Facility registration, a named Responsible Person, product listing, and label rules that replaced 84 years of near-zero federal oversight — laid out as one path, from your first FEI number to your first biennial renewal.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest expansion of FDA's authority over cosmetics since the original Federal Food, Drug & Cosmetic Act of 1938. If your facility manufactures or processes cosmetics for U.S. distribution — domestic or foreign — you now have mandatory obligations that didn't exist before: facility registration, a named Responsible Person, annual product listing, safety substantiation, adverse event reporting, and biennial renewal.
A note on where this guide differs from our food-import guides: Cosmetics are not FDA-regulated food, so two things that apply to coffee, spices, or seafood imports do not apply here. There is no FDA Prior Notice requirement for cosmetics — that's a food-only Bioterrorism Act rule; cosmetic shipments are instead screened against your Cosmetics Direct registration and listing data. And cosmetics don't use FSVP — the comparable food program — the cosmetics equivalent is the Responsible Person requirement below. We flag this explicitly so nothing here is inherited from food-specific logic by accident.
Every cosmetics manufacturer or processor selling into the U.S. moves through the same five obligations, in roughly this order.
Register each manufacturing or processing facility with FDA through the Cosmetics Direct portal using Form FDA 5066, and obtain a Facility Establishment Identifier (FEI). New facilities must register within 60 days of first manufacturing or processing for U.S. distribution. Foreign facilities must also designate a U.S. Agent as part of this filing.
Form FDA 5066 · FEI requiredEvery cosmetic product must have a named Responsible Person — the manufacturer, packer, or distributor whose name appears on the label — who is accountable for safety substantiation and for receiving adverse event reports. This is the cosmetics-specific equivalent of FSVP; food's importer-of-record program does not apply to cosmetics.
Not FSVP — MoCRA-specificThe Responsible Person submits a product listing (Form FDA 5067) for each marketed cosmetic, including the full ingredient list, product category, and linked facility FEI, in Structured Product Labeling (SPL) format via Cosmetics Direct. Listings must be reviewed and updated at least annually.
Form FDA 5067 · Annual updateLabels must carry a domestic address, phone number, or electronic contact for adverse event reports, and professional-use-only products must say so. Safety substantiation is now mandatory for every product — the old "safety not determined" warning statement is no longer a valid substitute. Fragrance allergen disclosure is a forthcoming requirement; FDA has not yet issued the final rule.
21 U.S.C. ยง 364eFacility registrations must be renewed every two years under Section 607(a)(2) of the FD&C Act — but unlike food facility renewal, this is not a shared calendar window. Your renewal date is tied to the anniversary of your own initial registration date. Cosmetics Direct now displays a live REGISTRATION STATUS and RENEWAL DATE and sends automated reminders ahead of it.
Anniversary-based, not a shared windowThese are the product-specific risk areas we see cause the most delays and warning letters — verified against current FDA guidance, not assumed from another product category.
A serious adverse event must be reported to FDA within 15 business days of the Responsible Person receiving it, with a copy of the product label, and records kept for six years. Missing this clock is an active enforcement priority.
Active requirementSubstantiation now has to actually exist and hold up — the pre-MoCRA disclaimer workaround is gone. Facilities relying on outdated or incomplete safety files are the most common warning-letter trigger we see today.
Active requirementFDA missed its statutory deadline for the fragrance allergen rule; a proposed rule is expected, with a final rule likely landing in 2027 or later. Not yet a filing requirement, but worth building your ingredient documentation toward now.
Forthcoming — monitorFDA proposed a standardized testing rule for talc-containing products in late 2024, then withdrew it in late 2025. Talc-containing powders and pressed products remain a heightened-scrutiny category while the rule is reworked.
Rule withdrawn — monitorUnder $1M in average annual U.S. sales exempts you from registration and listing — unless your product touches the eye's mucous membrane, is injectable, is used internally, or alters appearance for over 24 hours. Revenue alone doesn't decide this.
Category-dependentMoCRA directed FDA to finalize cosmetic GMP regulations by the end of 2025. That deadline was missed; no final rule is in force as of this guide. ISO 22716 remains the practical industry reference point in the meantime.
No final rule yetYour product type determines whether the small-business exemption is even available to you, and what extra label or testing burden applies.
| Product sub-type | Small-business exemption eligible? | Extra requirement |
|---|---|---|
| Leave-on cosmetics (lotions, serums, creams) | Yes, if under revenue threshold | Standard registration, listing & label rules |
| Rinse-off cosmetics (shampoo, cleansers, soap-adjacent) | Yes, if under revenue threshold | Standard registration, listing & label rules |
| Eye-area products (mascara, eyeliner, eye creams) | No — excluded category | Mandatory registration & listing regardless of revenue |
| Injectable cosmetic-adjacent products | No — excluded category | Mandatory registration & listing regardless of revenue |
| Talc-containing powders (pressed & loose) | Yes, if under revenue threshold | Heightened scrutiny pending finalized testing rule |
| Products altering appearance >24 hrs (non-customary removal) | No — excluded category | Mandatory registration & listing regardless of revenue |
| Professional/salon-use-only products | Yes, if under revenue threshold | Must bear "licensed professional use only" label statement |
Each of the five steps above has its own full walkthrough. Cluster pages coming online next — anchors below jump within this guide until then.
Who has to register, what counts as a facility, and how exemptions actually work.
Read the full guide → Cluster 02The FSVP-equivalent for cosmetics: designation, U.S. Agent, and safety substantiation duties.
Read the full guide → Cluster 03How CBP and FDA screen cosmetic shipments against your Cosmetics Direct data — no Prior Notice filing involved.
Read the full guide → Cluster 04Contact info, professional-use statements, and preparing for the coming allergen rule.
Read the full guide → Cluster 05What changes for foreign manufacturers shipping into the U.S. market under MoCRA.
Read the full guide → RenewalWhy cosmetics renewal runs on your own anniversary date, not a shared biennial window like food.
Read the full guide →No. Prior Notice is a food-only Bioterrorism Act requirement. Cosmetic shipments are instead screened against your facility's Cosmetics Direct registration and product listing data at entry — an inactive registration is the more common cause of a held shipment.
Every two years, on the anniversary of your facility's initial registration — not a fixed calendar window shared with food. FDA's Cosmetics Direct portal tracks your specific renewal date and reminds you ahead of it.
No. FSVP is food-only. The MoCRA equivalent is the Responsible Person requirement — a named party accountable for safety substantiation and adverse event handling for every product.
Only if your average annual U.S. cosmetic sales are under $1M over the prior three years, and only if your products aren't eye-area, injectable, internally-used, or long-duration appearance-altering. Even then, you're never exempt from adverse event reporting, safety substantiation, or labeling.
From your first FEI filing to your first biennial renewal, we handle the Cosmetics Direct submissions so nothing lapses.
Talk to our team