Substance Law provides legal and regulatory label review services for food, drugs, natural health products (NHPs), and consumer packaged goods (CPG) sold in Canada. We assist manufacturers, importers, and brand owners in ensuring their product labels comply with Canadian regulatory requirements before entering the market.
Product labelling in Canada is governed by a complex framework of federal legislation and regulatory guidance. Non-compliant labels can result in enforcement action, product recalls, import refusals, or delays in market entry.
We review labels for compliance with applicable laws and provide practical guidance to reduce regulatory risk.
Regulatory Framework for Product Labelling in Canada
Labelling requirements vary depending on product classification. Key legislation includes:
- the Food and Drugs Act
- the Food and Drug Regulations
- the Safe Food for Canadians Regulations
- the Natural Health Products Regulations
- the Consumer Packaging and Labelling Act
Regulatory oversight is primarily administered by Health Canada and the Canadian Food Inspection Agency.
Each product category—food, drugs, NHPs, and general CPG—has distinct requirements that must be assessed individually.
Label Review Services We Provide
We conduct detailed regulatory label reviews tailored to the product category and intended market.
Our services include:
- full label compliance review
- ingredient and formulation alignment
- claims and marketing review
- bilingual labelling assessment
- allergen and disclosure compliance
- regulatory classification support
- risk identification and mitigation
We provide clear, actionable feedback to help bring products into compliance.
Food Label Review and Compliance
Food products sold in Canada must comply with federal labelling rules under the Food and Drugs Act and the Safe Food for Canadians framework.
We review:
- Nutrition Facts Tables (NFTs)
- ingredient lists and allergen declarations
- bilingual labelling requirements
- front-of-package labelling rules
- nutrient content and health claims
- serving size and formatting requirements
Food labelling errors are a common source of enforcement action and should be addressed prior to market entry.
Drug Label Review and Regulatory Compliance
Drug products are subject to strict labelling and authorization requirements.
We assist with:
- drug facts table and required information
- product classification (drug vs NHP vs cosmetic)
- compliance with approved indications
- warnings, directions for use, and claims
- alignment with product licences and submissions
Drug labelling must align with regulatory approvals and product classification.
Natural Health Product (NHP) Label Reviews
Natural health products must comply with the Natural Health Products Regulations and require product licensing.
We review:
- Natural Product Number (NPN) requirements
- ingredient disclosure and medicinal ingredients
- recommended use and purpose statements
- risk information and cautionary statements
- claims compliance
NHP labelling must match the approved product licence and regulatory requirements.
Consumer Packaged Goods (CPG) Label Compliance
CPG products may fall outside specific food or drug frameworks but are still subject to general labelling and marketing rules.
We assist with:
- packaging and labelling compliance
- misleading advertising risks
- product classification issues
- bilingual and metric requirements
- general consumer protection compliance
CPG label reviews often require cross-analysis across multiple regulatory regimes.
Claims and Marketing Review
Claims on product labels are closely regulated in Canada.
We assess:
- health and therapeutic claims
- structure-function claims
- “natural,” “organic,” and similar claims
- comparative and performance claims
- implied claims and marketing language
Improper claims can trigger enforcement, even if other label elements are compliant.
Allergen, Ingredient, and Disclosure Requirements
Certain disclosures are mandatory across multiple product categories.
We review:
- allergen declarations
- gluten and sulphite disclosures
- ingredient listing requirements
- formatting and placement requirements
Accurate disclosure is critical for both compliance and consumer safety.
Bilingual Labelling Requirements
Most consumer products sold in Canada must comply with bilingual labelling requirements.
We assess:
- English and French translation requirements
- placement and prominence of required information
- compliance with federal bilingual standards
Failure to comply with bilingual requirements can result in enforcement action or product rejection.
Import and Market Entry Label Compliance
Imported products must meet Canadian labelling standards before entering the market.
We assist with:
- reviewing foreign labels for Canadian compliance
- adapting labels for Canadian requirements
- identifying gaps prior to import
- reducing risk of border or inspection issues
Pre-market label review helps avoid costly delays and enforcement action.
Why Work With Substance Law for Label Reviews
- experience with regulated products and compliance frameworks
- understanding of Health Canada and CFIA expectations
- practical, business-focused advice
- support for Canadian and international companies
- assistance across food, drugs, NHPs, and CPG categories
We provide legal guidance to help businesses bring compliant products to market.
Work With a Label Compliance Lawyer in Canada
If you are launching or selling products in Canada, label compliance is a critical step in regulatory approval and market entry.
Substance Law assists businesses with food, drug, NHP, and CPG label reviews and compliance strategy.
Contact Substance Law to discuss your label review.
Frequently Asked Questions
What is a label review for regulated products in Canada?
A label review is a legal and regulatory assessment of a product label to ensure it complies with Canadian laws and regulatory requirements before the product is sold.
Which products require label compliance review in Canada?
Food, drugs, natural health products, and consumer packaged goods all have labelling requirements that should be reviewed for compliance before entering the market.
Who regulates product labelling in Canada?
Product labelling is regulated primarily by Health Canada and the Canadian Food Inspection Agency, depending on the product category.
Do imported products need Canadian-compliant labels?
Yes. Imported products must meet Canadian labelling requirements, including bilingual labelling and required disclosures.
What are common label compliance issues?
Common issues include incorrect claims, missing allergen declarations, improper formatting, lack of bilingual labelling, and misclassification of products.
Do natural health products have special labelling rules?
Yes. Natural health products must comply with the Natural Health Products Regulations and must match the approved product licence.
Why are claims on labels regulated?
Claims are regulated to prevent misleading consumers and to ensure that health and performance claims are accurate and supported.
Can a lawyer help prevent product recalls due to labelling?
Yes. Legal review of labels can identify compliance issues early and reduce the risk of enforcement action or product recalls.
