US FDA Requirements for Fragrance in Cosmetics

The United States regulates fragrance in cosmetics under a framework that differs substantially from the EU. The FDA does not pre-approve cosmetic ingredients (with the exception of color additives), but the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) introduced the most significant regulatory changes in over 80 years. For B2B fragrance suppliers and brands selling into the US market, understanding these requirements is critical.

Regulatory Framework: FD&C Act and MoCRA

Fragrance products intended for application to the human body are regulated as cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Sections 201(i) and 601-602. The FDA’s authority historically focused on post-market enforcement: products must be safe and properly labeled, but no pre-market approval is required.

MoCRA, signed into law in December 2022 with implementation rolling through 2024-2025, added:

• Mandatory facility registration (Section 607)
• Product listing with ingredient information (Section 608)
• Adverse event reporting (Section 605)
• GMP compliance (Section 606)
• FDA mandatory recall authority (Section 611)

Facility Registration and Product Listing

Under MoCRA Section 607, every facility that manufactures or processes cosmetics sold in the US must register with the FDA. This includes foreign facilities. Key details:

• Registration deadline: Facilities operating before December 29, 2022, had until December 29, 2023, to register. New facilities must register within 60 days of first operation.
• Renewal: Every two years.
• Foreign facilities must designate a US agent for FDA communications.

Product listing (Section 608) requires submission of:

• Product category (e.g., “fragrance - eau de parfum”)
• Full ingredient list, including fragrance components (with trade secret provisions, see below)
• Product label image
• Facility registration number where manufactured

For B2B fragrance suppliers: if you manufacture fragrance compounds that are incorporated into finished cosmetics by your US customers, your facility likely requires registration as a cosmetic manufacturing facility.

Ingredient Listing: The “Fragrance” Exemption

Under 21 CFR 701.3(a), cosmetic labels must list ingredients in descending order of predominance. However, fragrance and flavor components may be listed simply as “Fragrance” or “Flavor” without disclosing individual constituents. This is the trade secret exemption.

What this means practically:

• A finished perfume label can list “Alcohol Denat., Aqua, Fragrance (Parfum)” without naming linalool, limonene, or any individual aroma chemical.
• The FDA does not require declaration of the 26 EU allergens on US cosmetic labels (unlike EU Regulation 1223/2009 Annex III).
• However, if a fragrance ingredient is also a color additive, it must be declared by its specific name.
• MoCRA product listings submitted to the FDA do require full ingredient disclosure, but this information is held confidentially and is not made public.

Limits of the exemption:

• The exemption applies only to ingredients used solely for fragrance or flavor. If a component serves a dual function (e.g., an essential oil marketed for both scent and skin benefit), it may need individual declaration.
• California Proposition 65 and other state laws may require additional disclosures regardless of the federal exemption.
• Retailers (Sephora, Credo, Target) increasingly require full ingredient transparency through their own restricted substance lists (RSLs), often exceeding FDA minimums.

Adverse Event Reporting

MoCRA Section 605 mandates adverse event reporting:

• Serious adverse events (death, hospitalization, disability, significant disfigurement): Must be reported to FDA within 15 business days of receipt.
• Non-serious adverse events: Records must be maintained for 6 years and made available to FDA upon inspection.
• Responsible person: The manufacturer, packer, or distributor whose name appears on the label bears the reporting obligation.

For fragrance products, the most common adverse events involve allergic contact dermatitis. B2B suppliers should:

1. Maintain a complaint tracking system with structured fields for reaction type, product lot, and ingredient exposure.
2. Provide customers with allergen declarations to support their adverse event investigations.
3. Include clear usage instructions and warnings in product documentation.

Good Manufacturing Practices

MoCRA Section 606 requires compliance with GMP regulations. The FDA published proposed GMP rules in 2024, aligning closely with ISO 22716:2007 (Cosmetics - Good Manufacturing Practices). For fragrance manufacturing, key GMP elements include:

• Documented batch records with full traceability
• Raw material qualification (certificate of analysis, identity testing)
• Environmental monitoring for microbial contamination
• Stability testing protocols (typically 3-month accelerated at 40 degrees C / 75% RH)
• Change control procedures for formulation modifications

State-Level Requirements

Federal FDA compliance does not preempt all state requirements:

• California Proposition 65: Products containing listed carcinogens or reproductive toxicants above safe harbor levels require a warning. Relevant fragrance substances include certain phthalates (DEHP, DINP) and formaldehyde.
• California SB 312 (2020): Requires disclosure of fragrance allergens to the California Department of Public Health for professional products.
• New York and other states: Various packaging and labeling requirements may apply.

Practical Compliance Checklist for B2B Suppliers

1. Register your manufacturing facility with FDA (and renew biennially).
2. Designate a US agent if your facility is outside the United States.
3. Provide customers with full ingredient disclosures under NDA for their product listings.
4. Maintain SDS and allergen documentation per OSHA HazCom 2012 (29 CFR 1910.1200).
5. Implement a structured adverse event complaint handling system.
6. Conduct stability testing and retain batch records for minimum 6 years.
7. Screen formulations against Prop 65 listed substances quarterly.

How Aromiso Supports US Market Entry

Aromiso provides US-bound fragrance products with:

• FDA facility registration support and US agent designation
• Full ingredient disclosure packages formatted for MoCRA product listing
• OSHA-compliant Safety Data Sheets (GHS format, 16 sections)
• California Prop 65 screening certificates
• IFRA compliance certificates for all fragrance formulations
• Stability testing data (ICH and ISO 22716 aligned protocols)

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This article summarizes federal requirements as of early 2025. MoCRA implementation is ongoing; check FDA.gov for final rule publications and updated compliance dates.