The expression FDA registration for cosmetics is widely used by companies seeking to market cosmetic products in the United States. However, the term is often misunderstood. Unlike medicines or certain medical devices, cosmetic products do not require FDA pre-market approval before being sold in the U.S.
MoCRA compliance refers to the set of legal obligations that now apply to many cosmetics marketed in the United States under the Modernization of Cosmetics Regulation Act of 2022. For cosmetics companies, MoCRA compliance is no longer a peripheral issue. It is now a core regulatory requirement that affects facility registration, product listing, safety substantiation, adverse event reporting, labeling, and FDA oversight. Because MoCRA significantly expanded FDA authority over cosmetics, companies placing products on the U.S. market need a structured compliance approach rather than a fragmented, product by product response.
The UK has introduced a new amendment to the Cosmetics Regulation (SI 2026/109), bringing important updates to Annex II and Annex III. Among the key changes, Hexyl Salicylate has been added to Annex III with specific restrictions, alongside the ban of 13 additional substances. With compliance deadlines now set, companies placing products on the UK market should review formulations and portfolios to ensure timely alignment.
White label cosmetics are not exempt from regulatory frameworks simply because a third party makes them. Legal responsibility attaches to the entity that places the branded product on the market and/or is named on the label under each jurisdiction’s laws. Understanding and mapping those roles across markets is essential for compliance and risk management.
One of the most common global compliance risks in private label models is the misalignment of legal responsibilities. Confusion often arises between branding, distribution, and regulatory accountability. For this reason, clearly designating the accountable entity and documenting the allocation of regulatory responsibilities are essential steps to ensure compliant market access.
The US beauty market offers significant growth opportunities, but success requires more than strong branding. In this article, we share key insights from our presentation at Cosme Week Tokyo 2026, covering US consumer trends, the rise of clean and ingredient focused beauty, the growing influence of Amazon, and the essential regulatory requirements under MoCRA and state level laws. Discover what brands need to know before entering the US market.
