Short answer
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) gave the US Food and Drug Administration new powers over cosmetics, which include perfume. For a fragrance brand, the main duties are: register manufacturing facilities, list each product and its ingredients with FDA, keep records substantiating each product's safety, report serious adverse events within 15 business days, and put a US contact on the label for adverse-event reports. Qualifying small businesses are exempt from some of these, but not from safety substantiation or adverse-event reporting. This is general information, not legal advice.
Who is responsible
MoCRA places most duties on the responsible person: the manufacturer, packer or distributor whose name appears on the product's label. For an indie perfume brand selling under its own name, that is usually the brand, even if a contract manufacturer makes the product. Facility registration falls on whoever owns or operates the facility where the product is manufactured or processed.
The main requirements
| Requirement | What it involves |
|---|---|
| Facility registration | Facilities that manufacture or process cosmetics for US distribution register with FDA and renew every two years. |
| Product listing | The responsible person lists each marketed cosmetic product, including its ingredients, and updates listings annually. |
| Safety substantiation | The responsible person must ensure each product is safe and keep records that support it. FDA does not prescribe specific tests. |
| Serious adverse events | Report serious adverse events to FDA within 15 business days of receiving the information, with a copy of the label; submit significant new information received within a year. |
| Label contact information | Labels must carry a domestic address, phone number or electronic contact through which the responsible person can receive adverse-event reports. |
| Fragrance allergen labeling | MoCRA requires FDA to issue regulations. At the time of writing (October 2026) we have not found a published rule; check FDA's MoCRA page. |
| Good manufacturing practice | MoCRA requires FDA to establish GMP regulations for cosmetics; FDA has issued draft materials. Check FDA for current status. |
MoCRA also gives FDA mandatory recall authority and access to certain records, including safety records, under specified conditions.
The small business exemption
Businesses whose average gross annual US sales of cosmetic products over the previous three years are less than $1 million (adjusted for inflation) are exempt from facility registration, product listing and the GMP requirements. The exemption does not apply to certain higher-risk products — for example, products that regularly come into contact with the mucous membrane of the eye, injected products, products intended for internal use, and products intended to alter appearance for more than 24 hours. A perfume spray is not normally in those groups, but confirm against FDA's guidance for your products.
Small businesses are not exempt from safety substantiation, adverse-event reporting or the labeling duties. Those apply to everyone.
What safety substantiation means for a perfume
MoCRA requires "adequate substantiation" of safety but leaves the evidence to the responsible person. For a fragrance product, a credible file typically draws on:
- the formula, by version, with every material identified;
- IFRA conformity for the product's category, with supplier certificates for purchased oils (see the IFRA Standards guide);
- supplier safety documents for each material;
- a safety assessment of the finished product by a qualified person;
- stability observations showing the product stays acceptable over its shelf life (see perfume stability testing);
- batch records showing what was actually made (see how to structure a perfume batch record).
The common thread is traceability: being able to show which formula version, made from which materials, is in a given bottle. That is a record-keeping problem long before it is a regulatory one.
Labeling basics that already applied
MoCRA added to, rather than replaced, existing US cosmetic labeling rules. Perfume labels must still declare ingredients, and fragrance may be declared collectively as "fragrance" under FDA's labeling regulations, until a fragrance allergen rule says otherwise. Net contents are stated in metric and US customary units (for example 50 mL / 1.7 fl oz). Some states have their own requirements; California, for instance, requires manufacturers to disclose certain fragrance ingredients to the state. Check the current requirements for every state you sell in.
Writing the ingredient list itself is covered in perfume ingredient labeling. California's separate fragrance-ingredient reporting law is described in California's fragrance disclosure law.
Records worth keeping now
- A formula record per product, versioned, with materials identified by name, supplier and CAS number where applicable.
- Supplier documents per material: SDS, specification, IFRA certificate, allergen statement.
- The safety assessment and the evidence it relied on.
- Batch records linking each lot of finished product to a formula version and material lots.
- A log of customer complaints and adverse events, with dates and actions — and the FDA report where one was required.
MoCRA also requires records of adverse-event reports to be kept for a set period; FDA's guidance gives the details, including any shorter period for small businesses.
How these rules compare with those of other markets — and the topics that cut across them, from claims to shipping — is set out in perfume regulations by market.
Sources
Frequently asked questions
Is perfume a cosmetic under US law?
Yes. Perfumes and colognes are cosmetics under the Federal Food, Drug, and Cosmetic Act, unless they make drug claims.
Do I need FDA approval before selling a perfume?
No. FDA does not approve cosmetics before sale (other than color additives). The responsible person is accountable for safety and compliance.
Does MoCRA apply to candles and room sprays?
No. MoCRA covers cosmetics. Candles and air fresheners are regulated differently, mainly as consumer products.
Written and reviewed by the RUŌOD Lab team. This article is general education about perfume formulation and record-keeping; it is not legal, regulatory or safety advice, and the examples are illustrations, not validated commercial formulas. How we write and check these guides.