Standards of Identity History

& Current Status

Andrea Krause, Ph.D.

Food Technologist
Center for Food Safety and Applied Nutrition
Food and Drug Administration
September 27, 2019
 A Look Back in Time…

1906 1939-1960‘s 1993 2005 2018

1900 2020

1938 1977 1995 Today!

All Photos from National Archives: https://www.flickr.com/photos/usnationalarchives

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 Pre-1906
• Industrialization led to the increasing
availability of mass-produced foods
• Consumers did not know how foods
were produced or what they
contained
• Patchwork of state laws for
consumer protection
• Legislation was introduced from
1879-1906, but was never enacted
• 1903: funding for the Bureau of
Chemistry to investigate adulteration
• Bureau of Chemistry developed
more than 200 “recipes” for
common foods Top: Inspection of Carcasses, 1910
Bottom: Cudahy Packing Co., Omaha, Nebraska, 1910.
National Archives Collection. 3
 1906: Pure Food and Drug Act
• Prohibited a food product if it
contained "any added poisonous or
other added deleterious ingredient
which may render such article
injurious to health“
• Established definitions for
adulteration and misbranding and
subjected foods to seizure if they
were in violation
• Intended to prevent adulteration in Candy factory inspection in 1908.
National Archives, Records of FDA
the form of dilution, substitution of
a valuable ingredient, concealment
of inferiority, or use of harmful
ingredients in foods
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 1906: Pure Food and Drug Act
• Protected the consumer against
contaminated food
– Prohibited products containing
"filthy, decomposed, or putrid"
ingredients
– Regulated the misbranding of food
products only against presenting false
and misleading information on the
label
– Did not require foods to have an
ingredient statement
FDA inspectors seizing crates of contaminated froze
• No ability to establish mandatory eggs.
National Archives, Records of FDA
standards
• Allowed marketing of foods under
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ambiguous distinctive names
 1938: Federal Food, Drug, and
Cosmetic Act (FD&C)

•Contained provisions for establishing food

standards to prevent economic
adulteration and ensure that food meets
consumer expectations
•Section 401:
–“[w]henever in the judgment of the Secretary
such action will promote honesty and fair dealing
in the interest of consumers, he shall promulgate
regulations fixing and establishing for any food,
under its common or usual name so far as
Letter from Acting Secretary of State Robert
practicable, a reasonable definition and standard Bacon to U.S. Ambassador to the United
of identity, a reasonable standard of quality, Kingdom Whitelaw Reid Discussing Postcards
Regarding the Chicago Meatpacking Industry,
and/or reasonable standards of fill of container.” 1907.
National Archives Collection.
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 1938 FD&C Act: Highlights Pertaining
to Standards

• Section 403(g) a food is deemed misbranded if:

“If it purports to be or is represented as a food for which a
definition and standard of identity has been prescribed by
regulations as provided by section 401, unless: (1) It conforms to
such definition and standard, and (2) its label bears the name of
the food specified in the definition and standard, and, insofar as
may be required by such regulations, the common names of
optional ingredients (other than spices, flavorings, and coloring)
present in such food.”
• Section 701(e)
– Issuance, amendment, or repeal of food standards required a
formal trial-type administrative hearing procedure
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 1938 FD&C Act: Highlights Pertaining
to Standards

• Required ingredient labeling only of optional

ingredients in standardized foods
• No preemption of state laws
– Provided only minimum standards
• A product that purported to be or was
represented as a standardized food but did not
conform to the definition and standard could not
be sold or had to be labeled as “imitation”
Mrs. Fidel Romero proudly
• Consumers could rely on a common name which exhibits her canned food, New
Mexico.
identified comparable products in a rapidly National Archives Collection
expanding marketplace
• Created a “level playing field” for food producers
– Minimum amount of valuable ingredients 8
 USDA-FSIS Food Standards

• Federal Meat Inspection Act (FMIA) and the

Poultry Products Inspection Act (PPIA)
• USDA-FSIS has established meat and poultry
product standards of identity or composition
– 9 CFR parts 319 and 381, subpart P for meat and
poultry products, respectively

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 1939-1960’s
• Flurry of activity: hearings,
proposed rules, and final rules
• “Recipe” approach:
– Detail about specific ingredients:
mandatory and optional
– Some specified manufacturing
procedures
– Added nutrients, those that had
been lost in processing, or
nutrients deemed critical to
improving public health
– Specific methods of analysis
World War II Poster.
National Archives Collection 10
The Early Days of Food Standards
• Standards of identity, quality and fill for
canned tomatoes
• Substandard canned tomatoes
• Eggs, liquid whole eggs, liquid mixed eggs,
frozen whole eggs, dried whole eggs, egg
yolk, frozen egg yolk, dried egg yolk
• Tomato puree, tomato paste, tomato catsup,
tomato juice
• Canned vegetables
• Cream, whipping cream, evaporated milk,
sweetened condensed milk, and dried skim
milk
Industrial age ketchup was often made from fermented
• Canned peaches, canned apricots, canned tomato cores and skins, vinegar for flavor, and dyes to
pears and canned cherries make it red.
National Archives, Records of FDA
• Fruit jams, fruit jellies, and fruit butters
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 1960’s: Safe and Suitable
• Passage of Food Additives
Amendment of 1958 and Color
Additive Amendments of 1960
• FDA developed “safe and
suitable” policy in 21 CFR 130.3(d)
for functional ingredients
• First applied this policy to frozen
raw breaded shrimp (21 CFR
161.175)
• Allowed additional flexibility in Dairy Plant, New Ulm, MN
the selection of ingredients National Archives Collection

• Since this policy was established,

many standards have been
revised 12
 1977: Renumbering and Republication

• 42 FR 14302
• Re-numbering
into the CFR
citations that we
use today: 21 CFR
130-169

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Modern Standards

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Modern Standards

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 1990 FD&C Act Amendments:
Nutrition Labeling and Education Act

• Section 403(i):
– Ingredient labeling: Removed language that limited full ingredient disclosure to
non-standardized foods
– Color additives: Certified colors must be declared by their common or usual
names rather than as “colorings”
• Section 403A:
– Preemption: States may not establish/continue in effect a standard if it is not
identical to the Federal standard
• Section 701:
– Removed formal rule-making requirements for establishing, amending, or
repealing standards for the vast majority of foods. The amendment or repeal of
standards of identity for dairy products continues to be subject to formal
rulemaking 16
 1993: NLEA Labeling Changes
• 58 FR 2850-2896
• Declaration of common or usual names of:
– All ingredients in standardized foods
– All color additives required to be certified by FDA
• Other labeling changes: After the 1906 Pure Food and Drugs
– Provide uniform format for voluntary declaration of Act passed, product labels
percentage ingredient information advertised purity.
National Archives, Records of the
– Permits inclusion of food source in the names of Patent and Trademark Office
sweeteners defined in 21 CFR 168
– Require declaration of protein hydrolysates and
identification of food source
– Require identification of a caseinate as a milk derivative
in foods that claim to be non-dairy
– Require label declaration of sulfiting agents that have a
functional effect in standardized food or at 10 ppm or
more
– Provide certain exemptions for listing preservative 17
 1993: NLEA Changes Affecting Standards

• FDA also amended

certain standards in 58
FR 2850
– Dairy products
– Maple syrup
– Canned tuna

Collecting maple sap in

Vermont.
National Archives Collection
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 1993: NLEA
• 58 FR 2302
– Regulations defining nutrient content claims
– Established 21 CFR 130.10
• Modification of standardized foods to achieve a nutrition
goal
• Covers foods that deviate from a standard due to
compliance with an expressed nutrient content claim
defined by FDA regulation
– Reduce the need for Temporary Marketing Permits

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 1995/1996 ANPRM
• Advance notices of proposed rulemaking
– 60 FR 67492 (FDA); 61 FR 47453 (USDA-FSIS)
• Food Standards of Identity, Quality and Fill of
Container; Common or Usual Name Regulations;
Request for Comments on Existing Regulations
• Requested public comment on the utility of food
standards, naming conventions and provided several
alternative approaches which could be considered
• Five options were proposed

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 ANPRM Comments
• FDA received 95 comments, USDA-FSIS received 28 comments
• Most comments strongly supported the concept of food standards
• Several requested that standards be eliminated
• Comments expressed support for standards:
– Protecting consumers from fraudulent and substandard products
– Ensuring that products meet consumers' nutritional expectations/needs
– Lessening burden on consumers: nutrition labeling and ingredient
declarations cannot substitute for food standards
– Ensuring a level playing field for industry because they provide direction
and consistency across products
– Preventing interstate trade complications from variable state standards
– Providing a basis for International trade and harmonization

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 ANPRM Comments
• However, few comments supported the existing food standards as currently written
• Many requested that food standards be simplified, be made more flexible, or be
clarified:
–Food standards be made more flexible to allow for alternative safe and suitable ingredients and
alternative technologies
–Recommended limiting food standards to the name of the product and the essential
characterizing properties of the product
–Recommended that FDA revise certain specific food standards
–Rescinding or modifying them on a case-by-case basis
–Recommended instituting advisory committees, contracting with independent groups, or
forming nongovernment groups to revise food standards
–Establishing general or "guiding“ principles or a fundamental philosophy for reviewing food
standards and revising them
–Revisions to standards should be initiated by petitions and supported by adequate data
–FSIS and FDA food standards should be consistent, and that we should attempt to harmonize
our efforts 22
 1997-2005
• In 1996, FDA convened an internal agency task force to
discuss the current and future role of food standards and
to draft a set of principles for reviewing and revising
FDA’s food standards regulations
• In January 1997, a joint FDA and FSIS Food Standard
Work Group was formed
• The group determined the most suitable option was to
create general principles to use when assessing food
standards
– Used to revise, eliminate, or establish standards in response to
petitions submitted by external parties or on FDA or USDA
initiative 23
 2005 Proposed Rule
• 70 FR 29214
• FDA + USDA joint proposed rule
• Proposal to establish a set of 13 general principles
for food standards
– 21 CFR 130.5 (FDA); 9 CFR 410.1 (USDA)
• Establish the criteria that the agencies would use in
considering whether to establish, revise, or eliminate
a food standard
– Citizen petition
– Agency initiative
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 2005 Proposed Rule Comments
• General support for idea of general principles
• Specific comments on the 13 principles
• Multiple comments that the agencies should
allow greater flexibility

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 Horizontal Approach
• Grocery Manufacturers Association (GMA)
Citizen Petition (2006)
– Proposes amending 21 CFR part 130 to modernize
food standards
– Docket ID: FDA-2007-P-0463-0367
• Identified six categories of variations from food
standards that GMA believed should be
permitted to provide flexibility

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 2018
• Nutrition Innovation Strategy (NIS) agency
initiative
• Public Meeting, July 2018
• Docket for public comments on the multiple
initiatives for the NIS
• FDA has reviewed these comments and is
working to proceed

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 2019
• Unified Agenda
– Revocation of several standards: Low-fat
yogurt and non-fat yogurt, French dressing,
Frozen cherry pie
– Re-open the comment period on the 2005
Proposed Rule
• FDA has been holding listening sessions
with stakeholders who are interested in
specific standards upon request
• Public meeting focusing on Standards
• Docket for written comments, open after
this meeting The Doughnut Corporation sought endorsement
from the Nutrition Division of the War Food
Administration for its Vitamin Doughnuts
campaign.
National Archives,
Records of the Agricultural Marketing Service
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