US LABELLING REGULATORY REVIEW

Written By Matt Higgins

Overview

Engaged by a consumer health brand to support the reformulation and regulatory alignment of an existing softgel supplement ahead of expansion into the U.S. market. The project focused on validating ingredient strategy, and ensuring label compliance under FDA/DSHEA.

Approach

  • Formulation Assessment

    • Assessed ingredient status under DSHEA to confirm no New Dietary Ingredient (NDI) requirements

  • Regulatory Review

    • Conducted a detailed audit of label compliance against 21 CFR 101.36

    • Identified gaps in Supplement Facts formatting, terminology, and required disclosures

  • Risk Analysis

    • Reviewed ingredient-specific considerations (e.g., beta-carotene risk profile in certain populations)

    • Assessed potential exposure from claims, labeling language, and positioning

  • Strategic Positioning

    • Evaluated use of “natural” claims and alignment with ingredient sourcing

    • Provided guidance on balancing regulatory defensibility with commercial messaging

Outcome

  • Delivered targeted label corrections to improve regulatory alignment

  • Identified and mitigated key compliance and liability risks

  • Strengthened linkage between formulation, claims strategy, and market positioning

  • Provided a clear pathway to U.S. market readiness

Matt Higgins
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Functional Product Design & Formulation Strategy