IA #66-28, 4/19/94 revised, "Automatic Detention of Unapproved
New Drugs Promoted By Dr. Hans Nieper of West Germany, ATTACH A -
8/23/95, ATTACH B - 11/29/00
SUBJECT : Automatic Detention of Unapproved New Drugs
Promoted by Dr. Hans A. Nieper of the Federal
Republic of Germany
TYPE OF ALERT: Automatic Detention
PRODUCT : All known drugs promoted by Dr. Hans Nieper (See
Attachment)
PRODUCT CODE : 66[][][][][]
HARMONIZED
CODE : 30[][].[][].[][][][]
PROBLEM : New Drug Without an Approved New Drug Application
(NDA) - DNRD
Inadequate Directions For Use - DRDW
PAC FOR
COLLECTION : 56008H
COUNTRY : Federal Republic of Germany (DE,394)
MANUFACTURER/
SHIPPER : Dr. Hans A. Nieper
c/o Paracelsus Silbersee Hospital
Hannover-Langenhagen, 3000,
Federal Republic of Germany
MANUFACTURER/
SHIPPER I.D.#: DEHANNIE21HAN
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 : Division of Import Operations & Policy, HFC-170
REASON FOR
ALERT : Dr. Hans A. Nieper, an internist practicing
"eumetabolic therapy", operates from the
Paracelsus Silbersee Hospital, Hannover-
Langenhagen, 3000, Federal Republic of Germany.
He claims to have treated thousands of Americans,
who cannot be helped by orthodox medicine for
medical conditions such as cancer, heart disease,
and multiple sclerosis (MS). The drugs promoted
by Dr. Nieper are usually labeled in German with
no English language labeling and seldom do they
contain directions for use.
Dr. Nieper attracts patients by using promotional
materials distributed by the Cancer Control
Society in Los Angeles, CA and the A. Keith Brewer
Science Library in Richland Center, WI, and by
periodically making speaking visits to the United
States. In June 1986, FDA was informed of the
establishment of the "Hans Nieper Foundation" in
San Juan Capistrano, CA. While no current
information has been obtained on this
organization, it is possible that it may be used
to attract patients and promote Dr. Nieper's drug
treatments.
The Agency's enforcement strategy regarding
handling of unapproved new drugs promoted by Dr.
Nieper has included:
- advising Dr. Nieper, German shippers of these
drugs, and domestic promoters of Nieper's
treatment regimen of the illegal status of
these drugs in the United States;
- contacting the U.S. Embassy in Bonn, Germany
and the German government to determine what
assistance they can provide in stopping the
shipments of these products at their source;
- developing public information and educational
materials in conjunction with major national
and international health organizations; and
- requesting the U.S. Customs Service and other
government agencies to include information
about foreign fraudulent health schemes and
the importation of misbranded and unapproved
new drugs and devices in their travelers'
information pamphlets.
The majority of the initiatives in the enforcement
strategy have now been completed. Dr. Nieper
responded stating that he believes that the World
Health Organization (WHO) regulations or
international law permit the importation of drugs
that have been prescribed in another country if
treatment was begun in that country. However,
this has been refuted by WHO.
Detention activity continues under this import
alert as evidenced by 327 and 331 detentions of
Nieper drugs reported in FY92 an FY93,
respectively.
INSTRUCTIONS : Automatically detain all entries of Nieper drugs
listed in Attachment B and from the known shippers
listed in Attachment A.
Districts have reported that in some cases medical
devices, such as syringes, labeled in German, are
included as part of the Nieper entries. When such
medical devices are encountered, automatically
detain citing the appropriate charge.
In most cases, neither Hans A. Nieper, nor the
Paracelsus Silbersee Hospital (hospital/clinic
associated with Dr. Nieper) are identified as
shippers of these drugs. In some cases, a
prescription or other statement from Dr. Nieper is
packed inside the shipping carton.
See Attachment A for a list of firms/individuals
from the Federal Republic of Germany that have
previously shipped Nieper drugs. See Attachment B
for a list of currently known Nieper products.
Most of the products are manufactured by German
drug firms; however a few may be compounded by
German pharmacies.
When districts encounter shipments of new Nieper
drugs which should be included in Attachment B,
the information, including label/labeling and any
accompanying promotional materials, should be
forwarded to the Division of Import Operations &
Policy, HFC-170.
For further guidance, contact Donald Leggett,
CDER, HFD-333, 301-594-0101 or Marvin Blumberg,
DIOP, 301-443-6553.
PRIORITIZATION
GUIDANCE : N/A
FOI : No purging required
KEYWORDS : Nieper, Unapproved New Drugs, Misbranded Drugs,
Paracelsus Silbersee Hospital
PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553.
Attachment A - Import Alert # 66-28 Revised 08/23/95
KNOWN SHIPPERS OF NIEPER PRODUCTS
Alte Apotheke
P.O.Box 1829
Walsroder Street 150
3012 Langenhagen 1
Federal Republic of
Germany
Attention: Klaus
Gritzman
E. Gaul
Schloss St 51 66593
Pirmasens, Germany
MID# DEGAU6659PIR
Herr Tews
Gevelsberg, 5820
Federal Republic of
Germany
(4/20/92)
Horst Matzek
Bussenstrasse 8
3008 Garbsen 4
Federal Republic of
Germany
Horst Matzek
Holcherstrasse 7,
3000 Hanover 1
West Germany
Internistische Klinik, Dr.
Muller
Isartalstrabe 84
8000 Munchen 70
West Germany
Jochen Domhardt
Tollenbrink 24
3000 Hanover 51
Federal Republic of
Germany
L. M. Reiter
Marienheim
Germany
Martina Rhienlander
Basen Bastles St. 38
3008 Garbsen
Federal Republic of
Germany
Mastina Coiese
Hebbelweg 2
3016 Seelze 5
Federal Republic of
Germany
Medalfa, A.G.,
Prattelen
Krummeneichstr 34 A,
CH
Prattein,
Switzerland
Rolf Lorenz
Schwanstr. 8
7600 Offenburg
Federal Republic of
Germany
Ulrich Weissgerber
(may be spelled
Weibgerber)
Blumhardthof 1 (old
address)
J Schwanenring 26
(new address)
3000 Hanover 61
Federal Republic of
Germany
Arcis Apotheke
Arcisstrasse 40
8000 Muenchen 40
West Germany
B. Lubke
Rosenwegg 3051
Suthfield
Federal Republic of
Germany
Dieter Harmel
Walsroderstrasse 150
3012 Langenhagen 1
Federal Republic of
Germany
Erma Weigand
8710 KitzFengen
Goethe - St.
W. Germany
Erna Eisenhofer
Donnergerferetr 51
8000 Mumchen 19
Federal Republic of
Germany
Flora Apotheke
Friesenstrasse, Ecke
Eichstrasse
Postfach 2003
3000 Hanover 1
Federal Republic of
Germany
Attention: F.R.
Domhardt
Frieda Verstandig
Hemmendirfer Str.4
3216 Salzhemmendorf
1
Federal Republic of
Germany
Waldschmidt
Bernauer Str 17
8 Munchen 80
Federal Republic of
Germany
ATTACHMENT B - Import Alert #66-28 REVISED 11/29/00
CURRENTLY KNOWN NIEPER PRODUCTS
Acetaldehyde
Anavit-F3
Aniflazyn
Argutin
Ascorbic Acid
Astenile
Benzalde E
Beriglobin
Bromelain
Calcium EAP
Calcipot-F, C,
phosphate
Calciretard
Calcium-EAP
Calciumcolaminphosph
at 0.4 Kaps
Calcium-ORO
Carnitin
Carnivora
Carnivora-VF
Carotaben
Ceasium Chloride
Chol-Kugeletten
Conjunctisan A.
Eyedrops
Coroverlan
Corticoide
Didrova`ltrate
Dionacea Muscipula
Dona 200-S
E-mulsine
Fertissimun
Enzynorm
Erogocalciferol
Eugalan Topfer
FegaCorea for
injection
Fermento
Floracit-Gummetten
Fluoro-Uracil
Fucus Vesiculosus
Gallen-Leber-Tee-N
Glandul-Supra-Renal
Harnosal
Helixor
Hepaticum-Medice
Hepa-Uvocal Tablets
Hornosal
Intralipid
Inzelloval
Iskador
Ixoten
Kalinor-Brausetablet
ten
Kreon (pancreatin)
K-Strophathin
Kupferorotat
L-Lysinmonohydrochlo
rid
L-Threonin 0.25
Lebertrankapseln
Lioresal 10
(Baclofen)
Lexotanil 6
Lithiumorotat
Logic Brand Pau
D'arco Capsules
Lyndiol
Magagrisevit
Magnesium - Mangil
Magnesium Orotat
(Magnerot)
Magnesium Verla
Mandelonitril Nicot
Mandelonitril ureat
Methotrexate
Millevit
Mulsal N
NeyChondrin for
injection
NeyGeront for
injection
Neylmmun for
injection
Neythymun F&K; for
injection
Noradral Retard
Nootrop Liquidum
(Piracetam)
Omniflora
Osteochondrin S.I.M.
injection
Oxazepam -
ratiopharm 10
Panzynorm
Pepsaletten
Pernical Forte
Pexan Forte
Phlogenzym
Phosetamin
Phosphatamin
Plv. Mandelonitrille
RH 50
Antirheumatikum -
injection
RN 13 Regeneresen
I.M. injection
Prednison-Ratiopharm
Predni-Tablinen
Progresin Retard
Purinetten forte
Resistocell
Selenium Chloride-H
Sol. Calciferol
Sol Germanium IV
Oxid
Solu-Decortin-H
Sorbit
Spasmo-Harnosal
Squalen Purum
Standinol with
Calcium EAP and
Phosetamin
Sterofundin
Sulf. Redox
Talusin
Taurin
Theo-Talusin
Thym-Uvocal
Thymus Extract
Thymus Multi
Thymus Uvocal
Tombusan
Traumanase forte
Tromcardin
Trophicard-Kohler
Ungt. Rad.
Valerianae
Valmane
Vegantobetten
Venostasin
Warnhlnwols Dieses
Arzneimittel
Wobzym
Wobe-Mugos
Zink-Aspartat
Zinkorotat
Zyloric