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Supplement guide SUPPLEMENTS PACKAGING ELEMENTS PLACEMENT LABELING AND CLAIMS an eBook from ESHA Research CSUPPLEMENTS PACKAGING TABLE OF CONTENTS Introduction De ?nition Packaging Basics What is Required Placement Packaging Areas De ?ned PDP Information

SUPPLEMENTS PACKAGING ELEMENTS PLACEMENT LABELING AND CLAIMS an eBook from ESHA Research CSUPPLEMENTS PACKAGING TABLE OF CONTENTS Introduction De ?nition Packaging Basics What is Required Placement Packaging Areas De ?ned PDP Information Panel Packaging Elements Statement of Identity Net Quantity Name and Address Supplement Facts Panel Placement Determining Style Required Elements Serving Size Servings per Container Nutrients Ingredient Statement Allergen Statement Claims Nutrient Content Claims Health Claims Structure Function Claims esha CSUPPLEMENTS PACKAGING Introduction In Congress passed the Dietary Supplement Health and Education Act DSHEA to de ?ne what a supplement is to set regulations for labeling and packaging and change the scope of the FDA to include removal of unsafe or misbranded products from the market and to establish safe manufacturing practices This ebook will brie y cover the ?rst two topics to help guide you through the regulations and requirements for Supplement Facts labeling compliance Please remember while we can provide you with basic guidelines for compliance you are ultimately responsible for understanding and applying the regulations esha CSUPPLEMENTS PACKAGING De ?nition WHAT IS A DIETARY SUPPLEMENT In general dietary supplements are products that contain one or more ??dietary ingredients ? are intended to supplement the diet and are not to be represented as conventional foods or as a sole item of a meal In addition they are typically ingested as gelcaps softgels capsules tablets liquids or powders More speci ?cally the Federal Food Drug and Cosmetic Act de ?nes a nontobacco dietary ingredient as a vitamin a mineral herb or other botanical amino acid dietary substance to supplement the diet by increasing the total dietary intake a concentrate metabolite constituent extract or combination of the preceding substances esha CSUPPLEMENTS PACKAGING Packaging Basics WHAT IS REQUIRED FDA-regulated supplement packages must contain the following components ? Statement of Identity ? Net Quantity Statement ? Name and address of manufacturer packer or distributor ? Supplement Labeling In addition when present or necessary packaging must also show ? Ingredient Statement ? Allergen Statement ? Nutrient Content Claim s All required items must be placed either on the Principle Display Area PDP or the Information Panel The regulations dictate each component ? s placement type size requirements and more esha CSUPPLEMENTS PACKAGING Packaging Basics PLACEMENT REQUIRED ON THE PDP PRINCIPLE DISPLAY PANEL ? Statement of Identity ? Net Quantity Statement CAN BE PLACED ON THE PDP OR INFORMATION PANEL ? Name and address of manufacturer packer or distributor ? Supplement Labeling ? Ingredient Statement ? Allergen Statement ? Nutrient Content Claim s esha CSUPPLEMENTS PACKAGING Packaging Areas De ?ned PDP Principle Display Panel The Principle Display Panel is the area most likely to be seen by a buyer at the time of purchase which in most cases is the front of the supplement bottle There may be other suitable areas called alternate PDPs but we will focus on the primary PDP here For a cylindrical container like a supplement bottle the PDP area is percent of the area which is found by