French Dressing; Revocation of a Standard of Identity, 2038-2042 [2022-00494]
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Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations
IV. Comments on the Proposed Rule and FDA
Response
A. Introduction
B. Description of the Comments and FDA
Response
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. References
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 169
[Docket No. FDA–2020–N–1807]
RIN 0910–AI16
French Dressing; Revocation of a
Standard of Identity
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or we) is revoking
the standard of identity for French
dressing. This action, in part, responds
to a citizen petition submitted by the
Association for Dressings and Sauces
(ADS). We conclude that this standard
no longer promotes honesty and fair
dealing in the interest of consumers.
Revocation of the standard of identity
for French dressing will provide greater
flexibility in the product’s manufacture,
consistent with comparable,
nonstandardized foods available in the
marketplace.
DATES: This final rule is effective on
February 14, 2022.
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, Center for Food
Safety and Applied Nutrition (HFS–
820), Food and Drug Administration,
5001 Campus Dr., College Park, MD
20740, 240–402–2371, or Carrol Bascus,
Center for Food Safety and Applied
Nutrition, Office of Regulations and
Policy (HFS–024), Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2378.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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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
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I. Executive Summary
A. Purpose of the Final Rule
The final rule revokes the standard of
identity for French dressing. This
action, in part, responds to a citizen
petition submitted by the ADS. We
conclude that the standard of identity
for French dressing no longer promotes
honesty and fair dealing in the interest
of consumers and revoking the standard
could provide greater flexibility in the
product’s manufacture, consistent with
comparable, nonstandardized foods
available in the marketplace.
B. Summary of the Major Provision of
the Final Rule
The final rule revokes the standard of
identity for French dressing.
C. Legal Authority
We are issuing the final rule to revoke
the standard of identity for French
dressing 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
dressings for salad and does not require
any of the affected firms within the
industry to change their manufacturing
practices.
Our analysis of current food
manufacturing practices and the
petition to revoke the standard indicate
that revoking the standard of identity
could provide benefits in terms of
additional flexibility and the
opportunity for innovation to
manufacturers. The potential for
innovation is evidenced by the growing
variety of dressings for salads on the
market that are formulated to meet
consumers’ preferences and needs.
Therefore, we conclude that the final
rule to revoke the standard of identity
for French dressing would provide
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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.
In the Federal Register of August 12,
1950 (15 FR 5227), we established a
standard of identity for French dressing.
We later amended that standard of
identity in the Federal Registers of May
10, 1961 (26 FR 4012), February 12,
1964 (29 FR 2382), February 1, 1967 (32
FR 1127 at 1128), May 18, 1971 (36 FR
9010), and November 8, 1974 (39 FR
39554), to allow the use of certain
ingredients in French dressing. We also
re-designated the French dressing
standard of identity as § 169.115 (21
CFR 169.115) (42 FR 14481, March 15,
1977).
We received a citizen petition from
the ADS asking us, in part, to revoke the
standard of identity for French dressing
(citizen petition from the ADS, dated
January 13, 1998, submitted to the
Division of Dockets Management, Food
and Drug Administration, Docket No.
FDA–1998–P–0669 (‘‘petition’’)). As a
partial response to the petitioner’s
request, we issued a proposed rule in
the Federal Register of December 21,
2020 (85 FR 82980), that would revoke
the standard of identity for French
dressing.
The petition asked us to revoke the
standard of identity for French dressing
(petition at page 1). The petition stated
that there has been a proliferation of
nonstandardized pourable dressings for
salads with respect to flavors (Italian,
Ranch, cheese, fruit, peppercorn, varied
vinegars, and other flavoring concepts)
and composition (including a wide
range of reduced fat, ‘‘light,’’ and fat-free
dressings) (petition at page 3). The
French dressing standard of identity,
according to the petition, no longer
serves as a benchmark for other
dressings because of the wide variation
in composition to meet consumer
interests (id.). Instead, the petition
claimed that the standard of identity has
become marginalized and restricts
innovation (id.). Therefore, the petition
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Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations
stated that the French dressing standard
of identity no longer promotes honesty
and fair dealing in the interest of
consumers (id.).
We reviewed the petition and
tentatively concluded that the standard
of identity for French dressing no longer
promotes honesty and fair dealing in the
interest of consumers. Therefore, we
proposed to revoke the French dressing
standard of identity at § 169.115.
When the standard of identity was
established in 1950, French dressing
was one of three types of dressings we
identified (15 FR 5227). We generally
characterized the dressings as
containing a fat ingredient, an acidifying
ingredient, and seasoning ingredients.
The French dressing standard allowed
for certain flexibility in manufacturers’
choice of oil, acidifying ingredients, and
seasoning ingredients. Tomatoes or
tomato-derived ingredients were among
the seasoning ingredients permitted, but
not required. Amendments to the
standard since 1950 have permitted the
use of additional ingredients, such as
any safe and suitable color additives
that impart the color traditionally
expected (39 FR 39543 at 39554–39555).
Most, if not all, products currently
sold under the name ‘‘French dressing’’
contain tomatoes or tomato-derived
ingredients and have a characteristic red
or reddish-orange color. They also tend
to have a sweet taste. Consumers appear
to expect these characteristics when
purchasing products represented as
French dressing. Thus, it appears that,
since the establishment of the standard
of identity, French dressing has become
a narrower category of products than
prescribed by the standard. These
products maintain the above
characteristics without a standard of
identity specifically requiring them.
Additionally, French dressing
products are manufactured and sold in
lower-fat varieties that contain less than
the minimum amount of vegetable oil
(35 percent by weight) required by
§ 169.115(a). In the preamble to the
proposed rule, we stated that we were
unaware of any evidence that
consumers are deceived or misled by
the reduction in vegetable oil when
these varieties are sold under names
including terms such as ‘‘fat free’’ or
‘‘low-fat’’ (85 FR 82980 at 82982). By
contrast, these varieties appear to
accommodate consumer preferences and
dietary restrictions.
Therefore, after considering the
petition and related information,
through the proposed rule, we
tentatively concluded that the standard
of identity for French dressing no longer
promotes honesty and fair dealing in the
interest of consumers consistent with
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section 401 of the FD&C Act and
proposed to revoke the standard of
identity for French dressing. 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.
B. Summary of Comments to the
Proposed Rule
There were more than 20 comments to
the proposed rule. A trade association,
a business association, and individuals
submitted the comments. Some
comments appeared to have been
submitted as part of a university course
assignment. In general, most comments
supported the revocation of the French
dressing standard of identity; their
reasons supporting the revocation
ranged from promoting innovation,
believing that consumers are not misled,
or stating that the standard of identity
was obsolete. A small number of
comments misinterpreted the proposed
rule as removing or prohibiting the use
of the name ‘‘French dressing,’’ and one
comment opposed revoking the
standard of identity because of public
health concerns.
III. Legal Authority
We are issuing this final rule to
revoke the standard of identity for
French dressing consistent with our
authority under the FD&C Act, which
directs the Secretary to issue regulations
fixing and establishing for any food a
reasonable definition and standard of
identity, quantity, 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
As stated earlier, there were more
than 20 comments to the proposed rule.
A trade association, a business
association, and individuals submitted
the comments. Several comments
appeared to have been submitted as part
of a university course assignment. In
general, most comments supported the
revocation of the French dressing
standard of identity.
A small number of comments
misinterpreted the proposed rule as
removing or prohibiting the use of the
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name ‘‘French dressing,’’ and one
comment opposed revoking the
standard of identity because of public
health concerns.
We describe and respond to the
comments in section IV.B. of this
document. 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 for organizational
purposes and does not signify the
comment’s value or importance or the
order in which comments were
received.
B. Description of the Comments and
FDA Response
(Comment 1) Most comments
supported revoking the standard of
identity for French dressing. In general,
the comments agreed with us that
revoking the standard of identity would:
• Allow manufacturers to innovate
their products in ways that consumers
want;
• Give French dressing manufacturers
the same treatment or flexibility to
innovate or modernize their products as
other dressing manufacturers have. One
comment added that revoking the
standard of identity for French dressing
would enable manufacturers to
substitute ingredients to address
allergies, ingredient sensitivities, or
even consumer preferences (particularly
consumers on a diet); and
• Eliminate an obsolete standard that
has not changed significantly over 70
years. Some comments added that
consumers recognize French dressing
and can judge for themselves whether to
buy a particular product.
Other comments said that the
standard of identity for French dressing
is no longer needed to promote honesty
and fair dealing for consumers. Some
comments explained that State
consumer protection laws and tort laws
could protect consumer interests, while
others said that consumers are able to
determine a product’s ingredients
through ingredient labeling. One
comment said that the standard of
identity for French dressing was
‘‘unnecessary red tape.’’
(Response 1) We agree with the
comments. The final rule revokes the
standard of identity for French dressing.
(Comment 2) Some comments
interpreted the proposed rule as
eliminating the name ‘‘French
dressing.’’ One comment said that
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products marketed as French dressing
range in color from orange to red and
differ in taste, so the product should
lose the ‘‘title’’ of French dressing.
Another comment said that they did not
understand why the name ‘‘French
dressing’’ has to be ‘‘revoked’’ and that
the consumer base for the dressing will
be ‘‘hurt’’ if they look for products
named French dressing and are unable
to find them.
(Response 2) The comments may have
misunderstood the scope of the
proposed rule and the distinction
between standards of identity and food
names. Standards of identity are
requirements related to the content and
production of certain food products.
They typically set forth permitted
ingredients, both mandatory and
optional, and sometimes describe the
amount or proportion of each
ingredient. They are established under
the common or usual name of the food;
however, 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 and are 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 21 CFR 102.5(d). Revocation of the
French dressing standard of identity
will eliminate requirements related to
the content and production of French
dressing and effectively place French
dressing in the category of
nonstandardized foods. As a
nonstandardized food, French dressing
must be labeled with its common or
usual name, ‘‘French dressing,’’ which
is still in common usage. Thus, food
products with the name French dressing
will continue to be available to
consumers.
(Comment 3) One comment objected
to the proposed rule. The comment said
that consumer health would be at risk
because consumers would be unaware
of changes before they buy the product
and that manufacturers might use more
‘‘fillers’’ in a product so that it is less
expensive to make. The comment said
we should ‘‘reconsider’’ revoking the
standard of identity for French dressing
because ‘‘it would ultimately put the
health of consumers at a slight risk.’’
(Response 3) As explained in the
proposed rule, the standard of identity
does not appear to constrain French
dressing products currently on the
market. French dressing has become a
narrower category of products than
prescribed by the standard. These
products maintain their characteristics
without a standard of identity
specifically requiring them. In the
absence of a standard of identity,
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manufacturers will have the flexibility
to use different ingredients to produce
products that meet consumer
expectations for French dressing.
We received no information to
support the assertion that manufacturers
might use ‘‘fillers’’ to ‘‘make the product
cheaper to produce.’’ It is unclear from
the comment what ‘‘fillers’’ means,
which ingredients this term would
encompass, whether such ingredients
are used in the manufacture of French
dressing, whether such ingredients are
prohibited under the standard of
identity, and why the use of such
ingredients in French dressing would
constitute economic adulteration. We
note that manufacturers must comply
with the ingredient labeling
requirements in 21 CFR 101.4.
Therefore, consumers will still be
informed about the ingredients in the
French dressing they purchase.
We also disagree that revoking the
standard of identity ‘‘would ultimately
put the health of consumers at a slight
risk.’’ The comment did not provide
information discussing what the health
risks would be, and we are unaware of
any evidence that supports this
statement.
(Comment 4) One comment said that
it could not believe that the proposed
rule was a priority.
(Response 4) We have the authority to
issue regulations establishing standards
of identity if it promotes honesty and
fair dealing in the interest of consumers.
Standards of identity are intended to
protect consumers against economic
adulteration, maintain the integrity of
food, and reflect consumers’
expectations about the food. This
rulemaking is part of our comprehensive
effort to modernize food standards to
reduce regulatory burden and remove
barriers to innovation. As stated in the
proposed rule, it appears that French
dressing has become a narrower
category of products than prescribed by
the standard (e.g., most, or all contain
tomatoes or tomato-derived ingredients,
which the standard of identity does not
require). These products maintain their
characteristics without a standard of
identity specifically requiring them. We
conclude that a standard of identity for
French dressing no longer promotes
honesty and fair dealing in the interest
of consumers. Therefore, we are
revoking the standard of identity for
French dressing.
This action is also consistent with our
responsibilities under section 6 of
Executive Order 13563, ‘‘Improving
Regulation and Regulatory Review’’
(January 18, 2011), which requires
agencies to periodically conduct
retrospective analyses of existing
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regulations to identify those ‘‘that might
be outmoded, ineffective, insufficient,
or excessively burdensome, and to
modify, streamline, expand, or repeal
them’’ accordingly.
V. Effective Date
This rule is effective on February 14,
2022.
VI. Economic Analysis of Impacts
We have examined the impacts of the
final rule under Executive Order 12866,
Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601–612), and
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4). Executive Orders
12866 and 13563 direct us to assess all
costs and benefits 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). We believe that
this final rule is not a significant
regulatory action as defined by
Executive Order 12866.
The Regulatory Flexibility Act
requires us to analyze regulatory options
that would minimize any significant
impact of a rule on small entities.
Because we have concluded, as set forth
below, 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 an assessment of anticipated
costs and benefits, 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 private sector, of
$100,000,000 or more (adjusted
annually for inflation) in any 1 year.’’
The current threshold after adjustment
for inflation is $158 million, using the
most current (2020) Implicit Price
Deflator for the Gross Domestic Product.
This final rule would not result in an
expenditure in any year that meets or
exceeds this amount.
The final rule affects manufacturers of
salad dressings. Our review of
supermarket scanner data for the year
2018 shows that a total of 227 distinct
pourable products sold as ‘‘French
dressing’’ that year were manufactured
by 53 firms. The final rule does not
require any of the affected firms to
change their manufacturing practices.
Our analysis of current food
manufacturing practices and the
petition to revoke the standard indicate
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that revoking the standard of identity
could provide benefits in terms of
additional flexibility to the
manufacturers of French dressing
products. Revoking the standard of
identity could provide an opportunity
for innovation and the introduction of
new French dressing products,
providing benefits to both consumers
and industry. Therefore, we conclude
2041
that the final rule, 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
Category
Benefits:
Annualized Monetized $millions/year ..............................
Annualized Quantified ......................................................
Qualitative ........................................................................
Costs:
Annualized Monetized $millions/year ..............................
Annualized Quantified ......................................................
Primary
estimate
Low
estimate
High
estimate
$0
..................
..................
..................
$0
..................
..................
..................
$0
..................
..................
..................
Year
dollars
2018
..................
..................
..................
Discount
rate
(%)
Period
covered
Notes
7
3
7
3
Benefits to manufacturers would be from additional flexibility, and the
opportunity for innovation regarding, French dressing products.
0
..................
..................
..................
0
..................
..................
..................
0
..................
..................
..................
2018
..................
..................
..................
7
3
7
3
..................
..................
..................
..................
..................
..................
..................
..................
7
3
Qualitative.
Transfers:
Federal Annualized Monetized $millions/year .................
From/To ............................................................................
From:
To:
Other Annualized Monetized $millions/year ....................
..................
..................
From/To ............................................................................
From:
..................
..................
..................
..................
..................
..................
7
3
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/reports/economic-impactanalyses-fda-regulations.
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.
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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.
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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
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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. References
The following reference is on display
at the Dockets Management Staff (see
ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. French Dressing: Revocation of a
Standard of Identity: Final Regulatory Impact
Analysis, Final Regulatory Flexibility
Analysis, Unfunded Mandates Reform Act
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Analysis available at https://www.fda.gov/
about-fda/reports/economic-impactanalyses-fda-regulations.
List of Subjects in 21 CFR Part 169
Food grades and standards, Oils and
fats, Spices and flavorings.
Therefore, under the Federal Food,
Drug, and Cosmetic Act, and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 169 is
amended as follows:
PART 169—FOOD DRESSINGS AND
FLAVORINGS
1. The authority citation for part 169
continues to read as follows:
■
Authority: 21 U.S.C. 321, 341, 343, 348,
371, 379e.
§ 169.115
■
[Removed]
2. Remove § 169.115.
Dated: January 6, 2022.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2022–00494 Filed 1–12–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 814
[Docket No. FDA–2019–N–3101]
RIN 0910–AI10
Revised Procedures for the
Announcement of Approvals and
Denials of Premarket Approval
Applications and Humanitarian Device
Exemption Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA, the Agency, or
we) is issuing a final rule to amend the
medical device regulations regarding the
procedures for the announcement of
approvals and denials of premarket
approval applications (PMAs) and
humanitarian device exemption
applications (HDEs). This final rule
discontinues the publication in the
Federal Register after each quarter of a
list of PMA and HDE approvals and
denials announced in that quarter. We
will continue to post approval and
denial notices for PMAs and HDEs on
FDA’s home page on the internet and
will also continue to make available on
the internet and place on public display
summaries of safety and effectiveness
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SUMMARY:
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data (SSED) for PMAs and summaries of
safety and probable benefit (SSPB) for
HDEs. FDA is taking this action to
improve the efficiency of announcing
approvals and denials of PMAs and
HDEs and to eliminate duplication in
the current process for announcing this
information. We are also updating
Agency contact information and
statutory references in certain sections
of the PMA and HDE regulations for
purposes of accuracy, clarity, and
consistency.
DATES: This rule is effective February
14, 2022.
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:
For information concerning the final
rule as it relates to devices regulated by
the Center for Biologics Evaluation and
Research: Tami Belouin, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
For information concerning the final
rule as it relates to devices regulated by
the Center for Devices and Radiological
Health: Joshua Nipper, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2438,
Silver Spring, MD 20993–0002, 301–
796–6524.
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
B. History of the Rulemaking
C. Summary of Comments to the Proposed
Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA
Response
A. Introduction
B. Specific Comments and FDA Response
C. Comments Outside the Scope of This
Rulemaking
V. Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
X. Consultation and Coordination With
Indian Tribal Governments
XI. Reference
I. Executive Summary
A. Purpose of the Final Rule
FDA is amending its medical device
regulations regarding the procedures for
the announcement of approvals and
denials of PMAs and HDEs to
discontinue the quarterly publication in
the Federal Register of a list of
approvals and denials of both PMAs and
HDEs. FDA will continue to post
approval and denial notices for PMAs
and HDEs on FDA’s home page on the
internet (https://www.fda.gov) and will
also continue to make available on the
internet and place on public display
SSED for PMAs and SSPB for HDEs.
FDA is taking this action to improve the
efficiency of announcing approvals and
denials of PMAs and HDEs and
eliminate duplication in the current
process for announcing this
information. We are also updating
Agency contact information and
statutory references in certain PMA and
HDE regulations for purposes of
accuracy, clarity, and consistency.
B. Summary of the Major Provisions of
the Final Rule
FDA is amending its regulations
regarding the announcement procedures
for the approval and denial of PMAs
and HDEs. FDA is discontinuing
publishing in the Federal Register after
each quarter a list of PMA and HDE
approvals and denials announced for
that quarter. We will continue to post
approval and denial notices for PMAs
and HDEs on FDA’s home page on the
internet, and we will also continue to
make SSED for PMAs and SSPB for
HDEs available on the internet and
place them on public display.
C. Legal Authority
FDA is issuing this final rule under
sections 515, 520(h), 520(m), and 701(a)
of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360e, 360j(h),
360j(m), and 371(a)).
D. Costs and Benefits
The benefit of this final rule is that it
will result in cost savings to FDA from
discontinuing publishing in the Federal
Register, on a quarterly basis, a list of
medical device PMA and HDE
approvals and denials. Annualized over
10 years, the estimated benefits (i.e.,
cost savings) to FDA range from $0.008
million to $0.013 million at both 3 and
7 percent discount rate, with a primary
estimate of $0.010 million. We estimate
that this final rule will result in no
additional costs to industry because the
E:\FR\FM\13JAR1.SGM
13JAR1
]]>Agencies
[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Rules and Regulations]
[Pages 2038-2042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00494]
[[Page 2038]]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 169
[Docket No. FDA-2020-N-1807]
RIN 0910-AI16
French Dressing; Revocation of a Standard of Identity
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is revoking the
standard of identity for French dressing. This action, in part,
responds to a citizen petition submitted by the Association for
Dressings and Sauces (ADS). We conclude that this standard no longer
promotes honesty and fair dealing in the interest of consumers.
Revocation of the standard of identity for French dressing will provide
greater flexibility in the product's manufacture, consistent with
comparable, nonstandardized foods available in the marketplace.
DATES: This final rule is effective on February 14, 2022.
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, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-2371, or Carrol Bascus,
Center for Food Safety and Applied Nutrition, Office of Regulations and
Policy (HFS-024), 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 the Comments and FDA Response
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. References
I. Executive Summary
A. Purpose of the Final Rule
The final rule revokes the standard of identity for French
dressing. This action, in part, responds to a citizen petition
submitted by the ADS. We conclude that the standard of identity for
French dressing no longer promotes honesty and fair dealing in the
interest of consumers and revoking the standard could provide greater
flexibility in the product's manufacture, consistent with comparable,
nonstandardized foods available in the marketplace.
B. Summary of the Major Provision of the Final Rule
The final rule revokes the standard of identity for French
dressing.
C. Legal Authority
We are issuing the final rule to revoke the standard of identity
for French dressing 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 dressings for salad and
does not require any of the affected firms within the industry to
change their manufacturing practices.
Our analysis of current food manufacturing practices and the
petition to revoke the standard indicate that revoking the standard of
identity could provide benefits in terms of additional flexibility and
the opportunity for innovation to manufacturers. The potential for
innovation is evidenced by the growing variety of dressings for salads
on the market that are formulated to meet consumers' preferences and
needs.
Therefore, we conclude that the final rule to revoke the standard
of identity for French dressing would 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.
In the Federal Register of August 12, 1950 (15 FR 5227), we
established a standard of identity for French dressing. We later
amended that standard of identity in the Federal Registers of May 10,
1961 (26 FR 4012), February 12, 1964 (29 FR 2382), February 1, 1967 (32
FR 1127 at 1128), May 18, 1971 (36 FR 9010), and November 8, 1974 (39
FR 39554), to allow the use of certain ingredients in French dressing.
We also re-designated the French dressing standard of identity as Sec.
169.115 (21 CFR 169.115) (42 FR 14481, March 15, 1977).
We received a citizen petition from the ADS asking us, in part, to
revoke the standard of identity for French dressing (citizen petition
from the ADS, dated January 13, 1998, submitted to the Division of
Dockets Management, Food and Drug Administration, Docket No. FDA-1998-
P-0669 (``petition'')). As a partial response to the petitioner's
request, we issued a proposed rule in the Federal Register of December
21, 2020 (85 FR 82980), that would revoke the standard of identity for
French dressing.
The petition asked us to revoke the standard of identity for French
dressing (petition at page 1). The petition stated that there has been
a proliferation of nonstandardized pourable dressings for salads with
respect to flavors (Italian, Ranch, cheese, fruit, peppercorn, varied
vinegars, and other flavoring concepts) and composition (including a
wide range of reduced fat, ``light,'' and fat-free dressings) (petition
at page 3). The French dressing standard of identity, according to the
petition, no longer serves as a benchmark for other dressings because
of the wide variation in composition to meet consumer interests (id.).
Instead, the petition claimed that the standard of identity has become
marginalized and restricts innovation (id.). Therefore, the petition
[[Page 2039]]
stated that the French dressing standard of identity no longer promotes
honesty and fair dealing in the interest of consumers (id.).
We reviewed the petition and tentatively concluded that the
standard of identity for French dressing no longer promotes honesty and
fair dealing in the interest of consumers. Therefore, we proposed to
revoke the French dressing standard of identity at Sec. 169.115.
When the standard of identity was established in 1950, French
dressing was one of three types of dressings we identified (15 FR
5227). We generally characterized the dressings as containing a fat
ingredient, an acidifying ingredient, and seasoning ingredients.
The French dressing standard allowed for certain flexibility in
manufacturers' choice of oil, acidifying ingredients, and seasoning
ingredients. Tomatoes or tomato-derived ingredients were among the
seasoning ingredients permitted, but not required. Amendments to the
standard since 1950 have permitted the use of additional ingredients,
such as any safe and suitable color additives that impart the color
traditionally expected (39 FR 39543 at 39554-39555).
Most, if not all, products currently sold under the name ``French
dressing'' contain tomatoes or tomato-derived ingredients and have a
characteristic red or reddish-orange color. They also tend to have a
sweet taste. Consumers appear to expect these characteristics when
purchasing products represented as French dressing. Thus, it appears
that, since the establishment of the standard of identity, French
dressing has become a narrower category of products than prescribed by
the standard. These products maintain the above characteristics without
a standard of identity specifically requiring them.
Additionally, French dressing products are manufactured and sold in
lower-fat varieties that contain less than the minimum amount of
vegetable oil (35 percent by weight) required by Sec. 169.115(a). In
the preamble to the proposed rule, we stated that we were unaware of
any evidence that consumers are deceived or misled by the reduction in
vegetable oil when these varieties are sold under names including terms
such as ``fat free'' or ``low-fat'' (85 FR 82980 at 82982). By
contrast, these varieties appear to accommodate consumer preferences
and dietary restrictions.
Therefore, after considering the petition and related information,
through the proposed rule, we tentatively concluded that the standard
of identity for French dressing no longer promotes honesty and fair
dealing in the interest of consumers consistent with section 401 of the
FD&C Act and proposed to revoke the standard of identity for French
dressing. 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.
B. Summary of Comments to the Proposed Rule
There were more than 20 comments to the proposed rule. A trade
association, a business association, and individuals submitted the
comments. Some comments appeared to have been submitted as part of a
university course assignment. In general, most comments supported the
revocation of the French dressing standard of identity; their reasons
supporting the revocation ranged from promoting innovation, believing
that consumers are not misled, or stating that the standard of identity
was obsolete. A small number of comments misinterpreted the proposed
rule as removing or prohibiting the use of the name ``French
dressing,'' and one comment opposed revoking the standard of identity
because of public health concerns.
III. Legal Authority
We are issuing this final rule to revoke the standard of identity
for French dressing consistent with our authority under the FD&C Act,
which directs the Secretary to issue regulations fixing and
establishing for any food a reasonable definition and standard of
identity, quantity, 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
As stated earlier, there were more than 20 comments to the proposed
rule. A trade association, a business association, and individuals
submitted the comments. Several comments appeared to have been
submitted as part of a university course assignment. In general, most
comments supported the revocation of the French dressing standard of
identity.
A small number of comments misinterpreted the proposed rule as
removing or prohibiting the use of the name ``French dressing,'' and
one comment opposed revoking the standard of identity because of public
health concerns.
We describe and respond to the comments in section IV.B. of this
document. 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 for organizational purposes and does not signify the
comment's value or importance or the order in which comments were
received.
B. Description of the Comments and FDA Response
(Comment 1) Most comments supported revoking the standard of
identity for French dressing. In general, the comments agreed with us
that revoking the standard of identity would:
Allow manufacturers to innovate their products in ways
that consumers want;
Give French dressing manufacturers the same treatment or
flexibility to innovate or modernize their products as other dressing
manufacturers have. One comment added that revoking the standard of
identity for French dressing would enable manufacturers to substitute
ingredients to address allergies, ingredient sensitivities, or even
consumer preferences (particularly consumers on a diet); and
Eliminate an obsolete standard that has not changed
significantly over 70 years. Some comments added that consumers
recognize French dressing and can judge for themselves whether to buy a
particular product.
Other comments said that the standard of identity for French
dressing is no longer needed to promote honesty and fair dealing for
consumers. Some comments explained that State consumer protection laws
and tort laws could protect consumer interests, while others said that
consumers are able to determine a product's ingredients through
ingredient labeling. One comment said that the standard of identity for
French dressing was ``unnecessary red tape.''
(Response 1) We agree with the comments. The final rule revokes the
standard of identity for French dressing.
(Comment 2) Some comments interpreted the proposed rule as
eliminating the name ``French dressing.'' One comment said that
[[Page 2040]]
products marketed as French dressing range in color from orange to red
and differ in taste, so the product should lose the ``title'' of French
dressing. Another comment said that they did not understand why the
name ``French dressing'' has to be ``revoked'' and that the consumer
base for the dressing will be ``hurt'' if they look for products named
French dressing and are unable to find them.
(Response 2) The comments may have misunderstood the scope of the
proposed rule and the distinction between standards of identity and
food names. Standards of identity are requirements related to the
content and production of certain food products. They typically set
forth permitted ingredients, both mandatory and optional, and sometimes
describe the amount or proportion of each ingredient. They are
established under the common or usual name of the food; however, 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 and are 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 21 CFR 102.5(d). Revocation of the French dressing
standard of identity will eliminate requirements related to the content
and production of French dressing and effectively place French dressing
in the category of nonstandardized foods. As a nonstandardized food,
French dressing must be labeled with its common or usual name, ``French
dressing,'' which is still in common usage. Thus, food products with
the name French dressing will continue to be available to consumers.
(Comment 3) One comment objected to the proposed rule. The comment
said that consumer health would be at risk because consumers would be
unaware of changes before they buy the product and that manufacturers
might use more ``fillers'' in a product so that it is less expensive to
make. The comment said we should ``reconsider'' revoking the standard
of identity for French dressing because ``it would ultimately put the
health of consumers at a slight risk.''
(Response 3) As explained in the proposed rule, the standard of
identity does not appear to constrain French dressing products
currently on the market. French dressing has become a narrower category
of products than prescribed by the standard. These products maintain
their characteristics without a standard of identity specifically
requiring them. In the absence of a standard of identity, manufacturers
will have the flexibility to use different ingredients to produce
products that meet consumer expectations for French dressing.
We received no information to support the assertion that
manufacturers might use ``fillers'' to ``make the product cheaper to
produce.'' It is unclear from the comment what ``fillers'' means, which
ingredients this term would encompass, whether such ingredients are
used in the manufacture of French dressing, whether such ingredients
are prohibited under the standard of identity, and why the use of such
ingredients in French dressing would constitute economic adulteration.
We note that manufacturers must comply with the ingredient labeling
requirements in 21 CFR 101.4. Therefore, consumers will still be
informed about the ingredients in the French dressing they purchase.
We also disagree that revoking the standard of identity ``would
ultimately put the health of consumers at a slight risk.'' The comment
did not provide information discussing what the health risks would be,
and we are unaware of any evidence that supports this statement.
(Comment 4) One comment said that it could not believe that the
proposed rule was a priority.
(Response 4) We have the authority to issue regulations
establishing standards of identity if it promotes honesty and fair
dealing in the interest of consumers. Standards of identity are
intended to protect consumers against economic adulteration, maintain
the integrity of food, and reflect consumers' expectations about the
food. This rulemaking is part of our comprehensive effort to modernize
food standards to reduce regulatory burden and remove barriers to
innovation. As stated in the proposed rule, it appears that French
dressing has become a narrower category of products than prescribed by
the standard (e.g., most, or all contain tomatoes or tomato-derived
ingredients, which the standard of identity does not require). These
products maintain their characteristics without a standard of identity
specifically requiring them. We conclude that a standard of identity
for French dressing no longer promotes honesty and fair dealing in the
interest of consumers. Therefore, we are revoking the standard of
identity for French dressing.
This action is also consistent with our responsibilities under
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.
V. Effective Date
This rule is effective on February 14, 2022.
VI. Economic Analysis of Impacts
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits 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). We
believe that this final rule is not a significant regulatory action as
defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because we have concluded, as set forth below, 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 an assessment of
anticipated costs and benefits, 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 private sector, of
$100,000,000 or more (adjusted annually for inflation) in any 1 year.''
The current threshold after adjustment for inflation is $158 million,
using the most current (2020) Implicit Price Deflator for the Gross
Domestic Product. This final rule would not result in an expenditure in
any year that meets or exceeds this amount.
The final rule affects manufacturers of salad dressings. Our review
of supermarket scanner data for the year 2018 shows that a total of 227
distinct pourable products sold as ``French dressing'' that year were
manufactured by 53 firms. The final rule does not require any of the
affected firms to change their manufacturing practices. Our analysis of
current food manufacturing practices and the petition to revoke the
standard indicate
[[Page 2041]]
that revoking the standard of identity could provide benefits in terms
of additional flexibility to the manufacturers of French dressing
products. Revoking the standard of identity could provide an
opportunity for innovation and the introduction of new French dressing
products, providing benefits to both consumers and industry. Therefore,
we conclude that the final rule, 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 $millions/year... $0 $0 $0 2018 7
.......... .......... .......... .......... 3
Annualized Quantified................. .......... .......... .......... .......... 7
.......... .......... .......... .......... 3
-------------------------------------------------------------------------------------------------------------
Qualitative........................... Benefits to manufacturers would be from additional flexibility, and
the opportunity for innovation regarding, French dressing products.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized $millions/year... 0 0 0 2018 7
.......... .......... .......... .......... 3
Annualized Quantified................. .......... .......... .......... .......... 7
.......... .......... .......... .......... 3
-------------------------------------------------------------------------------------------------------------
Qualitative...........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized Monetized $millions/ .......... .......... .......... .......... 7
year.
.......... .......... .......... .......... 3
-------------------------------------------------------------------------------------------------------------
From/To............................... From:
To:
-------------------------------------------------------------------------------------------------------------
Other Annualized Monetized $millions/ .......... .......... .......... .......... 7
year.
.......... .......... .......... .......... 3
-------------------------------------------------------------------------------------------------------------
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/reports/economic-impact-analyses-fda-regulations.
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. References
The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. French Dressing: Revocation of a Standard of Identity: Final
Regulatory Impact Analysis, Final Regulatory Flexibility Analysis,
Unfunded Mandates Reform Act
[[Page 2042]]
Analysis available at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
List of Subjects in 21 CFR Part 169
Food grades and standards, Oils and fats, Spices and flavorings.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 169 is amended as follows:
PART 169--FOOD DRESSINGS AND FLAVORINGS
0
1. The authority citation for part 169 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Sec. 169.115 [Removed]
0
2. Remove Sec. 169.115.
Dated: January 6, 2022.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2022-00494 Filed 1-12-22; 8:45 am]
BILLING CODE 4164-01-P
