Cosmetics
Selling cosmetics in the US changed significantly with the Modernization of Cosmetics Regulation Act (MoCRA) 2022, which added facility registration, product listing, a named Responsible Person and safety substantiation under the FD&C Act, all overseen by the FDA.
At Taylored Consultancy Ltd, we make cosmetic compliance clear and stress-free. We guide you through MoCRA registration, listing and safety substantiation so your products meet FDA requirements without unnecessary delays.
Clearing the path to market -
regulatory and quality expertise that gets your cosmetics safe, compliant, and ready for market.
We assess where you stand against MoCRA and build a clear action plan to get and stay compliant.
We help you register your manufacturing or processing facilities with the FDA and keep registrations renewed.
We handle your cosmetic product listings with the FDA, including ingredient information.
MoCRA requires adequate substantiation of safety. We help you assemble and document the records that demonstrate your products are safe.
We review your formulation against FDA requirements and prohibited or restricted substances.
We review your labelling to ensure mandatory information - including the Responsible Person's contact details - is correct and in English.
MoCRA places obligations on a named Responsible Person. We help you understand and meet those duties, including adverse-event record-keeping.
With FDA cosmetics GMP rules developing, we help you implement ISO 22716 as a strong, recognised baseline.
Regulations can feel like a headache, but they don't have to be. We make sure you're covered, compliant, and ready to sell - without unnecessary delays or legal pitfalls.
ISO 22716 - Cosmetics Good Manufacturing Practice (GMP)
ISO 9001 - General quality management
ISO 14001 - Environmental management (where relevant)
MoCRA, the Modernization of Cosmetics Regulation Act of 2022, is the biggest update to US cosmetics law in decades, introducing mandatory facility registration, product listing, a named Responsible Person, safety substantiation requirements and FDA authority to order recalls. Before MoCRA, US cosmetics regulation was comparatively light-touch, so brands already selling in the US need to check they're covering these newer obligations.
No, cosmetics don't go through FDA premarket approval the way drugs do, but that doesn't mean there's no oversight. Under MoCRA, you still need to register your facility, list your products with the FDA, and hold safety substantiation on file, so "no approval needed" doesn't translate to "no requirements." The FDA can still act against unsafe or mislabelled products already on the market.
Yes, if you manufacture or process cosmetics for the US market, MoCRA requires facility registration with the FDA, renewed every two years, alongside product listing for each cosmetic you sell. This applies whether your facility is based in the US or overseas, so international manufacturers exporting into the US are just as much in scope as domestic ones.
If a product makes a therapeutic claim (treating acne, reducing wrinkles at a cellular level, protecting against sun damage), the FDA can classify it as a drug (or drug-cosmetic) rather than a cosmetic, triggering a much stricter approval pathway. Wording matters enormously here, since the same formulation can sit on either side of that line depending purely on how it's marketed.
Cosmetic claims in the US need to describe cosmetic effects (cleansing, beautifying, improving appearance) without straying into drug territory by implying you're treating or preventing a medical condition. Claims also need to be truthful and not misleading, backed by evidence you can produce if the FDA or a competitor challenges them. Getting this wording right avoids reclassification risk as much as regulatory risk.
US cosmetic labels need ingredients listed in descending order of concentration using INCI (International Nomenclature of Cosmetic Ingredients) names, alongside other FD&C Act labelling requirements like net quantity and any required warnings. Getting INCI naming right matters for MoCRA product listing too, since the ingredients you list with the FDA need to match what's declared on pack.
Still have questions? Contact us and we'll be happy to help.
