FDA & Health Canada Approved

Compliance Labels Regulatory Excellence

Professional supplement labeling services ensuring FDA and Health Canada compliance. Bilingual labels, nutrition facts, and regulatory review for seamless market access.

1-2 weeks from start to approved labels
FDA Supplement Facts & Health Canada Product Facts tables
Print-ready files with regulatory compliance

View Process

Regulatory Compliance

FDA Requirements

Supplement Facts panels, DSHEA compliance

Health Canada Standards

Product Facts Table (PFT), 2025 PLL regulations

Bilingual Labels

English-French for Canadian market

Professional Design

Print-ready files, multiple formats

100% regulatory compliance guaranteed

IMPORTANT: 2025 Regulatory Updates

New Labeling Requirements in Effect

Stay compliant with the latest regulatory changes in both US and Canadian markets. We ensure your labels meet all current standards.

Canada

Plain Language Labelling (PLL) Regulations

Effective Date

June 21, 2025

Compliance By

June 22, 2028

Key Changes:

Standardized Product Facts Table (PFT) format required
Sans-serif fonts and high-contrast design mandatory
Enhanced allergen disclosure requirements
Simplified dosage and warning statements

Impact:

All Natural Health Products must transition to new labeling format

United States

Continued DSHEA Compliance

Effective Date

Ongoing

Compliance By

Immediate

Key Changes:

Supplement Facts panel format (established 2016)
New Dietary Ingredient (NDI) notification requirements
Enhanced structure/function claim substantiation
Minimum 8-point font size (6-point for column headings only)

Impact:

Stricter enforcement of existing supplement labeling standards

✓ We're fully updated with all 2025 labeling requirements

Our team stays current with regulatory changes to ensure your labels are always compliant

Regulatory Framework Expertise

We navigate complex regulatory requirements across multiple jurisdictions to ensure your labels meet all compliance standards.

United States - FDA

Food and Drug Administration regulations

Key Requirements:

Dietary Supplement Health and Education Act (DSHEA)
21 CFR 101.36 - Supplement Facts labeling
Structure/function claim regulations
New Dietary Ingredient (NDI) notifications

Required Label Elements:

Supplement Facts panel Ingredient list Net weight Manufacturer/distributor info Statement of identity

Timeline

5-7 business days

Canada - Health Canada

Natural and Non-prescription Health Products Directorate

Key Requirements:

Natural Health Products Regulations (SOR/2003-196)
2025 Plain Language Labelling (PLL) Regulations
Consumer Packaging and Labelling Act
Official Languages Act - bilingual requirements

Required Label Elements:

Product Facts Table (PFT) NPN/DIN-HM number Medicinal ingredients Non-medicinal ingredients Directions/warnings

Timeline

7-10 business days (PLL compliance deadline: June 2028)

Comprehensive Labeling Services

From nutrition analysis to print-ready files, we handle every aspect of supplement label compliance and design.

Label Design & Review

Professional label design with regulatory compliance verification

FDA and Health Canada compliant layouts
Eye-catching design that meets regulations
Multiple format options (bottles, pouches, boxes)
Print-ready files with proper specifications

Nutrition Analysis

Comprehensive nutritional analysis for accurate label information

Laboratory-verified nutrition facts
Serving size optimization
Nutrient content claims validation
Shelf-life and stability considerations

Regulatory Review

Expert review by regulatory specialists

FDA and Health Canada compliance verification
Claim substantiation review
Warning statement compliance
Market-specific requirement analysis

Bilingual Translation

Professional English-French translation for Canadian market

Certified regulatory translators
Terminology consistency across products
Cultural adaptation for French markets
Quebec-specific regulatory compliance

Essential Labeling Requirements

We ensure your labels include all mandatory information formatted according to FDA and Health Canada specifications.

FDA Supplement Facts Panel

Complete supplement information formatted per FDA DSHEA guidelines

Timeline: 2-3 days

Serving size and servings per container
Dietary ingredients with quantities and %DV
Proprietary blend information (if applicable)
Other ingredients listed separately

Health Canada Product Facts Table

Bilingual Product Facts Table (PFT) complying with 2025 Plain Language Labelling regulations

Timeline: 3-4 days

English/French bilingual table or separate tables
Medicinal and non-medicinal ingredients
Uses, warnings, and directions for use
Meets June 2025 PLL formatting standards

Ingredient Declarations

Complete ingredient lists with proper naming and order

Timeline: 1-2 days

Descending order by weight
Common and scientific names as required
Sub-ingredient declarations for compounds
Allergen highlighting and warnings

Health Claims & Warnings

Regulatory-compliant claims and mandatory warning statements

Timeline: 2-4 days

FDA structure/function claims verification
Health Canada approved health claims
Required warning statements and disclaimers
Age restrictions and usage guidelines

4-Phase Labeling Process

Our systematic approach ensures your labels are compliant, professional, and ready for production in just 1-2 weeks.

Product Analysis

Day 1-2

Deliverable:

Comprehensive product analysis report

Key Activities:

Review product formulation and specifications
Identify target markets and regulatory requirements
Conduct nutrition analysis if needed
Determine serving sizes and usage directions

Content Development

Day 3-5

Deliverable:

Complete label content in required languages

Key Activities:

Create nutrition facts panels/tables
Develop ingredient declarations
Write regulatory-compliant health claims
Prepare warning statements and disclaimers

Design & Layout

Day 6-8

Deliverable:

Professional label designs with regulatory compliance

Key Activities:

Design label layout and visual hierarchy
Ensure font sizes meet minimum requirements
Optimize space utilization and readability
Create multiple format variations

Review & Approval

Day 9-10

Deliverable:

Approved labels ready for production

Key Activities:

Regulatory expert review and verification
Client review and feedback incorporation
Final compliance check against regulations
Preparation of print-ready files

Labeling Challenges We Solve

Common labeling obstacles and how our expertise ensures compliance and market success.

Challenge:

Space Limitations

Our Solution:

Strategic layout optimization and hierarchical information design

Result:

100% regulatory compliance within space constraints

Challenge:

Multi-Market Requirements

Our Solution:

Unified design approach accommodating different regulatory frameworks

Result:

Single label design for multiple markets when possible

Challenge:

Language Requirements

Our Solution:

Professional regulatory translation and cultural adaptation

Result:

Perfect bilingual compliance for Canadian market

Challenge:

Claim Substantiation

Our Solution:

Evidence-based claim development and regulatory pre-approval

Result:

Zero claim-related regulatory rejections

Ready for Compliant Labels?

Get professional, regulatory-compliant labels designed for both US and Canadian markets in just 1-2 weeks.

Start Label Project

Compliance Labeling FAQ

Common questions about supplement label compliance and design

What are the 2025 Plain Language Labelling (PLL) changes for Canada?

Health Canada's new Plain Language Labelling regulations came into force June 21, 2025, requiring a standardized Product Facts Table (PFT) with specific formatting: sans-serif fonts, high-contrast design, and clear bilingual presentation. All Natural Health Products must comply by June 22, 2028. The PFT must include medicinal ingredients, uses, warnings, directions, non-medicinal ingredients, and contact information in an easy-to-read format.

What's the difference between Supplement Facts, Nutrition Facts, and Product Facts?

These are distinct labeling formats for different product types: 'Supplement Facts' panels are required by the FDA for dietary supplements in the US. 'Nutrition Facts' labels are for conventional foods. In Canada, 'Product Facts Tables (PFT)' are used for Natural Health Products following 2025 PLL regulations, while 'Nutrition Facts' tables are for foods. Each has specific formatting rules and required information unique to their regulatory framework.

What's the difference between US and Canadian labeling requirements?

US labels require FDA-compliant Supplement Facts panels and follow DSHEA regulations for dietary supplements. Canadian labels need bilingual Product Facts Tables (PFT) following 2025 Plain Language Labelling regulations, must comply with Natural Health Products Regulations, and require NPN numbers. Canada also requires full bilingual presentation in both English and French. We ensure your labels meet both jurisdictions' specific requirements.

Do I need separate labels for the US and Canadian markets?

How long does the label review and approval process take?

Can you help with nutrition analysis for the label facts?

What if my product claims are rejected by regulators?

Do you provide print-ready files for manufacturing?

Can you translate existing labels for the Canadian market?

How is pricing determined for label design and compliance review?

Pricing varies based on multiple factors including product complexity, number of ingredients, target markets (US, Canada, or both), formulation type, required testing, claim substantiation needs, and timeline requirements. Each project is unique, and we provide detailed custom quotes based on your specific requirements. Contact us for a personalized quote tailored to your product and business needs.

What's included in your label compliance review?

Our review covers Supplement Facts/Product Facts Table accuracy, ingredient declaration compliance, claim substantiation, warning statement requirements, font size regulations (minimum 8-point for standard packages, 6-point for column headings), mandatory information placement, bilingual requirements for Canada, and overall regulatory compliance for your target markets including 2025 PLL standards.