European skincare has a strong reputation with American customers. Yet many excellent European brands never reach the US, or reach it only through unofficial resellers. The barrier is rarely the product. It is regulation, logistics and the cost of building a presence from scratch.
MoCRA changed the rules
The Modernization of Cosmetics Regulation Act of 2022 gave the FDA its biggest set of new powers over cosmetics in decades. For a brand entering the US, the key obligations include:
- Facility registration for the facilities that manufacture or process the products.
- Product listing with the FDA, including ingredients, by the responsible person.
- Safety substantiation records showing each product is safe for its intended use.
- Adverse event reporting and a US contact on the label through which consumers can report issues.
Classification matters too. Products that are cosmetics in the EU can be over-the-counter drugs in the US. Sunscreens and anti-dandruff products are common examples, and they follow a different, stricter route. Colour additives and some claims are also treated differently. A label that is fully compliant in Europe often needs rework for the US.
Amazon.com is the fastest route to demand
For most European brands the first US channel is Amazon.com. It gives immediate access to customers who already search for the brand or the ingredient, and it provides data on what sells before any retail conversation. Success depends on US brand registration, listings written for American search behaviour, reviews built through legitimate programmes, and stock placed in US fulfilment centres.
A realistic first year
- Months 1 to 3: regulatory review, label adaptation, trademark position, US import and customs set-up.
- Months 3 to 6: first shipment, Amazon.com launch with a focused range of hero products, advertising to build visibility.
- Months 6 to 12: expand the range based on data, add TikTok Shop US and a direct website, prepare for further channels.
Why a distribution partner helps
Building a US entity, a regulatory function, an import process and a marketplace team costs a brand significant time and capital before the first sale. A distribution partner that already has these in place lets the brand focus on product and marketing while the partner buys, imports and sells. KOD distributes European brands in the US from the US, with the same single-seller approach we use in Europe.
This article is general information and not regulatory or legal advice. Requirements depend on the product and its claims. Always confirm your obligations with a qualified US regulatory specialist.
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