IA #66-27, REVISED 4/19/94
Automatic Detention of Drugs from the Hauptmann Institute Vienna,
Austria
TYPE OF ALERT: Automatic Detention
PRODUCT : All known drugs from The Hauptmann Institute (See
Attachment)
PRODUCT CODE : 66[][][][][]
HARMONIZED
CODE : 30[][].[][].[][][][]
PROBLEM : New Drug without an Approved New Drug Application
(NDA) -DRND
Inadequate directions for use - DRDW
PAC FOR
COLLECTION : 56008H
COUNTRY : Austria (AT, 165)
MANUFACTURER/
SHIPPER : The Hauptmann Institute (possibly doing business
as The Heitzinger Pharmacy)
Heitzinger Haupstr. 37
Vienna, A-1130, Austria
MANUFACTURER/
SHIPPER I.D.#: ATHAUINS37VIE
IMPORTER'S
I.D. # : N/A
CHARGE : The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears
to be a new drug within the meaning of Section
201(p) without an approved New Drug Application
(NDA) [Unapproved New Drug, Section 505(a); and it
appears to be misbranded in that it lacks adequate
directions for its intended use [Misbranding,
Section 502(f)(1)]".
RECOMMENDING
OFFICE : ORL-DO
REASON FOR
ALERT : Since August 1986, drugs from the Hauptmann
Institute have been subjected to automatic
detention. At that time, Karl-Gustov Hauptmann,
M.D., Director of the Institute, had purchased the
Longevity Institute S.A., Balboa, Republic of
Panama to promote therapies to Americans and
citizens from other countries who, he claimed, were
denied treatment essential to their health and longevity
by their governments. Although many of the drugs
were approved in the United States, claims were
made in promotional literature distributed by the
Institute that included treatment of medical
conditions for which the drugs were not approved.
Through January 1987, ORL-DO had detained over 300
shipments of drugs from the Hauptmann Institute. As
a result, additional drugs and promotional
literature were identified.
Promotional materials, solicitations and price lists
were noted postmarked from Atlanta, GA, Miami, FL.,
Van Nuys, CA, and Scarbrough, Ontario, Canada.
Orders were to be returned to The Hauptmann
Institute at a postal drop address A-1130 Vienna,
Heitzinger Hauptstr. 37, Austria.
Products mailed to individuals in the United States
have been by airmail postmarked Luton, England.
Mailed products may be contained in yellow padded
envelopes or small brown cartons. Customs
declarations of contents for these shipments have
indicated "nutritional supplements". Samples
induced by the U.S. Postal Service were declared as
non-consumable items such as a puzzle, a telephone
address book, or tankard.
ORL-DO reported that some shipments of Minoxidil had
been received in unlabeled bottles. Stick on labels
for Minoxidil, instructions for use, and in some
cases, a prescription, had been subsequently
provided by the Heitzinger Pharmacy which also uses
the same mail drop address as the Hauptmann
Institute.
Further, ORL-DO reported that a flyer had been
distributed by The Hauptmann Institute to customers
in the states of Florida and Georgia alleging that
FDA had detained these drugs illegally based on "the
FDA ruling that permits individuals to bring
unapproved drugs into the United States for personal
use". It was contended that The Hauptmann Institute
had filed a formal complaint and that FDA had not
yet issued a formal order regarding this matter. It
was stated that high ranking government officials
had assured that there should not be further problem
with regard to the detention of any shipment of
their products.
The flyer provided instructions to customers
regarding detention of their shipments as follows:
"If you have had your products detained by the Miami
Customs Office and/or the Miami FDA, please send us
the FDA form that you received notifying you of the
detention of your products. As soon as we receive
this form, we will reship your products
immediately."
The flyer presented false allegations regarding FDA
rulings, receipt of formal complaints, and
assurances by high ranking government officials.
Based on labeling, the drugs are misbranded because
they lack adequate directions for use and include
false and misleading claims. The drugs are limited
to prescription use and may be potentially lethal if
improperly administered, taken without adequate
directions for use, or administered without the
supervision of a licensed practitioner.
Detention activity continues under this import alert
as evidenced by 427 and 410 detentions reported for
FY92 and FY93, respectively.
INSTRUCTIONS: Automatically detain the drug products, including
promotional materials, listed in the Attachment,
as these are known to be associated with The
Hauptmann Institute.Shipments of these drugs may
be made by The Hauptmann Institute, Heitzinger
Pharmacy, or other shippers from countries other
than Austria.
Since these drugs are provided by The Hauptmann
Institute throughout the United States, we believe
they continue to come through all ports of entry
processing airmail from Europe.
Districts should provide a copy of this revised
alert to Customs and continue cooperation with
Custom to detain entries.
As districts encounter shipments of new drugs which
should be included in the Attachment of this alert,
the information, including the label/labeling and
any accompanying promotional materials, should be
forwarded to the Division of Import Operations and
Policy, HFC-170.
For additional guidance, contact Donald Leggett,
CDER, HFD-333, 301-594-0101 or Marvin Blumberg,
DIOP, 301-443-6553.
FOI : No purging is required
KEYWORDS : Hauptmann Institute, Heitzinger Pharmacy,
Unapproved New Drugs, Inadequate Directions,
Misbranded Drugs
PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553.
ATTACHMENT - IMPORT ALERT #66-27 REVISED 4/19/94
LIST OF DRUGS KNOWN TO BE ASSOCIATED WITH THE HAUPTMANN INSTITUTE
CENTROPHENOXIENE
CLONIDINE
CONJUNCTASIN A EYEDROPS
DILANTIN (DIPHENYLHYADTOIN)
ELUDRIL MOUTHWASH
ENCEFALUX 60
ETHOXYQUIN
HYDERGINE ERGOLOID MESYLATES
GEROVITAL CH3
GEROVITAL CH3 INJECTABLE
GEROVITAL GH3 FACE CREAM
KH3
ISOPRINOSINE
L-DOPA (LEVODOPA) SINEMET
LUCIDRIL
MINOXIDIL 3% LOTION (BIOMINX)
PARLODEL (BROMOCRIPTINE)
PRPRANOLOL
PIRACETAM
(REGENERSEN) RN-13
RN-13 (NEYGERONT)
RETIN-A CREAM
SYNTOPRESSIN NASAL SPRAY
TETRACYCLINE
VASOPRESSIN
ZOVIRAX CREAM
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