US FDA Regulatory Assessment & Label Compliance
Helping dietary supplement and wellness brands assess ingredient compliance, labeling requirements, and US market readiness before product launch.
A structured assessment of US regulatory readiness.
From label compliance to ingredient status and NDI considerations, every review is built on publicly available FDA regulations and guidance.
FDA Dietary Supplement Label Compliance Review
- Supplement Facts Panel Review
- Ingredient Statement Verification
- Structure/Function Claim Review
- Mandatory Disclaimer Review
- Warning Statement Assessment
- Principal Display Panel Review
- Marketing Claim Review
- Compliance Gap Analysis
GRAS Regulatory Assessment
- Preliminary review of ingredients against publicly available GRAS resources
- Assessment of ingredient regulatory status
- Identification of potential compliance concerns
- Review of intended use levels
- Research on existing GRAS determinations and scientific support
New Ingredient Regulatory Assessment
- Determine whether an ingredient appears to be: GRAS, Dietary Ingredient, Potential New Dietary Ingredient (NDI), or Food Additive
- Regulatory pathway recommendations
NDI (New Dietary Ingredient) Support
- Preliminary NDI applicability assessment
- Documentation review
- NDI submission preparation support
- Regulatory gap identification
US Market Entry Assessment
- Product classification review
- Ingredient compliance screening
- Label compliance screening
- Regulatory risk assessment
- Launch readiness review
Clear reports you can act on.
- Written Compliance Assessment Report
- Ingredient Review Summary
- Label Review Report
- Regulatory Risk Assessment
- Action Plan for Compliance
Flexible research and documentation support.
Extend the assessment with targeted research, documentation review, or supplier screening.
Who this service is for
Whether you are refining a formula or planning a US launch, this assessment identifies regulatory gaps before they become delays.
Dietary Supplement Brands
Wellness Startups
Contract Manufacturers
International Companies Entering the US
Practical regulatory support for the US market
Independent, detail-oriented assessments that help you make informed launch decisions.
Cross-Border Perspective
Experience with both Canadian and US regulatory frameworks helps brands align across markets.
Research-Backed Assessments
Reviews draw on publicly available FDA regulations, guidance documents, and scientific resources.
Practical Roadmaps
Deliverables include clear action plans so you know the next steps toward compliance readiness.
Launch-Focused Guidance
Advice is tailored to timelines, risk tolerance, and commercial goals — not just theory.
Ready to assess your US regulatory readiness?
Share your product details, label draft, and ingredient information for a scoped compliance assessment.
Professional disclaimer
Regulatory assessments are based on publicly available FDA regulations, guidance documents, and scientific resources. Services are advisory in nature and do not constitute legal advice, GRAS self-affirmation, FDA approval, or guarantee regulatory outcomes.