How many dietary supplements shipments from Australia did FDA refuse in 2026?

FDA refused 14 shipment lines of dietary supplements from Australia in 2026 through August 11, 2026, compared with 1 in 2025.

Why does FDA refuse dietary supplements from Australia?

FDA records a charge code on every refused shipment line. For dietary supplements from Australia the most frequent are NUTRIT LBL (nutrition information missing from label, 102 lines), NCONTACT (no U.S. adverse event contact on supplement label, 98 lines) and HEALTH C (unauthorized nutrient content or health claim, 81 lines). A charge describes what FDA's reference table says about one shipment line, not about every firm.

Which import alerts cover dietary supplements from Australia?

As of October 26, 2026, the FDA import alerts for this category that list Australia firms are Import Alert 54-12 (2 firms) and Import Alert 54-14 (1 firm). General food alerts numbered 99-xx can list Australia firms too; see the country page.

FDA import refusals

FDA import refusals: dietary supplements from Australia

FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to August 11, 2026

FDA refused 168 dietary supplements shipment lines from Australia between October 2016 and August 11, 2026, 14 of them in 2026; the most refused products were herbals & botanicals and vitamin, most often for NUTRIT LBL (nutrition information missing from label).

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

168
dietary supplements lines refused since October 2016: 14
refused so far in 2026: 23%
of all FDA refusals from Australia: 7
firms with the most records, listed below

Dietary supplements refusals from Australia by year

Shipment lines FDA refused each year. The table has the same numbers as the chart.

* 2026 is year to date, through August 11, 2026. FDA's refusal data starts on October 1, 2016, so 2016 covers three months.

Refusal lines by year
Year	Refusal lines	vs prior year
2026 (to date)	14
2025	1	-80%
2024	5	-62%
2023	13	+225%
2022	4	+33%
2021	3	-79%
2020	14	0%
2019	14	+600%
2018	2	-98%
2017	89
2016 (from Oct)	9

Herbals & botanicals refusals from Australia

FDA refused 96 herbals & botanicals lines from Australia between October 2016 and August 11, 2026, 57% of the dietary supplements lines.

Herbals & botanicals product descriptions refused from Australia
FDA product description	Lines	Share of dietary supplements
Herbals & botanicals (not teas), n.e.c.	96	57.1%

Recent herbals & botanicals refusals

Recent Herbals & botanicals refusals from Australia
Date	Firm	Product	Charges
May 14, 2025	Martin Pleasance Manufacturing Pty LtdLoganholme, Australia	Herbals & botanicals (not teas), n.e.c	MFR INJ	Source

Vitamin refusals from Australia

FDA refused 37 vitamin lines from Australia between October 2016 and August 11, 2026, 22% of the dietary supplements lines.

Vitamin product descriptions refused from Australia
FDA product description	Lines	Share of dietary supplements
Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.	31	18.5%
Vitamin, n.e.c.	6	3.6%

Recent vitamin refusals

Recent Vitamin refusals from Australia
Date	Firm	Product	Charges
Aug 11, 2026	BJP Laboratories Pty LtdYatala, Australia	Vitamin, n.e.c	SUPPL GMP	Source
Jul 25, 2026	Mega Lifesciences (Australia) Pty LtdPakenham, Australia	Vitamin, n.e.c	UNAPPROVED	Source
Jul 13, 2026	BJP Laboratories Pty LtdYatala, Australia	Vitamin, n.e.c	SUPPL GMP	Source
Jul 13, 2026	BJP Laboratories Pty LtdYatala, Australia	Vitamin, n.e.c	SUPPL GMP	Source
Mar 31, 2026	Mypause Health Pty LtdCastle Hill, Australia	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	UNAPPROVED	Source

Fiber refusals from Australia

FDA refused 7 fiber lines from Australia between October 2016 and August 11, 2026, 4% of the dietary supplements lines.

Fiber product descriptions refused from Australia
FDA product description	Lines	Share of dietary supplements
Fiber, n.e.c.	7	4.2%

Recent fiber refusals

Recent Fiber refusals from Australia
Date	Firm	Product	Charges
Dec 11, 2024	Medikane Operations Pty LtdNorth Ryde, Australia	Fiber, n.e.c	COLOR LBLG NCONTACT NUTRIT LBL	Source
Dec 11, 2024	Medikane Operations Pty LtdNorth Ryde, Australia	Fiber, n.e.c	COLOR LBLG NCONTACT NUTRIT LBL	Source
Dec 11, 2024	Medikane Operations Pty LtdNorth Ryde, Australia	Fiber, n.e.c	COLOR LBLG NCONTACT NUTRIT LBL	Source
Dec 11, 2024	Medikane Operations Pty LtdNorth Ryde, Australia	Fiber, n.e.c	COLOR LBLG NCONTACT NUTRIT LBL	Source

Other dietary supplements products refused from Australia

Products refused from Australia in dietary supplements
Product group	Lines	Share
Multiple vitamins	6	3.6%
Magnolia	2	1.2%
Milk thistle	2	1.2%
Omega-3	2	1.2%
Penny royal	2	1.2%
Probiotics	2	1.2%

Why FDA refused dietary supplements from Australia

FDA records a charge code on each refused line; one line can carry several.

Most frequent refusal charges for dietary supplements from Australia
Charge code	Meaning	Lines	Share
NUTRIT LBL	Nutrition information missing from label	102	28%
NCONTACT	No U.S. adverse event contact on supplement label	98	27%
HEALTH C	Unauthorized nutrient content or health claim	81	22%
DIETARYLBL	Not identified as a dietary supplement	25	7%
UNAPPROVED	Unapproved new drug	25	7%
LABELING	Fair Packaging and Labeling Act	15	4%
SUPPL GMP	Dietary supplement CGMP not met	8	2%
FALSE	False or misleading labeling	6	2%
COLOR LBLG	Artificial coloring not declared	4	1%
LIST INGRE	Ingredients not listed	4	1%

Import alerts for dietary supplements that list Australia firms

Import alerts for dietary supplements listing firms in Australia
Alert	Covers	Red	Green
54-12	Foods that do not properly declare ginseng	2
54-14	Supplements from firms not meeting supplement GMP	1

Australia dietary supplements firms with the most FDA records

Counts are FDA records in SupplierRadar's data, not a ranking of quality.

Australia dietary supplements firms with the most FDA records
Firm	City	FDA records
ONE Group	Ashmore	71
Natural Vitality	Brendale	11
Organic & Natural Enterprise Group	Molendinar	10
BJP Laboratories Pty Ltd	Yatala	8
Vitex Pharmaceuticals Pty Ltd.	Eastern Creek	7
Mypause Health Pty Ltd	Castle Hill	7
A.G.M. Foods Pty Ltd	Wynnum	2

Latest dietary supplements refusals from Australia

Latest FDA dietary supplements refusals from Australia
Date	Firm	Product	Charges
Aug 11, 2026	BJP Laboratories Pty LtdYatala, Australia	Vitamin, n.e.c	SUPPL GMP	Source
Jul 25, 2026	Mega Lifesciences (Australia) Pty LtdPakenham, Australia	Vitamin, n.e.c	UNAPPROVED	Source
Jul 13, 2026	BJP Laboratories Pty LtdYatala, Australia	Vitamin, n.e.c	SUPPL GMP	Source
Jul 13, 2026	BJP Laboratories Pty LtdYatala, Australia	Vitamin, n.e.c	SUPPL GMP	Source
Jul 9, 2026	Antaria Pty. Ltd.Rocklea, Australia	Zinc (mineral)	DRUG GMPS	Source
May 21, 2026	BJP Laboratories Pty LtdYatala, Australia	Probiotics (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.)	SUPPL GMP	Source
May 21, 2026	BJP Laboratories Pty LtdYatala, Australia	Probiotics (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.)	SUPPL GMP	Source
Mar 31, 2026	Mypause Health Pty LtdCastle Hill, Australia	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	UNAPPROVED	Source
Mar 31, 2026	Mypause Health Pty LtdCastle Hill, Australia	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	UNAPPROVED	Source
Mar 31, 2026	Mypause Health Pty LtdCastle Hill, Australia	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	UNAPPROVED	Source
Mar 31, 2026	Mypause Health Pty LtdCastle Hill, Australia	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	UNAPPROVED	Source
Mar 31, 2026	Mypause Health Pty LtdCastle Hill, Australia	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	UNAPPROVED	Source
Mar 31, 2026	Mypause Health Pty LtdCastle Hill, Australia	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	UNAPPROVED	Source
Mar 31, 2026	Mypause Health Pty LtdCastle Hill, Australia	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	UNAPPROVED	Source
May 14, 2025	Martin Pleasance Manufacturing Pty LtdLoganholme, Australia	Herbals & botanicals (not teas), n.e.c	MFR INJ	Source
Dec 11, 2024	Medikane Operations Pty LtdNorth Ryde, Australia	Fiber, n.e.c	COLOR LBLG NCONTACT NUTRIT LBL	Source
Dec 11, 2024	Medikane Operations Pty LtdNorth Ryde, Australia	Fiber, n.e.c	COLOR LBLG NCONTACT NUTRIT LBL	Source
Dec 11, 2024	Medikane Operations Pty LtdNorth Ryde, Australia	Fiber, n.e.c	COLOR LBLG NCONTACT NUTRIT LBL	Source
Dec 11, 2024	Medikane Operations Pty LtdNorth Ryde, Australia	Fiber, n.e.c	COLOR LBLG NCONTACT NUTRIT LBL	Source
Oct 7, 2024	EimeleNorth Sydney, Australia	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	LIST INGRE STD IDENT NUTRIT LBL	Source

Questions about dietary supplements refusals from Australia

How many dietary supplements shipments from Australia did FDA refuse in 2026?: FDA refused 14 shipment lines of dietary supplements from Australia in 2026 through August 11, 2026, compared with 1 in 2025.
Why does FDA refuse dietary supplements from Australia?: FDA records a charge code on every refused shipment line. For dietary supplements from Australia the most frequent are NUTRIT LBL (nutrition information missing from label, 102 lines), NCONTACT (no U.S. adverse event contact on supplement label, 98 lines) and HEALTH C (unauthorized nutrient content or health claim, 81 lines). A charge describes what FDA's reference table says about one shipment line, not about every firm.
Which import alerts cover dietary supplements from Australia?: As of October 26, 2026, the FDA import alerts for this category that list Australia firms are Import Alert 54-12 (2 firms) and Import Alert 54-14 (1 firm). General food alerts numbered 99-xx can list Australia firms too; see the country page.

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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.