Getting FDA labeling right is essential for any dietary supplement, and gummies are no exception. As a manufacturer, we make sure our products comply with the regulations from the FDA under DSHEA. Gummy supplements have to follow the same basic rules as other dietary supplements, but their candy-like form adds a few extra wrinkles.
Core FDA Labeling Requirements for Dietary Supplements
All dietary supplement labels, gummies included, must display these items:
- Statement of Identity: The product must be identified as a "dietary supplement" or "Vitamin C supplement."
- Net Quantity of Contents: This tells you the amount in the container (for example, "60 Gummies" or "Net Wt. 5.3 oz (150g)").
- Nutrition Labeling: The "Supplement Facts" panel lists each ingredient with amounts per serving. For gummies, watch how you declare sugars and other carbs.
- Ingredient List: All ingredients go in descending order by weight. That includes gelling agents (gelatin or pectin), colors, flavors, and coatings.
- Name and Place of Business: Name and address of the manufacturer, packer, or distributor.
Special Considerations for Gummy Supplements
Gummy formats add their own requirements:
- Supplement Facts Panel: Serving size is usually a number of gummies, and every nutrient amount must match that serving. Added sugars from the gummy base count and must be declared.
- Sugar Alcohols and Sweeteners: If you use sugar alcohols (like maltitol syrup), declare them on the Supplement Facts panel when you make a sugars or sugar-alcohol claim, such as "sugar-free." Otherwise the declaration is optional. Non-nutritive sweeteners appear only in the ingredient list.
- Allergen Labeling: If your gummies contain a major food allergen, declare it per FALCPA. The list is milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame (added January 2023). Colors are not major allergens, but carmine and cochineal extract must be listed by name.
- Child Safety & Packaging: Child-resistant packaging is not a blanket rule for gummies. The PPPA requires it for specific products, including supplements with 250 mg or more of elemental iron per package. Most gummies contain little or no iron, so it's usually voluntary.
Gummy weight and Supplement Facts accuracy
A Supplement Facts panel only works if the finished gummy matches what the formulator declared. Gummies are deposited as a liquid, so piece weight can drift from target during the run. If the target is 4 grams per piece and the line runs at 4.2 grams, a label declaring 2 grams of sugar per three-gummy serving is wrong, and so is every nutrient tied to that serving. Heavier gummies also overfill the container and undersell the net weight. Controlling moisture and piece weight keeps both statements truthful. We set weight and moisture targets before drafting the label, so it matches what the line makes.
What You Will NOT See on a Compliant Label
You won't find disease claims on a compliant label. Claims like "cures heart disease" or "treats arthritis" are illegal on a supplement. Structure/function claims such as "calcium builds strong bones" are allowed, but the company must have substantiation, include the required disclaimer, and notify FDA within 30 days of first marketing. The disclaimer states that the claim has not been evaluated by the FDA and the product is not intended to diagnose, treat, cure, or prevent any disease.
Following these rules isn't optional. It's the law. Proper labeling protects consumers and keeps the industry honest.