[Federal Register Volume 89, Number 52 (Friday, March 15, 2024)]
[Rules and Regulations]
[Pages 18784-18792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04598]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 152
[Docket No. FDA-2020-N-1690]
RIN 0910-AI17
Frozen Cherry Pie; Revocation of a Standard of Identity and a
Standard of Quality
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA or we) is revoking the
standard of identity and the standard of quality for frozen cherry pie.
This action, in part, responds to a citizen petition submitted by the
American Bakers Association (ABA). We conclude that these standards are
no longer necessary to promote honesty and fair dealing in the interest
of consumers. Revocation of the standards of identity and quality for
frozen cherry pie will provide greater flexibility in the product's
manufacture, consistent with comparable, nonstandardized foods
available in the marketplace.
DATES: This rule is effective April 15, 2024.
ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.
FOR FURTHER INFORMATION CONTACT: Rumana Yasmeen, Office of Nutrition
and Food Labeling (HFS-820), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-2371; or Alexandra Beliveau, Office of Regulations
and Policy (HFS-024), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-2378.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Background
A. Need for the Regulation/History of This Rulemaking
B. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
A. Introduction
B. Description of General Comments
C. Comments Related to Labeling of Frozen Cherry Pie
D. Comments Related to Quality of Frozen Cherry Pie
E. Comments Related to Safety of Frozen Cherry Pie
F. Miscellaneous Comments
V. Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination with Indian Tribal Governments
XI. Reference
I. Executive Summary
A. Purpose of the Final Rule
The final rule revokes the standards of identity and quality for
frozen cherry pie. This action, in part, responds to a citizen petition
submitted by the ABA. We conclude that the standards of identity and
quality for frozen cherry pie are no longer necessary to promote
honesty and fair dealing in the interest of consumers. Revoking these
standards will provide greater flexibility in the product's
manufacture, consistent with comparable, nonstandardized foods
available in the marketplace.
[[Page 18785]]
B. Summary of the Major Provisions of the Final Rule
The final rule revokes the standards of identity and quality for
frozen cherry pie.
C. Legal Authority
We are issuing the final rule to revoke the standards of identity
and quality for frozen cherry pie consistent with our authority under
the Federal Food, Drug, and Cosmetic Act (FD&C Act), which directs the
Secretary of Health and Human Services (Secretary) to issue regulations
fixing and establishing for any food a reasonable definition and
standard of identity, quality, or fill of container whenever, in the
Secretary's judgment, such action will promote honesty and fair dealing
in the interest of consumers.
D. Costs and Benefits
The final rule affects manufacturers of frozen cherry pie and does
not require firms within the frozen cherry pie industry to change their
manufacturing practices. Our analyses of current food manufacturing
practices and the petition to revoke the standards indicate that
revoking the standards of identity and quality could provide benefits
in terms of additional flexibility and the opportunity for innovation
to manufacturers. Therefore, we conclude that the final rule to revoke
the standards for frozen cherry pie will provide social benefits at no
cost to the respective industries.
II. Background
A. Need for the Regulation/History of This Rulemaking
Section 401 of the FD&C Act (21 U.S.C. 341) directs the Secretary
to issue regulations fixing and establishing for any food a reasonable
definition and standard of identity, quality, or fill of container
whenever, in the Secretary's judgment, such action will promote honesty
and fair dealing in the interest of consumers. The purpose of these
standards is to protect consumers against economic adulteration and
reflect consumers' expectations about food.
We proposed the standards of identity and quality for frozen cherry
pie in the Federal Register of November 1, 1967 (32 FR 15116) and
finalized them in the Federal Register of February 23, 1971 (36 FR
3364); the requirements were codified at 21 CFR 28.1 (``Frozen cherry
pie; identity; label statement of optional ingredients'') and 21 CFR
28.2 (``Frozen cherry pie; quality; label statement of substandard
quality''). We later amended the standards of identity and quality in
the Federal Register of June 13, 1973 (38 FR 15504), by removing
minimum frozen cherry pie weight requirements, aligning the definition
of blemished cherries with that in the U.S. Department of Agriculture's
(USDA's) U.S. Standards for Grades of Frozen Red Tart Pitted Cherries,
and adding clarifying language. We renumbered the two sections in the
Federal Register of March 15, 1977 (42 FR 14302 at 14449) and combined
them into Sec. 152.126 (21 CFR 152.126), with the new section covering
both the standards of identity and quality.
We received a citizen petition from ABA asking us, in part, to
revoke the frozen cherry pie standards of identity and quality (Citizen
Petition from the American Bakers Association, dated August 18, 2005,
Docket No. FDA-2005-P-0435 (``petition'')). Among other things, the
petition stated that there is no basis for singling out frozen cherry
pie for the imposition of standards of identity and quality (petition
at page 10). The petition observed that there are no standards of
identity and quality for any other types of frozen fruit pies, or for
any non-frozen fruit pies, including those filled with cherries (id.).
The petition further asserted that nonstandardized fruit pies have been
sold throughout the country for many years without any evidence of
public confusion (id.).
In the Federal Register of December 18, 2020 (85 FR 82395), we
issued a proposed rule to revoke the standards of identity and quality
for frozen cherry pie, which, in part, responded to the petitioner's
request. We tentatively concluded that the frozen cherry pie standards
of identity and quality were no longer needed to promote honesty and
fair dealing in the interest of consumers consistent with section 401
of the FD&C Act (85 FR 82395 at 82396). The preamble to the proposed
rule also noted that the proposed revocation is consistent with section
6 of Executive Order 13563, ``Improving Regulation and Regulatory
Review'' (January 18, 2011), which requires Agencies to periodically
conduct retrospective analyses of existing regulations to identify
those ``that might be outmoded, ineffective, insufficient, or
excessively burdensome, and to modify, streamline, expand, or repeal
them'' accordingly (85 FR 82395 at 82397). Consequently, we proposed to
revoke part 152 (21 CFR part 152) (``Fruit pies'') in its entirety
because the standards for frozen cherry pie are the only standards in
part 152.
We stated that we were unaware of any evidence suggesting that
consumers have different expectations for unbaked, frozen cherry pies
than for other cherry pies (85 FR 82395 at 82396). At the same time, no
other cherry pies are subject to a standard of identity or a standard
of quality, and we stated that we were unaware of any evidence
indicating that such standards are necessary to promote honesty and
fair dealing in the interest of consumers or to ensure that those
cherry pies meet consumer expectations (id.). Similarly, other fruit
pies are not subject to standards of identity or quality, and we stated
that we were unaware of any evidence indicating that such standards are
necessary to promote honesty and fair dealing in the interest of
consumers or to ensure that the pies meet consumer expectations (id.).
We also tentatively concluded that the prohibition of artificial
sweeteners in Sec. 152.126(a)(2) (21 CFR 152.126(a)(2)) does not
promote honesty and fair dealing in the interest of consumers (85 FR
82395 at 82397). Baked, frozen cherry pie and baked, non-frozen cherry
pie may be made with artificial sweeteners to produce reduced-sugar
varieties to accommodate consumer preferences and dietary restrictions.
Other types of fruit pies are manufactured with artificial sweeteners
to produce reduced-sugar varieties. These varieties appear to cater to
consumer preferences and needs, and we stated that we were unaware of
any evidence that these varieties create confusion or circumvent
consumer expectations (id.).
B. Summary of Comments to the Proposed Rule
The proposed rule provided a 90-day comment period. We received
over 60 comments to the proposed rule, and each comment discussed one
or more issues. Trade associations, consumer advocacy organizations,
individuals, academia, and industry submitted comments. Some comments
appeared to have been submitted as part of a university exercise or
assignment.
The comments discussed, among other things, the need for standards
of identity and quality for frozen cherry pie. Some comments supported
our proposed revocation, but others opposed it, expressing concerns
that the revocation could reduce product quality or impact public
health.
III. Legal Authority
We are issuing this final rule to revoke the standards of identity
and quality for frozen cherry pie consistent with our authority under
section 401 of the FD&C Act, which directs the Secretary to issue
regulations fixing and establishing for any food a reasonable
definition and standard of identity,
[[Page 18786]]
quality, or fill of container whenever, in the Secretary's judgment,
such action will promote honesty and fair dealing in the interest of
consumers.
IV. Comments on the Proposed Rule and FDA Response
A. Introduction
We describe and respond to the comments in sections B through F of
this section. We have numbered each comment to help distinguish between
different comments. We have grouped similar comments together under the
same number, and, in some cases, we have separated different issues
discussed in the same comment and designated them as distinct comments
for purposes of our responses. The number assigned to each comment or
comment topic is purely for organizational purposes and does not
signify the comment's value or importance or the order in which
comments were received.
B. Description of General Comments
(Comment 1) In general, most comments opposed the revocation of the
frozen cherry pie standards of identity and quality. A majority of
comments opposed revoking the standards because of general quality,
safety, and public health concerns, without any supporting evidence.
The comments asserted that revoking the standards would lower, or
remove, the requirements for frozen cherry pie, would not benefit or
protect consumers, and would provide frozen cherry pie manufacturers
too much flexibility in the manufacture of frozen cherry pie.
(Response 1) We disagree that removing the standards of identity
and quality for frozen cherry pie will result in lower protection for
consumers. While there will no longer be a standard of quality that
prescribes a required weight for the fruit content of frozen cherry pie
or a standard of identity specifying requirements for products labeled
as frozen cherry pie, other safeguards exist under the FD&C Act to
prevent adulterated and misbranded frozen cherry pie products. For
example, under section 403(a) of the FD&C Act (21 U.S.C. 343(a)),
manufacturers must ensure that all labeling is truthful and not
misleading.
Many foods are nonstandardized foods, and they must be labeled with
and sold under common or usual names that have been established by
common usage. See 21 U.S.C. 343(i)(1) and Sec. 102.5(d) (21 CFR
102.5(d)). As a nonstandardized food, frozen cherry pie must be labeled
with its common or usual name, ``frozen cherry pie,'' which is still in
common usage. The final rule recategorizes unbaked, frozen cherry pie
as a nonstandardized food, like baked, non-frozen and baked, frozen
cherry pies, as well as frozen and non-frozen fruit pies of other
varieties. We are unaware of any evidence to suggest aligning unbaked,
frozen cherry pie with baked, non-frozen cherry pies, baked, frozen
cherry pies, as well as frozen and non-frozen fruit pies of other
varieties as a nonstandardized food would create confusion or
circumvent consumer expectations. Revoking these standards will provide
greater flexibility in the product's manufacture while leaving other
requirements under the FD&C Act, such as product quality, ingredient
safety, and labeling, in place, consistent with comparable,
nonstandardized foods available in the marketplace. For example,
revoking the standards will allow for new varieties of frozen cherry
pies that cater to consumer preferences and needs, such as those lower
in added sugars. We conclude that the standards of identity and quality
for frozen cherry pie are no longer necessary to promote honesty and
fair dealing in the interest of consumers.
(Comment 2) Some comments supported revoking the standards of
identity and quality for frozen cherry pie. In general, the comments
agreed that the standards of identity and quality are no longer needed
to promote honesty and fair dealing in the interest of consumers, and
revoking the standards would:
Provide benefits in terms of additional flexibility to the
manufacturers of frozen cherry pie products; and
Promote innovation and the introduction of new unbaked,
frozen cherry pie products, providing benefits to both consumers and
industry.
(Response 2) We agree with these comments. The final rule revokes
the standards of identity and quality for frozen cherry pie.
(Comment 3) One comment provided a neutral summary of the frozen
cherry pie proposed rule but did not raise any issues or concerns for
us to address.
(Response 3) We generally agree with the comment's summary of the
proposed rule. We conclude that the standards of identity and quality
for frozen cherry pie are no longer necessary to promote honesty and
fair dealing in the interest of consumers. The final rule revokes the
standards of identity and quality for frozen cherry pie.
C. Comments Related to Labeling of Frozen Cherry Pie
(Comment 4) Some comments contended that, upon revocation,
consumers would not know what ingredients have been added to frozen
cherry pies. A couple comments interpreted the proposed rule as
eliminating labeling requirements, stating that if the standards are
revoked, there would be no labeling requirements. One comment stated
that labeling requirements are not stringent enough for consumers to
receive honest information from manufacturers as to what a product is.
Other comments stated that consumers deserve to know and should be
confident and able to trust that unbaked, frozen cherry pies contain a
significant or adequate amount of cherries. Another comment, while
supportive of the revocation of the standards, stated concern about
improperly labeled food products in various settings.
(Response 4) Although we are revoking the standards of identity and
quality for frozen cherry pie, labeling requirements will continue to
apply to these products. While standards of identity are typically
established under the common or usual name of the food (see 21 U.S.C.
341), a standard of identity does not need to be established for a food
to be labeled with and sold under its common or usual name. Most foods
are nonstandardized foods, which must be labeled with and sold under
common or usual names that have been established by common usage. See
21 U.S.C. 343(i)(1) and Sec. 102.5(d). The use of a common or usual
name allows consumers to identify more efficiently the type of
nonstandardized food product they find in the store. Revocation of the
frozen cherry pie standards of identity and quality will eliminate
requirements related to the content and production of frozen cherry
pie, and frozen cherry pie will become a nonstandardized food. As a
nonstandardized food, frozen cherry pie must be labeled with its common
or usual name, ``frozen cherry pie,'' which is still in common usage
(see 21 U.S.C. 343(i)(1)). Thus, products with the name frozen cherry
pie will continue to be available to consumers.
Manufacturers must also comply with identity labeling requirements,
which require that a food in package form bear a statement of the
identity of the product on the principal display panel (Sec. 101.3 (21
CFR 101.3)), and ingredient labeling requirements, which state that
ingredients must be listed by their common or usual name, in descending
order of predominance by weight unless
[[Page 18787]]
ingredients are present in amounts of 2 percent or less by weight, in
which case they can be listed at the end of the ingredient statement
following an appropriate quantifying statement (Sec. 101.4 (21 CFR
101.4)). Therefore, consumers will have information available to them
about the ingredients in the frozen cherry pies they purchase, as well
as other product information.
As for the comment about the labeling of food products in different
settings, different food labeling requirements exist, depending on
whether the food product is, for example, a packaged food sold at a
grocery store or a prepared food at a restaurant or cafeteria (see 21
CFR part 101). In the case of noncompliance with our regulations, FDA
may take enforcement actions, as appropriate.
(Comment 5) One comment noted that there is no need to revoke the
standards of identity and quality because manufacturers can already
make frozen cherry pie products that do not conform to the standards
and can simply identify on the label that the product falls below the
standard of quality.
(Response 5) It is true that manufacturers could produce a frozen
cherry pie product not conforming to the standard of quality (e.g.,
using fewer cherries than prescribed by the standard of quality) and
label the product with a general statement of substandard quality.
However, the fact that such products could legally be made and marketed
does not justify keeping the current standards of identity and quality
if they are no longer serving their purpose. We no longer believe that
the standards of quality and identity are necessary to promote honesty
and fair dealing in the interest of consumers or to ensure that frozen
cherry pies meet consumer expectations, and, therefore, we are revoking
the standards of identity and quality for frozen cherry pie.
D. Comments Related to Quality of Frozen Cherry Pie
(Comment 6) Several comments expressed concern that revoking the
standards for frozen cherry pie may compromise the quality of product
and that FDA has a duty to maintain minimum standards of quality. A few
comments stressed the importance of retaining the standards to maintain
food quality standards and freshness.
(Response 6) Manufacturers must comply with Federal statutes and
regulations to ensure a quality product. For example, quite apart from
whether a food product is subject to a standard of quality or standard
of identity, food products, including raw materials and ingredients,
must comply with the quality control operations requirements set forth
in current good manufacturing practices (CGMP) (see generally 21 CFR
part 117) and are also required to bear truthful and non-misleading
labeling, including a listing of their ingredients. We are unaware of,
and the comments did not provide, any specific quality concerns for
other varieties of unbaked, frozen fruit pies that are currently on the
market. Nor did the comments provide support for the concern that
revoking the standards for frozen cherry pie may compromise the quality
of the product. Similarly, the comments did not describe how revoking
the standards would affect the freshness of the product. As a general
matter, the standard of quality for frozen cherry pie did not have a
requirement for freshness, and we note that the standard of identity
allowed for the use of fresh, frozen, and canned cherries in frozen
cherry pies. If the comments are referring to freshness in terms of
quality of the ingredients, we note that, under the FD&C Act, a food is
adulterated if it consists in whole or in part of a filthy, putrid, or
decomposed substance or is otherwise unfit for food. See 21 U.S.C.
342(a)(3).
(Comment 7) A few comments asserted that, in the absence of a
standard of quality, manufacturers would be free to use subpar or
substandard ingredients in their frozen cherry pie products in order to
cut costs. Some comments expressed concern that the revocation of the
standards for frozen cherry pie would allow manufacturers to add an
unlimited number of blemished cherries, lower-quality cherries, or
rotten cherries to their pies, or alternatively, that manufacturers
would use fewer cherries, any amount or type of cherry, or no real
cherries at all in frozen cherry pies. Several comments stated that
cherry pie should be required to have cherries or that the standards
should require more cherries. Other comments suggested that FDA should
require manufacturers to label that a food contains numerous blemished
cherries or to otherwise hold industry accountable to ensure that the
cherries used are not spoiled. One comment suggested that revocation of
the standards might even benefit consumers who are looking to make
conscious purchases that mitigate food waste by purchasing a frozen
cherry pie using blemished cherries.
(Response 7) We are unaware of any evidence that suggests
revocation of the standards of identity and quality of frozen cherry
pie may result in manufacturers adding subpar or substandard
ingredients. In addition, other safeguards exist to ensure the quality
of the food supply. A food is deemed to be adulterated if it consists
in whole or in part of any filthy, putrid, or decomposed substance, or
if it is otherwise unfit for food. See 21 U.S.C. 342(a)(3). Therefore,
a food would be adulterated if it used rotten, spoiled, or otherwise
unfit cherries. We also note that any food, including raw materials and
ingredients, must comply with the quality control operations
requirements set forth in CGMPs (21 CFR 117.80(b)).
As explained in the preamble to the proposed rule, frozen cherry
pie is the only fruit pie, either frozen or non-frozen, that is
currently subject to a standard of identity or quality (85 FR 82395 at
82396). We are unaware of any evidence suggesting that consumers have
different expectations for unbaked, frozen cherry pies than for other
fruit pies. We are also unaware of any evidence indicating that such
standards are necessary to ensure that frozen cherry pie products
continue to be produced with the characteristics consumers expect. FDA
disagrees that revocation of the standards may result in having
unbaked, frozen cherry pies in the marketplace with fewer cherries. As
shown by widespread consumer acceptance of the variety of non-
standardized fruit pies in the marketplace, such products meet consumer
expectations and demands. Additionally, under the FD&C Act,
manufacturers must ensure that all labeling is truthful and not
misleading; otherwise, it is deemed misbranded (21 U.S.C. 343(a)).
Therefore, a product marketed as frozen cherry pie that does not
contain any cherries, would be misbranded. See 21 U.S.C. 343(a) and
(b).
Manufacturers also must comply with identity labeling requirements,
which require that a food in package form be labeled with its common or
usual name, or in the absence thereof, a statement of identity that
accurately describes the food on the principal display panel (Sec.
101.3). If a product is offered for sale under the name of another food
(e.g., a frozen cherry pie that does not contain cherries), it would be
misbranded under 21 U.S.C. 343(b).
Regarding the comment stating that manufacturers will now be able
to use any type of cherry, we note that neither the existing standard
of identity nor the existing standard of quality for frozen cherry pie
specified the variety of cherry to be used; however, the standard of
identity did allow for fresh, frozen, or canned cherries to be used.
Consumers will be able to continue to purchase
[[Page 18788]]
products that align with their tastes and preferences.
(Comment 8) Some comments stated that revoking the standards would
allow manufacturers to use unknown additives and fillers to make frozen
cherry pies less expensive to produce.
(Response 8) In the absence of a standard of identity,
manufacturers will have the flexibility to use different ingredients
than those previously allowed to produce products that meet consumer
expectations for frozen cherry pie. However, those different
ingredients must still be lawful. Manufacturers must comply with
ingredient labeling requirements (Sec. 101.4), as well as food and
color additive regulations, which require additives to meet the safety
standard of reasonable certainty of no harm under its intended
conditions of use (21 CFR 70.3 and Sec. 170.3 (21 CFR 170.3)).
Consumers can also look at the product labeling to see the ingredients
in frozen cherry pies and can purchase based on their preferences.
Removing the standard of identity for frozen cherry pie will allow
manufacturers to make products with different ingredients than those
allowed under the prior standard of identity, but those products must
still comply with the FD&C Act and implementing regulations. We
conclude that the standards of identity and quality for frozen cherry
pie are no longer necessary to promote honesty and fair dealing in the
interest of consumers, and we are revoking the standards of identity
and quality for frozen cherry pie.
E. Comments Related to Safety of Frozen Cherry Pie
(Comment 9) Some comments expressed concern over the potential use
of unsafe ingredients or dangerous substitutes by manufacturers if we
revoked the standards. Some comments stated that revoking the standards
would allow manufacturers to use cheaper ingredients, such as
artificial sweeteners, that the comments claimed pose serious health
risks to consumers. One comment stated that FDA should conduct a
comprehensive safety re-assessment of specific artificial sweeteners
before encouraging reformulation with them. A few comments supported
the revocation on the grounds that it would allow marketing of low-
sugar varieties that some consumers may desire and classified
artificial sweeteners as acceptable, sometimes desirable, and healthier
than the current sweeteners used. Many comments expressed concerns
about not knowing whether future frozen cherry pie products would meet
any safety standards.
(Response 9) Our regulations, at 21 CFR 70.42 and 170.20, require
evidence that each color or food additive used in food, such as an
artificial sweetener, is safe at its intended level of use before it
may be added to foods. All food additives or ingredients are required
to undergo a premarket approval process unless the substance is
generally recognized as safe (GRAS) or was approved for use by FDA or
USDA prior to the food additive amendments of the FD&C Act (21 U.S.C.
321) (see also 21 CFR parts 170, 171, 130, and 181). Our regulations in
Sec. 170.30 (21 CFR 170.30) require that a GRAS determination based on
scientific procedures be made by experts qualified by scientific
training and experience to evaluate its safety, who have concluded,
based on publicly available information, that the substance is safe
under the conditions of its intended use. Both substances approved for
use as a food additive and those determined to be GRAS must meet the
safety standard of reasonable certainty of no harm under its intended
conditions of use (Sec. Sec. 170.3 and 170.30). A prior sanction for a
food substance exists only for a specific use(s) in food for which
there was explicit approval by FDA or USDA prior to September 6, 1958
(21 CFR 181.5(a)). All known prior sanctions are listed in our
regulations, and any such regulation is subject to amendment to impose
whatever limitations or conditions are necessary for the safe use of
the ingredient (21 CFR 181.5(b)).
Furthermore, all FDA-approved food additives are subject to ongoing
safety review. If new evidence indicates that a food ingredient in use
may be unsafe, we may prohibit its use or conduct further studies to
determine if the use can still be considered safe (21 CFR 180.1). We
also note that, under the FD&C Act, a food is adulterated if it bears
or contains a naturally occurring poisonous or deleterious substance
that may render it injurious to health (21 U.S.C. 342).
As for the comments concerning the safety of artificial sweeteners,
we disagree that we should conduct a comprehensive safety reassessment
on specific artificial sweeteners before revoking the standards. Our
regulations require that only safe and suitable ingredients are used in
food production (21 CFR 130.3). An artificial sweetener is regulated as
a food additive unless its use as a sweetener is GRAS. FDA-approved
artificial sweeteners, as well as those that are GRAS, are safe for the
general population. We also disagree with the assertion that we are
encouraging reformulation with artificial sweeteners. As a result of
revoking the standards, manufacturers will simply have greater
flexibility and the opportunity for greater product innovation,
consistent with what is currently allowed for other fruit pies.
Revocation of the standards of identity and quality will permit the use
of artificial sweeteners in frozen cherry pies, thus allowing reduced-
sugar frozen cherry pie varieties to be sold in the marketplace under
the same common or usual name of frozen cherry pie. We have seen no
evidence of dishonesty, confusion, or the use of low-quality
ingredients in other nonstandardized fruit pies, and we have no reason
to believe that frozen cherry pies would be treated any differently.
Therefore, we are revoking the standards of identity and quality for
frozen cherry pie.
F. Miscellaneous Comments
(Comment 10) A few comments suggested a revision of the standard,
instead of a revocation. One comment stated that the requirement to
have at least a minimum of 25 percent cherries relative to the pie's
weight should not be repealed in order for consumers to know that a
frozen cherry pie is made with real cherries. In an effort to prevent
substitution of fillers, one comment proposed to eliminate the
requirements for sieving and percent blemished fruit but retain the
requirement for a minimum of 25 percent fruit, and another comment said
we should remove regulations that require certain inspection processes
for pies but keep in place the regulations requiring 25 percent minimum
cherries and no greater than 15 percent blemished cherries.
(Response 10) We do not see a need for any such modification of the
existing standards. As stated in the proposed rule, frozen cherry pie
is the only fruit pie, either frozen or non-frozen, that is subject to
standards of identity and quality (85 FR 82395 at 82396). Other fruit
pies, including baked frozen cherry pie and baked non-frozen cherry
pie, are not standardized, and these foods appear to meet consumer
expectations in the absence of established definitions and standards.
There appears to be no need to treat frozen cherry pie differently from
other fruit pies available in the marketplace. Therefore, we have
concluded that the frozen cherry pie standards of identity and quality
are no longer needed to promote honesty and fair dealing in the
interest of consumers or to ensure that those cherry pies meet consumer
expectations. Revocation of the standards will provide greater
flexibility
[[Page 18789]]
and allow for innovation in product manufacture, consistent with
comparable, nonstandardized foods available in the marketplace.
(Comment 11) Some comments questioned why there are not standards
for other types of fruit pies besides frozen cherry pie and stated that
the standards of identity and quality for frozen cherry pie should not
be revoked but rather extended to other fruit pies available in the
marketplace. One comment questioned why FDA fails to place more
regulations, restrictions, and standards on other pies and food items
on the American market.
(Response 11) Section 401 of the FD&C Act directs the Secretary to
issue regulations fixing and establishing for any food a reasonable
definition and standard of identity, quality, or fill of container
whenever, in the Secretary's judgment, such action will promote honesty
and fair dealing in the interest of consumers. The purpose of these
standards is to protect consumers against economic adulteration and
reflect consumers' expectations about food. Regarding other types of
fruit pies, we are unaware of any evidence, and the comments provided
no evidence, indicating that such standards are necessary to promote
honesty and fair dealing in the interest of consumers or to ensure that
the pies meet consumer expectations. Most fruit pies available in the
marketplace, including baked cherry pies (both frozen and non-frozen
varieties), are nonstandardized foods that are labeled with and sold
under common or usual names. These foods appear to meet consumer
expectations in the absence of established definitions and standards.
Thus, we simply do not see a need to extend or to create standards of
identity for other fruit pies in the marketplace that are currently
regulated as nonstandardized foods.
We have the authority to issue regulations fixing and establishing
for any food a reasonable definition and standard of identity, quality,
or fill of container whenever, in the Secretary's judgment, such action
will promote honesty and fair dealing in the interest of consumers, and
we will continue to use this authority as needed to protect consumers.
(Comment 12) One comment stated that it is not clear if revoking
the standards of identity and quality for frozen cherry pie would
benefit consumers. The comment noted a lack of consumer calls asking
for a greater variety of frozen cherry pie products and a lack of
complaints about frozen cherry pies having too many cherries. The
comment added that frozen cherry pie manufacturers could sell reduced-
sugar frozen cherry pie products while the standards of identity and
quality existed, and therefore, the standards did not create a barrier
to marketing or selling reduced sugar varieties.
(Response 12) Standards of identity and quality are established to
promote honesty and fair dealing in the interest of consumers.
Standards protect consumers against economic adulteration and reflect
consumers' expectations about food. Many fruit pies have been in the
marketplace as nonstandardized foods for many years, and non-cherry
fruit pies, either frozen or unfrozen, are not subject to the
requirements of any standard. Unbaked, frozen cherry pie is the only
fruit pie that is subject to standards of identity or quality. While
these standards did not mandate that a certain amount of sugar be used
in product formulation and, therefore, manufacturers could already sell
reduced-sugar frozen cherry pie products, the standard of identity
prohibited the use of artificial sweeteners (see Sec. 152.126(a)(2)).
Revocation of the standards of identity and quality for frozen cherry
pie will not only provide greater flexibility in the product's
manufacture (e.g., by allowing the use of artificial sweeteners to
lower the sugar content of frozen cherry pies), but revocation of the
standards will also align frozen cherry pies with other comparable
fruit pies available in the marketplace. We conclude that standards of
identity and quality for frozen cherry pie are no longer needed to
promote honesty and fair dealing in the interest of consumers.
Therefore, we are revoking the standards of identity and quality for
frozen cherry pie.
(Comment 13) One comment stated that the proposed rule was the
result of a food industry association's petition and not a petition
from consumers, and FDA should reject industry attempts to revoke
consumer protections.
(Response 13) We disagree that FDA should reject the petition that
requested the revocation of the standards because it was from a food
industry association and not from consumers. We evaluate all citizen
petitions that meet the requirements of our citizen petition regulation
at 21 CFR 10.30. After considering the petition and related
information, including comments to the proposed rule, we conclude that
the standards of identity and quality for frozen cherry pie are no
longer needed to promote honesty and fair dealing in the interest of
consumers consistent with section 401 of the FD&C Act, and we are
revoking the standards of identity and quality for frozen cherry pie.
(Comment 14) One comment stated that this proposal is a poor
expenditure of FDA's resources. This comment urged FDA to direct its
efforts to priorities that align with the goals of FDA's Nutrition
Innovation Strategy by, for example, allowing the use of sodium
substitutes such as potassium chloride across standardized foods.
(Response 14) Since FDA first announced its Nutrition Innovation
Strategy in 2018, we have shifted our efforts to a general national
nutrition strategy. We are prioritizing our nutrition initiatives to
ensure people in the United States have greater access to healthier
foods and nutrition information that everyone can use to identify
healthier choices more easily. The key elements of this strategy are
sodium reduction, maternal and infant health and nutrition, labeling
and claims, consumer education, and innovation support. FDA is
continuing to update its standards of identity program with the goal of
maintaining the basic nature and essential characteristics of
standardized foods while permitting flexibility with respect to their
composition. In the Federal Register of April 10, 2023 (88 FR 21148),
we published a proposed rule entitled ``Use of Salt Substitutes To
Reduce the Sodium Content in Standardized Foods,'' which, if finalized,
would amend FDA standard of identity regulations that specify salt
(sodium chloride) as a required or optional ingredient to permit the
use of salt substitutes in standardized foods, to reduce the sodium
content. This action represents an example of a recent initiative under
our general national nutrition strategy, and, if finalized, it would
help support a healthier food supply by providing flexibility to
facilitate industry innovation in the production of standardized foods
lower in sodium while maintaining the basic nature and essential
characteristics of the foods.
We have the authority to issue regulations establishing standards
of identity and quality to promote honesty and fair dealing in the
interest of consumers (21 U.S.C. 341). Standards of identity and
quality are intended to protect consumers against economic
adulteration, maintain the integrity of food, and reflect consumers'
expectations about the food. We will continue to prioritize our efforts
as time and resources permit. While our general national nutrition
strategy is just one of many priorities for FDA, we have many other
projects that we simultaneously work on to carry out our work. For
example, Executive Order 13563, ``Improving Regulation and Regulatory
[[Page 18790]]
Review'' (January 18, 2011), requires Agencies to periodically conduct
retrospective analyses of existing regulations to identify those that
might be outmoded, ineffective, insufficient, or excessively
burdensome, and to modify, streamline, expand, or repeal them
accordingly. In this case, we conclude that standards of identity and
quality for frozen cherry pie are no longer needed to promote honesty
and fair dealing in the interest of consumers. Therefore, we are
revoking the standards of identity and quality for frozen cherry pie.
(Comment 15) One comment urged FDA to review and identify what
factors have changed since the promulgation of the initial rule
creating standards of identity and quality for frozen cherry pie, to
the extent that evidence remains available to us. The comment also
stated that we should explain our reasons for eliminating this specific
standard, as distinguished from other identity standards that we would
preserve.
(Response 15) In the Federal Register of February 23, 1971 (36 FR
3364), FDA finalized the standards of identity and quality for frozen
cherry pie. We concluded at that time that the standards would promote
honesty and fair dealing in the interest of consumers, and we noted
that abuse had been recognized by certain members of the frozen food
industry. Around the same time, the President signed into law the Fair
Packaging and Labeling Act (Pub. L. 89-755), which is designed to
prevent unfair or deceptive packaging and labeling of many household
consumer commodities, including food (15 U.S.C. 1452). These and other
regulatory changes, including mandatory ingredient labeling, have led
to a different environment than that which existed when the standards
were established.
Consistent with FDA priorities on nutrition initiatives and
Executive Order 13563, ``Improving Regulation and Regulatory Review''
(January 18, 2011), we will continue to evaluate the necessity of
different standards, as appropriate, and may propose changes in the
future if we determine a standard is no longer needed to promote
honesty and fair dealing in the interest of consumers.
(Comment 16) Some comments mentioned that revocation of the
standards of quality and identity would further contribute to the
health disparities experienced among lower-income Americans. The
comments state that access to quality foods should not be a luxury that
only some can afford.
(Response 16) The standards of identity and quality for frozen
cherry pie were established to promote honesty and fair dealing in the
interest of consumers. Standards of identity do not ensure access to a
food nor do they address the price(s) of a standardized food. Standards
of identity also do not address consumer health disparity issues.
Matters pertaining to access to food, food prices, and health
disparities between different populations are outside the scope of this
rulemaking.
(Comment 17) One comment mentioned that frozen cherry pie should
have to maintain, at a minimum, the standards for frozen foods during
transport and storage.
(Response 17) Frozen food product must follow our CGMPs (21 CFR
117.80) and risk-based preventive controls (21 CFR 117.206) among other
regulations. The final rule does not impact the other statutory
requirements or regulations that food manufacturers must follow.
(Comment 18) One comment stated that revocation of the standards of
identity and quality will allow manufacturers to substitute cherries
with yams.
(Response 18) A product labeled as cherry pie, but containing yams
rather than cherries, would be misbranded under 21 U.S.C. 343(a)(1)
because the labeling would be false or misleading. Additionally,
section 301(a) of the FD&C Act (21 U.S.C. 331(a)) prohibits the
introduction or delivery for introduction into interstate commerce any
food that is misbranded.
V. Effective Date
This rule is effective 30 days after the date of publication in the
Federal Register.
VI. Economic Analysis of Impacts
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 14094, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review
Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801,
Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4).
Executive Orders 12866, 13563, and 14094 direct us to assess all
benefits, costs, and transfers of available regulatory alternatives
and, when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). Rules are ``significant'' under Executive Order 12866
Section 3(f)(1) (as amended by Executive Order 14094) if they ``have an
annual effect on the economy of $200 million or more (adjusted every 3
years by the Administrator of the Office of Information and Regulatory
Affairs (OIRA) for changes in gross domestic product); or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, territorial, or tribal governments or
communities.'' OIRA has determined that this final rule is not a
significant regulatory action as defined by Executive Order 12866
Section 3(f)(1).
Because this rule is not likely to result in an annual effect on
the economy of $100 million or more or meets other criteria specified
in the Congressional Review Act/Small Business Regulatory Enforcement
Fairness Act, OIRA has determined that this rule does not fall within
the scope of 5 U.S.C. 804(2).
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because we conclude that this rule would not generate
significant compliance costs, we certify that the final rule will not
have a significant economic impact on a substantial number of small
entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes estimates of
anticipated impacts, before issuing ``any rule that includes any
Federal mandate that may result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $183
million, using the most current (2023) Implicit Price Deflator for the
Gross Domestic Product. This final rule will not result in an
expenditure in any year that meets or exceeds this amount.
The final rule would not require firms within the frozen cherry pie
industry to change their manufacturing practices. Our analysis of
current food manufacturing practices and the petition to revoke the
standards indicate that revoking the standards of identity and quality
could provide benefits in terms of additional flexibility to
manufacturers of frozen cherry pie products. We also conclude that
these standards are obsolete because the requirements are not necessary
to ensure that frozen cherry pie meets consumers' expectations about
the food, and in some respect, place restrictions on the food that are
inconsistent with consumers' expectations. Revocation of the standards
would allow additional flexibility for, and the opportunity for
[[Page 18791]]
innovation regarding, frozen cherry pie, providing benefits to both
consumers and industry. Therefore, we conclude that the final rule to
revoke the standards for frozen cherry pie would provide social
benefits at little to no cost to the respective industries (table 1).
Table 1--Summary of Benefits, Costs, and Distributional Effects of Final Rule
----------------------------------------------------------------------------------------------------------------
Units
Primary Low High ------------------------------------
Category estimate estimate estimate Year Discount Period Notes
dollars rate (%) covered
----------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $0 $0 $0 2023 7
$millions/year......... 3
Annualized Quantified... .......... .......... .......... .......... 7
3
-----------------------------------------------------------------------------------
Qualitative............. Benefits to manufacturers would be from additional flexibility and the
opportunity for innovation regarding frozen cherry pie products.
----------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized 0 0 0 2023 7
$millions/year......... 3
Annualized Quantified... .......... .......... .......... .......... 7
3
-----------------------------------------------------------------------------------
Qualitative.............
----------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized .......... .......... .......... .......... 7
Monetized $millions/ 3
year...................
-----------------------------------------------------------------------------------
From/To................. From:
To:
-----------------------------------------------------------------------------------
Other Annualized .......... .......... .......... .......... 7
Monetized $millions/ 3
year...................
-----------------------------------------------------------------------------------
From/To................. From:
To:
----------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal
Government:
Small Business:.........
Wages:..................
Growth:.................
----------------------------------------------------------------------------------------------------------------
We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 1) and at
https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.
VII. Analysis of Environmental Impact
We have determined under 21 CFR 25.32(a) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VIII. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
IX. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.
X. Consultation and Coordination With Indian Tribal Governments
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive order and, consequently, a
tribal summary impact statement is not required.
XI. Reference
The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. Although FDA
verified the website addresses in this document, please note that
websites are subject to change over time.
1. FDA, ``Regulatory Impact Analysis: Frozen Cherry Pie; Revocation
of a Standard of Identity and a Standard of Quality (Final Rule).''
Available at: https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
List of Subjects in 21 CFR Part 152
Bakery products, Food grades and standards, Frozen foods, Fruits.
[[Page 18792]]
PART 152--[REMOVED]
0
Therefore, for the reasons discussed in the preamble, under the Federal
Food, Drug and Cosmetic Act, and under authority delegated to the
Commissioner of Food and Drugs, the Food and Drug Administration
removes 21 CFR part 152.
Dated: February 27, 2024.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2024-04598 Filed 3-14-24; 8:45 am]
BILLING CODE 4164-01-P