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: 11/08/2023
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Germanium Supplements for Human Consumption"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 11/8/2023 updates the IA title, reason for alert, guidance, agency contacts, charge codes, PAF, PAC. Changes to the import alert are bracketed by asterisks (***).

***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 offered for entry as food products such as dietary supplements.***

Guidance:

***Divisions may detain without physical examination, all Germanium products offered for entry, including unlabeled bulk entries, except for those products listed on the Green List of this Alert.

Germanium may be offered for entry under a variety of names including:

Products using the term Germanium (e.g. Germanium Sesquioxide, germanium-lactate-citrate, etc.)
GE-132
GE-OXY-132
Vitamin "O"
Pro-Oxygen
Nutrigel 132
Immune Multiple
Germax

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.

If product labeling includes claims for the diagnosis, cure, mitigation, treatment, or prevention of disease field staff should refer to CDER under IA 66-41.
Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:

In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide evidence that the intended use is other than for human consumption. Only products imported for human consumption are subject to this import alert. Other evidence could include Private Laboratory analysis of a representative sample(s) collected from the affected article.
Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, volume III, section 7. Third party laboratories may use any methods that are found acceptable to FDA. Division Compliance Officers are advised to submit acceptable private lab analytical packages to CFSAN's Dietary Supplement and Labeling Assessment Branch prior to release for final admissibility decision. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.

Removal from Detention without Physical Examination (ADD TO GREEN LIST)

Recommendations for additions to the Green List of this import alert, should be forwarded to the Division of Import Operations (DIO) who will coordinate with FDA's Center for Food Safety and Applied Nutrition (CFSAN) to evaluate regulatory packages on a case-by-case basis.

In order to add a firm's product to the Green List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from detention without physical examination (Add to Green List) under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email to: Importalerts2@fda.hhs.gov

Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov.

Questions or issues on policy, sample collection recommendations, or any other additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Dietary Supplement and Labeling Assessment Branch at CFSANEnforcement@fda.hhs.gov.

                                                                                                                                                                        ***

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 ***

Countries

MULTIPLE COUNTRIES

  • (54 Y - - 09) Germanium (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)

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 (THE REPUBLIC OF)


Geranti Pharm Ltd.
Date Published : 12/28/2018
678-2 , Seoul, Korea, KOREA (THE REPUBLIC OF)
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