What is Import Alert 54-07?

Import Alert 54-07, “Detention without physical examination of germanium supplements for human consumption”, is an FDA import alert. Its listed firms are on the green list, which exempts their listed products from detention without physical examination under that alert; FDA last published the alert on March 5, 2026.

Which firms are on Import Alert 54-07?

As of October 26, 2026, 1 firm is listed on Import Alert 54-07 in 1 country; the most listings are in South Korea (1). The full table, grouped by country, is below on this page and every firm links to its record.

How do firms get off Import Alert 54-07?

A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 54-07; our guide explains the steps and the evidence FDA usually asks for.

What charge does FDA use under Import Alert 54-07?

The charge section of Import Alert 54-07 names POISONOUS (poisonous or deleterious substance). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.

Import Alert 54-07: Detention without physical examination of germanium supplements for human consumption

FDA last published March 5, 2026FDA alert page

As of October 26, 2026, FDA Import Alert 54-07 (Germanium Supplements for Human Consumption) lists 1 firm on its green list in 1 country, covering germanium products; 0 firms were added and 0 removed in the last 90 days.

Data from FDA public records, last checked October 26, 2026. Request a correction

1
firms on the green list: 1
country: 0
added in the last 90 days: 0
removed in the last 90 days

What changed in the last 90 days

Additions use the date FDA published each listing. Removals are dated by the day SupplierRadar first saw the firm gone; the weekly and daily checks are described on the data sources page.

Removed from Import Alert 54-07

SupplierRadar has recorded no removals from Import Alert 54-07 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page, and on the firm's own page, the day it is found.

Added to Import Alert 54-07

No firm was added to Import Alert 54-07 in the last 90 days, as of October 26, 2026.

Firms on Import Alert 54-07, by country

1 listing in 1 country. Each name links to the firm's FDA record history; the date is the one FDA published on the alert.

Listings by country

Import alert listings by country
Country	Green list	Total
South Korea	1	1

South Korea (1)

FDA refusals from South Korea

Firms in South Korea on Import Alert 54-07
Firm	List	Products	Date published
Geranti Pharmaceutical Ltd.Seoul	Green	Geranti Bio-Germanium and Geranti Bio-Ge Yeast	May 22, 2024

Refusal charges named on this alert

FDA's alert page names these charge codes. The counts are refusal lines FDA recorded under each charge since October 2016, for all firms, not only firms on this alert.

Charge codes named on Import Alert 54-07
Charge code	Meaning	Refusal lines since 2016
POISONOUS	Poisonous or deleterious substance	2,420

What the alert covers and why FDA issued it

FDA's wording, with FDA's change markers removed.

Official title: Detention Without Physical Examination of Germanium Supplements for Human Consumption
Product scope: Germanium products
Last published: March 5, 2026

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.

FDA Import Alert 54-07, Reason for AlertRead it on FDA

Listing on an import alert is FDA's notice to the firm and a fact an importer must consider in its supplier evaluation under 21 CFR 1.505. What the red, green and yellow lists mean.

Questions about Import Alert 54-07

What is Import Alert 54-07?: Import Alert 54-07, “Detention without physical examination of germanium supplements for human consumption”, is an FDA import alert. Its listed firms are on the green list, which exempts their listed products from detention without physical examination under that alert; FDA last published the alert on March 5, 2026.
Which firms are on Import Alert 54-07?: As of October 26, 2026, 1 firm is listed on Import Alert 54-07 in 1 country; the most listings are in South Korea (1). The full table, grouped by country, is below on this page and every firm links to its record.
How do firms get off Import Alert 54-07?: A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 54-07; our guide explains the steps and the evidence FDA usually asks for.
What charge does FDA use under Import Alert 54-07?: The charge section of Import Alert 54-07 names POISONOUS (poisonous or deleterious substance). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.
Which firms were added to Import Alert 54-07 recently?: No firm was added to Import Alert 54-07 in the last 90 days, as of October 26, 2026.
Which firms were removed from Import Alert 54-07 recently?: SupplierRadar has recorded no removals from Import Alert 54-07 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page and on the firm's page the day it is found.

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.