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 differ in more than 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). The Directive sets EU-wide positive lists for vitamins and minerals and their permitted forms, but it does not harmonize everything. Other substances, such as botanicals and amino acids, fall under national rules that vary from one member state to another. Some member states require you to notify them before placing a product on the market; the Directive allows that requirement but does not impose it everywhere. Mandatory label information must appear in a language easily understood by consumers in each member state where the product is sold.
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). For 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 substance in absolute amounts per daily portion, 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 are not allowed.
- EU: The EU is much stricter. You can use only health claims that the European Food Safety Authority (EFSA) has assessed and the European Commission has authorized, and that appear on the EU Register of nutrition and health claims. The list is short, so approved claims are few and generic (for example, "Vitamin C contributes to the normal function of the immune system").
3. Ingredient Safety & Novel Foods
- US (FDA): Ingredients marketed before 1994 are grandfathered in, so you can use them. New Dietary Ingredients (NDIs) need a pre-market safety notification to the FDA.
- EU: The EU keeps positive lists of allowed vitamins, minerals, and their forms. Anything else, such as a new botanical or compound that was not commonly eaten in the EU before 15 May 1997, is a Novel Food and needs a pre-market safety assessment before you can sell it.
4. Additional Mandatory Statements
- US (FDA): You must include the words "Dietary Supplement," the net quantity of contents, your business name and address, and the DSHEA disclaimer on claims.
- EU: The product must be sold under the name "food supplement." You also need statements like: "Food supplements should not be used as a substitute for a varied diet" and "Keep out of reach of young children," and a warning not to exceed the stated 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 register are permitted. |
| Ingredient Approval | Post-market for grandfathered ingredients; NDI notification for new ones. | Positive lists for vitamins/minerals and their forms; pre-market authorization for Novel Foods. |
| Mandatory Statements | "Dietary Supplement," net quantity, business info, DSHEA disclaimer on claims. | Name "food supplement"; "not a substitute for a varied diet"; "keep out of reach of children"; dose warning. |
UK Labeling: Great Britain vs. Northern Ireland
Brands that add the United Kingdom to their distribution often assume an EU-compliant label carries over. It does not, at least not cleanly. Since leaving the EU, Great Britain (England, Scotland, Wales) runs its own food supplement rules under retained law, mainly the Food Supplements (England) Regulations 2003 as amended, with the Food Standards Agency handling post-market checks. The permitted vitamin and mineral forms still follow the old EU lists, but those lists now diverge as each side amends them.
Northern Ireland is different. It keeps following EU food labeling rules, and labels sold there must carry a Northern Ireland or EU food business operator address. Health claims split the same way: Great Britain works from the Food Standards Agency's register of authorized claims, Northern Ireland from the EU register. If you sell into the UK, plan for two labeling regimes, and verify claim wording against the register that applies where the product sits on the shelf.
Both the US and EU want to protect consumers, but they go about it very differently. The EU leans on a precautionary system: positive lists for nutrients, pre-approved claims, and a Novel Food authorization step for new ingredients. The US relies on a post-market approach that gives manufacturers more freedom and more responsibility. For any brand, knowing these differences is not optional; it is the price of entry.