FDA-Compliant Product Label – Required Before You Go to Market
Your product label is your first line of compliance. Under 21 CFR Part 101, all dietary supplement labels must meet FDA requirements before the product is legally sold or imported into the U.S. This includes proper structure, claims, formatting, and mandatory disclosures.
Who Needs It?
- • Dietary Supplement Brand Owners and Private Label Sellers
• Manufacturers developing new formulas or packaging
• Importers & Distributors bringing products into the U.S.
• Amazon, Walmart, and Retail Vendors needing compliant packaging
Why It’s Required:
- • Ensures compliance with FDA regulations under 21 CFR Part 101
• Prevents misbranding violations and FDA 483 observations
• Avoids detentions at U.S. ports or product removals from platforms
• Required for FSVP documentation and COA alignment
What’s Included:
- • Full Label Review or Custom Label Design
• FDA-Compliant Supplement Facts Panel Creation
• Ingredient Declaration Formatting (incl. botanical names)
• Allergen Statement, Warning, and Usage Directions
• Marketing Claims Compliance (structure/function)
• Net Quantity, Contact Info, and UPC/Barcode Guidance
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) |
|---|---|---|
| FDA-Compliant Product Label Setup | $1,500 | $750 |
- Support360 Members receive 50% OFF on all label review and creation services.
Don’t Let a Label Violation Stop Your Sales:
- Without an FDA-compliant label, you risk:
- • Product holds or rejections at customs
• Amazon/Walmart removals or account warnings
• FDA Warning Letters and civil penalties
• Loss of consumer trust due to inaccurate or illegal claims
