Cosmetic Regulatory Services
From a single launch to a full international line, we map the MoCRA requirements to your products and run registration, listing, labeling, and ongoing compliance — for domestic and overseas brands alike.
The Obligations Every Cosmetic Company Carries
Cosmetic Compliance Pricing
There is no single flat fee — cosmetic compliance scales with how many products and labels you sell. The core components are priced separately.
What We Handle
Facility registration & renewal
FDA cosmetic facility registration with biennial renewal management, for domestic and foreign facilities.
Product listing
Per-product listings linked to your registered facility, kept current with annual updates.
Label & claim review
Ingredient declaration, net quantity, firm identity, and claim checks so a cosmetic doesn't drift into drug classification.
Responsible Person & U.S. presence
A dependable U.S.-based contact and Responsible Person support for foreign brands — see U.S. Agent services.
Safety substantiation support
Help assembling and organizing the safety records MoCRA requires you to keep on file.
Adverse-event & recordkeeping setup
Procedures for serious-adverse-event reporting (15 business days) and six-year record retention.
Cosmetic Guides by Category
The same MoCRA framework applies across categories, but the claims and pitfalls differ. Explore the area that matches your products:
Hair & sulphate-free
Natural, organic & clean
Are natural cosmetics regulated by the FDA? — claims, USDA organic, and color additives.
Soaps & cleansers
FDA requirements for bar soaps — where “true soap” ends and cosmetics begin.
Skincare claims & the drug line
Clinically proven skincare and when a product becomes an OTC drug.
Small Businesses & International Brands
Is there a small-business exemption?
Businesses averaging under $1,000,000 in annual cosmetic gross sales over the prior three years are exempt from facility registration and product listing, with exceptions for eye-area, injected, internal-use, or products that alter appearance for more than 24 hours. Other MoCRA duties still apply.
How does this work for foreign brands?
International brands register their facility, list products, and designate a Responsible Person, and benefit from a U.S.-based contact for FDA communication. MoCRA does not impose a codified cosmetic U.S. Agent, but a reliable U.S. presence keeps things moving.
The cosmetic labeling rules live at 21 CFR Part 701 on eCFR, with MoCRA's requirements added to the FD&C Act.
Start Your Cosmetic Regulatory Compliance
Tell us your products, where they're made, and your U.S. launch plans, and we'll handle facility registration, product listing, the Responsible Person function, label and claim review, and adverse-event procedures. Trusted by 1,000+ companies across 135+ countries, with 15+ years of FDA regulatory experience. Email info@fdaregistrationassistance.com or call +1 (928) 275-8333.
Frequently Asked Questions — Cosmetic Regulatory Services
What are cosmetic regulatory services?
They are services that help a company meet FDA cosmetic requirements under MoCRA: facility registration, product listing, safety substantiation, compliant labeling and claims, adverse-event reporting, and ongoing compliance — plus a U.S. presence for foreign brands.
What is MoCRA?
The Modernization of Cosmetics Regulation Act of 2022 — the largest expansion of FDA cosmetic authority since 1938. It added mandatory facility registration, product listing, safety substantiation, adverse-event reporting, and recordkeeping, and gave the FDA mandatory recall authority for cosmetics.
Do cosmetic facilities need FDA registration?
Yes, unless they qualify for the small-business exemption. Facilities that manufacture or process cosmetics for the U.S. market must register with the FDA and renew every two years — see who must register a cosmetic facility. This applies to domestic and foreign facilities.
What is a cosmetic product listing?
An FDA submission for each marketed cosmetic that identifies the product, its ingredients, category, and the Responsible Person, and links it to the registered facility. Listings are submitted per product and updated annually.
Who is the “Responsible Person” under MoCRA?
The manufacturer, packer, or distributor whose name appears on the label, accountable for product listing, safety substantiation, adverse-event reporting, and recordkeeping. MoCRA's cosmetic framework centers on this role.
Do foreign cosmetic brands need a U.S. Agent?
MoCRA does not impose a codified “U.S. Agent” requirement for cosmetics the way the food, drug, and device rules do — it centers on the Responsible Person. In practice, foreign brands still need a dependable U.S.-based contact, which is where U.S. Agent services can help.
What is safety substantiation?
Adequate evidence that a cosmetic is safe under customary use, kept on file: toxicological data, ingredient safety information, and testing where applicable. The Responsible Person must maintain it, and the FDA can request it.
What are the adverse-event reporting rules?
The Responsible Person must report serious adverse events to the FDA within 15 business days and keep adverse-event records, generally for six years (three for certain small businesses).
What labeling does MoCRA require?
Cosmetic labeling under the FD&C Act and the Fair Packaging and Labeling Act (21 CFR Part 701): ingredient declaration, net quantity, and manufacturer, packer, or distributor identity, plus a Responsible Person contact for adverse-event reporting. Future MoCRA rules will add fragrance-allergen labeling.
Does the FDA approve cosmetics?
No. The FDA does not approve cosmetics or, with the exception of color additives, their ingredients. The Responsible Person is accountable for safety and compliance before marketing, and no cosmetic may claim or imply FDA approval.
Do color additives need approval?
Yes. Color additives must be FDA-approved for their intended use under 21 CFR Parts 73 and 74, and some require batch certification — this applies regardless of “natural” or “clean” positioning. See are natural cosmetics regulated by the FDA?.
Is there a small-business exemption?
Yes. Businesses averaging under $1,000,000 in annual cosmetic gross sales over the prior three years are exempt from facility registration and product listing, with exceptions for eye-area, injected, internal-use, or products that alter appearance for more than 24 hours. Other MoCRA duties still apply.
What does cosmetic facility registration cost?
Our cosmetic facility registration service is $849, with per-product listing at $200 and per-label review at $250. The FDA charges no government fee to register a facility or list a product; the fees scale with how many products and labels you have.
When is a cosmetic actually an OTC drug?
When it makes a therapeutic claim or contains a drug active. Sunscreen, antiperspirant, anti-dandruff, acne, and fluoride toothpaste products are OTC drugs, not just cosmetics, and need a Drug Facts panel — see is your OTC drug label FDA compliant?.
Do private-label cosmetic brands need MoCRA compliance?
Yes. The manufacturing facility registers and each product is listed; the Responsible Person (often the brand owner) carries the listing, safety, adverse-event, and labeling duties. A private-label arrangement does not remove these obligations.
Does MoCRA require Good Manufacturing Practices (GMP)?
MoCRA directs the FDA to establish cosmetic GMP regulations, and a proposed rule is expected. Even before final GMP rules take effect, maintaining sound manufacturing practices and records is prudent and supports your safety substantiation.
Does the FDA have cosmetic recall authority now?
Yes. MoCRA gave the FDA mandatory recall authority for cosmetics that are adulterated or misbranded and likely to cause serious adverse health consequences — a power the agency previously lacked for cosmetics.
What about talc, asbestos, and PFAS?
MoCRA directs the FDA to issue testing-method rules for asbestos in talc-containing cosmetics and to assess PFAS in cosmetics. Companies using talc or PFAS-related ingredients should track these developments and document their testing.
Do professional-use cosmetics fall under MoCRA?
Yes. Products used by salons and professionals are covered, with certain labeling considerations. Registration, listing, safety substantiation, and adverse-event duties generally apply to them as well.
How often do registrations and listings renew?
Facility registration renews every two years (biennially); product listings are updated annually and whenever product information changes. Keeping both current is part of ongoing MoCRA compliance.
Can incorrect labeling or claims cause problems?
Yes. A cosmetic that makes drug claims can be treated as an unapproved drug, and misleading or non-compliant labeling can draw enforcement — see FDA requirements for clinically proven skincare. Label and claim review is a core part of cosmetic compliance.
Do imported cosmetics face extra scrutiny?
Imported cosmetics must be properly registered and listed and must not be misbranded or adulterated; otherwise they can be detained or refused at the border. A U.S.-based Responsible Person contact smooths FDA communication.
What records must we keep?
Safety substantiation, adverse-event records (six years, or three for certain small businesses), and product and formulation documentation, all available to the FDA on request.
Can you handle compliance for our whole cosmetic line?
Yes. We register the facility, list every product, set up the Responsible Person function, review labels and claims, and establish adverse-event and recordkeeping procedures — scoped to the size of your product range.
How do I start cosmetic regulatory compliance?
Contact FDA Registration Assistance with your products, where they are made, and your target U.S. launch. Reach our team and we map the MoCRA requirements to your situation and handle registration, listing, labeling, and ongoing compliance. Email info@fdaregistrationassistance.com or call +1 (928) 275-8333.
