FDA import refusals
FDA import refusals from Australia
Food, dietary supplements and animal food · October 2016 to September 8, 2026 · how the data is collected
FDA refused 742 shipment lines from Australia between October 2016 and September 2026, including 30 in 2026 through September 8, 2026; the most common charges were UNSAFE COL, NUTRIT LBL and FSVP VIO, and the most refused category was color additives.
Data from FDA public records, last checked .
- 742
- refused shipment lines since October 2016
- 30
- refused so far in 2026
- 238
- Australia firms with an FDA record
- 53
- firms on an active import alert
Refusals from Australia by year
Shipment lines FDA refused each year. The table has the same numbers as the chart.
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 30 | |
| 2025 | 12 | +20% |
| 2024 | 10 | -84% |
| 2023 | 64 | -81% |
| 2022 | 344 | +4200% |
| 2021 | 8 | -84% |
| 2020 | 50 | -4% |
| 2019 | 52 | +79% |
| 2018 | 29 | -72% |
| 2017 | 104 | |
| 2016 (from Oct) | 39 |
Why FDA refused Australia shipment lines
FDA records a charge code on each refused line; one line can carry several. Each code opens FDA's official statement and the countries and products behind it.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNSAFE COL | Color additive unsafe under section 721 | 219 | 25% |
| NUTRIT LBL | Nutrition information missing from label | 168 | 19% |
| FSVP VIO | Importer not in compliance with FSVP | 123 | 14% |
| NCONTACT | No U.S. adverse event contact on supplement label | 100 | 11% |
| HEALTH C | Unauthorized nutrient content or health claim | 88 | 10% |
| PESTICIDE | Pesticide chemical residue | 57 | 6% |
| COSM COLOR | Appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it… | 36 | 4% |
| LABELING | Fair Packaging and Labeling Act | 34 | 4% |
| LACKS N/C | Net quantity statement missing | 32 | 4% |
| LIST INGRE | Ingredients not listed | 32 | 4% |
What FDA refused from Australia, by product category
FDA product categories, most refused first. Open a category for its product, charge and firm tables.
| Category | Most refused products | Lines |
|---|---|---|
| Color additivesColor Additives for Foods, Drugs, and Cosmetics | Henna; Cochineal extract | 239 |
| Dietary supplementsVitamins, Minerals, Proteins, and Unconventional Dietary Specialties | Herbals & botanicals (not teas), n.e.c.; Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.; Fiber, n.e.c. | 168 |
| Snack foodsSnack Food Items | Baked snack food, n.e.c.; Snack foods not elsewhere mentioned, n.e.c.; Mushroom snacks (flavored or unflavored), vegetable snacks (other than pulses) baked | 64 |
| Candy and chewing gumCandy without Chocolate, Candy Specialties, and Chewing Gum | Hard candy with nut or nut products, n.e.c. (without chocolate); Hard candy without nuts and fruit, n.e.c. (without chocolate); Flavored candy, soft (live savers, etc.), without nuts and fruit (without chocolate) | 59 |
| Vegetables (legumes and leafy)Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | Garbanzo bean; Chana dal; Mung bean, dried or paste | 58 |
| Baby foodBaby (Infant and Junior) Food Products | Other formula products, n.e.c., powder formula; Milk base infant formula product (0-12 months), powder formula; Toddler milk based formula/drink product (12-36 months), ready to feed | 27 |
| Grains and starchWhole Grains, Milled Grain Products, and Starch | Rice, cultivated, whole grain; Milled grain products, n.e.c.; Flours and meals n.e.c. | 20 |
| Bakery productsBakery Products, Doughs, Bakery Mixes, and Icings | Ice cream cones; Chocolate chip plain cookies,biscuits and wafers; Plain cookies,biscuits and wafers, n.e.c. | 12 |
| Soft drinks and waterSoft Drinks and Waters | Mixed drinks (nonalcoholic beverages); Bottled water with fruit flavors, noncarbonated (nonmedicinal); Nonalcoholic beverages, n.e.c. | 12 |
| Dressings and condimentsDressings and Condiments | Chutney; Condiments, n.e.c.; Mustard, prepared | 10 |
| Pet foodPet and Laboratory Animal Foods | Comb prod pet dog food; Meat (mammalian muscle), pet treats; Other pet food, n.e.c. | 10 |
| Sauces and prepared mealsMultiple Food Dinners, Gravies, Sauces, and Specialties | Curry paste; Barbecue sauce; Chili sauce | 9 |
| SweetenersFood Sweeteners (Nutritive) | Honey; Coconut sugar (sugar products); Food sweetners (nutritive) n.e.c. | 7 |
| Animal feed byproductsByproducts for Animal Feeds | Byprod for animal, n.e.c.; Slaughtered mammal by prod n.e.c. | 7 |
| Chocolate and cocoaChocolate and Cocoa Products | Chocolate candy pieces, with nuts and fruit; Chocolate candy pieces, without nuts and fruit; Chocolate covered candy pieces, with fruit and fruit products | 6 |
| Meal replacementsDietary Conventional Foods and Meal Replacements | Dietary conventional foods, n.e.c.; Foods with supplemental nutrients added, with or without artifical sweetners; Nutrtionally incomplete formulations (protein, carbohydrate or fat modulars) | 6 |
| Berries and citrusFruit and Fruit Products (berries, citrus and core fruits) | Grapes, dried or paste; Apple, core fruit juices or concentrates; Pear, jam, jelly, preserves, marmalade, butter and candied | 5 |
| Tropical and pit fruitFruit and Fruit Products (pit, subtropical and tropical fruits) | Coconut, subtropical and tropical fruit, juices, milk, creme, drinks and nectars; Fig, jam, jelly, preserves, marmalade, butter or candied; Mixed fruit, jam, jelly, preserves, marmalade, butter or candied, n.e.c. | 5 |
| SpicesSpices, Flavors, and Salts | Turmeric, ground, cracked (spice); Mixed spices and seasonings, liquid, with salt, n.e.c.; Vanilla, natural extract or flavor (spice) | 4 |
| Meat and poultryMeat, Meat Products, and Poultry | Kangaroo | 3 |
| Cereals and breakfast foodsCereal Preparations, Breakfast Foods | Cereal preparations not elsewhere mentioned, n.e.c.; Mixed cereal flakes,shredded and other forms ready to eat | 2 |
| Milk and butterMilk, Butter, and Dried Milk Products | Milk, concentrated, evaporated and condensed; Yogurt (plain, flavored or fruit added) | 2 |
| Vegetable oilsVegetable Oils (Includes Olive Oil) | Mustard oil, refined, single ingredient, see 28o for mustard oil as a flavoring; Vegetable shortening, n.e.c. | 2 |
| CheeseCheese and Cheese Products | Cheese, pasteurized, process (standardized) | 1 |
| SeafoodFishery/Seafood Products | Abalone | 1 |
| Vegetable proteinVegetable Protein Products (Simulated Meats) | Vegetable protein products not elsewhere mentioned, n.e.c. | 1 |
| Nuts and seedsNuts and Edible Seeds | Macadamia, shelled | 1 |
| Coffee and teaCoffee and Tea | Tea, n.e.c. | 1 |
Most refused products from Australia
FDA's product descriptions on the refused lines, grouped case-insensitively.
| Product | Lines | Share |
|---|---|---|
| Henna | 238 | 32.1% |
| Herbals & botanicals (not teas), n.e.c. | 96 | 12.9% |
| Baked snack food, n.e.c. | 56 | 7.5% |
| Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. | 31 | 4.2% |
| Hard candy with nut or nut products, n.e.c. (without chocolate) | 21 | 2.8% |
| Hard candy without nuts and fruit, n.e.c. (without chocolate) | 19 | 2.6% |
| Other formula products, n.e.c., powder formula | 18 | 2.4% |
| Garbanzo bean | 16 | 2.2% |
| Chana dal | 11 | 1.5% |
| Flavored candy, soft (live savers, etc.), without nuts and fruit (without chocolate) | 11 | 1.5% |
FDA import alerts that list Australia firms
13 alerts list at least one firm in Australia: 46 firms on a red list, 53 firms on any list.
| Alert | Covers | Red | Green |
|---|---|---|---|
| 45-02 | Foods with illegal or undeclared colors | 14 | |
| 71-04 | Animal food: Salmonella | 9 | |
| 99-08 | Processed human and animal foods: pesticides | 9 | |
| 99-19 | Food products: Salmonella | 8 | |
| 16-02 | Dried shark fins, fish maws and shark cartilage: filth | 4 | |
| 99-39 | Imported foods that appear to be misbranded | 3 | |
| 16-125 | Refrigerated raw fish in reduced oxygen packaging | 2 | |
| 54-12 | Foods that do not properly declare ginseng | 2 | |
| 16-81 | Seafood products: Salmonella | 1 | |
| 26-04 | Expressed Mustard Oil | 1 | |
| 40-05 | Adulterated and misbranded infant formula | 1 | |
| 54-14 | Supplements from firms not meeting supplement GMP | 1 |
The 12 alerts with the most listings. All alerts are on the import alerts page.
Australia firms with the most FDA records
Counts are FDA records in SupplierRadar's data (refusals, import alert listings and other events), not a ranking of quality.
| Firm | City | FDA records |
|---|---|---|
| Brow Code Pty Ltd | Molendinar | 238 |
| ONE Group | Ashmore | 71 |
| Arnott's Biscuits | North Strathfield | 57 |
| Nestles | New South Whales | 51 |
| Australian Choice Exports Pty Ltd | Kenmore | 44 |
| Mondelez Australia Pty Limited | South Melbourne | 24 |
| The Littleoak Company Pty Co | Byron Bay | 21 |
| Flavour & Spice Pty Ltd | Mudgeeraba | 13 |
| Natural Vitality | Brendale | 11 |
| Organic & Natural Enterprise Group | Molendinar | 10 |
Latest refusals from Australia
The 20 most recent refused lines, each with its FDA source.
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| BJP Laboratories Pty LtdYatala, Australia | Dietary conventional foods, n.e.c | SUPPL GMP | Source | |
| Southern Canning Pty LtdPortland, Australia | Abalone | NO PROCESS | Source | |
| BJP Laboratories Pty LtdYatala, Australia | Vitamin, n.e.c | SUPPL GMP | Source | |
| Mega Lifesciences (Australia) Pty LtdPakenham, Australia | Vitamin, n.e.c | UNAPPROVED | Source | |
| BJP Laboratories Pty LtdYatala, Australia | Vitamin, n.e.c | SUPPL GMP | Source | |
| BJP Laboratories Pty LtdYatala, Australia | Vitamin, n.e.c | SUPPL GMP | Source | |
| Antaria Pty. Ltd.Rocklea, Australia | Zinc (mineral) | DRUG GMPS | Source | |
| BJP Laboratories Pty LtdYatala, Australia | Probiotics (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.) | SUPPL GMP | Source | |
| BJP Laboratories Pty LtdYatala, Australia | Probiotics (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.) | SUPPL GMP | Source | |
| Darrell Lea Confectionery Co. Pty. Ltd.Ingleburn, Australia | Flavored candy, soft (live savers, etc.), without nuts and fruit (without chocolate) | UNSAFE COLLIST INGRENUTRIT LBL | Source | |
| Mondelez Australia Pty LtdScoresby, Australia | Flavored candy, soft (live savers, etc.), without nuts and fruit (without chocolate) | UNSAFE COLUSUAL NAMENUTRIT LBL | Source | |
| Mondelez Australia Pty LtdScoresby, Australia | Flavored candy, soft (live savers, etc.), without nuts and fruit (without chocolate) | UNSAFE COLUSUAL NAMENUTRIT LBL | Source | |
| Mondelez Australia Pty LtdScoresby, Australia | Flavored candy, soft (live savers, etc.), without nuts and fruit (without chocolate) | UNSAFE COLUSUAL NAMENUTRIT LBL | Source | |
| Darrell Lea Confectionery Co. Pty. Ltd.Ingleburn, Australia | Flavored candy, soft (live savers, etc.), without nuts and fruit (without chocolate) | UNSAFE COLLIST INGRENUTRIT LBL | Source | |
| Mondelez Australia Pty LtdScoresby, Australia | Flavored candy, soft (live savers, etc.), without nuts and fruit (without chocolate) | LIST INGRECOLORLABELNUTRIT LBL | Source | |
| Darrell Lea Confectionery Co. Pty. Ltd.Ingleburn, Australia | Flavored candy, soft (live savers, etc.), without nuts and fruit (without chocolate) | UNSAFE COLLIST INGRENUTRIT LBL | Source | |
| Darrell Lea Confectionery Co. Pty. Ltd.Ingleburn, Australia | Flavored candy, soft (live savers, etc.), without nuts and fruit (without chocolate) | UNSAFE COLLIST INGRENUTRIT LBL | Source | |
| Darrell Lea Confectionery Co. Pty. Ltd.Ingleburn, Australia | Flavored candy, soft (live savers, etc.), without nuts and fruit (without chocolate) | UNSAFE COLLIST INGRENUTRIT LBL | Source | |
| Darrell Lea Confectionery Co. Pty. Ltd.Ingleburn, Australia | Flavored candy, soft (live savers, etc.), without nuts and fruit (without chocolate) | UNSAFE COLLIST INGRENUTRIT LBL | Source | |
| Mondelez Australia Pty LtdScoresby, Australia | Flavored candy, soft (live savers, etc.), without nuts and fruit (without chocolate) | USUAL NAMENUTRIT LBL | Source |
Questions about FDA refusals from Australia
- How many Australia shipments did FDA refuse in 2026?
- FDA refused 30 shipment lines from Australia in 2026 through September 8, 2026, compared with 12 in 2025 (a full year).
- Why does FDA refuse food from Australia?
- FDA records a charge code on every refused shipment line. For Australia the most frequent are UNSAFE COL (color additive unsafe under section 721, 219 lines), NUTRIT LBL (nutrition information missing from label, 168 lines) and FSVP VIO (importer not in compliance with FSVP, 123 lines). A charge describes what FDA's reference table says about one shipment line; it is not a finding about every firm in the country.
- Which Australia firms have the most FDA refusals?
- In SupplierRadar's records the Australia firms with the most FDA records (refusals, import alert listings and other events) are BROW CODE PTY LTD (Molendinar) with 238 records, ONE Group (Ashmore) with 71 records and Arnott's Biscuits (North Strathfield) with 57 records. Each firm's page lists every record with its FDA source.
- Which FDA import alerts list Australia firms?
- As of October 26, 2026, 13 FDA import alerts list at least one firm in Australia. The alerts with the most Australia listings are Import Alert 45-02 (14 firms), Import Alert 71-04 (9 firms) and Import Alert 99-08 (9 firms).
- How many Australia firms are on an FDA import alert red list?
- As of October 26, 2026, 46 Australia firms are on the red list of at least one FDA import alert in SupplierRadar's records, and 53 firms are on any list.
All Australia suppliers with FDA records (69)
Every Australia firm in SupplierRadar's data with an active import alert, a warning letter or at least five FDA records, most recently active first. Each name opens the firm's FDA record history.
- BJP Laboratories Pty LtdYatala
- Darrell Lea Confectionery Co. Pty. Ltd.Ingleburn
- Mondelez Australia Pty LtdScoresby
- Mypause Health Pty LtdCastle Hill
- Watch and Grow Food Co.Heatherton
- Arnott's Biscuits Ltd (Arnott's Intl)North Strathfield
- Agrifoods Australia Pty TldDalby
- Steric Trading Pty LtdFairfield East
- U Chews AustraliaClontarf
- Michael Pond Family TrustKarrinyup
- Naturally Australian Pet CareWarranulla
- Dailis Pty Ltd T/a Natural Pet Treats AustraliaCaloundra West
- Cool Off Pty LtdHowlong
- Blend and Pack PTY LTDHallam
- Homart Pharmaceuticals Pty. Ltd.Rydalmere
- Encore Beverages Pty LtdDandenong South
- Mainfreight Warehousing Dandenong SouthDandenong South
- Vitex Pharmaceuticals Pty Ltd.Eastern Creek
- The Littleoak Company Pty CoByron Bay
- A.G.M. Foods Pty LtdWynnum
- Brow Code Pty LtdMolendinar
- Arnott's BiscuitsNorth Strathfield
- Mondelez Australia Pty LimitedSouth Melbourne
- NestlesNew South Whales
- Aust-Grain Exports Pty LtdHorsham
- Australian Choice Exports Pty LtdKenmore
- Societa CoficaCremorne
- Naturally Australian Meat & GameMorningside
- Australian Tallow Producers Pty LtdBrooklyn
- J K Int'L Pty Ltd.Brisbane
- Mars Petcare AustraliaWodonga
- Henry Jones Foods Pty LtdVictoria
- Lennonville OrchardsNorth Bruny
- Flavour & Spice Pty LtdMudgeeraba
- ONE GroupAshmore
- Natural VitalityBrendale
- Pariya FoodSt Peters
- Organic & Natural Enterprise GroupMolendinar
- Hanks Brands Pty LimitedBrookvale
- Yandilla Mustard Oil Enterprise PtyCootamundra
- Masterfoods Australia New ZealandWyong
- Ultra Mix (Aust) Pty LtdWest Footscray
- rosedale meatsHampton East
- Rosedale MeatsHampton
- Clover Valley Meat Co.Mascot
- Job Fish Australia Pty LtdClontarf
- Australian Hiramasa Pty LtdWHYALLA
- D'Groot International Food MarketinRedland Bay
- Arnott'S Biscuits Pty LtdNorth Strathfield
- Cadbury Schweppes Pty LtdTullamarine
- Cadbury Scwepps Pty Ltd.Melbourne
- Campbells Cash & Carry Pty Ltd.Nerang
- Golden Circle Ltd.Northgate
- Nelson & Robertson Exports Pty LtdSydney
- Nelson & Robertson Pty LtdSydney
- Spiroski Foods Pty LtdPadstow
- Ag-Exports Pty Ltd.Chatswood
- B & G Export Corporation Pty LtdSydney
- Food Ingredients Australia Pty LtdChatswood
- Intercontinental Grain ExportsNewport
- J K International Pty Ltd.Queensland
- J.K International Pty. Ltd.Brisbane
- Lenah Game MeatsRocherlea
- Meramist Pty. Ltd.Caboolture
- Southern Game Meat Pty LtdSilverwater
- Cottee Dairy Products Pty Ltd.Gordon
- Cottee Health Products Pty LimitedFrenchs Forest
- Lane Labs Australia PTY Ltd.Brisbane
- Probiotic PTY LMTDParadise Point
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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.