Germanium Is Legal To Import And Sell
Source
I, Karl Loren, probably know more about the supposed
"restrictions" on the import of germanium than any other person willing to tell
the story.
I wrote a Book on germanium and predicted that the FDA would try
to make it illegal to import germanium into the US.
Shortly after my Book was published the FDA issued the "import
alert" shown below.
In fact that "alert" did not make it illegal to import
germanium, but simply
allowed FDA officials to seize import shipments of germanium. This
alert did not require anyone to seize shipments and did not make it
illegal for a person to import germanium.
If some FDA official did seize some imported germanium, it would then be up
to the importer to show that the importation was not of the type described in
the "alert." The "alert," of course, describes "germanium" as being
"poisonous" which is not true -- could be proven easily by feeding the true
germanium to mice, the usual test for toxicity.
There is a very simple and standard test for toxicity of various substances
-- it called the "LD50" test -- the "dose" that will kill 50% of a batch of test
animals:
The amount of germanium dioxide (not the form we sell) that is
toxic has been established:
LD/Lc50
values that are relevant for classification:
Germanium (IV) oxide (CAS# 1310-53-8), 100%
Oral: LD50: 5400 mg/kg (mus) (source)
The above reference indicates that "germanium oxide" is lethal
to a group of mice, to 50% of them, when fed to them at a rate of 5 grams per
1000 grams (one kg) of body weight. On this same basis, a human who might
weight 100 kilograms (220 pounds) would have to ingest 500 grams of germanium
oxide for it to be toxic -- this would be about one full pound at one dose.
This very unlikely possibility applies to the "oxide" form of germanium.
Dr. Asai created a very different form, called "organic germanium" and there has
never been any showing of any LD50 rate for this form. It is not toxic in
any dosage.
In 1995 Congress passed a new law restricting the FDA from the
unproven types of allegations they were making.
Thus, in 1995 the earlier "alert" was canceled.
So, as of 1995 there has been no "import alert" affecting
germanium.
There are, of course, several companies claiming to be selling
germanium. One even claims to be selling germanium which is manufactured
within the United States. I have claimed, in writing, that none of these
sources has the authentic germanium which was the subject of patents in Japan.
None of those companies is willing to disclose the source, or country, of their
supply of germanium.
I suspect that fake germanium is made in China and imported, but
those who import this fake stuff are unwilling to put the "made in China" name
on their product.
In any event, there is only one genuine source of germanium in
the US -- that sold by Vibrant Life.
And, it is completely legal to import and sell. Likewise,
it is safe to take in any dosage.
Karl Loren
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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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