Supplement Compliance

Pass Your FDA Supplement Inspection. Guaranteed Compliant Labels.

DSHEA compliance check in 30 seconds. Prevent 483 observations, warning letters, and the dreaded supplement facts panel violations that trigger enforcement.

FDA increased supplement inspections 34% in 2024. Is your label ready?

Validate Supplement Label Now → [$29]

Common 483 Observations We Prevent

Structure/Function Claim Violations (38% of 483s)

Missing disclaimer statement
Disease claims disguised as structure/function
Incorrect disclaimer placement or font size
Unapproved health claims

Supplement Facts Panel Errors (31% of 483s)

Incorrect ingredient order
Missing "**" for daily values
Wrong units for vitamins/minerals
Proprietary blend violations

cGMP Labeling Issues (27% of 483s)

Missing or incorrect establishment registration
Allergen control failures
Identity testing claims without support
Expiration date non-compliance

Every Supplement Rule Checked

Comprehensive DSHEA compliance validation

Core DSHEA Regulations

21 CFR 111 - Current Good Manufacturing Practices
21 CFR 101.36 - Supplement Facts formatting
21 CFR 101.93 - Structure/function claims
DSHEA Section 6 - Statements of nutritional support

Additional Requirements

21 CFR 101.9(j)(8) - Dietary ingredient declarations
FDA Guidance Documents - Current enforcement priorities
NDI and GRAS database integration
Recent warning letter pattern matching

Violations Caught This Week

❌ CRITICAL: "Supports immune health" claim missing FDA disclaimer

CFR: 21 CFR 101.93(c)

Fix: Add disclaimer within 2 inches of claim

❌ HIGH: Vitamin D listed as "IU" not "mcg" (new requirement)

CFR: 21 CFR 101.9(c)(8)(iv)

Fix: Convert to mcg and add (IU) in parentheses

❌ MEDIUM: Proprietary blend doesn't list ingredients by weight

CFR: 21 CFR 101.36(c)

Fix: Reorder blend ingredients by predominance

From Upload to FDA-Ready in 30 Seconds

Upload your supplement label

or artwork file

Auto-extraction

of claims, ingredients, and panel

447-point check

against DSHEA and current FDA guidance

Detailed report

with CFR citations and fixes

Supplement Compliance Solutions

Inspector-ready compliance validation

Single Label Check: $29

Complete DSHEA validation

Complete DSHEA validation
Structure/function claim analysis
Supplement Facts panel audit
Multi-jurisdiction check (US + international)

Validate Supplement Label - $29

Inspector-Ready Plans:

Startup Brand: $79/mo

50 checks + claim database

Growing Line: $149/mo

250 checks + regulatory updates

Enterprise: $499/mo

unlimited + API + white-label + SOP templates

Why 400+ Supplement Brands Trust LabelGuard

Our Expertise:

Updated weekly with FDA warning letters patterns
Trained on 10,000+ supplement labels
Integrated with NDI and GRAS databases
White-label reports for client presentations
API for automated pre-production checks

Success Story

"FDA inspector spent 3 hours on our labels and found nothing. LabelGuard had caught and fixed 7 issues pre-production. Best $29 insurance ever."

— QA Director, Premium Supplements USA

Frequently Asked Questions

Short answers to help you pass FDA inspections.

Every Day Without Compliance Checking Is A Risk

18 months

Average time to first FDA inspection from launch

30 seconds

Average time using LabelGuard

$29 vs $50,000+

Cost difference

Start Compliance Check - $29

Per-Check

Best for occasional use

$29

Single label check
PDF compliance report
Multi-jurisdiction checking
Less than 15 minutes of consultant time ⏱️
Email support

Essentials

Small producers

$79/mo

Up to 50 checks/month
Just $1.58 per label check
Multi-market compliance
Priority email support
Usage analytics
Save $800+/mo vs consultants