Importing into the United States - Indo-American Chamber Of ...

the Food and Drug Administration, Center for
Devices and Radiological Health, Rockville,
MD 20850.
The declaration must describe the compliance
status of the product. The importer must
affirm that the product was (1) not subject to a
standard (e.g., manufactured prior to the effective
date of the applicable federal standard), or
(2) complies with the standard and has a label
affixed by the manufacturer certifying compliance,
or (3) does not comply with the standard
but is being imported only for purposes of
research, investigation, study, demonstration,
or training, or (4) does not now comply with
the standard but will be brought into compliance.
The provisions of the Federal Food, Drug,
and Cosmetic Act, Chapter V, Subchapter C —
Electronic Product Radiation — apply to electronic
products manufactured in the United
States as well as to imported products.
22. Radio Frequency Devices. Radios, tape
recorders, stereos, televisions, citizen band
radios or combinations thereof, and other radio
frequency devices are subject to radio emission
standards of the Federal Communications
Commission, Washington, DC 20554, under the
Communications Act of 1934, as amended.
Importations of such products may be accompanied
by an FCC declaration (FCC 740) certifying
that the imported model or device is in
conformity with, will be brought into conformity,
or is exempt from, the Federal Communication
Commission requirements.
FOODS, DRUGS, COSMETICS, AND
MEDICAL DEVICES
23. Foods, Cosmetics, etc. The importation into
the United States of food, drugs, devices, and
cosmetics is governed by the provisions of the
Federal Food, Drug, and Cosmetic Act, which
is administered by the Food and Drug Administration
of the Department of Health and
Human Services, Rockville, MD 20857. That
Act prohibits the importation of articles that are
adulterated or misbranded, including products
that are defective, unsafe, filthy, or produced
under unsanitary conditions. The term “misbranded”
includes statements, designs, or pictures
in labeling that are false or misleading, or
that fail to provide required information in
labeling. The Act also prohibits the importation
of pharmaceuticals that have not been
approved by the FDA for admission into the
United States.
Imported products regulated by the Food
and Drug Administration are subject to inspection
at the time of entry. Shipments found not
to comply with the laws and regulations are
subject to refusal. They must be brought into
compliance, destroyed, or re-exported. At the
discretion of the Food and Drug Administration,
an importer may be permitted to bring a
nonconforming importation into compliance if
it is possible to do so. Any sorting, reprocessing,
or relabeling must be supervised by
the Food and Drug Administration at the
importer’s expense.
Various imported foods such as confectionery,
dairy products, poultry, eggs and egg
products, meats, fruits, nuts, and vegetables are
also subject to requirements of other agencies
as discussed in this book. Certain aquatic
species may also be subject to the requirements
of the National Marine Fisheries Service of the
National Oceanic and Atmosphere Administration
of the Department of Commerce, 1335
East-West Highway, Silver Spring, MD 20910.
24. Biological Drugs. The manufacture and
importation of biological products for human
consumption are regulated under the Public
Health Service Act. Domestic and foreign manufacturers
of such products must obtain a U.S.
license for both the manufacturing establishment
and the product intended to be produced
or imported. Additional information may be
obtained from the Food and Drug Administration,
Department of Health and Human Services,
Rockville, MD 20857.
Biological drugs for animals are regulated
under the Virus Serum Toxin Act, which is
administered by the Department of Agriculture.
The importation of viruses, serums, toxins
and analogous products, and organisms and
vectors for use in the treatment of domestic
animals, is prohibited unless the importer
holds a permit from the Department of Agriculture
covering the specific product. These
importations are also subject to special labeling
requirements.
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