Import Alert 54-07

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 54-07
Published Date: 04/23/2019
Type: DWPE

Import Alert Name:

"Germanium Products"

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. Note: Charge statement revised on 04/23/2019.

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

Product Description:

Germanium products

Charge:

“The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. [Adulteration, Section 402(a)(1)]” Contains:

OASIS charge code - POISONOUS

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 (NDA) [Unapproved new drug, Section 505(a)]"

OASIS charge code - UNAPPROVED

Countries

MULTIPLE COUNTRIES (PODS ONLY)

  • (54 Y Y - 09) Germanium (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.), Not Elsewhere Classified (NEC)
  • (66 V - - 99) Miscellaneous Patent Medicines, Etc.

List of firms and their products that have met the criteria for exclusion from Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Green List)


KOREA, REPUBLIC OF (SOUTH)


Geranti Pharm Ltd.
Date Published : 12/28/2018
678-2 , Seoul, Korea, KOREA, REPUBLIC OF (SOUTH)
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/28/2018

Desc: Geranti Bio-Germanium and Geranti Bio-Ge Yeast

66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/28/2018

Desc: Geranti Bio-Germanium and Geranti Bio-Ge Yeast