• Label & Claims Review

Understanding Label & Claims Review Services

Many supplement brands feel overwhelmed navigating FDA compliance. Learning how regulatory consultants evaluate labels, validate claims, identify compliance risks, and translate complex regulations unveils a clear path from concept to market-ready packaging that keeps you audit-proof.
  • Our Mission
Confidence

When you understand business valuation, deal structures, and buyer motivations, uncertainty transforms into confidence throughout your business exit journey.

Clarity

M&A terms like earnouts, LOIs, and working capital adjustments become clear through straightforward explanations, removing the intimidation of business sale jargon.

Empowerment

Armed with knowledge about negotiation leverage, due diligence preparation, and exit timing, you gain complete control over your business sale and future path.

  • Sell-Side Advisory Functions

Key Services Label Review Consultants Provide

Label Audit

Skilled regulatory consultants apply forensic review methods from FDA warning letters to dissect every claim for compliance risk. Brand owners benefit from understanding violation patterns to identify red flags before submitting products to market. Recognizing how inspectors evaluate acquisitions helps address potential citations early and positions the product for clean market entry.

Claims Validation

Finding the right substantiation requires more than accepting the first study. Consultants tap into networks of clinical researchers, published papers, and GRAS databases focused on specific ingredients. Understanding each claim's burden of proof often leads to stronger positioning, better market fit, and smoother FDA interactions after launch.

Risk Mitigation

Successful launches require navigating more than just label copy. Understanding complex elements like structure-function boundaries, dosing claims, and disclaimer requirements helps avoid warning letters. Brands who grasp these components before printing create a defensible path toward scaling without regulatory surprises, ultimately achieving safer growth terms.

The Label & Claims Review Process

01.

Getting to Know You

Regulatory consultants begin by deeply understanding your product formula, target claims, and competitive positioning. This initial discovery reveals what drives your label decisions and what matters most beyond compliance. This foundation helps align expectations and identify potential warning letter triggers before they surface.
02.

Label Analysis & Documentation

Expert reviewers thoroughly analyze ingredient panels, structure-function claims, and FDA warning letter patterns to determine compliance gaps. This critical step identifies opportunities to strengthen claims, enhance documentation, and optimize key metrics before approaching retail buyers or distributors.
03.
Claims Substantiation & Validation
Skilled consultants compile compelling clinical evidence that validates your product claims while maintaining regulatory compliance. They then leverage extensive networks to identify testing labs, research partners, and certification bodies that match your substantiation needs and exit timeline.
04.
Final Review & Market Clearance

This final phase navigates complex compliance terms beyond just label copy – from disclaimer placement and font size requirements to allergen declarations and GMP certifications. Understanding these elements helps protect business value and ensures a smooth transition toward successful market launch.

Free Assessment