What Are the Legal Requirements for Labeling Gummy Supplements?

Labeling gummy supplements correctly is a legal requirement. The U.S. Food and Drug Administration (FDA) enforces it under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. A compliant label gives consumers the information they need and keeps your brand out of enforcement trouble.

Mandatory Label Elements (Principal Display Panel & Information Panel)

Every gummy supplement label has to include certain information, typically split between the Principal Display Panel (the front label) and the Information Panel (usually the side or back).

Principal Display Panel (PDP) Requirements:

• Statement of Identity: The term "dietary supplement" must be part of the statement of identity. The word "dietary" can be replaced by the name of the dietary ingredient, as in "Calcium 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. It has to list:
  1. Servings per container and serving size (e.g., "2 gummies").
  2. All dietary ingredients, listed by quantity per serving and as a percentage of the Daily Value (%DV) where established.
  3. Ingredients without a DV, such as herbal extracts, have to be listed by weight per serving.
  4. 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 need strict attention:

• Structure/Function Claims: You can make claims about a nutrient's role in the body's structure or function (e.g., "Calcium builds strong bones"). Each claim has to carry the FDA disclaimer in bold type next to the claim: "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." You also need substantiation that the claim is truthful and not misleading, and you must notify FDA within 30 days of first marketing the product.
• Avoiding Drug Claims: It's illegal to claim a supplement diagnoses, treats, cures, or prevents any disease. Stay far away from medical or health claims about specific supplements or ingredients.
• Accurate Nutrition Labeling: All declared amounts have to be accurate and actually present through the product's shelf life.
• Allergen Labeling: Major allergens have to be declared under the Food Allergen Labeling and Consumer Protection Act (FALCPA). The list is milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame, which became the ninth major allergen on January 1, 2023. Declare allergens in parentheses after the ingredient name, as in "lecithin (soy)," or in a "Contains" statement, and name the specific species for fish, crustacean shellfish, and tree nuts.

In December 2025, FDA said it is considering changing the rule that requires the disclaimer on every label panel where a claim appears, and it will exercise enforcement discretion on that placement rule in the meantime. The obligation to include the disclaimer and link it to each claim is unchanged.

Added Sugars on Gummy Supplement Labels

Gummies are the supplement format where added sugars most often show up, and the current Supplement Facts regulation requires Added Sugars to be declared in grams per serving whenever the amount present exceeds what can be declared as zero. The line comes from FDA's 2016 revision of the Nutrition Facts and Supplement Facts labels. If your gummy base uses sugar, corn syrup, honey, or another caloric sweetener, those amounts belong on this line. When a brand reformulates to cut sugar, or switches to sugar alcohols or a no-sugar sweetener system, the values on this line change, so the panel has to be updated with every formula revision.

Best Practices for Gummy Supplement Brands

To stay compliant and build trust, we recommend:

• Third-Party Testing: Work with a manufacturer that does rigorous testing for identity, potency, purity, and disintegration to back up label claims.
• Clear & Legible Type: All required info has to be in English and easy to read. The lettering for required information has to be at least 1/16 inch tall, based on the lower case "o."
• Professional Regulatory Review: Have your final label copy and claims reviewed by a regulatory expert or attorney specializing in FDA law before printing.

Supplement labeling regulations are complex. The most critical step is to partner with an experienced, compliant manufacturer that can help you meet every legal requirement from the start.