Skincare is one of the fastest-growing categories of cosmetics imports into the U.S., and it’s also one of the most exposed to compliance mistakes. Moisturizers, serums, cleansers, and treatment products all fall under the Modernization of Cosmetics Regulation Act (MoCRA), the 2022 law that gave FDA real enforcement authority over cosmetics for the first time. If you’re a foreign or indie skincare brand planning to sell in the U.S., here’s what actually has to happen before your products can legally reach shelves or fulfillment centers.
Facility Registration (Every Two Years)
Any facility that manufactures or processes skincare products for U.S. distribution must register with FDA through the Cosmetics Direct portal. This includes foreign facilities, not just domestic ones. Registration must be renewed every two years, and the deadline is tied to your original registration date, not a single fixed calendar date.
Product Listing (Every Year)
Separately from facility registration, each individual skincare product you sell needs to be listed with FDA, including its ingredients. This is an annual obligation, not a two-year one. It’s easy to conflate the two schedules since they both run through Cosmetics Direct, but facility registration and product listing renew on different clocks.
Safety Substantiation
MoCRA requires “adequate substantiation” that your skincare products are safe for their intended use, backed by real testing, research, or other reliable evidence, before they go to market. For active ingredients like retinoids, exfoliating acids, or SPF-adjacent claims, this bar is higher than for a basic moisturizer, and documentation needs to be ready to produce if FDA asks for it.
Adverse Event Reporting and Recordkeeping
Serious adverse events tied to your skincare products (things like significant reactions requiring medical attention) must be reported to FDA within 15 business days. Records related to safety and adverse events generally need to be kept for six years, or three years for small businesses.
Who Handles the Responsible Person Role
MoCRA requires every skincare product label to name a Responsible Person, typically the manufacturer, packer, or distributor. This role is legally tied to whoever is actually named on the label. It isn’t something a third party can take on by contract alone. If your brand is based outside the U.S. and you don’t yet have someone filling that role, FDA Entry can support your Responsible Person’s compliance obligations (safety substantiation, recordkeeping, adverse event tracking) while also serving as your required U.S. Agent, a separate role that acts as your official FDA point of contact.
A Fragrance Allergen Rule Is Coming, But Isn’t Final Yet
FDA is expected to propose a new rule requiring on-label disclosure of a much longer list of fragrance allergens, with a proposed rule anticipated around May 2026 and phased enforcement likely stretching into 2027 and beyond. If your skincare line is fragranced, it’s worth watching, but nothing is enforceable yet. Don’t let anyone tell you otherwise.
What FDA Entry Does for Skincare Importers
FDA Entry serves as your U.S. Agent, the required FDA point of contact for foreign facilities, and supports the registration, product listing, and safety documentation work that keeps your skincare line compliant on an ongoing basis, not just at launch.
FAQ
Yes. Facility registration and product listing both need to be in place before your skincare products are legally distributed in the U.S. market.
No. Facility registration covers where your products are made and renews every two years. Product listing covers each individual product and its ingredients, and renews every year.
FDA Entry Point serves as your U.S. Agent and supports your Responsible Person compliance work, but the Responsible Person role is tied to whoever is named on your product label, it can’t be outsourced by contract to a third party.
Serious adverse events need to be reported to FDA within 15 business days, and supporting records generally need to be retained for six years (three for small businesses).
Yes. Any foreign facility manufacturing or processing skincare products for the U.S. market must designate a U.S. Agent as its official FDA point of contact.
Ready to get your skincare line compliant? Contact FDA Entry today or contact our team with questions.