Structure/Function Claim Disclaimer – Required for Health Claims on Labels & Ads
If your supplement label or marketing materials include statements like "supports immune health" or "promotes digestion", FDA requires a Structure/Function Claim Disclaimer under 21 CFR § 101.93. This disclaimer ensures consumers are not misled and that your claims stay within legal limits.
Who Needs It?
- • Supplement Brands making non-FDA-approved claims about body function
• Private Label Sellers using health-related marketing language
• Importers & Distributors verifying U.S. market readiness
• Retailers & Amazon Sellers with product pages or packaging claims
Why It’s Required:
- • Legally required when using structure/function claims on labels or websites
• Protects your brand from being accused of making unauthorized drug claims
• Avoids FDA misbranding violations and enforcement
• Ensures compliance across labeling, ads, and online listings
What’s Included:
- • FDA-Compliant Structure/Function Claim Disclaimer Language
• Placement & Formatting Guidance for Labels, Packaging & Ads
• Audit of Existing Product Claims (online and print)
• Claim Categorization (structure/function vs. disease claims)
• Supplement Facts Label Alignment
• Review of Web, Amazon, and Social Media Descriptions
What’s Included:
- • FDA Facility Registration (New or Renewal)
• U.S. Agent Appointment (for foreign facilities)
• Registration Confirmation and Number
• Biennial Renewal Reminders & Monitoring
• FDA Compliance Guidance & Support
Pricing:
| Service | Standard Price | Support360 Member Price (50% Off) |
|---|---|---|
| Structure/Function Claim Disclaimer Setup | $1,500 | $750 |
- Support360 Members get 50% OFF all marketing and label compliance services.
Avoid Costly Labeling Errors:
- Without the required disclaimer, your product may be:
- • Flagged as an unapproved drug by the FDA
• Removed from Amazon, Walmart, or retailer platforms
• Subject to FDA warning letters or civil penalties
• Denied entry at U.S. ports if imported
