Who has to register a cosmetics facility with FDA?

In general, every person that owns or operates a facility manufacturing or processing a cosmetic product for distribution in the United States must register it. A small business under the sales test in section 612 can be exempt, unless the products fall into the categories that exemption does not cover. FDA’s enforcement discretion for registration and listing ran through July 1, 2024.

Does FDA send a certificate I can upload to Amazon?

No. FDA’s September 9, 2026 update says it does not issue a certificate of registration or listing, a letter confirming registration, or a letter confirming an exemption. A registration number is not FDA approval.

Are fragrance allergens required on the label yet?

FDA’s MoCRA page still lists fragrance-allergen labeling as a regulation the agency is required to establish. The October 14, 2026 information-collection notice counts the section 609(a) contact line and the section 609(c) professional-use line. It does not count a fragrance-allergen disclosure. Do not treat an allergen list as a finished FDA labeling rule.

What does Amazon ask for in Beauty?

Amazon’s February 17, 2026 Beauty article says approval can require invoices dated within 180 days for at least 10 units, product photos, a GMP certificate, a certificate of analysis, and MoCRA documentation, which that page describes as facility registration, product listings, and safety records. Many listings show Apply to sell when approval is required.

MoCRA for cosmetics brands selling in the US

MoCRA, the Modernization of Cosmetics Regulation Act of 2022, is the US law that made facility registration, product listing, serious-adverse-event reporting, and safety substantiation duties for cosmetics. It was signed on December 29, 2022. A cosmetics or personal-care brand selling in the United States, including on Amazon, has to know which of those duties apply to its facility and its responsible person, and which items FDA has not finished as regulations.

This is not legal advice. Classify the product, then read the FDA pages linked below. A drug, a device, or a product that is both a cosmetic and a drug follows a different listing path. The marketplace side of the same work is Amazon product compliance and gated categories. The engagement is Services.

What are facility registration and product listing?

Section 607 of the FD&C Act requires registration of a facility that manufactures or processes a cosmetic product for distribution in the United States, and a product listing from the responsible person. The responsible person is the manufacturer, packer, or distributor whose name appears on the label. FDA explains the program on its registration and listing page and in the December 2024 guidance, Registration and Listing of Cosmetic Product Facilities and Products.

Dates in that guidance:

A facility that was already manufacturing or processing cosmetics on December 29, 2022 had to register no later than December 29, 2023.
A facility that started after that date registers within 60 days of first engaging in the activity, or by February 27, 2024, whichever is later.
A product marketed on December 29, 2022 had to be listed no later than December 29, 2023. A product first marketed after that date is listed within 120 days of marketing. FDA expects that later listing within 120 days of marketing, or by April 27, 2024, whichever is later.
On November 8, 2023, FDA said it did not intend to enforce section 607 registration and listing until July 1, 2024. The same date is in the Cosmetics Direct launch note.

Registration is renewed every two years from the date of the initial registration. FDA’s guidance answers that question directly. An update to the registration is due within 60 days of a change. Product listings are updated annually, including when a product is discontinued. There is no fee for a section 607 registration or listing.

A contract manufacturer needs only one registration for the facility, even if it makes products for more than one responsible person. The facility or a responsible person whose products are made there may submit it. A foreign facility registration includes a US agent contact. FDA describes that role as a communications contact. It does not endorse a particular agent.

Submit through Cosmetics Direct at direct.fda.gov, through an SPL file on the Electronic Submissions Gateway, or on paper Forms FDA 5066 and 5067. Cosmetics Direct is the registration and listing portal. It is not the adverse-event system. The product listing includes the facility registration number, the product name as it appears on the label, the category, and the ingredients. A prior voluntary registration was not carried into this system. FDA does not treat those old submissions as MoCRA compliance.

Certain small businesses are exempt from registration and listing. FDA’s guidance uses the section 612 test: average gross annual US sales of cosmetic products for the previous three years under $1,000,000, adjusted for inflation. The exemption does not apply, regardless of sales, to products that regularly contact the mucus membrane of the eye, products that are injected, products intended for internal use, or products intended to alter appearance for more than 24 hours where removal by the consumer is not part of customary use. Read section 612 and the guidance before you decide you are exempt. Do not invent an inflation-adjusted dollar figure. FDA points to the BEA implicit price deflator for the adjustment.

A product that is also a drug is not listed under section 607. A facility that only makes those drug-cosmetic products is not registered under section 607 either, unless it also makes cosmetics that are not drugs. That is section 613, as the guidance describes it.

FDA does not issue a certificate of registration or listing, a letter that a facility is registered, or a letter that someone is exempt. A registration number is not an approval and not a promotional claim. FDA said so again on September 9, 2026, including for sellers that an ecommerce platform has asked for proof.

What is safety substantiation?

Section 608, 21 U.S.C. § 364d, requires the responsible person to ensure, and keep records supporting, adequate substantiation of safety. Adequate substantiation means tests, studies, research, analyses, or other information that qualified experts would consider sufficient to support a reasonable certainty the product is safe under the labeled or customary use. “Safe” does not mean the product can never cause a minor, transient irritation.

FDA’s MoCRA page says neither the law nor FDA regulations require specific tests to demonstrate the safety of an individual product or ingredient, and that animal testing is not a requirement for marketing a cosmetic. Use data from scientifically robust methods. FDA’s October 14, 2026 information-collection notice counts section 608(a) recordkeeping as a current burden. There is no FDA test menu to photocopy. The records have to support the specific product.

Coal-tar hair dye that otherwise meets the statute is carved out of the subsection (a) duty. The responsible person for that dye still keeps safety records. If you are not sure the product is a cosmetic, stop and classify it before you treat this paragraph as the whole file.

How does adverse-event reporting work?

Section 605 requires the responsible person to report a serious adverse event associated with the use of a cosmetic in the United States within 15 business days, with a copy of the label on or within the retail package. If more medical information arrives within one year of the initial report, that information goes to FDA within another 15 business days. FDA’s December 14, 2023 instructions say these reports are enforceable starting December 29, 2023.

FDA’s definition of a serious adverse event, on the how to report page, includes death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability, a congenital anomaly or birth defect, an infection, or significant disfigurement, including serious and persistent rashes, second- or third-degree burns, significant hair loss, or a persistent or significant alteration of appearance other than what the customary use intended. It also includes a medical or surgical intervention needed to prevent one of those outcomes.

Responsible persons can submit through the Electronic Submissions Gateway, through the Safety Reporting Portal, or on Form FDA 3500A by email to [email protected] or by mail to the address on that page. FDA encourages the electronic paths. The October 14, 2026 notice says the responsible person keeps a record of each report it must submit for six years, or three years for a qualifying small business. FDA can see adverse-event records in an inspection.

A customer complaint that is not a serious adverse event is still a record the statute expects the responsible person to be able to keep. Do not wait for Amazon to be the system of record.

Which labeling deadlines are actually in force?

Section 609(a) requires the label to include a domestic address, a domestic phone number, or electronic contact information, which may be a website, where the responsible person can receive adverse-event reports. Section 609(c) requires a professional-use statement when the product is for professional use only. FDA’s October 14, 2026 notice treats both as current labeling duties and estimates the time to put them on labels.

Fragrance-allergen labeling is a different item. MoCRA tells FDA to establish that requirement by regulation. FDA’s MoCRA page still lists it among the regulations the agency must establish, alongside cosmetic GMP and a standardized method for asbestos in talc-containing cosmetics. The October 14, 2026 notice does not include a fragrance-allergen line in its labeling table. Do not print an allergen list because a trade article said a deadline passed. Wait for the regulation that names the allergens, and keep following the ingredient declaration FDA already requires under 21 CFR 701.3.

GMP is in the same unfinished set. FDA’s MoCRA page points to draft guidance and to a listening session, not to a final GMP rule you can comply with line by line. The June 1, 2023 listening-session materials identified December 29, 2025 as the statutory target for a final rule. That page still does not link a final rule. Amazon may ask for a GMP certificate anyway. That is Amazon’s document request. It is not evidence that FDA has finished the regulation.

FDA also proposed testing methods for asbestos in talc-containing cosmetics and, as its MoCRA page notes, withdrew that proposal in November 2025. There is no final method on that page to cite as a completed rule.

Existing cosmetic labeling still applies: identity, net quantity, the name and place of business, and ingredients in descending order of predominance. MoCRA did not repeal 21 CFR part 701. What the brand is allowed to claim about the formula is a separate question, covered in the claims essay.

What does Amazon ask for?

Amazon’s article How to sell beauty products, dated February 17, 2026, says many Beauty products need approval before you can sell them. In Seller Central, a listing that shows “Sell this product” is one you can already offer. “Apply to sell” means you need approval. Amazon says the documents can include invoices dated within 180 days showing at least 10 units from an authorized distributor, product photos of the front, back, ingredient list, and batch code, a GMP certificate, a certificate of analysis, and MoCRA compliance documentation. On that page, MoCRA documentation means facility registration, product listings, and safety records. Labels must be in English, the unit must be new and sealed in original packaging, and it must show a lot or serial code.

The same article’s FAQ says that under MoCRA you register the manufacturing facility with FDA and renew it every two years. That sentence is Amazon’s summary. It does not replace the product-listing duty, the safety-substantiation records, or the adverse-event clock. FDA will not write you a certificate to attach to the case. If Amazon’s form asks for one, the September 9, 2026 FDA update is the answer you can point to, and you still need the registration and listing numbers the portal actually issues.

Amazon also says the review, once the documents are in, typically takes one to five business days. That is Amazon’s sentence. Do not plan a launch on it. Gated Beauty is still a predecessor to freight, which is the point of the restricted-categories essay.

Dangerous goods are a separate Amazon rule. Perfume, hairspray, nail polish, and other flammable or aerosol products can require the FBA dangerous-goods program. A cream that is not a dangerous good can still be a cosmetic under MoCRA. Do not collapse the two checklists.

Questions

Who has to register?

The owner or operator of a facility that manufactures or processes a cosmetic for US distribution, unless a section 612 or section 613 exemption actually applies. The responsible person lists the product. Read the guidance before you skip either step.

Will FDA email a certificate for Amazon?

No. FDA said on September 9, 2026 that it does not provide certificates, verification letters, or exemption letters. A facility number is not an approval.

Do I have to print fragrance allergens now?

Not from a finished FDA allergen list. FDA has not issued the regulation that would name them. The contact line for adverse-event reports, and a professional-use statement when it applies, are the section 609 items FDA’s October 2026 notice already counts.

What should we hand Amazon?

Whatever the Apply to sell screen asks for on that ASIN. Amazon’s February 17, 2026 Beauty article describes invoices, photos, a GMP certificate, a certificate of analysis, and MoCRA registration, listing, and safety records. Match the screen. Do not invent a document FDA does not issue.

Sources

MoCRA. FDA’s overview of adverse events, safety substantiation, and the regulations FDA still has to establish.
Registration and listing and the December 2024 guidance (PDF). Who registers, who lists, the dates, the small-business test, and the July 1, 2024 enforcement discretion.
Cosmetics Direct launch, December 18, 2023. The portal, and the same July 1, 2024 date.
Serious adverse event instructions, December 14, 2023 and how to report. The 15-business-day clock and the definition.
No certificates, September 9, 2026.
Federal Register, October 14, 2026. Current burdens for sections 605, 607, 608, 609(a), and 609(c).
21 U.S.C. § 364d. Safety substantiation.
How to sell beauty products. Amazon’s February 17, 2026 description of Beauty approval documents.

Book a strategy call

If a cosmetics brand is entering the US, or Amazon has asked for MoCRA files the team cannot find, send a brief or Book a strategy call. Bring the label and the facility name. We will not guess the classification. The surrounding work is Services.