IA#61-01, This revision updates information and reformats the text of the alert which issued 9/17/82. TYPE OF ALERT: Automatic Detention PRODUCT : Gerovital, also known as KH3, GH3, Procaine Hydrochloride (HCL), Trofibial H3, Aslavital, Zell H3 PRODUCT CODE : 66V--99 HARMONIZED CODE : 2933 PROBLEM : New Drug without an Approved New Drug Application (NDA)(DRND) PAC FOR DETENTION : 56008H COUNTRY : All MANUFACTURER/ SHIPPER : All MANUFACTURER/ SHIPPER I.D.#: N/A IMPORTER'S I.D. # : N/A CHARGE : "The article is suject 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)]." 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 RECOMMENDING OFFICE : CDER, Office of Compliance, HFD-300 and Division of Import Operations & Policy, HFC-170 INSTRUCTIONS : Automatically detain: - 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) at (301) 295-8070. PRIORITIZATION GUIDANCE : N/A FOI : No purging is required KEYWORDS : Gerovital, KH3, GH3, Aging, Fraud, Procaine HCL PREPARED BY : Linda Wisniowski, DIOP, 301-443-6553.