[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