Fragrance and Perfume Export to the United States: What the FDA Requires and What It Does Not

Fragrances and perfumes are cosmetic products under US law, subject to the same MoCRA facility registration, product listing, and labeling requirements that apply to all cosmetics. But the fragrance category has several unique regulatory characteristics that foreign perfume brands must understand. The FDA does not require premarket approval of fragrances. The FDA does not currently require disclosure of individual fragrance ingredients on the product label (although MoCRA directs the FDA to develop rules for fragrance allergen disclosure). And the FDA does not regulate fragrance safety through a positive list system the way the EU does. These differences create both opportunities and compliance traps for foreign fragrance brands entering the US market.

MoCRA requirements for fragrance products

Under MoCRA, foreign facilities that manufacture or process fragrances for distribution in the US must register with the FDA. The responsible person must list each fragrance product, including the product name, category, and ingredient list. The responsible person must also maintain safety substantiation for each product and ingredient, report serious adverse events within 15 business days, and include adverse event contact information on the product label. These requirements apply to all fragrances regardless of price point, distribution channel, or country of origin. A niche artisan perfumer in France and a mass-market fragrance factory in China are subject to the same MoCRA obligations.

Fragrance ingredient disclosure rules

Under current FDA labeling rules (21 CFR 701.3), fragrance ingredients do not need to be individually listed on the product label. Instead, the term 'fragrance' or 'parfum' may be used as a single ingredient declaration that encompasses the entire fragrance composition — which may contain dozens or hundreds of individual aroma chemicals and natural extracts. This contrasts with the EU approach under Regulation 1223/2009, Annex III, which requires the declaration of 26 specific fragrance allergens (such as linalool, limonene, citronellol, geraniol, and coumarin) when they exceed specified concentration thresholds. MoCRA directs the FDA to issue rules requiring disclosure of individual fragrance allergens, but as of mid-2026, the specific allergen list and concentration thresholds have not been finalized.

Foreign fragrance brands that already comply with EU fragrance allergen disclosure on their labels can maintain that disclosure for the US market — the FDA does not prohibit listing individual fragrance ingredients, and doing so may provide a competitive advantage with US consumers who increasingly demand ingredient transparency. However, the current US requirement remains limited to the general 'fragrance' declaration, and the future MoCRA fragrance allergen rule may use a different allergen list or different thresholds than the EU.

IFRA standards and US regulatory context

The International Fragrance Association (IFRA) publishes standards for the safe use of fragrance ingredients, including use limits for specific materials based on safety assessments by the Research Institute for Fragrance Materials (RIFM). IFRA standards are widely adopted by the global fragrance industry and are referenced by the EU in its regulatory assessments. In the US, IFRA standards are not legally binding — they are industry self-regulatory guidelines. However, compliance with IFRA standards is broadly considered to represent good industry practice and can contribute to the safety substantiation that MoCRA requires. The FDA has recognized IFRA and RIFM's role in fragrance safety evaluation, and products formulated in accordance with IFRA standards are generally well-positioned to meet the MoCRA safety substantiation requirement.

Prohibited and restricted fragrance ingredients

While the US does not maintain a comprehensive positive list of permitted fragrance ingredients, certain substances are prohibited or restricted in cosmetics under 21 CFR Part 700, and these prohibitions apply to fragrance formulations. Additionally, certain fragrance ingredients that are not explicitly prohibited by FDA regulation may be subject to state-level restrictions — California Proposition 65, for example, lists several fragrance chemicals as known carcinogens or reproductive toxins, and products containing these substances must carry specific warnings when sold in California. Foreign fragrance brands should verify that their formulations comply with both federal FDA regulations and relevant state requirements.

How FDABridge helps fragrance brands

FDABridge provides MoCRA facility registration and product listing services for foreign fragrance brands, from niche perfume houses to mass-market fragrance manufacturers. We ensure your facilities and products are properly registered with the FDA and that your labels meet current US requirements. Visit fdabridge.com/cosmetics to see our cosmetics services or fdabridge.com/contact to discuss your fragrance compliance needs.