Rule2022-00494
French Dressing; Revocation of a Standard of Identity
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 13, 2022
Effective
February 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 9 (Thursday, January 13, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00494]
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Allow manufacturers to innovate their products in ways
that consumers want;
<bullet> 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
<bullet> 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, 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
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Units
Primary Low High ------------------------------------
Category estimate estimate estimate Year Discount Period Notes
dollars rate (%) covered
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Benefits:
Annualized Monetized $millions/year... $0 $0 $0 2018 7
.......... .......... .......... .......... 3
Annualized Quantified................. .......... .......... .......... .......... 7
.......... .......... .......... .......... 3
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Qualitative........................... Benefits to manufacturers would be from additional flexibility, and
the opportunity for innovation regarding, French dressing products.
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Costs:
Annualized Monetized $millions/year... 0 0 0 2018 7
.......... .......... .......... .......... 3
Annualized Quantified................. .......... .......... .......... .......... 7
.......... .......... .......... .......... 3
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Qualitative...........................
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Transfers:
Federal Annualized Monetized $millions/ .......... .......... .......... .......... 7
year.
.......... .......... .......... .......... 3
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From/To............................... From:
To:
-------------------------------------------------------------------------------------------------------------
Other Annualized Monetized $millions/ .......... .......... .......... .......... 7
year.
.......... .......... .......... .......... 3
-------------------------------------------------------------------------------------------------------------
From/To............................... From:
To:
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Effects:
State, Local or Tribal Government:..................................................................................................................
Small Business:.....................................................................................................................................
Wages:..............................................................................................................................................
Growth:.............................................................................................................................................
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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
<a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
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
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