FDA & EFSA Supplement Labeling Compliance: Avoiding Common Claims Pitfalls

Structure-Function Claims vs. Disease Treatment Warnings

The most common pitfall in supplement labeling is confusing structure-function claims with disease treatment warnings. In the US and Europe, the line between describing normal structure or function and claiming to treat a disease determines whether a label stays compliant in its target market.

Beyond claim wording, active ingredient callouts, allergen disclosures, and daily value percentage formatting must all be correct before mass printing: a single error can force label rework and distribution delays for export shipments.

How Our In-House Regulatory Team Audits Labels

Our in-house regulatory team audits active ingredient callouts, allergen disclosures, and daily value percentage formatting before mass printing:

  • Claim Language: structure-function claim wording vs. disease treatment warnings for the US and EU frameworks.
  • Active Ingredient Callouts: declared active ingredients and their amounts on the Supplement Facts / Nutrition panel.
  • Allergen Disclosures: mandatory allergen statements for every ingredient in the formula.
  • Daily Value Percentage Formatting: correct %DV presentation and rounding rules.

Contact our regulatory team for a pre-print label audit, or review our label regulatory audit approach.

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