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 — yes, even gummies — must display these items clearly:
- Statement of Identity: The product must be identified as a "Dietary Supplement" or something like "Vitamin C Gummies."
- Net Quantity of Contents: This tells you the amount in the container (e.g., "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 from the base.
- 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.
It's straightforward, but the details matter.
Special Considerations for Gummy Supplements
Gummy formats bring their own headaches. Here's what to watch out for:
- Supplement Facts Panel: Serving size is usually a number of gummies. All nutrient amounts must match that serving. Added sugars from the gummy base count, so include them.
- Sugar Alcohols and Sweeteners: If you use sugar alcohols (like maltitol syrup) or non-nutritive sweeteners, you'll need to declare them with the right footnote on the Supplement Facts panel.
- Allergen Labeling: If your gummies contain major allergens (e.g., soy or certain colors), declare them per FALCPA.
- Child Safety & Packaging: Because they look like candy, gummy supplements usually need child-resistant packaging under the PPPA to prevent kids from eating too many.
What You Will NOT See on a Compliant Label
You won't find disease claims on a compliant label — they're illegal. No "cures heart disease" or "treats arthritis." Only structure/function claims like "calcium builds strong bones" are allowed, and they need the standard FDA disclaimer.
Following these rules isn't optional — it's the law. Proper labeling protects consumers and keeps the industry honest.