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Dietary supplement labels must meet specific U.S. regulatory requirements covering everything from the Supplement Facts panel and ingredient declarations to product identity, claims, warnings, and required label statements. Ensuring your label is compliant before packaging goes to market can help reduce regulatory risk and avoid costly revisions.
SGS Nutrasource's U.S. Dietary Supplement Labeling Compliance Reviews provide a comprehensive assessment of your label against applicable FDA requirements. Our regulatory experts review the content, claims, formatting, and presentation of your label to identify potential compliance issues and provide practical recommendations for addressing them.
Our label reviews can include:
- Supplement Facts panel and serving size
- Dietary ingredient declarations and nomenclature
- Other Ingredients statements
- Product name and statement of identity
- Net quantity of contents
- Manufacturer, packer, or distributor information
- Required domestic contact information for serious adverse event reporting
- Required warnings, cautions, and other statements
- Nutrient content and structure/function claims
- Label formatting, placement, and prominence
- Consistency between the formula, label, and supporting documentation
- Identification of potential regulatory gaps or compliance concerns
Whether you are launching a new dietary supplement, updating an existing label, reformulating a product, or entering the U.S. market, our team can help ensure your label meets applicable requirements and supports a compliant path to market.