AOH :: SMART.TXT|
FDA press release of ban on overseas smart drug companies
P92-3 Food and Drug Administration
FOR IMMEDIATE RELEASE Brad Stone -- (301)443-3285
Jan. 30, 1992 (Home) -- (703)892-04 The Food and Drug Administration announced today it has issued an import
alert against unapproved mail-order drugs promoted by six overseas companies.
Many of these drugs are illegally advertised in periodicals and through
direct mail, as foreign versions of approved prescription drugs. The
promotion and distribution of unapproved drug products within the United
States is illegal.
"In some cases, the drugs are counterfeit -- lacking any real similarity
to the approved drug. The uncertain character and quality of these drugs
constitute an unreasonable risk to the public health," FDA Commissioner
David A. Kessler, M.D., said.
The import alert instructs FDA field offices to automatically detain all
imported unapproved prescription products manufactured by six overseas
companies which have promoted their products in this country. The companies
cited are Interpharm, Inc., of Nassau, Bahamas; Northam Medication Service
International Pharmacy of Nassau, Bahamas; Inhome Services of Delemont,
Switzerland; International Products of Hannover, Germany; Azteca Trio
Internacional, S.A. de C.V., of Zona Rio Tijuana, Mexico; and Interlab of
These companies have been promoting a wide variety of products purported
to treat various conditions, including depression, high blood pressure,
fungal infections, fatigue, chronic bronchitis and hair loss.
Many of the ads for these unapproved drugs claim that people can save
money on the costs of prescription drugs, but in reality the drugs may pose
a risk to the patient's health. Dr. Kessler said so-called "foreign
versions" of prescription drugs are often of unknown quality with inadequate
directions for use.
For many years FDA has permitted -- and will continue to permit -- its
field offices to exercise discretion regarding the release for entry into
the United States of small "personal-use" quantities of drugs sold abroad
but not approved in the United States -- provided that the drugs do not pose
unreasonable safety risks, that their use is not promoted in the United
States and that they are for a serious condition for which there is no
satisfactory treatment available in this country. The policy was designed
to give FDA field offices discretion to release small quantities of
medicines with which individuals returning to the United States may have
been treated while traveling abroad and to allow individuals with serious
conditions the ability to import, under certain limited conditions,
personal-use quantities of unapproved drugs that they believe might be
helpful in treating their conditions.
Personal-use quantities are generally considered to be amounts for a
patient's treatment for three months or less. Imports involving larger
quantities are not permitted as they lend themselves to commercialization.
FDA approves drugs on the basis of scientific data proving them to be
safe and effective. FDA-approved labeling provides information on how and
when the drugs can be used to maximize their effectiveness and minimize
their harmful side effects. The manufacturing facilities and procedures for
approved products are also carefully regulated by FDA to ensure product
The unapproved drugs promoted by these overseas operations lack these
safeguards and quality assurance standards.
Consumers should also be aware that the acquisition and use of
prescription drugs without the valid prescription of a physician or other
licensed health professional may violate state or local laws. FDA warns
that severe adverse reactions, including death, can result from the improper
use of prescription drugs.
Persons with questions about importation of drugs for personal use
should consult with their local FDA district office or the FDA Imports
Operations Branch in Rockville, Md., at (301) 443-6553.
The Food and Drug Administration is one of the eight Public Health
Service agencies within HHS.
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