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