Accurate and compliant labeling is one of the most important requirements for cosmetic products marketed in the United States. The FDA enforces 21 CFR Part 701 – Cosmetic Labeling Regulations, which outline the standards for ingredient statements, net quantity of contents, warnings, and allergen declarations. Non-compliance can lead to misbranding, regulatory enforcement, import refusals, or product recalls.

A label is more than just a design element it is the first point of regulatory review and consumer trust. Labels must be truthful, not misleading, and formatted in compliance with FDA rules. Ingredient lists must use proper INCI (International Nomenclature of Cosmetic Ingredients) names, the net quantity must appear in both metric and U.S. customary units, and warnings must be included where applicable (e.g., products for children or eye-area use).

Equally important are product claims. The FDA closely monitors cosmetic marketing language to ensure that claims do not cross into “drug” territory. For example, a claim like “moisturizes dry skin” may be acceptable for cosmetics, but “heals acne” would classify the product as a drug, requiring drug approval pathways. Terms such as organic, hypoallergenic, cruelty-free, or gluten-free must also be used carefully to avoid misleading consumers.

At XPRO America, we provide expert FDA labeling and claims review services to ensure cosmetic products meet all applicable requirements. Our review process covers:

• Ingredient Statement Compliance – Proper INCI names, descending order, allergens.
• Net Quantity Accuracy – Clear display in metric and U.S. customary units.
• Warning & Caution Statements – As required for safety and FDA compliance.
• Claim Validation – Distinguishing cosmetic vs. drug claims to prevent misbranding.
• Marketing Review – Guidance on acceptable claims such as “organic” or “vegan.”

By partnering with XPRO America, cosmetic companies can avoid costly regulatory setbacks, protect brand reputation, and build consumer trust. Our services not only ensure compliance with FDA regulations but also support successful product launches and long-term U.S. market presence.

XPRO America offers FDA cosmetic labeling & claims review services to ensure compliance with 21 CFR Part 701 and prevent misbranding or enforcement issues.