other statutes, has wide-ranging authority.
It is under the jurisdiction of the U.S.
Department of Health and Human Services.
This agency has had a profound impact on
the food industry, especially in the control of
adulterated foods. Under the Food, Drug,
and Cosmetic Act, food is considered to be
adulterated if it contains any filth or putrid
and/or decomposed material or if it is other-
wise unfit as food. This act states that food
prepared, packed, or held under unsanitary
conditions that may cause contamination
from filth or that is injurious to health is
adulterated. The act gives the FDA inspector
authority, after proper identification and
presentation of a written notice to the per-
son in charge, to enter and inspect any estab-
lishment where food is processed, packaged,
or held for shipment in interstate commerce
or after shipment. Also, the inspector has the
authority to enter and inspect vehicles used
to transport or hold food in interstate com-
merce. This official can check all pertinent
equipment, finished products, containers,
and labeling.
Adulterated or misbranded products that
are in interstate commerce are subject to
seizure. Although the FDA initiates action
through the federal district courts, seizure is
performed by the U.S. Marshal’s office.
Legal action can also be taken against an
organization through an injunction. This
form of legal action is usually taken when
serious violations occur. However, the FDA
can prevent interstate shipments of adulter-
ated or misbranded products by requesting
a court injunction or restraining order
against the involved firm or individual. This
order is effective until the FDA is assured
that the violations have been corrected. To
correct flagrant violations, the FDA has
taken legal steps against finished products
made from interstate raw materials, even
though they were never shipped outside the
state.
The FDA does not approve cleaning com-
pounds and sanitizers for food plants by
their trade names. However, the FDA regula-
tions indicate approved sanitizing compounds
by their chemical names. For example,
sodium hypochlorite is approved for “bleach-
type” sanitizers, sodium or potassium salts of
isocyanuric acid for “organic chlorine” sani-
tizers, n-alkyldimethylbenzyl ammonium
chloride for quaternary ammonium products,
sodium dodecylbenzenesulfonate as an acid
anionic sanitizer component, and oxypoly-
ethoxy–ethanol–iodine complex for iodophor
sanitizers. A statement of maximum allow-
able use concentrations for these compounds
without a potable water rinse on product con-
tact surfaces after use is also provided.Good Manufacturing Practices
On April 26, 1969, the FDA published the
first Good Manufacturing Practice (GMP)
regulations, commonly referred to as the
umbrellaGMPs. These regulations deal pri-
marily with sanitation in manufacturing,
processing, packing, or holding food.
The sanitary operations section establishes
basic minimum rules for sanitation in a food
establishment. General requirements are pro-
vided for the maintenance of physical facili-
ties; cleaning and sanitizing of equipment
and utensils; storage and handling of clean
equipment and utensils; pest control; and the
proper use and storage of cleaning com-
pounds, sanitizers, and pesticides. Minimum
demands for sanitary facilities are included
through requirements for water, plumbing
design, sewage disposal, toilet and hand
washing facilities and supplies, and solid
waste disposal. There is also a short section
on education and training of employees.Spe-
cificGMPs supplement the umbrella GMPs
and emphasize wholesomeness and safety of
several manufactured products.
Each regulation covers a specific industry
or a closely related class of foods. The criti-