What is Import Alert 54-18?

Import Alert 54-18, “Detention without physical examination of dietary supplements and bulk dietary ingredients that are or contain new dietary ingredients”, is an FDA import alert. FDA may detain new dietary ingredients from the firms on its red list without physical examination; FDA last published the alert on June 27, 2025.

Which firms are on Import Alert 54-18?

As of October 26, 2026, 3 firms are listed on Import Alert 54-18 in 1 country; the most listings are in China (3). 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 54-18?

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 54-18; our guide explains the steps and the evidence FDA usually asks for.

What charge does FDA use under Import Alert 54-18?

The charge section of Import Alert 54-18 names NDIDIETSP (appears to be a food that is a dietary supplement or that contains a dietary ingredient that is a new…). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.

Import Alert 54-18: Detention without physical examination of dietary supplements and bulk dietary ingredients that are or contain new dietary ingredients

FDA last published June 27, 2025FDA alert page

As of October 26, 2026, FDA Import Alert 54-18 (Supplements and ingredients with new dietary ingredients) lists 3 firms on its red list in 1 country, covering new dietary ingredients; 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

3
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 54-18

SupplierRadar has recorded no removals from Import Alert 54-18 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 54-18

No firm was added to Import Alert 54-18 in the last 90 days, as of October 26, 2026.

Firms on Import Alert 54-18, by country

3 listings 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
China	3	3

China (3)

FDA refusals from China

Firms in China on Import Alert 54-18
Firm	List	Products	Date published
Jingjiang Jiangyang Fine Chemicals Co.,LtdJingjiang	Red	Higenamine	Feb 22, 2021
Suzhou Win Health International Co.,Ltd.Dongtai City	Red	Higenamine	Feb 22, 2021
Xi'an Le Sen Bio-technology Co.,LtdXian	Red	Sakae NAA	Jul 9, 2021

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 54-18
Charge code	Meaning	Refusal lines since 2016
NDIDIETSP	Appears to be a food that is a dietary supplement or that contains a dietary ingredient that is a new…	23

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 DIETARY SUPPLEMENTS AND BULK DIETARY INGREDIENTS THAT ARE OR CONTAIN NEW DIETARY INGREDIENTS
Product scope: New Dietary Ingredients
Last published: June 27, 2025

This Import Alert (IA) has been developed for bulk dietary ingredients and dietary supplements that have been imported or offered for import into the United States that are or contain ingredients that FDA has determined to be adulterated under section 402(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(f)(1)(B)].
A "new dietary ingredient" (NDI) is defined as a dietary ingredient that was not marketed in the United States before October 15, 1994, (Section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)]). Under section 402(f)(1)(B) of the FD&C Act [21 U.S.C. § 342(f)(1)(B)], a food shall be deemed to be adulterated if it is a dietary supplement or contains a dietary ingredient that is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

FDA Import Alert 54-18, Reason for AlertRead it on FDA

Read the rest of the reason

Based on FDA's review of the available information, the products listed in the Red List of this import alert are or contain one or more new dietary ingredients for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Therefore, the new dietary ingredients and dietary supplements labeled to contain the new dietary ingredients are adulterated under section 402(f)(1)(B) of the Act [21 U.S.C. § 342(f)(1)(B)].

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 54-18

What is Import Alert 54-18?: Import Alert 54-18, “Detention without physical examination of dietary supplements and bulk dietary ingredients that are or contain new dietary ingredients”, is an FDA import alert. FDA may detain new dietary ingredients from the firms on its red list without physical examination; FDA last published the alert on June 27, 2025.
Which firms are on Import Alert 54-18?: As of October 26, 2026, 3 firms are listed on Import Alert 54-18 in 1 country; the most listings are in China (3). 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 54-18?: 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 54-18; our guide explains the steps and the evidence FDA usually asks for.
What charge does FDA use under Import Alert 54-18?: The charge section of Import Alert 54-18 names NDIDIETSP (appears to be a food that is a dietary supplement or that contains a dietary ingredient that is a new…). 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 54-18 recently?: No firm was added to Import Alert 54-18 in the last 90 days, as of October 26, 2026.
Which firms were removed from Import Alert 54-18 recently?: SupplierRadar has recorded no removals from Import Alert 54-18 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.