1

An Overview of FDA’s Food

Regulatory Responsibilities

Y. H. HUI
Science Technology System, West Sacramento, California, U.S.A.

This chapter provides a summary of the legal requirements affecting manufacture and
distribution of food products within and those imported into the United States. The last
chapter in this book further expands the data. The United States Food and Drug Adminis-
tration (FDA) has provided a description of these requirements to the public at large. The
information has been translated into several languages and it is reproduced below with
some minor updating by the author.
The FDA regulates all food and food-related products, except commercially pro-
cessed egg products and meat and poultry products, including combination products (e.g.,
stew, pizza), containing 2% or more poultry or poultry products or 3% or more red meat
or red meat products, which are regulated by the United States Department of Agriculture’s
Food Safety and Inspection Service (FSIS). Fruits, vegetables, and other plants are regu-
lated by the that department’s Animal and Plant Health Inspection Service (APHIS) to
prevent the introduction of plant diseases and pests into the United States. The voluntary
grading of fruits and vegetables is carried out by the Agricultural Marketing Service
(AMS) of the USDA.
All nonalcoholic beverages and wine beverages containing less than 7% alcohol are
the responsibility of FDA. All alcoholic beverages, except wine beverages (i.e., fermented
fruit juices) containing less than 7% alcohol, are regulated by the Bureau of Alcohol,
Tobacco, and Firearms of the Department of Treasury.
In addition, the Environmental Protection Agency (EPA) regulates pesticides. The
EPA determines the safety of pesticide products, sets tolerance levels for pesticide residues
in food under a section of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and

© 2003 by Marcel Dekker, Inc.

 publishes directions for the safe use of pesticides. It is the responsibility of FDA to enforce
the tolerances established by EPA.
Within the United States, compliance with the FD&C Act is secured through peri-
odic inspections of facilities and products, analyses of samples, educational activities,
and legal proceedings. A number of regulatory procedures or actions are available to
FDA to enforce the FD&C Act and thus help protect the public’s health, safety, and well-
being.
Adulterated or misbranded food products may be voluntarily destroyed or recalled
from the market by the shipper, or may be seized by U.S. marshals on orders obtained
by FDA from federal district courts. Persons or firms responsible for violation may be
prosecuted in the federal courts and if found guilty may be fined and/or imprisoned. Con-
tinued violations may be prohibited by federal court injunctions. The violation of an in-
junction is punishable as contempt of court. Any or all types of regulatory procedures
may be employed, depending upon the circumstances.
A recall may be voluntarily initiated by the manufacturer or shipper of the food
commodity or at the request of FDA. Special provisions on recalls of infant formulas are
in the FD&C Act. While the cooperation of the producer or shipper with FDA in a recall
may make court proceedings unnecessary, it does not relieve the person or firm from
liability for violations.
It is the responsibility of the owner of the food in interstate commerce to ensure
that the article complies with the provisions of the FD&C Act, the Fair Packaging and
Labeling Act (FPLA), and their implementing regulations. In general, these acts require
that the food product be a safe, clean, wholesome product and its labeling be honest and
informative.
The FD&C Act gives FDA the authority to establish and impose reasonable sanita-
tion standards on the production of food. The enclosed copy of Title 21, Code of Federal
Regulations, Part 110 (21 CFR 110) contains the current good manufacturing practice
(GMP) regulations for manufacturing, packing, and holding human food concerning per-
sonnel, buildings and facilities, equipment, and product process controls, which, if scrupu-
lously followed, may give manufacturers some assurance that their food is safe and sani-
tary. In 21 CFR 110.110, FDA recognizes that it is not possible to grow, harvest, and
process crops that are totally free of natural defects. Therefore, the agency has published
the defect actions for certain food products. These defect action levels are set on the basis
of no hazard to health. In the absence of a defect action level, regulatory decisions concern-
ing defects are made on a case-by-case basis.
The alternative to establishing natural defect levels in food would be to insist on
increased utilization of chemical substances to control insects, rodents, and other natural
contaminants. The FDA has published ‘‘action levels’’ for poisonous or deleterious sub-
stances to control levels of contaminants in human food and animal feed. However, a
court in the United States invalidated FDA’s action levels for poisonous or deleterious
substances on procedural grounds. In the interim we are using their ‘‘Action Levels for
Poisonous or Deleterious Substances in Human Food and Animal Feed’’ as guidelines
which do not have the force and effect of law. The Agency has made it clear that action
levels are procedural guidelines rather than substantive rules.
The FDA does not approve, license, or issue permits for domestic products shipped
in interstate commerce. However, all commercial processors, whether foreign or domestic,
of thermally processed low-acid canned foods (LACFs) packaged in hermetically sealed
containers, or of acidified foods (AF-), are required by regulations to register each pro-
© 2003 by Marcel Dekker, Inc.
 cessing plant. In addition, each process for a LACF or AF must be submitted to FDA and
accepted for filing by FDA before the product can be distributed in interstate commerce.
A low-acid food is defined as any food, other than alcoholic beverages with a fin-
ished equilibrium pH greater than 4.6 and a water activity greater than 0.85. Many canned
food products are LACF products, and packers are therefore subject to the registration
and processing filing requirements. The only exceptions are tomatoes and tomato products
having a finished equilibrium pH less than 4.7. An acidified food is a low-acid food to
which acid(s) or acid food(s) are added resulting in a product having a finished equilibrium
pH of 4.6 or below.
The FDA’s LACF regulations require that each hermetically sealed container of a
low-acid processed food shall be marked with an identifying code that shall be perma-
nently visible to the naked eye. The required identification shall identify, in code, the
establishment where the product is packed, the product contained therein, the year and
day of the pack, and the period during the day when the product was packed [21 CFR
113.60(c)]. There is no requirement that a product be shipped from the United States
within a stipulated period of time from the date of manufacture. If a LACF or AF is
properly processed, it would not require any special shipping or storage conditions.
Regulations require that scheduled processes for LACFs shall be established by
qualified persons having expert knowledge of thermal processing requirements for low-
acid foods in hermetically sealed containers and having adequate facilities for making
such determinations (21 CFR 113.83). All factors critical to the process are required to
be specified by the processing authority in the scheduled process. The processor of the
food is required to control all critical factors within the limits specified in the scheduled
process.
The FDA has the responsibility to establish U.S. identity, quality, and fill of con-
tainer standards for a number of food commodities. Food standards, which essentially are
definitions of food content and quality, are established under provisions of the FD&C Act.
Standards have been established for a wide variety of products. These standards give
consumers some guarantee of the kind and amount of major ingredients in these products.
A food which purports to be a product for which a food standard has been promulgated
must meet that standard or it may be deemed to be out of compliance and, therefore,
subject to regulatory action.
Amendments to the FD&C Act establish nutrient requirements for infant formulas
and provide FDA authority to establish good manufacturing practices and requirements
for nutrient quantity, nutrient quality control, recordkeeping, and reporting. Under these
amendments, FDA factory inspection authority was expanded to manufacturer’s records,
quality control records, and test results necessary to determine compliance with the FD&
C Act.
The FDA has mandated Hazard Analysis Critical Control Point (HACCP) proce-
dures for several food categories including seafood and selected fruit and vegetable prod-
ucts. Such procedures assure safe processing, packaging, storage, and distribution of both
domestic and imported fish and fishery products and fruit and vegetable products. The
HACCP system allows food processors to evaluate the kinds of hazards that could affect
their products, institute controls necessary to keep hazards from occurring, monitor the
performance of the controls, and maintain records of this monitoring as a matter of routine
practice. The purpose is to establish mandatory preventative controls to ensure the safety
of the products sold commercially in the United States and exported abroad. The FDA will
review the adequacy of HACCP controls in addition to its traditional inspection activities.
© 2003 by Marcel Dekker, Inc.
 The food labeling regulations found in 21 CFR 101 and 105 contain the requirements
which when followed result in honest and informative labeling of food. Mandatory label-
ing of food includes a statement of identity (common or usual name of the product—21
(CFR 101.3); a declaration of net quantity of contents (21 CFR 101.105); the name and
place of business of the manufacturer, packer, or distributor (21 CFR 101.5); and, if fabri-
cated from two or more ingredients, each ingredient must be listed in descending order
of predominance by its common or usual name (21 CFR 101.4 and 101.6). Spices, flavor-
ing, and some coloring, other than those sold as such, may be designated as spices, flavor-
ing, and coloring without naming each. However, food containing a color additive that
is subject to certification by FDA must be declared in the ingredients statement as con-
taining that color.
On January 6, 1993, the FDA issued final rules concerning food labeling as mandated
by the Nutrition Labeling and Education Act (NLEA). These rules, which are included
in the enclosed food labeling booklet, significantly revise many aspects of the existing
food labeling regulations, mainly nutrition labeling and related claims for food. The NLEA
regulations apply only to domestic food shipped in interstate commerce and to food prod-
ucts offered for import into the United States. The labeling of food products exported to
a foreign country must comply with the requirements of that country.
If the label on a food product fails to make all the statements required by the FD&
C Act, the FPLA, and the regulations promulgated under these acts, or if the label makes
unwarranted claims for the product, the food is deemed to be misbranded. The FD&C
Act provides for both civil and criminal action for misbranding. The FPLA provides for
seizure and injunction. The legal responsibility for full compliance with the terms of each
of these acts and their regulations, as applied to labels, rests with the manufacturer, packer,
or distributor when the goods are entered into interstate commerce. The label of a food
product may include the Universal Product Code (UPC) as well as a number of symbols
which signify that (1) the trademark is registered with the U.S. Patent Office; (2) the
literary and artistic content of the label is protected against infringement under the copy-
right laws of the United States; and (3) the food has been prepared and/or complies with
dietary laws of certain religious groups. It is important to note that neither the UPC nor
any of the symbols mentioned are required by, or are under the authority of, any of the
acts enforced by the U.S. Food and Drug Administration.
The FD&C Act requires premarket approval for food additives (substances whose
use results or may reasonably be expected to result, directly or indirectly, either in their
becoming a component of food or otherwise affecting the characteristics of food). The
approval process involves a very careful review of the additive’s safety for its intended
use. Following the approval of a food additive, a regulation describing its use is published
in the Code of Federal Regulations. As defined in the CFR, the term safe or safety ‘‘means
there is a reasonable certainty in the minds of competent scientists that the substance is
not harmful under the intended conditions of use. It is impossible in the present state of
scientific knowledge to establish with complete certainty the absolute harmlessness of the
use of any substance. Premarket clearance under the FD&C Act does assure that the risk
of adverse effects occurring due to a food additive is at an acceptably small level.
The FDA’s regulation of dietary supplements is under the authority of the Dietary
Supplements Health and Education Act of 1994. It ensures that the products are safe and
properly labeled and that any disease or health-related claims are scientifically supported.
The legal provisions governing the safety of dietary supplements depend on whether the

© 2003 by Marcel Dekker, Inc.

 product is legally a food or a drug. In either instance the manufacturer is obligated to
produce a safe product. Premarket safety review by FDA is required for new drugs.
The label of a dietary supplement is to state what the product contains, how much
it contains, how it should be used, and precautions necessary to assure safe use with all
other information being truthful and not misleading. If the dietary supplement is a food,
a review of any disease or health-related claim is conducted under the NLEA health claim
provisions.
This book presents an important aspect of the stated requirements: the sanitation of
an establishment that manufactures and distributes processed food.

© 2003 by Marcel Dekker, Inc.