Exporting gummy supplements to international markets? It's complex. You need to understand each country's specific rules on ingredients, labeling, manufacturing, and customs. As a full-service manufacturer, we guide our partners through the process to ensure a smooth market entry.
Key Regulatory Areas to Consider
Regulations differ by country, but most focus on a few core areas. Plan for them early; it pays off.
1. Ingredient Compliance and Novel Foods
Start by verifying that every ingredient in your gummy is allowed in the target market. Many countries maintain positive or negative lists for dietary supplements.
- Novel Food Regulations: If your ingredient wasn't widely consumed in the EU or the UK before 15 May 1997, it may be classified as a Novel Food. That means it needs a pre-market safety assessment and authorization.
- Country-Specific Bans: An ingredient allowed in the US might be banned in the EU. For instance, certain botanical extracts or high-dose vitamins often need extra review.
2. Labeling and Language Requirements
Accurate labeling is a must. Labels must be in the official language(s) of the destination country and include specific mandatory information.
- Mandatory Declarations: Required declarations include product name, net quantity, ingredient list, nutritional information (often in a specific format), recommended dosage, and warnings like "Keep out of reach of children."
- Business Information: The name and address of the manufacturer, packer, distributor, or importer must be clearly stated.
- Country of Origin: Almost every country requires a clear "Made in [Country]" statement.
3. Claims and Marketing Language
You must follow the claims regulations of the export market. These rules define what you can say about your product.
- Structure/Function Claims: Some regions allow general statements about supporting normal bodily function (e.g., "supports immune health") without pre-approval, provided they are truthful and not misleading.
- EU Authorized Claims: In the EU, health claims must be authorized under Regulation (EC) No 1924/2006 and appear in the EU Register of Nutrition and Health Claims.
- Prohibited Claims: Claims that diagnose, treat, cure, or prevent any disease are prohibited for dietary supplements in every major market. Never imply medical effects in your marketing.
4. Manufacturing Standards and Certifications
Many countries require evidence of rigorous quality control. Certain certifications can open doors.
- Good Manufacturing Practices (GMP): Proof of GMP compliance, such as a GMP certificate from a recognized authority, is usually a prerequisite.
- Third-Party Certifications: Certifications like NSF, ISO 22000, or specific organic certifications may be required or highly advantageous for certain markets or retailers.
5. Import Licenses, Duties, and Customs
Handling international logistics is the final step, and just as important.
- Importer of Record: You'll need a licensed importer or distributor in the destination country to handle customs clearance.
- Product Registration: Some countries require pre-market notification or full registration of dietary supplements with a national health authority.
- Documentation: You'll need a commercial invoice, packing list, certificate of analysis (CoA), certificate of origin, and any required health certificates for customs.
- Duties and Taxes: Factor in applicable import duties, value-added tax (VAT), or other tariffs, which vary by country and product classification.
Pre-Market Registration in Canada, Australia, and China
Registration works differently in each major market. In Canada, natural health products need a product license from Health Canada before they can be sold, and the label must carry a Natural Product Number (NPN). The importer or manufacturing site also holds a site license. In Australia, vitamin and supplement gummies are therapeutic goods that must be entered in the Australian Register of Therapeutic Goods (ARTG) before import. Most qualify for the listed pathway (AUST L), which permits only low-risk ingredients and low-level claims, with the sponsor self-certifying compliance.
In China, an imported health food sold through domestic retail needs approval from the State Administration for Market Regulation (SAMR), either full registration or the lighter filing route, and the approved product carries the blue hat mark. Under rules that took effect in June 2026, overseas manufacturers must also register with China's General Administration of Customs (GACC). Some brands skip the full registration by selling through cross-border e-commerce platforms, which run under a separate positive-list system. Confirm the route before you lock the formula; these approvals add months to a launch.
Partnering for Export Success
Export rules change by market and by product type. That's why choosing an experienced manufacturing partner can make all the difference. We help you understand regional requirements, develop compliant formulations and labels, and provide the necessary documentation and certifications. Start with compliance from day one, and you'll build a solid base for growth.