How do firms get off Import Alert 54-13?

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 54-13; our guide explains the steps and the evidence FDA usually asks for.

What charge does FDA use under Import Alert 54-13?

The charge section of Import Alert 54-13 names EPHEDALK (is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents…). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.

Import Alert 54-13: Detention without physical examination of dietary supplements and bulk dietary ingredients containing ephedrine alkaloids from all countries

FDA last published February 21, 2025FDA alert page

As of October 26, 2026, FDA Import Alert 54-13 (Dietary supplements and bulk dietary ingredients) has no foreign food firms listed in SupplierRadar's records; it covers dietary supplements containing ephedrine alkaloids.

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

0
foreign food firms listed: 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 54-13

SupplierRadar has recorded no removals from Import Alert 54-13 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 54-13

No firm was added to Import Alert 54-13 in the last 90 days, as of October 26, 2026.

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 54-13
Charge code	Meaning	Refusal lines since 2016
EPHEDALK	Is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents…	16

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 Containing Ephedrine Alkaloids From All Countries
Product scope: Dietary Supplements Containing Ephedrine Alkaloids; Bulk Dietary Ingredients Containing Ephedrine Alkaloids
Last published: February 21, 2025

NOTE: Revision to this Import Alert dated 8/13/2021 updates the language of the "Guidance" section, agency contacts and PAF section. Changes are noted and bracketed by three asterisks ().
Section 402(f)(1)(A) of the Act provides that a dietary supplement or dietary ingredient is adulterated if it presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling of the product, or if no conditions of use are suggested in the labeling, under ordinary conditions of use. We issued "Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk" (69 FR 6787, Feb. 11, 2004) based upon the well-known and scientifically established pharmacology of ephedrine alkaloids, the peer-reviewed scientific literature about the effects of ephedrine alkaloids, published case reports of adverse events, and the adverse events reported to us that have occurred in individuals using products containing ephedrine alkaloids, particularly dietary supplements. As set forth…

FDA Import Alert 54-13, 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 54-13

What is Import Alert 54-13?: Import Alert 54-13, “Detention without physical examination of dietary supplements and bulk dietary ingredients containing ephedrine alkaloids from all countries”, is an FDA import alert; FDA last published the alert on February 21, 2025.
How do firms get off Import Alert 54-13?: 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 54-13; our guide explains the steps and the evidence FDA usually asks for.
What charge does FDA use under Import Alert 54-13?: The charge section of Import Alert 54-13 names EPHEDALK (is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents…). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.

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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.