[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]



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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 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

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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

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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 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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

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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