FDA-Compliant Label Review – Required Before You Sell in the U.S.
Before your dietary supplement hits the shelves or ships to Amazon, your product label must comply with FDA regulations under 21 CFR Part 101. Every element—from the Supplement Facts panel to ingredient formatting and marketing claims—must meet strict standards to avoid warnings, import holds, or retailer takedowns.
Who Needs It?
- • Supplement Brands launching or rebranding products
• Private Label Sellers importing from overseas
• Amazon & Shopify Sellers preparing product packaging
• Distributors & Co-Packers responsible for labeling oversight
• eCommerce Brands seeking to stay audit-ready
Why It’s Required:
- • Enforced under 21 CFR Part 101 (Labeling Requirements)
• Prevents misbranding violations and FDA enforcement
• Required for retail readiness, Amazon listing approval, and customs clearance
• Ensures label elements (claims, panel, disclosures) meet FDA formatting rules
What’s Included (Per Product):
- • Full FDA Label Compliance Audit
• Formatting Review of Product Identity, Net Quantity, Supplement Facts Panel
• Ingredient Statement & Allergen Disclosure Check
• Placement & Font Size Guidance
• Warning Statements, Usage Instructions, and Contact Info Review
• Claim Risk Flagging (drug vs. structure/function vs. nutrient)
• Final Report with Required Corrections and Suggested Revisions
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 Label Review | $750 per product | $375 per product |
- Support360 Members receive 50% OFF all regulatory label and product compliance services.
What Happens If It’s Not Compliant:
- • FDA 483s or warning letters for mislabeling
• Product rejections by Amazon, Walmart, or third-party retailers
• Delays at customs for import shipments
• Loss of buyer trust due to misleading or noncompliant packaging
