Australian founders who ask how Australian brands enter the US market are usually past the hard part. They have a product that wins at home, a loyal customer base and often a reputation in the Asia-Pacific region. What they underestimate is that the United States is not one market but a stack of rules, retailers and cost layers that behave differently from Woolworths, Coles, Chemist Warehouse or Priceline. This guide sets out the realistic route in 2026: what to settle before you ship, which regulatory regimes apply to food, beauty and sunscreen, how to think about tariffs while they are still moving, and how to sequence retail.
Brand Refinery is a CPG consulting firm that helps international consumer brands enter the U.S. market and win retail partnerships with Walmart, Target, Kroger, Costco, Ulta and others. This article is general information, not legal, customs or tax advice; confirm duty rates and regulatory status with a licensed customs broker and regulatory counsel before you commit inventory.
What makes the US different for an Australian brand
The first shock is scale and fragmentation. A national launch in Australia can be run from two cities. In the US, retailers buy by region, distributors cover different territories, and the cost of freight, warehousing and marketing rises with every state you add.
The second shock is compliance. Australian labels, claims and ingredient lists rarely transfer as they are. The US treats food, cosmetics and drugs as three separate regulatory categories, and a product you sell as a cosmetic or a complementary medicine at home can be a drug in the US.
The third shock is the pay-to-play structure of retail. Slotting, promotional funding, deductions and chargebacks are a normal cost of doing business, and they are rarely visible in a first conversation with a buyer. Our guide to what it costs to launch a consumer brand in the US shows how those costs stack.
Step 1: Decide whether you are ready
Before you spend on a US entity or a pallet of stock, answer four questions honestly.
- Do you have a repeatable domestic engine, meaning stable margins, a working supply chain and capacity to supply a market roughly twelve times larger by population?
- Can the product survive US shelf life, shipping time and temperature exposure? Ocean freight from Australia to the US typically adds weeks, so shelf life at arrival matters.
- Is the formula and claim set compliant, or fixable at reasonable cost?
- Do you have the working capital to fund six to twelve months of stock, deductions and marketing before cash returns?
If the answer to any is no, fix that first. Our guide to how international brands enter US retail covers the readiness test in more detail.
Step 2: Understand the regulatory category
Food and beverage
Foreign food facilities that manufacture, process, pack or hold food for US consumption must register with the FDA and designate a U.S. agent. Every shipment of imported food needs prior notice filed with FDA before it arrives. Under the Foreign Supplier Verification Program, the US importer is responsible for verifying that the foreign supplier produces food that meets US safety standards. Labeling must meet US rules, including the Nutrition Facts panel, allergen declaration and ingredient naming conventions that differ from Food Standards Australia New Zealand requirements. Our guide to FDA labeling requirements for 2026 walks through the current obligations.
Beauty and personal care
Cosmetics sold in the US fall under the FDA's cosmetics rules as amended by the Modernization of Cosmetics Regulation Act (MoCRA). That regime includes facility registration, product listing, safety substantiation and adverse event reporting. If your brand makes claims that treat or prevent a disease or change the structure or function of the body, the product can move from cosmetic to drug status.
Sunscreen: the trap that catches Australian brands
Australia is known for sun care, and many Australian brands see the US as an obvious next market. The catch is that in the US, sunscreen is an over-the-counter drug, not a cosmetic. Manufacturing facilities, including foreign ones, must maintain FDA drug establishment registration, products must be listed with the FDA, foreign manufacturers must designate a U.S. agent, and labels must follow Drug Facts formatting. Formulas must also fit the US OTC sunscreen monograph, and the set of permitted active ingredients is narrower than in Australia.
There is movement here. According to Registrar Corp, the FDA finalized an administrative order adding bemotrizinol to the OTC sunscreen monograph, with an effective date of 9 August 2026 unless disputed, and with an 18-month exclusivity period for the requester, DSM Nutritional Products. Because exclusivity affects who can use the ingredient and when, confirm the current status with regulatory counsel before you reformulate around it.
For a sunscreen brand, budget regulatory time before marketing time. Our guide to how to sell to Ulta Beauty also explains why a clean compliance file speeds up retailer review.
Step 3: Treat tariffs as a scenario, not a number
US tariff policy has changed repeatedly in 2026, so any single rate quoted in an article can go stale. As reported by the ABC, the US Supreme Court struck down earlier emergency tariffs in February 2026, a temporary 10 percent tariff then lapsed, and on 24 July 2026 a 12.5 percent tariff on Australian exports took effect, with the Australian government lobbying against it. The same report noted that some products exempt under the previous tariff, including some food products, remained exempt. Treat that rate as unsettled.
The practical response is to model three cases in your pricing: the current rate, a higher rate and a lower rate. Decide who absorbs the difference between you, your importer and the retailer, and write that into your distribution agreement. Duties are paid by the importer of record, which makes your choice of importer a commercial decision, not a paperwork one.
Also note that the US suspended the de minimis exemption for low-value shipments from 29 August 2025, according to Queensland government trade guidance. Sending small parcels direct to consumers no longer avoids duties and formal entry the way it once did. Check current rules with a customs broker.
Step 4: Build the US operating base
You need four things in place before the first retail conversation.
- A US importer of record and customs broker. Without them, goods do not clear.
- A US entity or a distributor-of-record arrangement. Many Australian brands start with a Delaware company and a registered agent, then add a state sales tax registration where needed.
- A US warehouse partner. Choose between a 3PL, a distributor warehouse and direct-store delivery based on your product and channel. Our guide to CPG distribution: 3PL, DSD and warehouse compares them.
- US barcodes, insurance and pricing in US dollars. Retailers expect certificates of insurance and a clean item master.
Step 5: Choose the retail route
Australian brands tend to pick one of three routes.
Direct-to-consumer first. Shopify and Amazon allow you to test demand, collect reviews and build data. This works for brands with strong digital creative and a product that ships well, but it rarely produces retail leverage on its own.
Specialty and natural channel. Natural grocers, specialty beauty and regional chains reward differentiated products and give you a proof of velocity. Our guides to selling to Whole Foods and onboarding with UNFI and KeHE explain how this channel buys.
Mass and club. Walmart, Target and Costco offer scale but demand supply chain discipline, EDI and a deduction budget. These are second or third year targets for most foreign brands.
Whichever you pick, do it in a limited geography first. A regional launch lets you prove velocity per store per week, which is the number buyers care about.
Step 6: Fund the gap
Australian brands often underfund the working capital gap between paying a manufacturer and collecting from US retailers on net 30 to 60 day terms, with deductions taken before payment. Plan for funding before you need it. See our guide on how to raise capital for a CPG brand.
A 12-month roadmap
- Months 1 to 2: regulatory gap review, label and claim review, tariff scenario model, importer and broker selection.
- Months 3 to 4: US entity, insurance, warehouse and item master set up; first production run for US specification.
- Months 5 to 6: DTC and marketplace soft launch in a controlled set of states.
- Months 7 to 9: distributor and retailer outreach using early sell-through data.
- Months 10 to 12: first regional retail test, then a decision on national scale based on velocity and margin.
Common mistakes
- Assuming Australian compliance equals US compliance.
- Pricing on today's tariff rate as if it were permanent.
- Treating sunscreen as a cosmetic.
- Launching nationally with no velocity data.
- Choosing an importer on price alone.
- Ignoring deductions and chargebacks in the margin model.
Frequently Asked Questions
Do Australian brands need an FDA approval to sell in the US? The FDA does not pre-approve most food or cosmetic products, but the facilities and products must comply with US rules. Food facilities must register and name a U.S. agent, cosmetics fall under MoCRA, and sunscreens are OTC drugs that require drug establishment registration and product listing. Which regime applies depends on the product and its claims.
Is sunscreen regulated differently in the US than in Australia? Yes. In the US, sunscreen is an over-the-counter drug governed by the OTC monograph process, with Drug Facts labeling and a limited list of permitted active ingredients. Australian formulas often need to be reformulated or adapted before they can be sold in the US.
What tariff do Australian goods face entering the US? The rate has changed several times in 2026. The ABC reported a 12.5 percent tariff on Australian exports from 24 July 2026, with some products remaining exempt. Because policy is still moving, model several scenarios and confirm the current rate with a customs broker before pricing.
Should an Australian brand launch on Amazon or go straight to retail? Most brands benefit from a controlled direct-to-consumer or marketplace launch first, because it produces sales data and reviews that make retail conversations easier. Going straight to a national retailer without a US operating base or velocity data usually leads to costly deductions and thin margins.
How much does it cost for an Australian brand to launch in the US? Costs depend on category, channel and compliance needs, and they include regulatory work, freight, duties, warehousing, marketing, retailer fees and working capital. Build a bottom-up budget for the first twelve months and keep a contingency for tariff and deduction changes.
Next step
Brand Refinery helps Australian and other international founders pressure-test their U.S. entry plan, from compliance and pricing to retail sequencing. If you are planning a launch, book a strategy call and see how we work on our services and about pages.