Germanium Sesquioxide
Organic Germanium

Bis (2-Carboxyethylgermanium)sesquioxide

Analysis of an Import Alert

The following contains actual excerpts from an import alert issued by the FDA, against germanium products for human consumption. For convenience we have broken it down into the various sections of interest (and points of potential confusion) followed by an accurate analysis.

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.**** (source)

Analysis: At first glance one may assume that the import alert was cancelled in 1995 but nothing could be further from the truth. The import restriction against Germanium Sesquioxide has not been cancelled, but clearly states that an earlier alert issued in 1988 was cancelled, for the purpose of revising specific language, with the simultaneous issuance of another in 1995. The fact that this particular germanium import alert is still in effect was confirmed on May 9, 2005 by a compliance officer at the Dallas International activities Branch of the FDA. Anyone wishing to verify this can contact the FDA personally at: Food and Drug Administration
Dallas International Activities Branch. Compliance Officer: Catherine Vieweg
Ph: 1-800-991-4881 Email: cvieweg@ora.fda.gov

PROBLEM.......:...Poisonous and deleterious substance (PSNC) or
..................Unapproved new drug (DRND)

Analysis: These are the stated concerns of the FDA that led to the issuance of the import alert. The language “Poisonous and deleterious” was selected on account of contaminated material imported from Asian countries that caused nephrotoxicity (kidney damage) and even some fatalities between the mid to late 80’s. “Unapproved new drug” is used on account of the material being marketed to treat or mitigate disease related conditions. Both of these categories will be mentioned again later in the document

COUNTRY.......:...All

Analysis: This import alert against germanium products covers all countries of foreign origin.

MANUFACTURER
or SHIPPER
....:...All

Analysis: This import alert against germanium products covers all manufacturers and shippers of imported germanium products.

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)]."

Analysis: Germanium products can be stopped at the U.S. border under either the poisonous and deleterious substance and/or the unapproved drug charge.

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, ..................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.

Analysis: This portion clearly states the reasons the import alert against germanium was issued. Past incidences of injury and death gave reason for the FDA to conclude that germanium posed a significant health hazard. The fact that germanium products were being marketed for disease related conditions, and incidentally still are by many profiteers, justified the FDA in leveling a new unapproved drug charge. This is the first place that dietary supplements are specifically mentioned and targeted.

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.

Analysis: Latitude is given to import / customs authorities to detain all germanium products without inspection. This covers bottled finished dosages in addition to bulk material. Specific instruction is given on what charges to use as justification for the action. The only germanium products exempt from this action are those intended for semiconductor use.


..................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.

Analysis: The FDA has determined that germanium can legitimately be imported for semiconductor use but not human consumption. Germanium for which the stated intended use is other than human consumption should be released and its ultimate disposition verified where possible.

..................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

Analysis: This is a list of the popular names for germanium dietary supplements at the time the import alert was issued. These are the names of products that importers were offering for entry into the U.S. This does not instruct the FDA to allow these products in but simply flags the names they should be on the lookout for and detain.
One must not forget that sloppy process controls, greedy profiteers, rampant ignorance, and ineptitude led to this import alert being issued in the first place. Historically, reversing or canceling an import alert of this nature requires a far greater burden of proof than that which led to issuance of the alert. Designed Nutritional reaffirms its earlier position that any US importer of Germanium Sesquioxide is violating import restrictions that prevent the product from entering legally.

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