Import Alert 61-01
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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 # 61-01
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Gerovital (KH3 - GH3, Etc.)"
Reason for Alert:
Gerovital (KH3) which generally consists of some form of Procaine HCL is regarded as a new drug for all indications when offered for the conditions for which it was found effective under DESI 763. It requires an approved Abbreviated New Drug Application (ANDA) for legal marketing.
These products are frequently accompanied by promotional literature or labeled as a cure all for such ailments as old age, premature graying of hair, wrinkling of skin, mental disorders, insomnia, decreased sexual vigor, rheumatism, arthritis, heart problems, depression, etc.
Products frequently enter the United States through the mail and may be labeled as "Free Trial Medical Samples."
Review of FY90 FY92 detention data indicated that shipments of these products continue into the United States from various areas.
Commercial size shipments have been noted from:
Francois J. Borking and Rogier Borking Vinkeveen, Netherlands
Life Extension, Richmond, British Columbia, Canada
Drug Faite, and I.C.E. Chima, Bucharest, Romania
L. Lobeck & R. Schmid, Zurich, Switzerland
Zita Dros, Antwerp, Belgium
M. Jose Fernandez, Madrid, Spain
Farmatalia Carlo Erb., Pepetua De Magada, Spain
These products are frequently accompanied by promotional literature or labeled as a cure all for such ailments as old age, premature graying of hair, wrinkling of skin, mental disorders, insomnia, decreased sexual vigor, rheumatism, arthritis, heart problems, depression, etc.
Products frequently enter the United States through the mail and may be labeled as "Free Trial Medical Samples."
Review of FY90 FY92 detention data indicated that shipments of these products continue into the United States from various areas.
Commercial size shipments have been noted from:
Francois J. Borking and Rogier Borking Vinkeveen, Netherlands
Life Extension, Richmond, British Columbia, Canada
Drug Faite, and I.C.E. Chima, Bucharest, Romania
L. Lobeck & R. Schmid, Zurich, Switzerland
Zita Dros, Antwerp, Belgium
M. Jose Fernandez, Madrid, Spain
Farmatalia Carlo Erb., Pepetua De Magada, Spain
Guidance:
Districts may detain without physical examination:
All products offered for entry as Gerovital, GH3, KH3, Zell H3, GH3, GH3 Cream, etc.
All commerical entries of finished injectable and oral dosage forms of Procaine Hydrochloride unless it is the subject of an approved NDA/ANDA.
All bulk Procaine Hydrochloride unless it is being shipped to firms holding approved NDA/ANDA's or is otherwise permitted to be obtained for research or teaching purposes. If shipments are consigned to drug brokers, assurance should be provided that the material is destined for firms or individuals meeting the criteria cited above (i.e., holders of approved NDA/ANDA's, etc.).
Questions should be directed to the Center for Drug Evaluation and Research, Health Fraud Staff (HFD 304).
All products offered for entry as Gerovital, GH3, KH3, Zell H3, GH3, GH3 Cream, etc.
All commerical entries of finished injectable and oral dosage forms of Procaine Hydrochloride unless it is the subject of an approved NDA/ANDA.
All bulk Procaine Hydrochloride unless it is being shipped to firms holding approved NDA/ANDA's or is otherwise permitted to be obtained for research or teaching purposes. If shipments are consigned to drug brokers, assurance should be provided that the material is destined for firms or individuals meeting the criteria cited above (i.e., holders of approved NDA/ANDA's, etc.).
Questions should be directed to the Center for Drug Evaluation and Research, Health Fraud Staff (HFD 304).
Product Description:
Gerovital, also known as KH3, GH3, Procaine Hydrochloride (HCL), Trofibial H3, Aslavital, Zell H3
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 201(p), without an approved new drug application [Unapproved New Drug, Section 505(a)]."
OASIS charge code - UNAPPROVED
OASIS charge code - UNAPPROVED
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(55 - - - --) Pharm Necess & Ctnr For Drug/Bio
(60 - - - --) Human and Animal Drugs
(61 - - - --) Human and Animal Drugs
(62 - - - --) Human and Animal Drugs
(63 - - - --) Human and Animal Drugs
(64 - - - --) Human and Animal Drugs
(65 - - - --) Human and Animal Drugs
(66 - - - --) Human and Animal Drugs
BELGIUM
Zita Tros
Date Published : 09/10/2009
P O Box 108 , Antwerp, BELGIUM
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
CANADA
Life Extension
Date Published : 09/10/2009
unknown , Richmond, BC CANADA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
NETHERLANDS
Francois J Borking
Date Published : 09/10/2009
unknown , Vinkeveen, NETHERLANDS
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
Rogier Borking
Date Published : 09/10/2009
unknown , Vinkeveen, NETHERLANDS
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
ROMANIA
Drug Faite
Date Published : 09/10/2009
unknown , Bucharest, ROMANIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
I C E Chima
Date Published : 09/10/2009
unknown , Bucharest, ROMANIA
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
SPAIN
Farmatalia Carlo Erb
Date Published : 09/10/2009
unknown , Pepetua De Magada, SPAIN
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
M Jose Fernandez
Date Published : 09/10/2009
unknown , Madrid, SPAIN
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
SWITZERLAND
L Lobeck & R Schmid
Date Published : 09/10/2009
unknown , Zurich, SWITZERLAND
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
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