Import Alert 66-63
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 66-63
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Carnivora NDMP Drops"
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.
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.
Guidance:
Districts may 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.
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.
Product Description:
Carnivora N-DMP, injection, 50 ml (injectable)
Carnivora N-DMP, 100 ml (drops)
Carnivora N-DMP, 100 ml (drops)
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)]".
OASIS charge code - UNAPPROVED
OASIS charge code - UNAPPROVED
GERMANY
Carnivora Forschungs GmbH (Dr Helmut Keller)
Date Published : 09/10/2009
Lobensteiner Strasse 3 , P O Box 8 , Nordhalben, GERMANY
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
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