Guide to compliant cross-border logistics for health and wellness brands in the U.S. and Canada

Expanding your health and wellness brand across the U.S.–Canada border opens the door to a booming market, with home healthcare projected to reach USD 27.4 billion in Canada and USD 253.4 billion in the U.S. by 2030.

However, success relies on the ability to navigate complex cross-border compliance, from import regulations and labelling requirements to maintaining supply chain integrity. Whether you're localizing fulfillment or expanding internationally, understanding and addressing these regulatory demands is essential.

This guide explores the top challenges in cross-border health and wellness logistics, outlines the key compliance requirements in both the U.S. and Canada and provides practical strategies to help retailers streamline operations and ensure consistent, compliant growth across North American supply chains.

Understanding cross-border healthcare compliance

Health and wellness products, including dietary supplements, natural health products (NHPs), over-the-counter items and personal care goods, are regulated in both the U.S. and Canada. Each country has its own governing bodies, licensing requirements and import/export restrictions, which must be adhered to for seamless cross-border logistics.

Regulatory authorities in the U.S. and Canada

• U.S. Oversight: The Food and Drug Administration (FDA) regulates health and wellness products, ensuring they meet safety, efficacy and labelling standards.
• Canadian Oversight: Health Canada supervises the import and distribution of health and wellness products, enforcing strict guidelines on product labelling, quality assurance and market approvals. Additionally, the Canada Border Services Agency (CBSA) plays a role in monitoring imports for regulatory compliance.

A common mistake is assuming a product compliant in one country is automatically compliant in the other, but it’s not. Labels, formulations and even marketing claims often require review and adjustment.

Key compliance considerations in U.S.-Canada healthcare logistics

Cross-border logistics and localization strategies for healthcare products introduce specific compliance hurdles that retailers must address. The following are some of the most pressing challenges:

1. Compliant warehousing and storage facilities

To sell regulated health and wellness products effectively across North America, products need to be distributed from facilities that meet specific regulatory and quality standards. These requirements are essential for maintaining safe, traceable and compliant supply chains:

• FDA-registered facilities (U.S.): U.S warehouses are registered with the Food and Drug Administration to store and handle regulated products like food, dietary supplements, drugs and medical devices. Registration ensures the facility meets applicable federal safety and handling requirements.
• Health Canada–licensed facilities (Canada): Canadian warehouses must hold appropriate licenses from Health Canada. This is essential for distributing pharmaceuticals, natural health products and controlled substances, and ensures compliance with Canadian regulatory standards.
• GMP-compliant warehouses (both U.S. and Canada): Good Manufacturing Practices (GMP)-compliant facilities follow strict protocols on cleanliness, temperature control, documentation, personnel hygiene and training. GMP standards safeguard product quality and safety across the supply chain.

Retailers should partner with a 3PL that has compliant facilities in the US and Canada to uphold trust with regulatory authorities and end consumers.

Metro Supply Chain has FDA-registered, GMP-compliant, and Health Canada-compliant facilities across North America, maintaining a rigorous set of quality assurance standards and operational protocols.

2. Licensing and import approvals

Health and wellness products entering Canada from the U.S. must obtain market authorization from Health Canada. The licensing process includes:

• Reviewing the safety and efficacy of products before distribution.
• Registering healthcare products with Health Canada’s Drug Identification Number (DIN) system.
• Complying with restrictions on certain pharmaceutical ingredients that may be classified differently in Canada.

Additionally, distributing and selling NHPs or OTC wellness products in Canada typically requires one or more Health Canada licenses, such as a Site License or Medical Device Establishment License (MDEL), depending on the product type.

Canadian health and wellness brands seeking entry into the U.S. market must navigate a set of regulatory and operational requirements enforced by the U.S. Food and Drug Administration (FDA).

• FDA registration & market authorization: Products must be evaluated and listed with the FDA, including appropriate pre-market notifications or approvals depending on the product classification (e.g., cosmetics, dietary supplements, OTC drugs, or medical devices).
• Ingredient Compliance: Ingredients must align with FDA-approved substances, as U.S. regulations may differ from Health Canada's classifications.

Retailers should confirm that their logistics providers can legally store and distribute licensable goods. At Metro Supply Chain, we hold Drug Establishment Licenses, NHP Site Licenses, MDEL and operate FDA-registered facilities to support seamless, compliant movement of health and wellness goods.

3. Labelling and packaging compliance

Canada mandates bilingual labelling (English and French) for all retail products. Labels must also include:

• Clear instructions for use, dosage information and ingredient lists
• Any necessary consumer warnings or advisories specific to Canadian regulations
• Compliance with Health Canada’s packaging standards for safety and accessibility

In the U.S., product labelling must meet U.S. format, language and content requirements, including supplement facts, drug facts, and intended use disclaimers.

Retailers must adjust their packaging design and ensure that labelling meets the required standards before distribution in either country.

Metro Supply Chain offers licensed in-house services for kitting, repackaging, relabeling and detailed inspections. With Natural Health Product (NHP) and Drug Packaging and Labelling Licenses, we can rework U.S. packaging to meet Health Canada’s regulations. This includes reprinting directly on products and repackaging into new bilingual-compliant boxes.

4. Specialized handling and product integrity

From probiotics to essential oils and collagen supplements, many wellness products are temperature-sensitive or require strict handling protocols.

Metro Supply Chain has an extensive supply chain network that includes compliant facilities with temperature controls, humidity monitoring and specialized handling procedures to maintain the safety and efficacy of products throughout the storage period.

5. Quality assurance and audits

Maintaining product integrity across borders requires smooth logistics and rigorous quality assurance. From supplements to personal care items, health and wellness products must meet strict regulatory and safety standards at every stage.

Effective QA includes:

• Inbound inspections to verify product quality
• Lot traceability and chain-of-custody tracking for fast issue resolution
• Ongoing staff training and SOPs for consistent, compliant handling
• Internal audits to proactively identify and correct risks

Metro Supply Chain’s in-house team of compliance and QA experts ensures that all regulatory requirements are met and that the highest quality standards are maintained across all their processes.

We also maintain relationships with regulatory compliance firms that are experts in Health Canada and FDA policies, processes, and language to assist your company in meeting requirements. Additionally, Metro Supply Chain has strong quality management systems, inbound inspections, and designated returns and quarantine areas to ensure your operations are fully compliant in Canada and the US.

6. Tracking and automation

In cross-border health and wellness logistics, real-time visibility and automation are key to staying compliant and responsive.

Retailers need systems that:

• Track shipments and inventory from origin to shelf
• Trace lots and batches to quickly isolate quality or recall issues
• Automate compliance tasks, like generating documentation or alerting for inventory risks

These tools reduce manual errors, speed up customs clearance and ensure regulatory deadlines are met.

Metro Supply Chain uses a validated warehouse management system (WMS) that complies with requirements for recall reporting and retention sampling. It enables efficient inventory tracking, including lot numbers and expiration dates, to ensure healthcare products are safely managed and consistently high in quality.

7. Changing trade and product regulations

Trade policies between the U.S. and Canada evolve frequently, impacting cross-border healthcare logistics. Retailers must:

• Monitor changes in import tariffs and trade agreements that affect healthcare retail products
• Engage with industry groups and compliance workshops for regulatory insights
• Collaborate with legal teams and customs specialists for up-to-date compliance guidance

For example, in 2022, Health Canada announced amendments to the Natural Health Product Regulations, introducing new labelling requirements for NHPs, including a product facts table and revised allergen labelling, which will come into force on June 21, 2025. In March 2025, Health Canada extended the scope of the transition period.

In the U.S., as of July 2025, the U.S. Food and Drug Administration (FDA) is changing the rules for how low-value shipments (under $800, known as “de minimis” shipments) that contain FDA-regulated products are handled at the border. Previously, some low-value shipments like cosmetics or food could skip FDA review if they met certain criteria. That’s no longer the case, and the FDA is canceling all earlier guidance that allowed these exemptions.

Partnering with Metro Supply Chain for a resilient and compliant supply chain

Expanding into the US or Canadian health and wellness market requires more than just ambition. It demands deep regulatory insight, precision logistics and the right partners. From licensing and bilingual labelling to customs clearance and temperature-controlled storage, every detail matters.

By working with an experienced North American 3PL like Metro Supply Chain, retailers can simplify complexity, reduce risk and accelerate time to market. Metro Supply Chain:

• Operates GMP-certified, FDA-registered, and Health Canada-licensed facilities
• Holds key Health Canada licenses:

• Drug Establishment License
• Medical Device Establishment License

• Maintains product integrity with dedicated in-house Quality Assurance teams overseeing compliance from inbound receipt to final delivery

Ready to expand your market reach and strengthen your compliance strategy? Contact Metro Supply Chain to speak with our health and wellness logistics specialists.

Cross-border logistics compliance summary for U.S. and Canadian health & wellness products