IA#66-63, --- 8/31/92
TYPE OF ALERT: Automatic Detention
PRODUCT : a. Carnivora N-DMP, injection, 50 ml
(injectable)
b. Carnivora N-DMP, 100 ml (drops)
PRODUCT CODE : 66VBP99
HARMONIZED
CODE : a. 2009.80.60908
b. 3004.50.50400
PROBLEM : New drug without an Approved New Drug
Application (NDA) (DRND)
PAC FOR
COLLECTION : 56008H
COUNTRY : Germany (DD, 394)
MANUFACTURER/
SHIPPER : Carnivora Forschungs GmbH (Dr. Helmut Keller)
Lobensteiner Strasse 3 (P.O. Box 8)
D-8646 Nordhalben
Germany
MANUFACTURER/
SHIPPER I.D.#: DECARFOR3NOR
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)]".
RECOMMENDING
OFFICE : CIN-DO, HFR-MA440
REASON FOR
ALERT : CIN-DO has reported that these unapproved
drugs are "double" invoiced in that the
external/visible invoice for these items
misdeclares them as vitamins, Nectar or juice,
but another invoice packed inside the shipping
boxes identifies the true nature of the
products. These shipments are of non-
commercial size and appear to be for personal
use. Accompanying the drug shipment is a
protocol which includes the dosage and
treatment schedules. This document states
that the drugs are "proven safe and effective
in the treatment of cancer, chronic diseases
and HIV infection in man." Fraudulent
promotion by these means is evident.
Label indications for both Carnivora N-DMP,
injectable and drops, include
"immunemodulation in case of malignant
diseases, immunestimulation after surgery,
pathologic Helper/Suppressor ratio, colitis
ulcerosa and Crohn's disease".
FDA continues to note an increase in the
promotion and importation of unapproved drugs
such as Carnivora DMP, injectable and drops,
of foreign origins. Unapproved new drugs,
especially injectables, present unreasonable
risks and serious safety and effectiveness
concerns.
INSTRUCTIONS : Automatically detain, without physical
sampling and analysis, all dosage forms of
these unapproved new drugs.
Districts with overnight courier operations
and foreign mail desks should check flight
manifests and incoming packages for shipments
of this drug. Please inform your local U.S.
Customs and Postal Service officials of
FDA interest in these types of products.
If other carnivora products are noted from
this manufacturer advise Division of Import
Operations and Policy, HFC-170, at 301-443-
6553.
Carnivora and Carnivora - VF are listed in
import alert #66-28 "Automatic Detention of
Unapproved New Drugs Promoted by Dr. Hans
Nieper, W. Germany", however, the manufacturer
is not identified.
PRIORITIZATION
GUIDANCE : N/A
KEYWORDS : No purging is required
FOI : Carnivora, DMP, Cancer, Carnivora N-DMP
PREPARED BY : Linda Wisniowksi, DIOP, 301-443-6553.
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