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Compliance Guide · Beauty & Personal Care · US Market

Six things to check
before entering the US.

The rules have moved fast these past two years — many brands find out after the container is packed. Open each item for the requirement, the deadline and the most common trap.

Last verified 2026-08Based on FDA public sourcesAbout a 6-minute read

This edition covers beauty & personal care (MoCRA). Electronics (UL / FCC) and children's-products (CPSIA) editions are in the works.

MoCRA puts most obligations on the “responsible person” — the manufacturer, packer or distributor named on the product label. Not your operating agency, not your freight forwarder, unless you put them on the label.

A foreign brand with no US entity must appoint a US responsible person or US agent, with reachable contact details on the label. The labeling deadline passed on December 29, 2024.

Who carries it
The party named on the label — not an intermediary
Foreign brands
Must appoint a US responsible person or agent
Label deadline
Passed 2024-12-29

Common trap Registering the responsible person under your agency or forwarder for convenience — that hands your US compliance identity to someone else. Switch partners, and registrations, listings and history start over.

Facilities that manufacture or process cosmetics for the US market must register with the FDA. And registration doesn't end there: changes must be updated within 60 days, and registration renews every two years; a new facility registers within 60 days of starting production.

On February 11, 2026 the FDA updated the Cosmetics Direct portal, adding registration-status and renewal-date fields to the facility registration page — built precisely around the two-year renewal cycle.

Where to file
Cosmetics Direct (Form FDA 5066)
Renewal cycle
Every 2 years
Change updates
Within 60 days
New facilities
Within 60 days of production

Common trap An agent registered the facility years ago and nobody owns the renewal. The lapse surfaces at an audit or a port inquiry — after it has already expired.

The responsible person must file a product listing with the FDA for every cosmetic product on the market, including the full ingredient statement. Listings update annually; new products are listed within 120 days of entering the market.

Note that free gifts and samples fall within listing scope too, unless separately exempt.

Where to file
Cosmetics Direct (Form FDA 5067)
Update cycle
Annually
New products
Within 120 days of market entry
Scope
Includes free gifts and samples

Common trap The hero SKU is listed; the shades, limited editions and gift-with-purchase samples added later are not. At inspection, those gaps put the whole shipment at risk.

The FDA has formally enforced facility registration and product listing since July 1, 2024. Products missing either are deemed adulterated or misbranded — exposing them to port detention, refused entry and recalls.

What this really means: compliance isn't “nice to have.” It is the precondition for your goods clearing the border at all.

Enforcement since
2024-07-01
Finding
Adulterated or misbranded
Main risks
Port detention, refused entry, recall

Companies averaging under $1M in US cosmetics sales over the prior three years may be exempt from facility registration and product listing. But the exemption has hard exceptions — these four product types never qualify, regardless of revenue:

Exception 1
Products that contact the eye's mucous membrane in normal use
Exception 2
Injected products
Exception 3
Products intended for internal use
Exception 4
Products altering appearance for 24+ hours that consumers can't remove themselves

Common trap Judging “small business” by revenue alone — and missing that eyeliner, eyeshadow and lash products fall under the first exception.

The duty-free treatment for small parcels has been eliminated, and tariffs have risen sharply in some categories. Customs scrutiny of under-declared values, product certifications and IPPC wood-packaging marks has visibly tightened.

The practical impact: your cost structure needs a full re-run. Margins modeled on direct shipping rarely survive domestic stocking plus tariffs — pricing and replenishment rhythms both need redesigning.

De-minimis
Eliminated
Scrutiny focus
Under-declared values, certifications, IPPC marks
Model shift
Direct shipping → domestic stocking & brand-building

Common trap Pricing domestic stock with the old direct-shipping model — the first container lands, and duties plus storage have already eaten the margin.

Found a gap
after the check?

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Regulatory information on this page is compiled from FDA and other public sources, last verified August 2026. It is general reference only, not legal or compliance advice. Rules change — confirm specific filings against FDA publications and licensed agencies.