IA #57-06, REVISION - 5/3/96, "*DETENTION WITHOUT PHYSICAL EXAMINATION*
OF 714X CANCER/AIDS SERUM"
This revision contains new information in the REASON FOR ALERT and
changes "automatic detention" to "detention without physical
examination." New information is designated by asterisks (*).
TYPE OF ALERT: *Detention Without Physical Examination*
(Note: This import alert contains
guidance to FDA field personnel
only. It does not establish any
requirements, or create any rights
or obligations on FDA or on
regulated entities.)
PRODUCT : 714X Cancer/AIDS serum
PRODUCT CODE : 57 [] [] [] [] []
PROBLEM : New Drug without an approved New Drug Application
(NDA) (DRND)
PAC : 58008H
COUNTRY : Canada (CA, 260)
MANUFACTURER/
SHIPPER : Gaston Naessens Laboratory *Distributed By:
Sherbrooke, Canada Centre D'Orthibiologie
a/k/a C.O.S.E. Inc. Somatidienne De
Rock Forest L'Estrie, Inc.
Quebec, Canada 5270 Mills
Rock Forest, QC
J1N 386*
MANUFACTURER/
SHIPPER ID # : N/A
IMPORTER'S : N/A
I.D.#
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
[Unapproved New Drug, Section 505(a)]."
RECOMMENDING
OFFICE : Division of Import Operations & Policy (HFC-170)
CIN-DO/IPM/HFR-MA440
REASON FOR
ALERT : In January, 1990, Health Protection Branch of
National Health and Welfare Canada issued an Issues
paper on 714X: An Unproven Product. 714X was being
promoted by Gaston Naessens, its inventor and
manufacturer as a cure for cancer, AIDS, and other
degenerative conditions. No scientific evidence
has been provided to support any claims made for
the drug. The expert advisory committee on HIV
therapy to the Health Protection Branch Canada
deplored the use of 714X for the treatment of
cancer and Human Immunodeficiency Virus
(HIV)-related disease, including AIDS.
Canadian Food and Drug Regulations, however, permit use of an
investigational drug in extenuating circumstances involving
illness of a serious or life-threatening nature. Under the
Canadian Emergency Drug Release Program (EDRP), a Canadian
physician may request, under a compassionate plea, use of an
unapproved drug for a specific patient.
During 1991, FDA has become aware of an increase in the
importation of 714X. Investigation into the situation has
uncovered several promotional operations soliciting individuals to
purchase 714X for treatment of AIDS, cancer and other associated
immune system diseases. As part of the promotional system,
individuals were instructed to provide a letter indicating the
drug was being taken under their doctor's supervision, or if they
did not have a physician, the individual could be put in contact
with a doctor through the promoter's physician referral service.
The orders would then be processed through the promoter and
shipped from the manufacturer in Canada.
*CIN-DO has been advised by Customs that 714X and accompanying
promotional literature was being shipped into the U.S. in
overnight letter packets, declared as "documents" and valued at
$1.00. Manifests listing shipments of letter courier packets
declared as "documents" are normally given by a courier, directly
to Customs Inspectors, bypassing the import filer.
Shipments sampled by CIN-DO were sent from 5270 Mills, Rock
Forest,
Quebec, Canada by Daniel Sidicu and P. Letourneau.
All districts having overnight air courier operations within their
jurisdiction are encouraged to provide copies of this revised
import alert to the Customs inspection teams at all air hub
sites.
Additionally, districts with mail and/or overnight mail operations
in their jurisdiction should be alert to this change in the
shipper's method of entering the unapproved new drug.*
RPM Chapter 9-71, "Coverage of Personal Importations" prohibits
unapproved new drugs from entry where promotion of the product is
noted, or the drug is unapproved for sale in the country where it
is manufactured or distributed.
GUIDANCE : Promotional activity in the U.S. removes this
product from the scope of the guidance of
Regulatory Procedures Manual Chapter 9-71
"Coverage of Personal Importation."
Accordingly, detain *without physical
examination* all shipments, commercial and
personal, of 714X.
FOI : No purging required
REVISED BY : Alwin W. Collins, Operations & Policy SDWG, DIOP,
(301) 443-6553
KEYWORDS : 714X, Gaston Naessens Laboratory, C.O.S.E. Inc.,
*Cancer/Aids, Rock Forest,
Trimethylbicyclonitraminoheptane Cl*.
Date Loaded
into FIARS : May 3, 1996
|
