If you're selling gummy supplements in the US and the EU, the labeling rules are surprisingly different. Both regions have solid rules, but their approaches don't just differ in details—they reflect different philosophies. Get these straight, and you'll keep regulators happy and consumers trusting.
Regulatory Foundations
The core difference is in how each region thinks about regulation. In the US, dietary supplements—including gummies—fall under the Dietary Supplement Health and Education Act (DSHEA) of 1994, enforced by the FDA. The system is mostly post-market: products can sell without prior approval, but the FDA cracks down on bad actors later.
In the EU, gummy supplements are food supplements under the Food Supplements Directive (2002/46/EC). Regulation is more unified and pre-market. You often need to notify national authorities before selling, and only certain ingredients—especially vitamins and minerals—are allowed.
Key Labeling Requirement Differences
1. Ingredient Lists & Nutrient Declarations
- US (FDA): You'll need a "Supplement Facts" panel that lists dietary ingredients, amounts per serving, and % Daily Value (%DV). Proprietary blends? List total weight and ingredients in descending order.
- EU: You'll use a "Nutrition Information" panel closer to what you'd see on a food label. For supplements, you must show each vitamin/mineral and other substances in absolute amounts, plus the percentage of the Nutrient Reference Value (NRV).
2. Health & Structure/Function Claims
- US (FDA): You can make structure/function claims (like "supports immune health") without pre-approval, as long as they're truthful and not misleading. But you also need this 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." Disease claims? Not allowed.
- EU: Much stricter. Only health claims that the European Food Safety Authority (EFSA) has okayed and put on the EU's permitted list can be used. The list is short, so approved claims are few and generic (e.g., "Vitamin C contributes to the normal function of the immune system").
3. Ingredient Safety & Novel Foods
- US (FDA): Ingredients marketed before 1994 are "grandfathered"—you can use them. New Dietary Ingredients (NDIs) need a pre-market safety notification.
- EU: They keep positive lists of allowed vitamins, minerals, and their forms. Anything else—like a new botanical or compound—that wasn't commonly eaten in the EU before 1997 is a Novel Food. That means a tough pre-market safety assessment before you can sell it.
4. Additional Mandatory Statements
- US (FDA): You must include the words "Dietary Supplement," your business name and address, and the DSHEA disclaimer on claims.
- EU: You need statements like: "Food supplements should not be used as a substitute for a varied diet" and "Keep out of reach of young children." If applicable, warn against exceeding the daily dose.
Summary Table
| Requirement | United States (FDA/DSHEA) | European Union (EFSA/Directive) |
|---|---|---|
| Core Panel | Supplement Facts | Nutrition Information (with %NRV) |
| Claim Regulation | Permits structure/function claims with disclaimer; prohibits disease claims. | Only pre-approved, authorized health claims from the EU list are permitted. |
| Ingredient Approval | Post-market for grandfathered ingredients; NDI notification for new ones. | Pre-market approval for vitamins/minerals (positive lists) and Novel Foods. |
| Mandatory Statements | "Dietary Supplement," business info, DSHEA disclaimer on claims. | "Not a substitute for a varied diet," "Keep out of reach of children," dose warnings. |
Bottom line? Both the US and EU want to protect consumers, but they go about it very differently. The EU leans on a precautionary, pre-market system with tight controls on claims. The US relies on a post-market approach that gives manufacturers more freedom—and more responsibility. For any brand, knowing these differences isn't optional. It's the price of entry.