A mandatory MoCRA requirement for any facility manufacturing or processing cosmetics sold in the U.S. Registration identifies your site in the FDA database and must be updated annually between October 1 and December 31.

Yes. All foreign cosmetic facilities registered with the FDA must designate a U.S. Agent as the official FDA point of contact for communications, inspections, and correspondence.

The process of registering each cosmetic product you market in the U.S. with the FDA via Cosmetics Direct. Every registered facility must list all cosmetic products it manufactures or distributes.

Under MoCRA, all cosmetics sold in the U.S. must meet FDA requirements for facility registration, product listing, labeling, and safety substantiation. Products making drug claims are regulated as both.

Yes. A DUNS number is required to complete FDA cosmetic facility registration through Cosmetics Direct. Without a valid DUNS, registration cannot be processed.

Your cosmetic shipments will be automatically detained at U.S. ports of entry. To resolve, identify the root cause and submit corrective documentation to FDA.

CSCA requires cosmetic manufacturers, packers, and distributors with annual California sales of $1M+ to report any product containing an ingredient listed as a potential carcinogen or reproductive toxicant.

Annually between October 1 and December 31. Failure to renew on time results in a lapsed registration.

Your products may be considered adulterated or misbranded under the FD&C Act, resulting in import refusals, FDA enforcement, warning letters, product seizure, or recall.

Yes, but regulatory mistakes are common and costly. Professional assistance reduces risk, improves submission quality, and accelerates market entry.

Typically 24–48 hours when the application is complete and accurate. Delays usually result from missing DUNS or incomplete owner/operator information.

No. Unlike drugs or devices, cosmetics do not require FDA premarket approval. However, MoCRA requires all facilities to register and all products to be listed.

Under MoCRA, manufacturers must submit Serious Adverse Event Reports to FDA within 15 business days. Records must be retained for 6 years.

Yes. We review cosmetic labels, ingredient lists, and promotional materials to ensure they meet FDA labeling requirements under 21 CFR Part 701.

Facility registration confirmation, product listing records, MoCRA documentation, complaint files, labeling files, safety substantiation data, SAERs, and inspection records.

Yes, if they comply with FDA facility registration, product listing, and MoCRA requirements before entering U.S. commerce.

FDA inspectors review facility registration, product listings, manufacturing processes, ingredient documentation, safety substantiation, and adverse event records.

Yes. Selling cosmetics online does not exempt a company from FDA requirements. Any establishment manufacturing, repackaging, relabeling, or importing must register.

Facility legal name and address, DUNS number, owner/operator info, U.S. Agent details, type of establishment activity, and a product list with categories and INCI ingredients.

Documented evidence that a cosmetic product is safe for its intended use — ingredient safety assessments, toxicological data, stability testing, and clinical or consumer safety data.

Yes. We track your annual renewal deadlines, handle required updates, and ensure your compliance is maintained year-round.

Labels must comply with 21 CFR Part 701: product identity, net quantity, manufacturer/packer/distributor name and address, and full INCI ingredient declaration in descending order.

Yes. We perform a root-cause review of the Import Alert, prepare response documentation, and submit corrective action evidence to the FDA.

The manufacturer, packer, or distributor whose name appears on the cosmetic product label. Legally accountable for safety, listing, and SAER reporting.

End-to-end support — from registration and listing through labeling, U.S. Agent services, import alert resolution, and annual renewals.

A flat professional fee with $0 in government filing charges — the FDA does not charge a fee for MoCRA facility registration. The service fee includes intake review, DUNS verification, facility data preparation, U.S. Agent linking review, Cosmetics Direct submission, written confirmation of your FDA Establishment Registration Number, and a downloadable compliance certificate. Most clients bundle MoCRA Product Listing alongside facility registration in the same 24–48 hour window.

Technically yes, but strongly discouraged. The FDA requires only a physical U.S. address reachable during business hours. However, a friend or relative who misses an FDA email, ignores an inspection notice, or fails to respond on time can cause your registration to be flagged, your shipments placed on Import Alert, and your products detained. A professional U.S. Agent is monitored every business day, trained in FDA correspondence, and accountable through a written service agreement.

The FDA treats it as if you never responded. Consequences include placement on Import Alert (automatic Detention Without Physical Examination), suspension of facility registration, refusal of entry, Warning Letters, and civil penalties. Many brands first learn about a missed notice when a container is stopped at the port.

Update the registration in Cosmetics Direct with the new agent's information, and the new agent must confirm acceptance to the FDA. We handle the full switchover: preparing the updated record, coordinating acceptance from the new agent, submitting through Cosmetics Direct, and providing written confirmation. Most changes complete within 24–48 business hours. No FDA fee.

It depends. True soap (alkali + fats, marketed only for cleansing) is regulated by CPSC, not FDA. Soap making cosmetic claims IS a cosmetic and requires MoCRA. Candles are generally not cosmetics. Perfumes, fragrances, body sprays, and colognes ARE cosmetics and require full MoCRA registration and product listing.

Yes. The sales channel does not change the requirement. Amazon and Walmart Marketplace actively request proof of MoCRA registration and will delist non-compliant products. Shopify and Etsy do not pre-screen, but selling cosmetics without registration violates the FD&C Act.

In most cases yes. Manufacturers with average gross annual U.S. cosmetic sales under $1,000,000 over the previous three years are exempt — unless they manufacture higher-risk products such as injectables, products contacting eye mucus membranes, products for internal use, or products altering appearance for more than 24 hours.

Not publicly. The FDA does not publish a public search tool for MoCRA registrations. Verification is done internally by FDA and CBP at the port of entry. Request a copy of the FDA Establishment Registration Number and product listing numbers from your supplier.

Yes — both, in different roles. Every facility that physically manufactures or processes a cosmetic must register. Separately, the Responsible Person (brand owner whose name appears on the label) must submit the product listing.

The facility address must be the physical location where cosmetics are actually manufactured — no P.O. Boxes or pure virtual offices. A home-based manufacturer may register the home address if real production occurs there. The U.S. Agent address must also be a physical U.S. address.

No, and claiming so is illegal. MoCRA registration is an administrative compliance step — it does NOT constitute FDA approval. Marketing a cosmetic as 'FDA approved' or displaying the FDA logo is a misbranding violation. Use 'FDA registered' or 'MoCRA compliant' instead.

The FDA recognizes only two categories: cosmetics and drugs. There is no FDA classification called 'cosmeceutical' — the term has no legal meaning. Products making BOTH cosmetic and drug claims (sunscreens, antiperspirants, anti-dandruff shampoos, acne treatments) are regulated as BOTH.

Within hours, when registration is correct. CBP and FDA verify status electronically at the port. Compliant shipments typically clear within hours. Non-compliant shipments are flagged for Detention Without Physical Examination, adding days to weeks of delay.

VCRP is dead — MoCRA replaced it. The Voluntary Cosmetic Registration Program was officially terminated on March 27, 2023. VCRP registrations do NOT carry over to MoCRA — every cosmetic facility must file a fresh MoCRA registration in Cosmetics Direct.