FDA Stories #018 — A Nigerian Shea Butter Producer Had Two Facilities But Only One Registration

A luxury perfume house based in Grasse, France, had been selling in the US market through department stores for decades. Fragrances, candles, body care — a portfolio of over 40 products. Their US distribution was handled by an American partner who managed retail relationships, marketing, and logistics.

In January 2025, the American partner mentioned during a routine call that they had received an inquiry from a retailer asking whether the brand was MoCRA-compliant. The brand's regulatory team in France had never heard of MoCRA.

What they missed

The Modernization of Cosmetics Regulation Act was signed into law in December 2022. It required cosmetic facility registration and product listing beginning in 2023. The French perfume house had been selling in the US for the entire duration of MoCRA's existence without registering their manufacturing facility or listing any of their products. They had no adverse event reporting system. They had no US Agent designated for cosmetics. They were out of compliance on every MoCRA obligation.

The perfume house's regulatory team was experienced in EU cosmetics regulation — CPNP notifications, Responsible Person designation, Product Information Files, Safety Assessments. They knew European rules inside and out. But MoCRA was a US law, and no one in their compliance department was monitoring US regulatory changes.

What we did

We registered their Grasse manufacturing facility with the FDA under MoCRA within one week. We listed all 40+ products through FDA's Cosmetics Direct system — each product with its full INCI ingredient list, product category, and responsible person information. We designated ourselves as their US Agent. We established an adverse event intake process that routes consumer complaints from their US distributor to the responsible person in France within the MoCRA-required timeline. Total time from first contact to full compliance: 18 business days.

The lesson

MoCRA is new. Many European cosmetic brands — even sophisticated ones with full EU compliance programs — do not know it exists. If you sell cosmetics in the United States and you have not registered under MoCRA, you are out of compliance. The law does not have a grace period for brands that were already in the market before it was enacted. Register now. fdabridge.com/cosmetics.