IA#87-01 --- 11/30/87
BACKGROUND:
Buffalo district investigated a mail order forwarder for Magnetic Health
Products, identified as Gloria Aubrey, 75 State Street, Rouses Point, New
York, as a follow-up to a consumer complaint. Gloria Aubrey was found to be
an unregistered initial distributor of imported magnetic support devices.
These devices are promoted by Magnetic Health Products, a Canadian firm, in
tabloid type newspapers for the relief of back, knee, and elbow pain. The
product is an elasticized band with magnets sewn in place and a velcro closure.
The district investigation further revealed that magnetic support devices have
been imported by Magnetic Health Products, Globe Health Products, and Gloria
Aubrey, 75 State Street, Rouses Point, New York 12979. The parent firm for
Magnetic Health Products is Marathon Health Products, 2165 Vincent Street,
Saint Laurent, Quebec, Canada. The foreign manufacturer identified by
Magnetic Health Products is Lih Hwa Industrial Company, Ltd., Taipei, Taiwan.
Shippers/manufacturers identified from entry documents include Taiwan Daido,
Ltd. of Taipei, Taiwan and Harter Corporation of Taipei, Taiwan.
Consumer orders for magnetic support devices are processed by Magnetic Health
Products via a Rouses Point, New York post office box. The orders are filled
and mailed to customers by Gloria Aubrey, Rouses Point, New York as directed
by the Canadian firm.
We also have information that imported knee and elbow supports have been
invoiced as magnetic acupuncture products under other entries. According to
one entry labeled as a "Port-a-Paedic" support for Shelbud Products
Corporation, New Rochelle, New York, the device was ordered through a Rouses
Point, New York mailbox and mailed from Gloria Aubrey, Rouses Point, New York
to the distributor.
CDRH has reviewed a 510(k) notification received from Magnetic Health Products
and determined that magnetic support devices are class III devices under
section 513(f) of the Federal Food, Drug, and Cosmetic Act. Section 515(a)(2)
of the Act requires class III devices to have an approved premarket approval
(PMA) application before they can be legally marketed in the U.S. No PMA has
been approved for these magnetic support devices.
GUIDANCE:
Detain all entries of magnetic support devices which can be associated clearly
with promotional claims or labeling for use in the relief of pain or any other
medical indications. The charge should be as follows:
"The article is subject to refusal of admission pursu-
ant to section 801(a)(3) of the Federal Food, Drug, and
Cosmetic Act (the Act) in that the article appears to
be an adulterated device within the meaning of section
501(f)(1) of the Act, since no premarket approval (PMA)
application has been approved as required by section
515(a)(2), and the article appears to be misbranded
within the meaning of section 502(f) of the Act, since
it lacks adequate directions for use."
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