IA #54-07 - Revised 9/13/95, "GERMANIUM PRODUCTS"
****NOTE: Import Alert #62-02, "Germanium Products" dated 06/28/88, is
cancelled simultaneously with the issuance of this alert. The alert
is revised to remove the food additive charge in accordance with the
requirements of the Dietary Supplement, Health, and Education Act
(DSHEA) of 1994.****
TYPE OF ALERT: AUTOMATIC DETENTION
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 : Germanium products
PRODUCT CODE : 54YY-09
66V--99
PROBLEM : Poisonous and deleterious substance (PSNC) or
Unapproved new drug (DRND)
PAC : 21008
56008H
COUNTRY : All
MANUFACTURER
or SHIPPER : All
CHARGES : "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to contain a poisonous
and deleterious substance which may render it injurious to
health [Adulteration, 402(a)(1)]."
or
"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 : CFSAN: Division of Program and Enforcement Policy, Regulatory
Branch (HFS-456); Division of Field Program Planning and
Evaluation, Import Programs Branch (HFS-637).
REASON FOR
ALERT : Germanium is a nonessential trace element that has caused
nephrotoxicity (kidney injury) and death when used chronically
by humans, even at recommended levels of use. Germanium
containing products have been labeled for drug use (e.g., with
claims that they are intended for use in the diagnosis, cure,
IMPORT ALERT #54-07, 7/26/95 PAGE 2
mitigation, treatment, or prevention of diseases such as AIDS
or cancer), although there are no approved new drug
applications (NDAs) or current investigational new drug
applications (INDs) on file. Germanium containing products
also have been offered for entry as food products such as
dietary supplements.
GUIDANCE : Districts may detain all Germanium products offered for entry,
without physical examination, including unlabeled bulk
entries, except for semiconductor use as discussed below. If
the product claims to be useful in the diagnosis, cure,
mitigation, treatment, or prevention of disease, use the drug
charge; otherwise use the "poisonous and deleterious" charge.
There are legitimate uses for germanium in the semiconductor
industry. If an importer shows that the intended use of the
product is other than for human consumption, the entry should
be released with comment. If possible, appropriate follow up
should be made to assure the ultimate disposition is as
indicated by the importer.
Germanium may be offered for entry under a variety of names
including:
Germanium Sesquioxide
GE-132
GE-OXY-132
Vitamin "O"
Pro-Oxygen
Nutrigel 132
Immune Multiple
Germax
PRIORITIZATION
GUIDANCE : I
FOI : No purging required.
KEYWORDS : Germanium, Germax, Immune Multiple, Nutrigel 132, Pro-Oxygen,
Vitamin "O", GE-OXY-132, GE-132.
PREPARED BY: The Drugs, Devices, & Biologics SDWG, DIOP, HFC-170,
(301) 443-6553.
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