Proper labeling is not just a regulatory requirement—it's your first line of defense against FDA warning letters, consumer lawsuits, and damaged brand reputation. This comprehensive guide covers everything you need to know about FDA-compliant supplement labeling.
Understanding FDA Label Regulations
The FDA regulates dietary supplement labeling under the Dietary Supplement Health and Education Act (DSHEA) of 1994 and subsequent regulations. Non-compliance can result in warning letters, product seizures, and legal action.
Principal Display Panel (PDP) Requirements
The PDP is the part of the label most likely to be displayed to consumers. It must include:
1. Statement of Identity
- Must include the term "dietary supplement" or specific type (e.g., "Vitamin C Supplement")
- May include descriptive terms (e.g., "High Potency Multivitamin Supplement")
- Must be in bold type and parallel to the base of the package
- Size must be prominent and proportional to package size
2. Net Quantity of Contents
- Must appear in the lower 30% of the PDP
- Express in terms of count (e.g., "60 Capsules") or weight/volume
- Use both metric and US customary units
- Specific type size requirements based on PDP area
Information Panel Requirements
The information panel (typically the right side of the PDP) must contain:
1. Supplement Facts Panel
The most complex element of supplement labeling:
Required Elements:
- Title: "Supplement Facts" in larger, bold type
- Servings: Serving size and servings per container
- Nutrients: Listed in specific order with amounts per serving
- % Daily Value: When established (based on 2,000 calorie diet)
- Other Ingredients: Listed below the panel in descending order by weight
Formatting Requirements:
- Black type on white background (no reverse type)
- Minimum 8-point type (6-point for certain elements)
- Hairline rules between sections
- Specific spacing and indentation rules
2. Ingredient List
- List all ingredients not in the Supplement Facts panel
- Descending order by weight
- Common names required (no proprietary blend names here)
- Include all processing aids and excipients
3. Manufacturer Information
- Name and address of manufacturer, packer, or distributor
- Include street address unless listed in phone directory
- City, state, and ZIP code required
- Phone number recommended but not required
Nutrient Declaration Requirements
Order of Nutrients:
- Vitamin A, C, D, E, K
- B vitamins in specific order
- Minerals in specific order
- Other dietary ingredients
Units of Measure:
- Use metric units with US customary in parentheses when appropriate
- Specific units required for each nutrient (mcg, mg, g, IU)
- Express amounts to appropriate significant figures
Proprietary Blends:
- Total weight of blend must be listed
- Individual ingredients listed in descending order by weight
- Cannot hide behind "proprietary" for individual amounts
Claims and Statements
Permitted Health Claims:
Only FDA-approved health claims allowed. Examples:
- Calcium and osteoporosis
- Folic acid and neural tube defects
- Plant sterols and heart disease
Structure/Function Claims:
Allowed with restrictions:
- Must be truthful and not misleading
- Cannot claim to diagnose, treat, cure, or prevent disease
- Require disclaimer (see below)
- FDA notification within 30 days of marketing
Required Disclaimer:
For structure/function claims, must include:
"These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
- Must be in bold type
- Box around text optional but common
- Adjacent to claims when possible
Allergen Labeling
Major food allergens must be declared:
- Milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans
- State "Contains: [allergen]" immediately after ingredients
- Or include allergen source in ingredient name
- Sesame added as 9th major allergen in 2023
Common Labeling Violations
1. Disease Claims
Avoid these prohibited statements:
- "Prevents heart disease"
- "Treats arthritis"
- "Cures insomnia"
- Any reference to specific diseases
2. Incorrect Serving Sizes
- Must reflect amount recommended for consumption
- Cannot manipulate to show better % Daily Values
- Must be consistent with directions for use
3. Missing or Incorrect Units
- Using "mg" instead of "mcg" (1000x difference!)
- Incorrect Daily Value calculations
- Missing units entirely
4. Improper Ingredient Names
- Using Latin names instead of common names
- Trademark names in ingredient list
- Incomplete identification of botanicals
Special Labeling Situations
Botanical Ingredients:
- Common name and Latin binomial required
- Plant part must be specified
- Extract ratio or standardization if applicable
Probiotics:
- Genus, species, and strain designation
- Colony forming units (CFUs) at expiration
- Storage conditions if stability-dependent
Small Packages:
- May use abbreviated format if PDP less than 12 sq inches
- Phone number or website for full information
- Still must include critical safety information
International Considerations
If exporting, be aware of additional requirements:
- Country of origin statement
- Bilingual labeling requirements
- Different nutrient declaration formats
- Restricted ingredients by country
Label Review Checklist
Before printing, verify:
Content Review:
- □ All required elements present
- □ Serving size appropriate and consistent
- □ Math checked on all calculations
- □ Claims substantiated and compliant
- □ Disclaimer present if needed
- □ Allergen declarations complete
Format Review:
- □ Type sizes meet minimums
- □ Proper contrast and spacing
- □ Required bold type used
- □ Hairlines in correct positions
- □ Net contents in lower 30% of PDP
Final Review:
- □ Proofread by multiple people
- □ Legal review if making new claims
- □ Compare to FDA labeling guide
- □ Check against competitor labels
- □ Verify with contract manufacturer
Best Practices
- Work with experienced regulatory consultants
- Keep records of all label versions and changes
- Document substantiation for all claims
- Review labels annually for compliance updates
- Consider FDA "pre-review" for novel ingredients
Conclusion
FDA-compliant labeling requires attention to detail and understanding of complex regulations. While this guide covers the essentials, regulations can change, and specific products may have additional requirements.
Partner with manufacturers and consultants who stay current with regulatory changes and can guide you through the labeling process. The investment in compliant labeling protects your brand and ensures your products reach consumers without regulatory delays.