Book a Consultation

Label Compliance

Labeling Essentials for Dietary Supplements

Your product label is both a legal document and a marketing tool. The Skalli Group ensures every label component is FDA-compliant under 21 CFR Part 111 and DSHEA.

Overview

Proper labeling is not just about marketing—it’s a core FDA requirement. Labels must be truthful, not misleading, and must provide required information as per 21 CFR 101 and DSHEA.

Principal Display Panel (PDP)

  • Contains the statement of identity (e.g., “Dietary Supplement”).
  • Includes the net quantity of contents in weight, measure, or numerical count.

Information Panel

  •  Located immediately to the right of the PDP.
  • Includes: Supplement Facts Panel (format and nutrient listings)
  • Serving size and servings per container
  •  List of dietary ingredients and their amounts per serving
  •  % Daily Value for each listed nutrient (if applicable)

Other Required Elements

  • Other ingredients listed in descending order by weight.
  • Directions for use and warning statements.
  • Name and place of business (e.g., “Distributed by…” + address).
  • Domestic address or phone number for serious adverse event reporting.

Structure/Function Claims

  • Permitted under DSHEA, provided they are substantiated and accompanied by the FDA disclaimer:
    “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Prohibited Claims

  • Cannot imply disease treatment or prevention unless an approved drug.
  • Avoid terms like “cure,” “prevent,” “treat,” or disease-specific wording.

Best Practices

  • Ensure label formatting follows 21 CFR 101.36 guidelines.
  • Review all claims against FTC substantiation standards.
  • Maintain internal label approval and version control.

Optional Services

  •  Pre-market label review for FDA compliance
  •  Comparative label benchmarking
  •  Claims substantiation report draftin

Label Requirements:

  • Principal Display Panel (PDP)
  • Supplement Facts Panel
  • Other Ingredients, Directions for Use
  • Warnings / Cautions
  • Distributor/Manufacturer Info
  • DSHEA Disclaimers
  • Label Claims (Structure/Function, Health, Nutrient Content)
  • Substantiation Requirements

Requirements for Components, Packaging, and Labels

Identity testing of all incoming dietary ingredients is strictly required and documented. Establish clear, written specifications for each component used.

Packaging and Labeling
Control System

Prevent mislabeling and ensure proper label reconciliation procedures. Finished product labels must consistently meet established specifications.

The Skalli Group is a regulatory consultancy specializing in FDA and global compliance for dietary supplements and wellness products. We bring clarity, and strategy to help innovators succeed in a complex regulatory landscape.
Facebook Twitter Youtube Pinterest

Quick Links

Our Services

Subscribe Our Newslater

Get Our Latest Update & New Offers Sales Discount

Copyright © 2025, All Right Reserved.