The short answer
Perfumes are cosmetics, so the MoCRA steps apply. The two US-specific points are claims — aromatherapy promises can turn a fragrance into a drug — and the fragrance allergen labeling rule that FDA is still working on.
| Requirement | What it means | Who |
|---|---|---|
| Facility registration (MoCRA) | Facilities that manufacture or process cosmetics for the US register with FDA and renew every two years | The manufacturing facility |
| Product listing | Each product is listed with its ingredients, and updated every year | The Responsible Person |
| Label | English label: identity, net quantity, ingredients in descending order, name and place of business, warnings, and a contact for adverse event reports | The brand |
| Claims check | No therapeutic (drug) claims such as sleep, stress relief or pain relief | The brand |
| Safety substantiation | Records showing the product is safe as used | The Responsible Person |
| Adverse event reporting | Serious adverse events reported to FDA within 15 business days | The Responsible Person |
Declaring fragrance on the label
US ingredient lists generally allow fragrance ingredients to be declared simply as “fragrance” (or “parfum”-style US equivalents), placed according to FDA's labeling rules. Other ingredients — alcohol, solvents, preservatives, colors — must still be listed in descending order by their US names.
The fragrance allergen rule: coming, not yet in force
MoCRA requires FDA to issue rules on disclosing fragrance allergens on cosmetic labels. As of November 2026:
- FDA has not published a final rule.
- FDA's regulatory agenda (July 2026) targeted a proposed rule for November 2026.
- A proposed rule would be followed by comments, a final rule and a compliance date — so no allergen labeling is required in the US yet.
Practical tip
If you already label fragrance allergens for the EU, keep that information organized by product. When the US rule arrives, you will be ready faster — but do not assume the US list or thresholds will match the EU.
Essential oils and aromatherapy: cosmetic or drug?
| Claim | Status |
|---|---|
| “A fresh floral scent” / makes you more attractive | Cosmetic |
| “Helps you sleep”, “relieves stress”, “helps quit smoking” | Drug |
| Massage oil to soften skin and add fragrance | Cosmetic |
| Massage oil to relieve muscle pain | Drug |
A drug needs drug registration, listing and Drug Facts labeling — so keep perfume and essential oil marketing to scent, mood-free descriptions and skin feel.
Example
A perfume house in France registers its filling facility under MoCRA and lists each fragrance. Its US labels declare “fragrance” with the other ingredients, it removes “calming” and “sleep” claims from its essential oil roll-ons, and it keeps its EU allergen data on file for the coming US rule.
What FDA does — and does not do — for cosmetics
FDA does not approve cosmetic products or their labels before they are sold (color additives are the exception). Registration and listing are not an approval, so never write “FDA approved” or “FDA certified” on a cosmetic label or website. Under MoCRA, the brand carries the responsibility: it must be able to show the product is safe as used, and FDA can inspect records, ask for safety information and, in serious cases, suspend a facility's registration or order a recall.
At the US border, FDA reviews imported cosmetics and can detain a shipment that appears adulterated or misbranded — for example a wrong or missing English label, an unapproved color, a prohibited ingredient or drug claims. Detained goods must be brought into compliance, exported or destroyed, so it pays to fix problems before the first shipment.
Small businesses: what MoCRA exempts
MoCRA exempts certain small businesses from facility registration, product listing and GMP. The exemption does not cover products that regularly touch the eye's mucous membrane, injected products, products for internal use, or products meant to change appearance for more than 24 hours. Labeling, safety substantiation and adverse event reporting are not on the exempt list — and many US retailers and marketplaces ask for registration and listing anyway.
Step by step: selling your perfume in the US
- 1Decide: cosmetic, drug or bothYour claims and ingredients decide it. A drug needs drug registration, listing and Drug Facts labeling.
- 2Register the manufacturing facilityUnder MoCRA, and renew every two years. Foreign facilities name a U.S. Agent.
- 3List every productThe Responsible Person lists each product with its ingredients and updates the listing every year.
- 4Make the label US-readyEnglish text, ingredient list, warnings, contact for adverse events — and the product-specific points above.
- 5Keep safety records and an adverse event processSafety substantiation on file; serious adverse events reported within 15 business days.
Checklist
- MoCRA facility registration and product listing done
- Ingredient list with “fragrance” and all other ingredients in order
- No sleep, stress, pain or other drug claims
- Allergen data organized for the coming US rule
- Safety records and adverse event process in place
Tell us your products — we send your MoCRA and FDA requirements in writing, free.
Frequently asked questions
Do I have to list every fragrance ingredient on a US label?
Today, fragrance ingredients can generally be declared as “fragrance” in the ingredient list. MoCRA requires FDA to set rules for disclosing fragrance allergens on labels, so this may change — check the rule’s status before you design new packaging.
Has FDA published the fragrance allergen labeling rule?
Not as a final rule. FDA’s regulatory agenda (July 2026) targeted a proposed rule for November 2026. Until a final rule is published and takes effect, there is no US fragrance allergen labeling requirement in force.
Is an essential oil a cosmetic?
It depends on the claims. FDA says a fragrance marketed to make someone more attractive is a cosmetic, but an aromatherapy product claiming to help sleep or quit smoking is a drug. A massage oil for muscle pain relief is also a drug.
Do perfumes need product listing under MoCRA?
Yes. Perfumes and fragrances are cosmetics. The facility must be registered and the Responsible Person must list each product with its ingredients, unless an exemption such as the small business exemption applies.
Who is the Responsible Person under MoCRA?
The manufacturer, packer or distributor whose name appears on the label. The Responsible Person lists the products, keeps safety records and reports serious adverse events to FDA within 15 business days.
Are small cosmetic businesses exempt from MoCRA?
Certain small businesses are exempt from facility registration, product listing and GMP — but not for products that touch the eye’s mucous membrane, injected products, products for internal use or products that change appearance for more than 24 hours. Labeling, safety records and adverse event reporting still apply.
Sources
- FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA) (content current as of Oct 29, 2026)
- FDA — Summary of Cosmetics Labeling Requirements
- FDA — Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
- ChemLinked — FDA Unified Agenda timeline for fragrance allergen and formaldehyde rules (July 2026)
Dates, fees and regulation numbers checked against FDA and Federal Register sources on November 8, 2026. This article is general information, not legal advice.