Service overview
Our PCQIs review your supplement labels against 21 CFR Part 101, check Supplement Facts, claims and ingredient lists, and set out the corrections you need.
Why this service matters
- Dietary supplement labels must meet FDA labelling rules under 21 CFR Part 101.
- Common mistakes include incorrect Supplement Facts panels and unsubstantiated structure-function claims.
- Non-compliant labels can lead to import refusals, recalls and warning letters.
Full Label Compliance Review Service
Our PCQIs review your supplement labels in full against FDA dietary supplement labelling rules.
- Supplement Facts panel review for FDA-compliant formatting and content
- Ingredient list validation for accuracy and proper order
- Review of font sizes, placement, and formatting per FDA guidelines
Dietary Supplement Labelling Compliance
Supplement Facts Panel Creation & Verification
The Supplement Facts panel is a critical part of supplement labelling, so we check serving sizes, nutrient amounts and daily values for accuracy and format.
- Creation of FDA-compliant Supplement Facts panels
- Serving size validation and daily value percentage checks
- Compliance with font, size, and formatting requirements
Ingredient List & Allergen Declaration Review
The FDA requires accurate ingredient lists and allergen declarations on dietary supplements, and we review both on your labels.
- Ingredient list review for proper naming and descending order by weight
- Verification of allergen declarations for the major food allergens
- Allergen labelling checks against the Food Allergen Labeling and Consumer Protection Act (FALCPA)
Structure-Function & Health Claims Compliance
Structure-function claims describe how a product supports normal body functions, and the FDA regulates them to prevent misbranding.
- Review of structure-function claims for regulatory compliance
- Substantiation requirements for health claims
- Assessment of permissible vs. restricted claims
Warning Statements & Required Disclaimers
Some supplements need FDA-mandated warnings based on intended use, ingredient risks or health concerns, and we check that required warnings and disclaimers are included.
- Evaluation of ingredient safety profiles for required warnings
- Proper use of FDA disclaimers for structure-function claims
- Compliance with state-specific warnings (e.g., California Prop 65)
International Labelling Compliance (UK & EU Markets)
Selling in the UK and EU means meeting Trading Standards and EU food supplement labelling rules, and we review your labels for those markets.
- Regulation (EU) No 1169/2011 labelling compliance for the EU
- Allergen and nutrition information formatted for international standards
- Translation and localisation services for non-US markets
Ongoing compliance support
Time-Saving
One review covers the panel, ingredients, claims and disclaimers together.
Regulatory Assurance
Labels checked against FDA dietary supplement labelling rules before you ship.
Peace of Mind
Reduce the risk of import refusals, warning letters and misbranding issues.
What you'll need
Share the draft label and the facts that sit behind every claim.
- Supplement Facts panelDraft panel with serving sizes and daily values.
- Ingredient listNames in descending order by weight.
- Allergen declarationsAny major food allergens in the formula.
- Structure-function claimsThe wording you want to use on pack.
- Target marketsUS only, or UK and EU as well.
Official sources
Related services: FDA labelling training