant amount, as defined in
Sec. 317.309(g)(1), of all nutrients, the per-50-g criterion refers to
the prepared form, except that:
(i) A meal-type product, as defined in Sec. 317.313(l), and
including meal-type products that weigh more than 12 ounces (oz) per
serving (container), shall not contain more than 90 mg of cholesterol
per labeled serving size; and
(ii) Single-ingredient, raw products may meet the cholesterol
criterion for ``extra lean''in Sec. 317.362.
(3) The product shall not contain more than 360 mg of sodium,
except that it shall not contain more than 480 mg of sodium during the
first 24 months of implementation, per reference amount customarily
consumed, per labeled serving size, and, only for foods with reference
amounts customarily consumed of 30 g or less or 2 tbsp or less, per 50
g, and, for dehydrated products that must be reconstituted with water
or a diluent containing an insignificant amount, as defined in
Sec. 317.309(g)(1), of all nutrients, the per-50-g criterion refers to
the prepared form, except that:
(i) A meal-type product, as defined in Sec. 317.313(l), and
including meal-type products that weigh more than 12 oz per serving
(container), shall not contain more than 480 mg of sodium, except that
it shall not contain more than 600 mg of sodium during the first 24
months of implementation, per labeled serving size; and
(ii) The requirements of this paragraph (b)(3) do not apply to
single-ingredient, raw products.
(4) The product shall contain 10 percent or more of the Reference
Daily Intake or Daily Reference Value as defined in Sec. 317.309 for
vitamin A, vitamin C, iron, calcium, protein, or fiber per reference
amount customarily consumed prior to any nutrient addition, except
that:
(i) A meal-type product, as defined in Sec. 317.313(l), and
including meal-type products that weigh at least 6 oz but less than 10
oz per serving (container), shall meet the level for two of the
nutrients per labeled serving size; and
(ii) A meal-type product, as defined in Sec. 317.313(l), and
including meal-type products that weigh 10 oz or more per serving
(container), shall meet the level for three of the nutrients per
labeled serving size.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
3. The authority citation for part 381 continues to read as
follows:
Authority: 7 U.S.C. 450, 21 U.S.C. 451-470; 7 CFR 2.17, 2.55.
4. Section 381.463 is added to read as follows:
Sec. 381.463 Nutrient content claims for ``healthy.''
(a) The term ``healthy,'' or any other derivative of the term
``health,'' may be used on the labeling of any poultry product,
provided that the product is labeled in accordance with Sec. 381.409
and Sec. 381.413.
(b)(1) The product shall meet the requirements for ``low fat'' and
``low saturated fat,'' as defined in Sec. 381.462, except that single-
ingredient, raw products may meet the total fat and saturated fat
criteria for ``extra lean'' in Sec. 381.462.
(2) The product shall not contain more than 60 milligrams (mg) of
cholesterol per reference amount customarily consumed, per labeled
serving size, and, only for foods with reference amounts customarily
consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per
50 g, and, for dehydrated products that must be reconstituted with
water or a diluent containing an insignificant amount, as defined in
Sec. 381.409(g)(1), of all nutrients, the per-50-g criterion refers to
the prepared form, except that:
(i) A meal-type product, as defined in Sec. 381.413(l), and
including meal-type products that weigh more than 12 ounces (oz) per
serving (container), shall not contain more than 90 mg of cholesterol
per labeled serving size; and
(ii) Single-ingredient, raw products may meet the cholesterol
criterion for ``extra lean'' in Sec. 381.462.
(3) The product shall not contain more than 360 mg of sodium,
except that it shall not contain more than 480 mg of sodium during the
first 24 months of implementation, per reference amount customarily
consumed, per labeled serving size, and, only for foods with reference
amounts customarily consumed of 30 g or less or 2 tbsp or less, per 50
g, and, for dehydrated products that must be reconstituted with water
or a diluent containing an insignificant amount, as defined in
Sec. 381.409(g)(1), of all nutrients, the per-50-g criterion refers to
the prepared form, except that:
(i) A meal-type product, as defined in Sec. 381.413(l), and
including meal-type products that weigh more than 12 oz per serving
(container), shall not contain more than 480 mg of sodium, except that
it shall not contain more than 600 mg of sodium during the first 24
months of implementation, per labeled serving size; and
(ii) The requirements of this paragraph (b)(3) do not apply to
single-ingredient, raw products.
(4) The product shall contain 10 percent or more of the Reference
Daily Intake or Daily Reference Value as defined in Sec. 381.409 for
vitamin A, vitamin C, iron, calcium, protein, or fiber per reference
amount customarily consumed prior to any nutrient addition, except
that:
(i) A meal-type product, as defined in Sec. 381.413(l), and
including meal-type products that weigh at least 6 oz but less than 10
oz per serving (container), shall meet the level for two of the
nutrients per labeled serving size; and
(ii) A meal-type product, as defined in Sec. 381.413(l), and
including meal-type products that weigh 10 oz or more per serving
(container), shall meet the level for three of the nutrients per
labeled serving size.
Done at Washington, DC, on: May 4, 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-11140 Filed 5-5-94; 10:27 am]
BILLING CODE 3410-DM-M