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An accurate label that displays the required content for a dietary supplement is important from both a consumer education and regulatory perspective.
In the U.S., dietary supplements must adhere to the FDA’s specific formulation and labeling requirements under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and related regulations. This includes ensuring the product is safe, the ingredients are permitted, and the label meets all legal standards.
Our regulatory team will review your formulation and label to ensure compliance before going to market.
Dietary supplement formulations must comply with FDA guidelines, including:
- Use of Permitted Ingredients: Permitted dietary ingredients include vitamins, minerals, herbs, amino acids, enzymes and probiotics; however, confirming compliance requires expertise ad there is no comprehensive positive list of dietary ingredients permitted for use in the US.
- New Dietary Ingredients (NDI): Any ingredient not in use before October 15, 1994, must undergo FDA notification prior to use.
- Avoidance of Banned Substances: Formulas must exclude prohibited ingredients, such as ephedrine alkaloids or drugs.
- Adherence to GMP Standards: Manufacturing processes must follow 21 CFR Part 111 for quality and consistency.
Dietary supplement labels must also comply with FDA regulations, including:
- Supplement Facts Panel including accurate source information, serving size, and % Daily Value (DV), where applicable.
- Ingredient listing
- Product claims which are permitted and accurate. Structure/Function claims require substantiation, notification to FDA and a labeling disclaimer.
- Other mandatory information such as statement of identity, net quantity, name and place of business of the manufacturer, packer, or distributor.
- Appropriate format, layout, and sizing of text and other elements
- Other special labeling provisions as required, including directions for use, warnings, and storage instructions.
At SGS Nutrasource, our experts are ready to guide you through every step of dietary supplement labeling and formulation compliance. From ensuring your label layout meets FDA standards to reviewing claims and ingredient safety, we’ll help you navigate the complexities of the U.S. regulatory landscape.
Learn how we can help you achieve label compliance according to the latest regulations.
