
Developing a dietary supplement formula for the U.S. market requires more than selecting appropriate ingredients.
The composition, identity, levels, intended use, and regulatory status of each ingredient must be considered to help ensure the finished product meets applicable requirements.
Our U.S. Dietary Supplement Formula Compliance Reviews provide a comprehensive assessment of your formulation to identify regulatory considerations and potential compliance issues early in the product development process. Our experts evaluate your formula against applicable U.S. dietary supplement requirements and provide practical guidance to help support a compliant, market-ready product.
Our formula compliance reviews can include:
- Review of dietary ingredients and overall formulation
- Assessment of ingredient regulatory status and eligibility for use in dietary supplements
- Evaluation of New Dietary Ingredient (NDI) considerations and notification requirements
- Review of ingredient levels, conditions of use, and intended use
- Assessment of potential safety and regulatory concerns
- Identification of applicable regulatory pathways and requirements
- Review of specifications and potential compliance gaps
- Guidance on formulation changes or alternative regulatory approaches
- Considerations for alignment between formulation, labeling, claims, and manufacturing requirements
Whether you are developing a new dietary supplement, reformulating an existing product, introducing an innovative ingredient, or preparing to enter the U.S. market, our team can help you understand the regulatory considerations surrounding your formula and determine the appropriate path forward.