From the right retail route for your brand to the reorder — we prepare with you.
Book a free 20-min Market Readiness Checkof US Food and Drug Administration (FDA) cosmetic import refusals in February 2025 came from Korea — more than any other country that month.
of EU product-safety alerts (Safety Gate) in 2025 were cosmetics — the largest single category, ahead of toys and electronics.
Korean cosmetic brands consistently rank near the top of FDA import refusals. In parallel, cosmetics are the single most-flagged product category in the EU's own safety-alert system. A leading cause in the US is marketing language that crosses from cosmetic claim into drug claim, along with sunscreen (SPF) products that the US regulates as drugs. In the EU, it's a mix of banned-ingredient exposure and brands treating the mandatory EU Responsible Person role as a paperwork afterthought.
cosmetic batches refused by FDA in 2024 alone, across 42 countries — a steady enforcement pattern, not a one-off.
Korea's standing among refusal-source countries in February 2025 — topping every other exporting nation that month.
of EU cosmetic safety alerts in 2025 traced back to one ingredient (Lilial/BMHCA) — banned in March 2022. Three-plus years later, it's still the majority of what's getting caught (2025 Safety Gate report).
The EU General Product Safety Regulation (GPSR) has tightened recalls and enforcement on online sales since December 2024.
“Boosts the activity of genes… stimulates cell regeneration.”
In 2012, the FDA sent a warning letter over exactly this kind of claim on L’Oréal’s Lancôme Génifique line — concluding the marketing language alone made the product an unapproved new drug under US law.
A global, sophisticated brand with full legal resources got this wrong in the US. The same holds in the EU: Lilial was banned in 2022, and it's still the largest driver of EU cosmetic safety alerts today — “everyone used to use it” doesn't reset the clock once a rule changes.
This risk isn't about company size, and it isn't about how established an ingredient or a claim feels. It's about wording, and about staying current.
A brand-specific audit of your product claims and label language against current FDA cosmetic-vs-drug rules and the EU Cosmetics Regulation.
Responsible Person, PIF, CPSR, and CPNP in the EU; MoCRA registration and importer structuring in the US — coordinated through qualified partners, not performed in-house.
Once the compliance foundation is solid: whether to prioritize the US, the EU, or run both in parallel — and how to position for Western retail buyers in each.
Before you meet pharmacies, concept stores or distributors, we prepare what buyers check first: product sheet, price structure and brand story.
Free. No pitch. If there's nothing to fix, you'll hear that too.