Organic Germanium

FDA Confirms Organic Germanium Import Alert Still in Effect

May 10, 2005

The Import Alert against Germanium Sesquioxide is NOT cancelled, though some importers will say just about anything to convince you otherwise. This matter is quickly put to bed by simply asking the agency that issued it.

Designed Nutritional has long maintained that importation of Germanium products intended for human consumption is illegal under restrictions outlined in IA #54-07 - Revised 9/13/95, "GERMANIUM PRODUCTS". This Import Alert is readily available and easily understood. However, lest there be any question as to the legitimacy of this interpretation, Designed Nutritional recently contacted the FDA for comment.

According to Compliance Officer Catherine Vieweg, employed by the Dallas International Activities Branch of the FDA, Import alert #54-07 http://www.fda.gov/ola/2004/dietarysupplements0324.html
is still considered in effect as of May 9, 2005.

Email correspondance: FDA’s Current Stand on Germanium Importation

-----Original Message-----
From: Vieweg, Catherine [mailto:CVIEWEG@ORA.FDA.GOV]
Sent: Monday, May 09, 2005 12:34 PM
To: 'david@designednutritional.com'
Cc: Caterinevieweg@fda.org.hhs.gov
Subject: RE: Import Alert Clarification

The Import Alert currently posted is in effect. I suspect where the 1995 date comes from is that there was an adjustment to what charges would be used to detain such a product after the Dietary Supplement Health Education Act was passed. That didn't eliminate the Import Alert, just altered it a bit.

-----Original Message-----
From: David [mailto:XX@designednutritional.XXX]
Sent: Monday, May 09, 2005 1:25 PM
To: Vieweg, Catherine
Cc: Caterinevieweg@fda.org.hhs.gov
Subject: Import Alert Clarification

Dear Caterine,

There is some confusion as to whether the following import alert is still in effect. I believe it is, yet another individual importing this material from Japan or China, claims this import restriction was cancelled in 1995. Could you provide the FDA's official stand on this issue? The actual document is found at http://www.fda.gov/ora/fiars/ora_import_ia5407.html.

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.****

Regards,

Dave Parish

Importers who continue to bring Germanium Products into the U.S., in spite of restrictions that prevent them from legally doing so, are in violation of Federal Import and U.S. Bioterrorism Laws. We encourage every importer of Germanium to personally verify this fact. Contact information is provided below

Food and Drug Administration
Dallas International Activities Branch.
Compliance Officer: Catherine Vieweg
Ph: 1 800 991 4881
cvieweg@ora.fda.gov.

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