Can supplements be sold without FDA approval?

The global dietary supplement market continues to grow rapidly, with more businesses seeking opportunities across borders. Canada, in particular, is a lucrative market for dietary supplements, but entering this market requires compliance with both U.S. Food and Drug Administration (FDA) regulations and Canadian laws. For manufacturers, distributors, and online sellers, understanding these regulations is key to successful importing and exporting.

The Role of the FDA in Dietary Supplement Regulation

If you’re manufacturing supplements in the U.S. for export to Canada, the FDA regulates the manufacturing, labeling, and quality standards under the Dietary Supplement Health and Education Act (DSHEA). Your products must comply with:

• Good Manufacturing Practices (GMPs): The FDA requires dietary supplements to be produced in a quality manner, confirming identity, purity, strength, and composition.
• Labeling Requirements: Labels must accurately represent the product, including ingredients, net contents, and truthful health claims.
• New Dietary Ingredients (NDIs): If your supplement contains an NDI, you may need to notify the FDA before marketing.

While these regulations are mainly for U.S. markets, exported supplements must also comply unless they conflict with the requirements of the country of import—in this case, Canada (FDA’s Guidance on Exporting Supplements).

Health Canada and Natural Health Product (NHP) Regulations

Once your product crosses into Canada, it becomes subject to Health Canada’s regulations:

• Natural Health Product Regulations (NHPR): Most dietary supplements are regulated as Natural Health Products (NHPs) in Canada.
• Product Licensing: Each supplement must have a product license, designated by an eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM).
• Site Licensing: Companies manufacturing, labeling, packaging, or importing NHPs in Canada must hold a valid site license.
• Labeling & Packaging: Labels must be bilingual and include specific information such as recommended use, medicinal and non-medicinal ingredients, dosage, risk information, and NPN or DIN-HM number.
• Evidence of Safety and Efficacy: Documentation must support product claims and safety, such as clinical studies or references to accepted compendia.

For more on Health Canada guidelines, visit the Health Canada Natural Health Products Regulations page.

Importing Dietary Supplements into Canada

Importing supplements into Canada requires thorough preparation:

1. Product & Site Licensing: Ensure both your products and operation sites are licensed by Health Canada.
2. Documentation: Prepare detailed paperwork, including a bill of lading, product licenses, supplier information, and evidence of compliance.
3. Customs Declaration: Accurate classification and valuation are crucial for customs. Incorrect declarations can result in delays or penalties.
4. Random Inspections: The Canadian Border Services Agency (CBSA) and Health Canada may randomly inspect shipments to ensure regulatory compliance.
5. Restricted Ingredients: Some ingredients permitted in the U.S. may be restricted or require special approval in Canada. Always check the Health Canada NHP Ingredients Database.

Exporting Dietary Supplements from Canada

Exporters must also meet Canadian regulatory obligations:

• Product Legality: Ensure the product is legal for export and complies with the foreign country’s import laws.
• Documentation: Detailed export documents, including certificates of free sale, contracts, and permits, are required depending on the destination country.
• Labeling: For some markets, you may need to adjust labeling to meet recipient country regulations.

Why Work with a Licensed Customs Broker?

Dietary supplement regulations are complex and can change quickly. Failure to comply can mean costly delays, shipments held at the border, or even being barred from the Canadian market altogether. A licensed customs broker is invaluable:

• Expert Guidance: Brokers understand both FDA and Canadian regulations, import permits, and required documentation.
• Faster Processing: Avoid customs delays by having all necessary information and forms ready for your shipment.
• Compliance Assurance: Stay up-to-date with changing requirements and ensure ongoing compliance.

Take the Next Step

If you plan to import or export dietary supplements to or from Canada, don’t risk facing compliance issues or border delays. Partner with a trusted customs broker who understands the intricacies of FDA and Health Canada regulations. Get in touch today for personalized advice and seamless solutions for your supplement business.

Contact our team of expert customs brokers and simplify your cross-border supplement trade.