INTERNATIONAL TRADE LAW
Importing Cosmetics: FDA Rules Under MoCRA
Importing cosmetics into the United States changed significantly with the Modernization of Cosmetics Regulation Act (MoCRA) of 2022 — the biggest expansion of FDA cosmetics authority in decades. Where cosmetics once faced relatively light federal oversight, importers and responsible persons now face mandatory facility registration and product listing, with the FDA enforcing these requirements since July 1, 2024. Cosmetics still don’t require pre-market FDA approval the way drugs do, but the new registration and listing regime, along with longstanding rules on adulteration, misbranding, and color additives, make compliance a real obligation. This guide covers the current framework.
What MoCRA Changed
MoCRA introduced a registration-and-listing system modeled on other FDA-regulated products. The two core obligations:
- Facility registration. Every person who owns or operates a facility that manufactures or processes cosmetics for U.S. distribution must register that facility with the FDA, update it within 60 days of changes, and renew every two years.
- Product listing. The responsible person must list each cosmetic product with the FDA, including product category, ingredients (including fragrances, flavors, and colors), and facility identifiers.
The FDA built an electronic portal (Cosmetics Direct) for these submissions and began enforcing the requirements on July 1, 2024.
Who Is the “Responsible Person”
MoCRA centers obligations on the responsible person — the manufacturer, packer, or distributor whose name appears on the product label. For imported cosmetics, identifying who holds that role matters, because the responsible person is who must submit the product listing and bears core compliance duties (including, over time, safety substantiation and adverse-event reporting as MoCRA’s provisions phase in).
What Hasn’t Changed: Adulteration, Misbranding, and Colors
Cosmetics still must not be adulterated (e.g., containing harmful or filthy substances) or misbranded (e.g., false or misleading labeling, or labeling that omits required information). And color additives used in cosmetics generally must be FDA-approved for their intended use — one of the few true pre-market approvals in cosmetics. Imported cosmetics that are adulterated, misbranded, or contain unapproved color additives can be detained and refused at the border, as with any FDA-regulated product.
Practical Steps for Cosmetic Importers
| Step | What to do |
|---|---|
| Confirm facility registration | Ensure the manufacturing/processing facility is registered with FDA |
| Confirm product listing | Verify the responsible person has listed each product via Cosmetics Direct |
| Check labeling | Confirm labels meet FDA requirements and aren’t misleading |
| Verify color additives | Confirm any colors are FDA-approved for the intended use |
| File entry properly | Clear FDA review at import like other FDA-regulated goods |
Note that some MoCRA provisions (such as certain Good Manufacturing Practice requirements) have phased or delayed timelines, so confirm the current effective dates when you set up compliance.
Frequently Asked Questions
Do imported cosmetics need FDA approval?
Cosmetics generally do not need pre-market FDA approval the way drugs do — with the notable exception of color additives, which must be FDA-approved for their intended use. However, under MoCRA, facilities must be registered and products listed with the FDA, and cosmetics must not be adulterated or misbranded.
What is MoCRA?
The Modernization of Cosmetics Regulation Act of 2022, which significantly expanded FDA oversight of cosmetics. It introduced mandatory facility registration and product listing (enforced since July 1, 2024), along with provisions on safety substantiation, adverse-event reporting, and records that phase in over time.
Who is the “responsible person” for an imported cosmetic?
The manufacturer, packer, or distributor whose name appears on the product label. The responsible person must submit the MoCRA product listing and carries core compliance obligations for the cosmetic, which matters for imported products where roles can be split across parties.
Can imported cosmetics be refused entry?
Yes. Cosmetics that are adulterated, misbranded, contain unapproved color additives, or fail to meet FDA requirements can be detained and refused at the border. Proper facility registration, product listing, labeling, and color-additive compliance keep entries clean.
MoCRA turned cosmetics importing into a real FDA compliance project with registration and listing at its core. Reidel Law Firm helps cosmetic importers and responsible persons meet MoCRA and FDA requirements on flat-fee terms. Get an import compliance memo.
