Import Alert 66-28

"Dentention Without Physical Examination of Unapproved New Drugs Promoted By Dr. Hans Nieper Germany"

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.

- 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.

Districts may detain without physical examination all entries of Nieper drugs identified from the known shippers identifed in the Red list

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, 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 a list of Red list firms/individuals from Germany that have previously shipped Nieper drugs. 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 the production descriptions, the information, including label/labeling and any accompanying promotional materials, should be forwarded to the Division of Import Operations & Policy, HFC-170.

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

"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)]."

OASIS Chrage Code - UNAPPROVED

and

"...it appears to be misbranded in that it lacks adequate directions for its intended use [Misbranding, Section 502(f)(1)]."

OASIS Charge Code - DIRECTIONS