Import Alert 80-05
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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 # 80-05
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Magnets Promoted for Pain Relief Identified as 'Mag Pad(s)' from the Bahamas and 'Mag Spot'"
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, >>b(4)>Procoin in Deerfield Beach, Fl <<
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 all parts 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.
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 all parts 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.
Guidance:
Districts may detain, without physical examination, devices from the named shippers/manufacturers listed in the attachment to this alert.
Product Description:
Devices using magnets which are promoted by medical claims (see Attachment)
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)]."
OASIS charge code - NO PMA
and
"... the article lacks adequate directions for use [Misbranding, Section 502(f)(1)]."
OASIS charge code - DIRECTIONS
OASIS charge code - NO PMA
and
"... the article lacks adequate directions for use [Misbranding, Section 502(f)(1)]."
OASIS charge code - DIRECTIONS
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