What is Import Alert 54-10?

Import Alert 54-10, “Detention without physical examination of bulk/finished dietary supplements products containing aristolochic acid”, is an FDA import alert. FDA may detain products from the firms on its red list without physical examination; FDA last published the alert on December 10, 2020.

Which firms are on Import Alert 54-10?

As of October 26, 2026, 1 firm is listed on Import Alert 54-10 in 1 country; the most listings are in Taiwan (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 54-10?

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 54-10; our guide explains the steps and the evidence FDA usually asks for.

What charge does FDA use under Import Alert 54-10?

The charge section of Import Alert 54-10 names UNAPPROVED (unapproved new drug), POISONOUS (poisonous or deleterious substance), DIRECTIONS (is a device whose label appears to not bear adequate directions for use.), UNSFDIETUS (appears to be a dietary supplement or contain a dietary ingredient that renders it adulterated under section…) and UNSFDIETLB (the article appears to be a dietary supplement or contain a dietary ingredient that presents a significant…). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.

Import Alert 54-10: Detention without physical examination of bulk/finished dietary supplements products containing aristolochic acid

FDA last published December 10, 2020FDA alert page

As of October 26, 2026, FDA Import Alert 54-10 (Bulk/finished dietary supplements products) lists 1 firm on its red list in 1 country; 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 red 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 54-10

SupplierRadar has recorded no removals from Import Alert 54-10 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 54-10

No firm was added to Import Alert 54-10 in the last 90 days, as of October 26, 2026.

Firms on Import Alert 54-10, 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	Red list	Total
Taiwan	1	1

Taiwan (1)

FDA refusals from Taiwan

Firms in Taiwan on Import Alert 54-10
Firm	List	Products	Date published
Kaiser Pharmaceutical Co.Tai Nan Shi	Red	Herbals & Botanicals (not Teas), N.E.C.	Sep 18, 2009

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 54-10
Charge code	Meaning	Refusal lines since 2016
UNAPPROVED	Unapproved new drug	5,203
POISONOUS	Poisonous or deleterious substance	2,420
DIRECTIONS	Is a device whose label appears to not bear adequate directions for use.	297
UNSFDIETUS	Appears to be a dietary supplement or contain a dietary ingredient that renders it adulterated under section…	42
UNSFDIETLB	The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant…	10

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 Bulk/Finished Dietary Supplements Products Containing Aristolochic Acid
Product scope: Dietary Supplements or Drugs, Bulk or Finished, labeled as containing Aristolochia spp., certain Asarum spp., certain Cocculus spp., and certain Thottea spp.
Last published: December 10, 2020

The botanical Aristolochia spp. and other plants in the Aristolochiaceae family are widely used as ingredients in traditional Chinese herbal medicines and other traditional medicines. These products may often be labeled for drug use (e.g., claims that they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases), although there are no approved new drug applications (NDAs). Some products containing botanicals in this family may also be labeled as dietary supplements or may not be labeled in accordance with the requirements for any specific FDA-regulated product.
Plants in the Aristolochiaceae family contain aristolochic acid, which is a substance known to result in serious adverse health effects when taken orally by humans or animals. Several outbreaks of renal failure in recent years have been attributed to the use of Chinese herbal medicines that were later shown to contain aristolochic acid. In each instance, the source of aristolochic acid was determined to be an aristolochia spp. plant that was used in the product for one of two reasons: (1) the plant ingredient that was listed on the label was mis-identified; or (2) the identity of the plant ingredient or product was confused with an aristolchia-containing ingredient or product because the traditional Chinese names were misinterpreted or similar.

FDA Import Alert 54-10, Reason for AlertRead it on FDA

Read the rest of the reason

Aristolochic acid is a potent carcinogen and nephrotoxin. Its nephrotoxic potential has been demonstrated in animals and humans in case reports and in at least one human clinical study. Products that contain a large amount of aristolochic acid have been documented to result in the rapid onset of acute toxicity symptoms. However, a product containing a small amount of aristolochic acid could be used for years with no apparent adverse effects until serious, irreversible effects, such as renal damage, has occurred. In sum, products containing aristolochic acid cause renal damage and can cause or contribute to renal failure.

There are analytical methods available to examine suspect raw material and finished product for the presence of aristolochic acid. products that contain Aristolochia spp. or other botanicals that contain aristolochic acid should be evaluated in order to establish that the product is free of aristolochic acid. Note: Charge statement revised on 04/23/2019.

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 54-10

What is Import Alert 54-10?: Import Alert 54-10, “Detention without physical examination of bulk/finished dietary supplements products containing aristolochic acid”, is an FDA import alert. FDA may detain products from the firms on its red list without physical examination; FDA last published the alert on December 10, 2020.
Which firms are on Import Alert 54-10?: As of October 26, 2026, 1 firm is listed on Import Alert 54-10 in 1 country; the most listings are in Taiwan (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 54-10?: 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 54-10; our guide explains the steps and the evidence FDA usually asks for.
What charge does FDA use under Import Alert 54-10?: The charge section of Import Alert 54-10 names UNAPPROVED (unapproved new drug), POISONOUS (poisonous or deleterious substance), DIRECTIONS (is a device whose label appears to not bear adequate directions for use.), UNSFDIETUS (appears to be a dietary supplement or contain a dietary ingredient that renders it adulterated under section…) and UNSFDIETLB (the article appears to be a dietary supplement or contain a dietary ingredient that presents a significant…). 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 54-10 recently?: No firm was added to Import Alert 54-10 in the last 90 days, as of October 26, 2026.
Which firms were removed from Import Alert 54-10 recently?: SupplierRadar has recorded no removals from Import Alert 54-10 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.