IA#8005, -----REVISED 02/02/93, Attachment 5/16/94
TYPE OF ALERT: Automatic Detention
PRODUCT : Devices using magnets which are promoted by
medical claims (see Attachment)
PRODUCT CODE : 80[][][]99
PAC : 82008
HARMONIZED
CODE : 9018
PROBLEM : No premarket approval application
COUNTRY : see Attachment
MANUFACTURER/
SHIPPER : see Attachment
MANUFACTURER/
SHIPPERS ID : see Attachment
IMPORTER'S
I.D. : N/A
CHARGE : "The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that an
application for premarket approval has not been
approved as required by Section 515(a)(2)
[Adulteration, Section 501(f)(1)(b)] and the
article lacks adequate directions for use
[Misbranding, Section 502(f)(1)]."
RECOMMENDING
OFFICE : ORL-DO, Miami R.P. and SEA-DO/HFR-PA340
Import Alert #80-05, Revised 2/2/93 Page 2
REASON FOR
ALERT : At least 300 units of Magspots have been
detained by ORL-DO/Miami R.P. This product
claims to relieve pain and be effective for
health problems ranging from blood pressure
and kidney problems to stomach cramps. The
distributor of Mag Pads, ^
^ receives orders and
advertises the product. Procoin in
the Bahamas fills and ships customers orders.
Distribution is nationwide.
SEA-DO detained a shipment of Sanidad Facial
Units. The labeling states that the product
consists of a "powerful magnet" which
produces "magnetic waves." The waves are
transmitted to the "magnetic fields of your
heart and allparts of your body." The
labeling states that the product is
beneficial for removing wrinkles, prevention
of farsightedness, hemorrhoid and
constipation treatment,toothaches, sore
throats, prevention of urine discharge
at night, etc.
More recently, Poly brand Acupuncture Magneto
Therapeutic Device was detained by SEA-DO.
Labeling for the device claimed improved
circulation, heightened blood oxygen level,
relief of pain etc. from effects of magnetic
force in medical treatment.
INSTRUCTIONS : Automatically detain devices listed in the
attachment from named shippers/manufacturers.
FOI : This import alert requires purging of
information between ^ ^.
KEYWORDS : Mag Pad, Mag Spot, pad, spot, pain, Sanidad
facial toner, Poly Acupunture Magneto
therapeutic, acupuncture
PREPARED BY: Linda A. Wisniowski, DIOP, (301) 443-6553.
Attachment to Import Alert 80-05 Revised 5/16/94
Devices/Manufacturers in automatic detention
Bahamas Device Mfr/Shipper
(BS, 180) Mag Pad(s): Procoin (shipper)
P.O. Box F-705
Freeport, Bahamas
ID# BSPRO705FRE
Mag Pad(s): Margene (shipper)
P.O. Box F-2763
Freeport, Bahamas
ID# BSMAR2763FRE
Canada Poly Brand Acupuncture MFR (unknown)
(CN, 580) Magneto-Therapeutic R and R devices:
International (Shipper)
2306 Sherbrooke
East, Suite 1
Montreal,
Quebec, Canada
ID# XQRRINT2306MON
AKA International
Health Organization
same address
ID# XQINTHEAA2306MON
Germany Mag Spot: Werner M. Spande
(manfacturer)
(DE, 394) Promotion-Insitut
Postfach 4839
8500 Nurnberg 1 West
Germany
ID# DEWERSPA4839NUR
Davey Germany
(shipper)
Lancaster Distral
Ground
Graf-Adolf Stra Be
BB, Duss Eldorf,
W. Germany
ID# DEDAVGERDUS
Attachment to Import Alert 80-05 Revised 5/16/94 Page 2
Devices/Manufacturers in automatic detention
China, PROC
(CN, 280)
China, People's Rep. Ceramic Magnetic Shanghai Electronics
Cup Componen
(CN, 280) 816 Yan An Road
Shanghai, PROC
MID# CNSHAELE816SHA
5/16/94
Tianjin Bei Dou Iron Plastic Magnetized drinking
Enterprise Co LTD cup
Harbin Magnetizer Manufacturing Factory 3/29/94
No. Fu 5 Dong Lin Street
Dong Li District
Harbin, China
MID # CNTIABEI5HAR
Taiwan
(TW, 281) Sanidad Facial: Sanidad Health
Toner Industries Inc.
Taipei, Taiwan
ID# TWSANHEATAI