Best if printed in landscape.
of US Government Response
about the safety of our food is not new, but it has received considerably
more attention during the past century. This web page provides a brief
historical perspective of food safety programs and laws.
- Concerns about
adulterated food can be traced back to as early a 200 BC (concerned
that wine was being diluted with water).
- European nations
have wrestled with food safety concerns, and due to our extensive European
heritage, have influenced our approach to food safety issues; e.g.,
cities enacted food laws, region in which wine was produced must be
accurately represented; cannot mask spoiled grain with good grain; concern
about what was being added to baked products, such as beans and peas
to replace flour.
- Food safety concerns
were addressed in America's colonial times; e.g., Massachusetts and
Virginia in 1641; e.g., bakers were required to place their identifying
mark on their bread.
- During the 19th
century, industrialization, urbanization, reliance on purchased food,
and food manufacturing expanded, and so did the concern over adulterated
and misbranded food.
- Roots of federal
food law lie in the U.S. Patent office. Because many of the patents
in the early 1800s dealt with advances in agricultural technologies,
an Agriculture Division was established in the Patent Office in 1842.
- US Department of
Agriculture was established in 1862 with the staff of the Agriculture
Division of the Patent Office; responsibilities of the new department
included roles that have grown into today's food regulatory agencies.
- Dr. Harvey Wiley
(1880s) expanded food adulteration studies and campaigned for federal
laws to address food safety issues; e.g., the Pure Food Congress in
- "Poison Squad"
-- volunteers tested the safety of food additives/preservatives.
- First food laws
in the United States were primarily state and local laws because the
federal government was slower to respond; but variation among local
laws made it difficult for an interstate business to comply with differing
- Example - California
enacted a food safety law in 1800s; North Dakota enacted a Pure Food
Law in 1903.
- Upton Sinclair's
"The Jungle" (1905) described the conditions of the meat packing industry;
this led to Congressional action.
- Two major pieces
of federal food legislation were enacted in 1906 -- Pure Food and Drug
Act and Meat Inspection Act. Although these have subsequently been extensively
amended and other complementary legislation has been enacted, they continue
to serve as the foundation for current food law. The following FDA web
pages provide additional insight.
- The Pure
Food and Drug Act regulated some food processing
and food additives to protect consumers
- Example -- 21
U.S.C. §331 "The following acts ... are prohibited:
(a) The introduction or delivery for introduction into interstate
commerce of any food, drug, device, or cosmetic that is adulterated
The adulteration or misbranding of any food, drug, device, or cosmetic
in interstate commerce.
The receipt in interstate commerce of any food, drug, device, or cosmetic
that is adulterated or misbranded, and the delivery or proffered delivery
thereof for pay or otherwise."
Example -- 21
CFR 189.1 "Substances prohibited from use in human food.
(a) The food ingredients listed in this section have been prohibited
from use in human food by the Food and Drug Administration because
of a determination that they present a potential risk to the public
health or have not been shown by adequate scientific data to be safe
for use in human food. Use of any of these substances in violation
of this section causes the food involved to be adulterated in violation
of the act."
Example -- 21
CFR 101.3(e) "Under ... the Federal Food, Drug, and Cosmetic Act,
a food shall be deemed to be misbranded if it is an imitation of another
food unless its label bears, in type of uniform size and prominence,
the word "imitation" and, immediately thereafter, the name of the
Example -- Oleomargarine (21
U.S.C. §347) led to some of the early food laws; arose over dairy
industry concern about margarine and its competition with butter.
"No person shall sell, or offer for sale, colored oleomargarine
or colored margarine unless (1) such oleomargarine or margarine
is packaged, (2) the net weight of the contents of any package sold
in a retail establishment is one pound or less, (3) there appears
on the label of the package (A) the word "oleomargarine" or "margarine"
in type or lettering at least as large as any other type or lettering
on such label, and (B) a full and accurate statement of all the
ingredients contained in such oleomargarine or margarine, and (4)
each part of the contents of the package is contained in a wrapper
which bears the word "oleomargarine" or "margarine" in type or lettering
not smaller than 20-point type."
Is this "oleomargarine" law motivated by science or economics?
- Meat Inspection
The Meat Inspection Act authorized USDA to assure meat
products are safe, and not adulterated, misbranded or mislabeled.
USDA's responsibilities include inspecting meat-processing facilities,
inspecting animals before and after slaughter (stamp with "US inspected
and passed"), inspecting meat products, and approving processed
meat product labels.
The Meat Inspection Act refers to Food and Drug Act for definitions
of food additive, color additive and other terms thus establishing
a close relationship between the Food and Drug Act and the Meat
Inspection Act even though they are administered by different agencies.
- Because federal
law preempts state law, the focus of food
law shifted from state to federal government as Congress began to address
food safety issues. However, the role for state government in regulating
food safety has not been eliminated, as is discussed on other pages
in this site.
Despite these two pieces of legislation, food safety issues continued
to arise and attempts were made to revise the legislation, especially
the Pure Food and Drug Act. A major issue was the continuing concerns
about safety of substances in food supply.
Example - USDA raised concern in the early 1900s about nonnutritive
sweeteners but President Teddy Roosevelt was using saccharin rather
than sugar. Frustration that the safety of the product was being
challenged led to an investigation of those who raised the concerns
about the sweeteners.
Affirmative labeling (a 1913 amendment) required information about content
and container size.
Adulteration and misbranding were being interpreted by the courts because
they were not defined in the 1906 statute; e.g., 1924 Supreme Court
There were unsuccessful attempts to legislatively address issues of
"no significant risk level" (e.g., a chemical that poses no significant
risk to an average person, but may pose a risk to a weaker person (perhaps
young, elderly, ill) is prohibited by the statute), "slack fill," "foreign
grown," "FDA authority to establish standards of identity" and "FDA
authority to inspect processing plants."
Tragedy - Jamaican Ginger, an over-the-counter drug, was used during
prohibition for an "alcoholic kick;" to reduce the cost of the Ginger,
an untested but lethal substance was added.
Tragedy -- sulfa drug was useful but it required the person to also
take a solvent to dissolve the drug; the safety of the solvent was not
tested and caused death.
These tragedies led to major legislative revision in 1938.
Drug, and Cosmetic Act of 1938
- The legislation
replaced the Pure Food and Drug Act of 1906
Story of the
Laws Behind the Labels Part II: 1938 Federal Food, Drug, and Cosmetic
Federal Food, Drug, and Cosmetic Act can be found at 21
U.S.C. §301 et. seq.
Food subchapter within Act is 21
U.S.C. §§341 to 350b
The Food, Drug and Cosmetic Act (FDCA) is administered by Food
and Drug Administration (FDA)
- Some provisions
of the FDCA:
authorized FDA to established identity standards for food.
broadened adulteration laws -- rather than FDA having to prove
the food was adulterated, the industry now had the burden of
proving an additive is safe.
authorized FDA to inspect processing facility anytime during
normal working hours.
prohibited false statements about the food item.
addressed labeling of imitation food (e.g, margarine/butter
issue); if product imitated another food product, the label
had to clearly state that fact.
mandated affirmative labeling - product name, quantity, contents,
required additional label information for dietary food.
prohibited misleading containers.
- Food, Drug and
Cosmetic Act (FDCA with its amendments) and Meat Inspection Act remain
the primary food laws, but additional issues have been addressed with
"The Food Additives Amendment (of 1958) exempted two groups of
substances from the food additive regulation process. All substances
that FDA or the U.S. Department of Agriculture (USDA) had determined
were safe for use in specific food prior to the 1958 amendment were
designated as prior-sanctioned substances. Examples of prior-sanctioned
substances are sodium nitrite and potassium nitrite used to preserve
second category of substances excluded from the food additive regulation
process are generally recognized as safe or GRAS substances. GRAS
substances are those whose use is generally recognized by experts
as safe, based on their extensive history of use in food before 1958
or based on publish scientific evidence. Salt, sugar, spices, vitamins
and monosodium glutamate are classified as GRAS substances, along
with several hundred other substances. Manufacturers may also request
FDA to review the use of a substance to determine if it is GRAS.
the Food Additives and Color Additives Amendments include a provision
which prohibits the approval of an additive if it is found to cause
cancer in humans or animals. This clause is often referred to as the
Delaney Clause, named for its Congressional sponsor, Rep. James Delaney
Also see Frequently Asked Questions About GRAS
"Delaney Clause" -- a known carcinogen cannot be added to food in
detectable quantities if the substance is shown to cause cancer in
test animals; implementing this standard became more rigorous as analytical
technologies advanced so that significantly smaller quantities can
now be detected; there was no provision that if a low level of the
substance poses "no significant risk," it would be tolerated; instead,
any detectable presence of a carcinogen was prohibited.
"In 1960, amendments to the Food, Drug, and Cosmetic Act of 1938
added the so-called Delaney anti-cancer clause to FDA's legal mandate.
Among other things, the clause prohibits marketing any color additive
the agency has found to cause cancer in animals or humans, regardless
recent years, regulators have faced a dilemma in light of technological
advances that enable scientists to identify smaller and smaller concentrations
of a substance and conduct more sensitive toxicological tests. Are
such tiny amounts a health threat?"
some colors additives likely to lead to allergic reactions when consumed?
of the Laws Behind the Labels Part III: 1962 Drug Amendments
- Fair Packaging
and Labeling Act, 1966
- Requires processors
ingredients on label by prominence (weight or volume) in product.
- Fortification Restriction
action to limit FDA's attempt to regulate level of "fortification"
in food products; FDA is authorized to determine "safe level" for
additives (based on the assumption that too much of an additive may
be dangerous) but industry (according to Congress) should decide how
much it wants to add to a product within the "safe" level. Thus
FDA cannot prohibit the sale of a supplement that provides more nutrient
than the consumer needs (as long as the level of the supplement is
not so great as to injure the consumer).
- Nutrition Labeling
and Education Act, 1990
nutrition labeling; no longer voluntary; applies to imported food
products as well as domestic products; such labeling is becoming a
Nutrition information must be presented on the basis of serving size,
rather than size of package.
State enforcement authority; FDA sets the standards and perhaps identifies
violations, but states agencies enforce the law.
Federal preemption for misbranding; replaced extensive state food
laws in some jurisdictions but simplified compliance for interstate
companies -- one standard rather than a different standard in each
Preemption -- legal concept that if there is a conflict between
federal and state law, federal law prevails (unless Congress allows
state law to be applied).
More detailed declaration of ingredients, to include colors, peanut,
and juice content; defined difference between butter, margarine and
spread; defined difference between fruit drink and fruit juice; allows
combination of food ingredients that may have been prohibited by some
state laws (but the ingredients must be accurately labeled), e.g.,
canola oil added to butter.
- Food Quality Protection
Summary of FQPA Amendments to FIFRA and FDCA at http://www.epa.gov/oppfead1/fqpa/fqpa-iss.htm
Mandates a single, health-based standard for all pesticides in all
Provides special protections for infants and children in determining
pesticide tolerances in food
legislation eliminates the Delaney Paradox. The Delaney clause no
longer applies to any tolerances set for pesticide residues in food.
Rather, the EPA must determine that tolerances are "safe,"
defined as "a reasonable certainty that no harm will result from
aggregate exposure" to the pesticide. EPA and others will be
able to devote resources that have been consumed by Delaney-related
activities to higher priority public health and environmental protection
- FDA Modernization
Act of 1997
- "The act
eliminates the requirement of FDA's premarket approval for most
packaging and other substances that come in contact with food and
may migrate into it. Instead, the law establishes a process whereby
the manufacturer can notify the agency about its intent to use certain
food contact substances and, unless FDA objects within 120 days,
may proceed with the marketing of the new product. Implementation
of the notification process is contingent on additional appropriations
to cover its cost to the agency. The act also expands procedures
under which FDA can authorize health claims and nutrient content
claims without reducing the statutory standard."
Safety from Farm to Table: A New Strategy for the 21st Century
initiative] to fund a nationwide early warning system for foodborne
illness, enhance seafood safety inspections, and expand food safety
research, risk assessment, training, and education."
of food contamination are almost as numerous and varied as the contaminants
themselves. Bacteria and other infectious organisms are pervasive
in the environment. Salmonella enteritidis enters eggs
directly from the hen. Bacteria (occasionally pathogenic) inhabit
the surfaces of fruits and vegetables in the field. Molds and their
toxic byproducts can develop in grains during unusually wet or dry
growing seasons, damage and stress during harvesting, or during
improper storage. Seafood may become contaminated from agricultural
and other runoff, as well as by sewage, microorganisms, and toxins
present in marine environments. Many organisms that cause foodborne
illness in humans can be part of the normal flora of the gastrointestinal
tract of food-producing animals without any adverse effects to the
animal. Milk, eggs, seafood, poultry, and meat from food-producing
animals may become contaminated due to contaminated feed, misuse
of veterinary drugs, or poor farming practices, including production
and harvesting activities, or disposal of solid waste on land. Foods
may become contaminated during processing due to malfunctioning
or improperly sanitized equipment; misuse of cleaning materials;
rodent and insect infestations; and improper storage. Foods may
become contaminated in retail facilities and in the home through
use of poor food handling practices."
- Scope of challenge:
issues involve farm; food processing; transportation; importation;
restaurants, supermarkets, and institutional food services; surveillance
of foodborne illness; home; research; and education.
early warning system; coordination; risk assessment; research; revised
inspections (HACCP); education.
- Agencies that
previously focused on commodity standards, promoting product utilization
and market development, and similar concerns now found themselves
becoming involved in assuring a safe food supply by working to minimize
the risk of food contamination during the production (pre-harvest)
following Background is an excerpt from Food
Safety Strategic Plan, January 19, 2001; note the description of the
jurisdictions of the three agencies:
[written in 2001 ] seven statutes provide HHS [Department of
Health and Human Services], USDA [US Department of Agriculture], and
EPA [Environmental Protection Agency] with the primary tools to regulate
Federal Food, Drug, and Cosmetic Act (FDCA);
Public Health Service Act (PHSA);
Federal Meat Inspection Act (FMIA);
Poultry Products Inspection Act (PPIA);
Egg Products Inspection Act (EPIA);
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); and
Food Quality Protection Act (FQPA).
statutes were enacted and amended over a span of 90 years, starting
in 1906 and 1907 with the first Federal food safety statutes, the Food
and Drugs Act and the Meat Inspection Act. From their inception, however,
these laws focused on different areas of the food supply, and they take
varying approaches to food safety.
Meat Inspection Act and its successor, the FMIA, required continuous
inspection of meat and meat food products, both ante- and post-mortem,
to identify animal diseases. The Meat Inspection Act also created an
inspection force, which is administered today by USDA's Food Safety
and Inspection Service (FSIS). Over the years, FSIS was also given
similar authority to oversee poultry and egg products inspection under
the PPIA and EPIA. Under these laws, FSIS carries out its food safety
activities and protects the public health by ensuring that meat, poultry,
and egg products distributed to consumers are wholesome, not adulterated,
and are properly marked, labeled, and packaged.
these statutes, FSIS is charged with preventing the preparation, distribution
and shipment of adulterated meat, poultry, and egg products to consumers,
and overseeing appropriate labeling and provision of other consumer
information. Meat, poultry, and egg products are not to be sold or transported
unless they bear the USDA mark of inspection - the signal that FSIS
has, through premarket inspections, determined that a product is wholesome,
and neither adulterated nor misbranded. The three statutes also require
that any country wishing to export meat, poultry, or egg products to
the U.S. maintain an inspection program that is equivalent to the U.S.
inspection program. This equivalence requirement goes not just to a
system of inspection, but also to the maintenance of that system and
to the equivalence of the products that are produced within that system.
Food and Drugs Act, as originally enacted, forbade adulteration and
misbranding of foods in interstate commerce. Under this statute, the
food industry is responsible for producing safe and wholesome food,
with the government, in effect, policing the industry through marketplace
surveillance rather than mandatory premarket inspection. In 1938, the
FDCA was enacted. It added controls over food processing, but did not
change the basic approach to food safety set out in the 1906 act. In
the 1950s and early 1960s, HHS' Food and Drug Administration
(FDA) was given additional authority over pesticides, contaminants,
and food and color additives. Since then, with the exception of pesticides
and dietary supplements, no fundamental changes have been made to the
food safety provisions of the FDCA. Under the FDCA, FDA exercises jurisdiction
over production, processing, packaging, storage, and holding of domestic
and imported food except meat, poultry, and some egg products. FDA seeks
under this authority to ensure that food products are safe, sanitary,
nutritious, wholesome, and adequately labeled. FDA's jurisdiction also
includes premarket approval and surveillance of new animal drugs, medicated
feed, and all food additives (including coloring agents, preservatives,
food packaging, and sanitizers) that can become part of food. FDA also
has jurisdiction related to food safety under the PHSA, which gives
FDA two valuable additional tools: very broad authority to adopt regulations
to prevent the spread of communicable diseases, and the ability to both
provide assistance to, and accept assistance from, state and local government
counterparts in the regulation of communicable disease.
Environmental Protection Agency (EPA) also plays a role in
food safety through its authorities to protect water and regulate pesticide
products used in this country. EPA's regulation of pesticides under
the FDCA and FIFRA has historically focused on determining whether a
pesticide should be licensed for use on designated crops and establishing
maximum allowable residue levels (so-called "tolerances")
in/on food. This authority was further strengthened by the Food Quality
Protection Act of 1996 (FQPA) which establishes a health-based standard
for pesticide residues and mandates that EPA look, among other things,
at aggregate exposure, cumulative risk, and the potential need for an
additional safety factor to protect infants and children.
- The Public Health
Security And Bioterrorism Preparedness And Response Act Of 2002
of provisions intended to protect our food supply
Safety and Security Strategy provisions of the Public Health
Security And Bioterrorism Preparedness And Response Act
Against Adulteration of Food
is to increase number of inspections of imported food to detect
to develop tests to rapidly detect intentionally adulterated
FDA to detain food that presents a threat of serious adverse
health consequences or death to humans or animals.
for Repeated or Serious Food Import Violations
- debars (prohibited
from importing) persons convicted of importing food that presents
a threat of serious adverse health consequences or death to humans
of Food Facilities
- requires the
owner, operator, or agent in charge of a domestic or foreign facility
to register facility
- defines facility
as any factory, warehouse, or establishment of an importer that
manufactures, processes, packs, or holds food. Specifically excludes
farms, restaurants, other retail food establishments, nonprofit
food establishments in which food is prepared for or served directly
to the consumer; and fishing vessels. Limits foreign facilities
to those that manufacture, process, pack, or hold food only if food
from such facility is exported to the U.S. without further processing
or packaging outside the U.S.
- makes failure
to register a prohibited act.
- Does this suggest that a third category of "prohibited acts" been added to the two historical categories of "adulterated" and "misbranded?"
and Inspection of Records for Foods
Secretary to access records when there is a reasonable belief
that an article of food is adulterated and presents a threat of
serious adverse health consequences or death to humans or animals.
It applies to all records relating to the manufacture, processing,
packing, distribution, receipt, holding, or importation of the
food. It excludes farms and restaurants. It excludes information
such as recipes, financial data, personnel data, research data,
and sales data (other than shipment data regarding sales).
Notice of Imported Food Shipments
- requires prior
notice of imported food shipments. The notice is required to provide
the article, the manufacturer and shipper, the grower (if known
within the specified time in which notice is required), the country
of origin, the country from which the article is shipped, and the
anticipated port of entry. States that, if notice is not provided,
the article shall be refused admission.
- makes it a
prohibited act to import an article of food in violation of these
to Mark Articles Refused Admission into United States
marking food that has been refused for import (other than food
required to be destroyed).
food as misbranded if it fails to bear the required label when
the Secretary has found that the food presents a threat of serious
adverse health consequences or death to humans and animals and
the Secretary has notified the owner that the label is required.
Against Port Shopping
food adulterated if it offered for import after it has been previously
refused admission, unless the person reoffering the food establishes
that the article is in compliance.
to States Regarding Imported Food
Secretary to notify States when there is credible evidence or
information indicating that a shipment, or portions of shipment,
of imported food presents a threat of serious adverse health consequences
or death to humans or animals.
to States for Inspections
Secretary to make grants to States that undertake examinations,
inspections, and investigations
to Commission Other Federal Officials to Conduct Inspections
Secretary to commission other Federal employees to conduct examinations
and inspections. Requires a memorandum of understanding (MOU)
between the Secretary and the head of the other Federal agency.
The MOU must address training and reimbursement. It is restricted
to facilities or other locations that are jointly regulated by
the Secretary and the other department or agency.
This page provided an overview of US federal food laws. The next page introduces/reviews the general strategies developed by government in response to concerns over food safety.
January 5, 2008