Exporting gummy supplements internationally? It's possible, but it's not simple. You'll need to plan carefully and follow the rules in both the exporting and importing countries. As a full-service manufacturer, we've helped partners navigate every step of this process.
What You'll Need for International Export
The requirements vary by destination, but these areas are universal. Here's what to focus on.
1. Know the Regulations and Classification
Start here. Find out how your gummy supplement is classified in the target market: dietary supplement, foodstuff, or something like "novel food" or "therapeutic goods." That classification tells you which agency's rules apply. For example:
- United States: FDA under DSHEA.
- European Union: EU Food Supplements Directive and novel food rules.
- Canada: NNHPD licensing.
- Australia: TGA.
2. Get Labeling and Documentation Right
Labels need translation and adaptation to local laws. Key documents include:
- Certificate of Analysis (CoA): Shows composition, purity, and strength.
- Certificate of Free Sale: Proves the product is legally sold in its origin country. A competent authority issues it, such as the FDA for U.S. products.
- Commercial Invoice & Packing List: Standard customs docs.
- Safety Data Sheets (SDS): For raw materials or bulk product.
3. Check Ingredients Carefully
Each country has its own list of approved and banned ingredients, and they don't always agree. An ingredient common in one market might be banned in another. You must check the target country's lists thoroughly.
4. Plan for Stability and Shelf Life
International shipping means temperature and humidity changes. You'll need stability testing data to back up your shelf life claims. Regulators and distributors often ask for this. Gummies are sensitive to heat and humidity, so ask for stability data that covers transit conditions as well as warehouse storage.
5. Handle Customs, Duties, and Logistics
Work with a freight forwarder who knows food and supplement imports. You'll need to:
- Use the right HS codes for customs.
- Understand import duties and taxes.
- Package for long-distance transit.
- Arrange cold-chain logistics if needed.
Ingredient Approval Gaps: Positive Lists and Novel Food Status
Checking banned ingredient lists is only half the work. Some markets maintain positive lists, where an ingredient must be explicitly approved before it can be used, and others run a novel food process for anything without an established history of consumption there. An ingredient that is standard in a U.S. gummy can require a full authorization dossier in the European Union, with safety data and evidence of prior use, before any product containing it can be sold. That adds lead time and cost across your whole product line. Choose a manufacturer that reviews ingredient status for your target markets before you commit to a formula. Changing one problematic ingredient early costs far less than reformulating after a registration is refused.
Why Your Manufacturer Matters
The complexity shows why a manufacturer with global experience is key. They should be able to:
- Formulate products to meet international standards from the start.
- Source compliant raw materials.
- Run the necessary tests and provide the right documentation.
- Guide you on labeling for key markets.
Research your target markets, then find a manufacturing partner who's been through it before. That's how you build a global brand.