Selling a fragrance in the United States

What changed, and why everyone is talking about it

From 1938 until the end of 2022, cosmetics were the least regulated category the FDA touched. There was no registration, no product listing, no requirement to tell anyone your product existed, and no power for FDA to order a recall. The Modernization of Cosmetics Regulation Act, signed on 29 December 2022 and universally called MoCRA, ended all of that.

A perfume is a cosmetic in the United States, so this is your law now. The obligations are less paperwork than the European Union asks for, but they are enforced by an agency that can now order a mandatory recall, and they are layered under state rules that reach further than the federal ones do.

Start here: are you a small business?

This is the first question because it decides whether two of the four main obligations apply to you at all.

A responsible person whose average gross annual sales in the United States over the previous three years were under one million dollars is a small business under MoCRA, and is exempt from facility registration and from product listing. The figure is adjusted for inflation. It is measured on the business, not on the product, and it is not a permanent status: cross the threshold and both obligations begin.

What the exemption does not touch is just as important. You still have to report serious adverse events, still have to keep the records, still have to substantiate that the product is safe, and still have to label it correctly. The exemption is about two filings, not about being outside the law.

There are product types that lose the exemption regardless of turnover, mostly things that contact the mucus membrane of the eye, are injected, are intended for internal use, or alter appearance for more than a day. A conventional fragrance is not among them, but check your own range rather than assuming.

Whichever side of the line you are on, write down the determination and the date you made it. A determination you cannot evidence is one you will be making again from memory in two years, under less friendly circumstances.

Facility registration

Any facility that manufactures or processes cosmetics for the US market must register with FDA, including a facility outside the United States that makes product destined for it. A new facility registers within 60 days of first manufacturing. Registration is renewed every two years, and a change to the registered details is reported within 60 days of the change.

A facility that only labels, relabels, packages, holds or distributes is generally not manufacturing or processing for this purpose. If you contract out the making, the maker registers, and you will need their registration number for your own product listing.

Product listing, and the fragrance shelter that does not apply to it

Every cosmetic product must be listed with FDA by the responsible person: the product name as it appears on the label, the category, the facility where it is made, contact details, and a list of ingredients. Listings are updated annually.

Here is the trap, and it is worth reading twice.

On the consumer label, US rules let you declare an entire fragrance blend as the single word Fragrance. You do not have to break it open, which is why almost every American cosmetic label ends that way. That shelter is a labeling rule and it covers the label only. It does not extend to the product listing you file with FDA, which asks for the ingredients themselves.

A business that assumes one disclosure rule covers both files an incomplete listing while believing it has complied. If you buy a finished fragrance oil from a supplier, this is also the moment you discover whether your supply agreement lets you obtain the composition at all, and that is a conversation to have before you commit to a material rather than after.

Adverse events, and the contact detail on your label

A serious adverse event must be reported to FDA within 15 business days of the responsible person receiving it, with any new medical information following within a year. Serious means death, a life-threatening experience, hospitalization, disfigurement, a birth defect, or an event needing medical intervention to prevent one of those. Under MoCRA it also expressly includes infection, and serious disfigurement including significant hair loss or persistent rash.

Records of adverse events, serious or not, are kept for six years, or three years for a small business. This obligation has no turnover exemption attached to the reporting itself.

It also has a labeling consequence people miss: the label must carry a domestic address, phone number or electronic contact through which an adverse event can be reported. A label showing only a website and an overseas address does not satisfy it.

Safety substantiation

The responsible person must hold adequate substantiation of safety: tests, studies, research, or the considered opinions of qualified experts, sufficient for a competent person to conclude the product is safe under customary use. There is no prescribed format and no filing, which makes it easy to mistake for nothing at all.

In practice a small fragrance house builds this out of exactly the material it already needs for other reasons: the composition of every ingredient, the toxicological position of each one, the IFRA assessment at the right category, and the reasoning that connects them to this product at this concentration. It is closer to the European safety report than it looks, and it is worth assembling in a form somebody else could read.

What US labeling requires

Cosmetic labeling in the United States is split between the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act, and it is more prescriptive about placement than the EU is. In outline:

• An identity statement and the net quantity of contents on the principal display panel, the part of the package a customer sees on the shelf.
• The name and place of business of the manufacturer, packer or distributor, with a qualifying phrase where it is not the manufacturer.
• The ingredient declaration, in descending order of predominance, using the dictionary names US rules recognize. Fragrance may be declared as Fragrance.
• The domestic contact for adverse event reporting introduced by MoCRA.
• Warning statements where required, and any needed to make the product safe in customary use.

One thing to be careful about that has nothing to do with fragrance chemistry: claims. A perfume that is said to relieve anxiety, aid sleep or affect the body's structure or function is not being marketed as a cosmetic any more, and the product it is being marketed as has an approval process behind it. This is the most common way a small brand walks into trouble, and it usually happens in the marketing copy rather than on the label.

California reaches you wherever you are

For most small fragrance businesses, the first real US obligation is not federal. California requires whoever is named on the label of a cosmetic sold in California to report certain ingredients to the state, product by product. There is no minimum sales volume and no small business exemption. Sell one bottle to a customer in San Diego and it applies, whether you are in Ohio or in Lisbon.

Proposition 65 is a separate California obligation and works differently again. It requires a clear and reasonable warning before exposing anyone to a listed chemical, from a list running to well over 900 substances, and it is enforced largely by private plaintiffs rather than by the state. That enforcement model is why it deserves attention out of proportion to its complexity: the cost of getting it wrong is a letter from a law firm, not a regulator's inspection.

Other states have their own ingredient restrictions and reporting rules, and several have been added in the last few years. If you sell nationally through your own website, you are selling into all of them.

Fragrance allergen labeling is coming, but is not here

MoCRA directed FDA to make a rule requiring fragrance allergens to be identified on cosmetic labels. As of August 2026 the proposed rule has still not been published: the statutory deadline was missed and the expected date has moved more than once.

The sensible position is to prepare without pre-empting. The shape of the eventual list is visible in the EU's, so a house that already knows its allergen figures will absorb the rule as a labeling change rather than as a data-gathering emergency. Knowing the numbers early costs nothing; printing them before the rule exists can create a claim you then have to stand behind.

Getting it to the customer

Most alcoholic perfume is a flammable liquid, and transport law does not care that it is a cosmetic. In the United States it typically ships as UN 1266, perfumery products, with the packing group set by flash point. That decides packaging, marking, labeling, documentation and which carriers and services will take it at all.

Two practical notes. Air is stricter than ground, and international air is stricter again, so a shipment that is routine domestically may be refused abroad. And an alcohol-free oil-based perfume often sits outside the flammable classification entirely, which is a real commercial reason some houses offer one.

How Orris Bench handles this

Orris Bench keeps the MoCRA record and writes the submissions. The small business determination is recorded with its basis and its date, so the decision is evidenced rather than remembered. Facility registrations are held with their two-year renewal clock, and product listings are held per product with their history.

It writes the submission in both the forms FDA accepts: the structured file FDA's own submission tool takes as an upload, and the field-by-field sheet a person types from or transfers onto FDA's paper forms. Both carry the same facts, because they are generated from the same record. The ingredient detail the listing asks for comes from the formula itself, which is the whole reason the listing and the label can differ without anybody having to remember that they do.

Submission stays a human act. The application prepares the papers; a person signs in to FDA and uploads them, and the certification that the contents are true is signed by the person who can honestly sign it.

Which markets a product is sold into is a fact you state once, and the documents that depend on it read it rather than defaulting to whichever regime the software was written for first. A product sold in both the EU and the United States gets both sets of paperwork from one record, without the formula being entered twice.

Sources

The registration, listing and adverse event mechanics are from the Federal Food, Drug, and Cosmetic Act as amended by the Modernization of Cosmetics Regulation Act of 2022, and from FDA's guidance for industry on registration and listing of cosmetic product facilities and products, revised final December 2024. The fragrance labeling shelter is 21 CFR 701.3(a). Labeling requirements are the FD&C Act and the Fair Packaging and Labeling Act with their implementing rules at 21 CFR 701. The California obligations are the Safe Cosmetics Act and the Safe Drinking Water and Toxic Enforcement Act of 1986. Transport classification is 49 CFR. This page is written for people who make fragrances and it is not legal advice; check the current CFR, FDA and state sources before relying on any statement.