Labeling gummy supplements correctly is not just a best practice-it's a legal requirement enforced by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Proper labeling ensures transparency for consumers and helps your brand maintain compliance and avoid costly regulatory actions.
Mandatory Label Elements (Principal Display Panel & Information Panel)
Every gummy supplement label must contain specific information, typically divided between the Principal Display Panel (PDP-the front label) and the Information Panel (usually the side or back).
Principal Display Panel (PDP) Requirements:
- Statement of Identity: Clearly identify the product as a "Dietary Supplement."
- Net Quantity of Contents: Declare the net weight or count of gummies (e.g., "60 Gummies" or "2.5 oz (70 g)").
Information Panel Requirements:
- Supplement Facts Panel: This is the core of your label. It must list:
- Servings per container and serving size (e.g., "2 gummies").
- All dietary ingredients, listed by quantity per serving and as a percentage of the Daily Value (%DV) where established.
- Ingredients without a DV (like herbal extracts) must be listed by weight per serving.
- The part of the plant used for botanical ingredients.
- Ingredient List: A complete list of all ingredients (e.g., gelatin, pectin, colors, flavors) in descending order of predominance by weight.
- Manufacturer/Distributor Information: The name and place of business of your manufacturer, packer, or distributor.
Critical Compliance Points
Beyond the basic elements, several key areas require strict attention:
- Structure/Function Claims: You may make general claims about the nutrient's role in the body's structure or function (e.g., "Calcium builds strong bones"). However, these claims must be accompanied by the FDA 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."
- Avoiding Drug Claims: It is illegal to claim a supplement diagnoses, treats, cures, or prevents a specific disease. Always stay away from making any medical or health claims about specific supplements or ingredients.
- Accurate Nutrition Labeling: All declared amounts of vitamins, minerals, and other ingredients must be accurate and present in the product at the labeled potency through its shelf life.
- Allergen Labeling: Major food allergens (like soy, gelatin (from fish or beef), or colors derived from allergens) must be declared as per the Food Allergen Labeling and Consumer Protection Act (FALCPA).
Best Practices for Gummy Supplement Brands
To ensure full compliance and build consumer trust, we recommend:
- Third-Party Testing: Work with a manufacturer that conducts rigorous testing for identity, potency, purity, and disintegration to verify label claims.
- Clear & Legible Type: All required information must be in English and easy to read.
- Professional Regulatory Review: Have your final label copy and claims reviewed by a regulatory expert or attorney specializing in FDA law before printing.
Navigating supplement labeling regulations is complex. Partnering with an experienced, compliant manufacturer is the most critical step to ensure your gummy supplements meet all legal requirements from the start.