The Modernization of Cosmetics Regulation Act of 2022 — MoCRA — is the most significant change to how the FDA regulates cosmetics in the United States in more than 80 years. Among the changes MoCRA introduced is a set of new mandatory labeling requirements that apply to cosmetic products sold in the US market. For foreign cosmetic brands that export to the United States, these requirements mean that labels approved under prior FDA guidance may no longer be sufficient. The MoCRA labeling requirements are being phased in, with key provisions taking effect in 2026 — and the deadline will not pause for companies that have not yet completed their label reviews.
The Principal Display Panel under MoCRA
The Principal Display Panel — the PDP — is the primary surface of a cosmetic product's packaging that faces the consumer at the point of sale. Under pre-MoCRA regulations, the PDP was required to carry an identity statement and a net quantity of contents declaration. MoCRA maintains those requirements and adds new ones. The identity statement must accurately describe the cosmetic product and cannot be misleading about its function or composition. The net quantity declaration must appear in both metric units and US customary units for products sold in the US market. Foreign brands that express net quantity only in metric units on their standard international packaging must add the US customary equivalent on US-market labels.
Ingredient labeling changes under MoCRA
MoCRA retained the existing requirement that cosmetic ingredient lists appear on the information panel in descending order of predominance, using International Nomenclature of Cosmetic Ingredients (INCI) names where applicable. The significant new development under MoCRA is the FDA's authority to require disclosure of fragrance allergens as individual ingredients rather than collectively under the term 'fragrance.' The FDA has been directed to issue a proposed rule on fragrance allergen labeling. Foreign cosmetic brands that rely heavily on complex fragrance formulations should begin mapping which fragrance allergens are present in their products now, before the rule is finalized, to avoid a labeling overhaul on a compressed timeline.
Responsible person and facility registration labeling connections
MoCRA requires that every cosmetic product sold in the US have a designated responsible person — the US-based entity (manufacturer, packer, or distributor) whose name appears on the label and who bears regulatory responsibility for the product's compliance. The responsible person's name and place of business must appear on the label, as has been required under prior FDA regulations. What MoCRA adds is the substantive compliance obligation that accompanies this label placement: the responsible person must have registered their cosmetic manufacturing facility with the FDA and submitted a cosmetic product listing for each product. A product whose label identifies a responsible person who has not completed facility registration and product listing is non-compliant under MoCRA.
Claims and what they require
Cosmetic claims on US labels and marketing materials must not cause a product to be regulated as a drug. A cosmetic claim that attributes a physiological effect to the product — 'repairs DNA,' 'stimulates collagen production,' 'treats acne' — crosses the line from cosmetic to drug claim and subjects the product to drug regulatory requirements including premarket approval. Foreign brands accustomed to claims language that is accepted in their home markets — particularly for skincare and hair products — sometimes use similar language on US labels without recognizing the regulatory significance. Claims that are acceptable in the EU or under Korean or Japanese regulations may not be acceptable in the US context, and FDA enforcement on drug claims embedded in cosmetic marketing has increased.
How FDABridge supports MoCRA labeling compliance
FDABridge manages cosmetic facility registration and product listing under MoCRA for foreign cosmetic brands. We review US label content for MoCRA compliance before product launch and track regulatory updates as the FDA issues new guidance on fragrance allergen labeling and other pending provisions. Visit fdabridge.com/cosmetics to see our cosmetics compliance services or fdabridge.com/apply/cosmetics to get started.
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