If you're marketing gummy supplements, the rules around what you can say matter. The FDA and FTC are the main watchdogs. They enforce standards to keep claims honest and backed by evidence.
Who Regulates What?
Two federal agencies oversee supplement advertising:
- The Food and Drug Administration (FDA): Regulates supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994. The FDA monitors product labeling, including package claims, to ensure they are not false or misleading and that supplements are marketed as foods, not drugs.
- The Federal Trade Commission (FTC): Polices advertising across all media, from print and TV to social media and influencer posts. The FTC requires that all objective claims be backed by "competent and reliable scientific evidence."
What You Can Say vs. What You Can't
You Can: Structure/Function Claims
These describe how a nutrient affects normal body function. They must be truthful and carry an FDA disclaimer, and they trigger a filing step: under 21 CFR 101.93, you notify the FDA of a structure/function claim no later than 30 days after first marketing the product with that claim. Examples for gummy supplements:
- "Calcium builds strong bones."
- "Vitamin C supports the immune system."
- "Fiber aids digestion."
You Can't: Disease or Drug Claims
Stay away from any claim that diagnoses, treats, cures, or prevents a disease. Also, don't present your supplement as a drug. Examples to avoid:
- "prevents heart disease"
- "treats arthritis"
- Any performance claim not supported by solid science
Best Practices for Compliant Ads
- Focus on General Well-being: Talk about supporting overall health and normal bodily functions, not treating specific conditions.
- Use the Required Disclaimer: The one that says: "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."
- Back Up Every Claim: Have scientific evidence ready before you make any structure/function claim.
- Be Transparent: List ingredients, nutrition facts, and serving sizes clearly. Make sure your label meets FDA rules.
- Cover All Channels: Your website, social media, packaging, and even customer testimonials all need to follow the same rules. A testimonial has to reflect what a typical user can expect, not an outlier result, and any paid influencer or free-product connection must be disclosed.
Potency Accuracy Backs Up Every Claim
An advertising claim is only as strong as the gummy behind it. If the actual vitamin or melatonin content does not match the label, the structure/function claim cannot be substantiated. A 2023 study in JAMA tested 25 melatonin gummy brands and found 22 with amounts that differed from the label. One contained 347% of the listed dose, another had 74%, and a third had no detectable melatonin. The FDA calls that misbranding, and the FTC treats the ad as deceptive. For a contract manufacturer, the fix is process control: verified active potency per batch, even dosing across the gummy tray, and third-party testing that matches the claim printed on the package.
Stick to truthful, substantiated structure/function claims, and you can market your gummy supplements confidently while staying on the right side of the law.