What law does EPHEDALK cite?

FDA's refusal charge table cites sections 801(a)(3) and 402(f)(1)(A) of the FD&C Act (adulteration) for EPHEDALK, and classifies the charge as adulteration. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.

Which countries have the most EPHEDALK refusals?

As of October 26, 2026, the countries with the most EPHEDALK refusal lines are South Korea (5), China (2) and Hong Kong (2). The full list with links is in the table on this page.

Is there an FDA import alert for EPHEDALK?

Yes. One FDA import alert names EPHEDALK as a charge code, including Import Alert 54-13 (Dietary supplements and bulk dietary ingredients). An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

FDA refusal charge

FDA refusal charge EPHEDALK

Is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents…

EPHEDALK is the FDA import refusal charge for is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents…; it cites sections 801(a)(3) and 402(f)(1)(A) of the FD&C Act (adulteration). FDA recorded it on 16 refused shipment lines from 8 countries between October 2016 and July 25, 2023, most often for dietary supplements from South Korea.

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

16
refused shipment lines carry this charge: 8
countries of origin: 1
import alert names this charge

What EPHEDALK means

SupplierRadar has not written a plain-English version of EPHEDALK yet. FDA's own statement is quoted below.

FD&C Act section: 801(a)(3)402(f)(1)(A)
Classification: adulteration

FDA's official statement

Copied unchanged from FDA's Refusal Charges reference table.

The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.

EPHEDALK · 801(a)(3), 402(f)(1)(A); ADULTERATIONFDA reference table (CSV)

Import alerts that name EPHEDALK

The charge section of each alert names this code. An alert lists firms; a charge is the reason recorded on one refused line.

Import alerts naming EPHEDALK as a charge
Alert	Covers	Red	Green
54-13	Dietary supplements and bulk dietary ingredients

Countries with the most EPHEDALK refusals

Shipment lines carrying EPHEDALK, by country of origin.

EPHEDALK refusal lines by country
Country	Lines	Share of EPHEDALK
South Korea	5	31%
China	2	13%
Hong Kong	2	13%
Nigeria	2	13%
Pakistan	2	13%
Australia	1	6%
Canada	1	6%
Taiwan	1	6%

Product categories with the most EPHEDALK refusals

EPHEDALK refusal lines by product category
Category	Lines	Share of EPHEDALK
Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties	16	100%

Latest EPHEDALK refusals

The 16 most recent refused lines, through July 25, 2023, each with its FDA source.

Latest FDA refusals carrying EPHEDALK
Date	Firm	Product	Charges
Jul 25, 2023	Fayus EnterprisesLagos, Nigeria	Ephedra (herbal & botanicals, not teas)	EPHEDALK	Source
Jul 25, 2023	Fayus EnterprisesLagos, Nigeria	Ephedra (herbal & botanicals, not teas)	EPHEDALK	Source
Sep 8, 2022	Qarshi Industries (Pvt) LtdHaripur, Pakistan	Herbals & botanical teas, n.e.c	EPHEDALK UNAPPROVED	Source
Sep 1, 2021	Qarshi IndustriesKhyber Pakhtunkhwa, Pakistan	Herbals & botanical teas, n.e.c	EPHEDALK UNAPPROVED	Source
Oct 19, 2020	Tai HingHong Kong, Hong Kong	Ephedra (herbal & botanicals, not teas)	EPHEDALK	Source
Dec 13, 2019	The Winning Combination Inc.Winnipeg, Canada	Ephedra (herbal & botanical teas)	EPHEDALK	Source
Oct 16, 2019	RFX Pharmaceutical Co., Ltd.Wuzhou, China	Herbals & botanicals (not teas), n.e.c	EPHEDALK	Source
Jul 18, 2017	Guangdong Yifang PharmaceuticalFoshan City, China	Ephedra (herbal & botanical teas)	EPHEDALK	Source
Jun 9, 2017	Hanpoong Pharm Co.,Ltd.Jeonju, South Korea	Herbals & botanical teas, n.e.c	EPHEDALK	Source
Jun 2, 2017	Hanpoong Pharm Co.,Ltd.Jeonju, South Korea	Herbals & botanical teas, n.e.c	NOT LISTED FALSE EPHEDALK+2	Source
Jun 2, 2017	Hanpoong Pharm Co.,Ltd.Jeonju, South Korea	Herbals & botanical teas, n.e.c	DIETARYLBL EPHEDALK DIETARYING+1	Source
Jun 2, 2017	Hanpoong Pharm Co.,Ltd.Jeonju, South Korea	Herbals & botanical teas, n.e.c	DIETARYLBL EPHEDALK DIETARYING+1	Source
Jun 2, 2017	Hanpoong Pharm Co.,Ltd.Jeonju, South Korea	Herbals & botanical teas, n.e.c	DIETARYLBL EPHEDALK DIETARYING+1	Source
Nov 30, 2016	Sun Herbal Pty LtdKingsgrove, Australia	Ephedra (herbal & botanicals, not teas)	EPHEDALK NCONTACT	Source
Oct 20, 2016	Sheng Chang Pharmaceutical Co., Ltd. Zhongli FactoryTaoyuan City, Taiwan	Herbals & botanicals (not teas), n.e.c	EPHEDALK	Source
Oct 11, 2016	Wing Sang Hong Wholesale Co LtdSai Ying Pun, Hong Kong	Herbals & botanical teas, n.e.c	EPHEDALK	Source

Questions about EPHEDALK

What does EPHEDALK mean on an FDA refusal?: EPHEDALK is the refusal charge “Is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents…”. FDA's official statement for the charge reads: “The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.”
What law does EPHEDALK cite?: FDA's refusal charge table cites sections 801(a)(3) and 402(f)(1)(A) of the FD&C Act (adulteration) for EPHEDALK, and classifies the charge as adulteration. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
Which countries have the most EPHEDALK refusals?: As of October 26, 2026, the countries with the most EPHEDALK refusal lines are South Korea (5), China (2) and Hong Kong (2). The full list with links is in the table on this page.
Is there an FDA import alert for EPHEDALK?: Yes. One FDA import alert names EPHEDALK as a charge code, including Import Alert 54-13 (Dietary supplements and bulk dietary ingredients). An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

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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.