Exporting gummy supplements internationally isn't simple. You have to follow the importing country's food and supplement laws, international quality standards, and customs and labeling rules. It's a lot to juggle. Get it right, and you'll open up new markets.
Core Regulatory Frameworks by Region
Every country has its own rules. You'll need to tailor your export strategy to each market's legal environment.
United States (FDA & DSHEA)
In the U.S., the FDA regulates gummy supplements under DSHEA. Here are the main requirements:
- Current Good Manufacturing Practices (cGMPs): You must follow FDA 21 CFR Part 111 for manufacturing, packaging, labeling, and holding operations.
- Labeling Compliance: Labels need a Supplement Facts panel (not Nutrition Facts). List all ingredients. If you make structure/function claims, include the DSHEA disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
- New Dietary Ingredient (NDI) Notification: If you're using a dietary ingredient not marketed in the U.S. before October 1994, you need a pre-market safety notification to the FDA.
European Union (EFSA & Food Safety Regulations)
The EU treats gummy supplements as "food supplements" under Directive 2002/46/EC. Here's what compliance means in practice:
- Permitted Ingredients: The Directive's positive lists (Annexes I and II) cover vitamins and minerals and their permitted forms. Botanicals and other substances are not on a harmonized EU list; they fall to member-state rules and may need authorization under the Novel Food Regulation (EU) 2015/2283 if they were not widely consumed before 15 May 1997. Harmonized maximum and minimum levels have never been adopted, so national limits still apply.
- European Food Safety Authority (EFSA) Health Claims: Any health claim must be authorized and listed on the EU register. You can use an authorized claim's exact wording, such as "Vitamin C contributes to the normal function of the immune system," without your own dossier. A claim not on the register requires an application backed by scientific evidence.
- Labeling (FIC): Must comply with the Food Information for Consumers (FIC) regulation, including mandatory nutrient declarations and allergen labeling.
Canada (Health Canada & NHP Regulations)
Canada classifies gummy supplements as Natural Health Products (NHPs). Requirements include:
- Product License: Pre-market approval from Health Canada, with detailed info on medicinal ingredients, source, potency, and recommended use.
- Site License: Your manufacturing facility needs a valid Site License proving GMP compliance.
- Bilingual Labeling: Everything must be in English and French.
Australia & New Zealand
Australia and New Zealand share a food standards agency, but they regulate supplements under different rules. Classification decides which regime applies.
- Australia: Gummy supplements are generally foods under the Food Standards Code (FSANZ), with supplemented foods covered by the Code's supplemented foods standard. If a gummy makes therapeutic claims, it is regulated as a therapeutic good by the TGA.
- New Zealand: Dietary supplements are regulated by Medsafe under the Dietary Supplements Regulations 1985, and supplemented foods under the Food (Supplemented Food) Standard 2016 administered by MPI. Products making therapeutic claims are medicines regulated by Medsafe. The government announced proposals in September 2026 to modernize the Dietary Supplements Regulations.
- Mandatory Warning Statements: Ingredients like caffeine require specific warning statements on the label.
Universal International Standards
On top of regional laws, there are international standards that big retailers and distributors often demand.
- ISO 22000 (Food Safety Management): A comprehensive framework for managing food safety across the supply chain.
- Hazard Analysis and Critical Control Points (HACCP): A systematic approach to identify and prevent biological, chemical, and physical hazards.
- Third-Party GMP Certifications: Certifications from bodies like NSF give independent verification of your quality systems and manufacturing integrity. In international trade, that's a strong selling point.
Key Export Documentation & Logistics
Documentation is just as important as product compliance.
- Certificate of Analysis (CoA): Shows the product's specifications, purity, potency, and contaminant testing (heavy metals, microbes).
- Certificate of Free Sale: Many importing countries require this from your country's authority, proving the product is legally sold at home. In the U.S., the FDA issues it.
- Customs Declarations: Accurate HS codes, ingredient lists, and product descriptions are crucial for customs clearance.
- Stability Testing Data: Proof that your gummies maintain their quality, strength, and purity under expected storage and transit conditions.
Duties, Tariffs, and the Cost of Clearing Customs
Regulatory clearance gets your product to the border. Customs clearance is where the cost shows up. The importing country sets the duty rate by the product's HS code, and gummy supplements generally fall under HS heading 2106, food preparations not elsewhere specified. A gummy that makes therapeutic claims can be reclassified as a medicament (heading 3004) in some markets, which changes the duty treatment and can trigger drug-licensing requirements. Classification is a compliance decision with real cost consequences.
Duties are usually calculated on the transaction value plus freight and insurance, so your landed cost can exceed the invoice price by more than the headline tariff rate suggests. Many markets then add VAT or GST on the duty-inclusive value. Free trade agreements can cut or remove the duty when your product meets the rules of origin, and a certificate of origin is the document that proves it.
Get the HS code wrong and customs can hold the shipment, reclassify it retroactively, and assess penalties and back duty. Before you quote a landed price to a distributor, confirm the correct code, the current duty rate, and any preferential treatment with a customs broker or the importing country's tariff schedule.
Exporting gummy supplements takes a proactive, detail-oriented approach: solid manufacturing quality, thorough legal research for each market, and perfect documentation. Working with a contract manufacturer that already meets these global standards from the start is your best bet for a smooth entry into international markets.