SUPPLEMENTS PACKAGING 101: ELEMENTS, PLACEMENT, LABELING AND CLAIMS an eBook fr

SUPPLEMENTS PACKAGING 101: ELEMENTS, PLACEMENT, LABELING AND CLAIMS an eBook from ESHA Research SUPPLEMENTS PACKAGING 101 2 esha TABLE OF CONTENTS Introduction. .......................................... 3 Definition. .............................................. 4 Packaging Basics.................................. 5 What is Required. .................................. 5 Placement. ............................................ 6 Packaging Areas Defined. .................... 7 PDP. ...................................................... 7 Information Panel. ................................. 7 Packaging Elements. ............................. 8 Statement of Identity............................. 8 Net Quantity. ........................................ 9 Name and Address............................... 10 Supplement Facts Panel. ....................... 11 Placement. ............................................ 11 Determining Style. ................................. 12 Required Elements. ................................ 13 Serving Size.........................................13 Servings per Container.........................13 Nutrients. .............................................14 Ingredient Statement. ...........................16 Allergen Statement. ..............................17 Claims. ................................................... 18 Nutrient Content Claims. ....................... 18 Health Claims....................................... 19 Structure/Function Claims..................... 20 SUPPLEMENTS PACKAGING 101 3 esha I n 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA) to (1) define what a supplement is (2) to set regulations for labeling and packaging and (3) 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 briefly cover the first 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. Introduction. SUPPLEMENTS PACKAGING 101 4 esha Definition. 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 specifically, the Federal Food, Drug, and Cosmetic Act defines a (non- tobacco) 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 SUPPLEMENTS PACKAGING 101 5 esha WHAT IS REQUIRED? F DA-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. Packaging Basics. SUPPLEMENTS PACKAGING 101 6 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) REQUIRED ON THE PDP (PRINCIPLE DISPLAY PANEL) • Statement of Identity • Net Quantity Statement Packaging Basics. esha PLACEMENT SUPPLEMENTS PACKAGING 101 7 esha Packaging Areas Defined. PDP (Principle Display Panel) T he 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 40 percent of the area, which is found by multiplying the height times the circumference. Example: A bottle is 3 inches in height and the circumference is 4 inches around. • 3 x 4 =12 square inches • 40% x 12 = 4.8 square inches In this example, the PDP is a 4.8 square-inch area. INFORMATION PANEL T he information panel is the panel or area (if, say, the package is a bottle) immediately to the right of the PDP, as displayed to the consumer. 3 in. 4 in. 4.8 sq. in. SUPPLEMENTS PACKAGING 101 8 esha STATEMENT OF IDENTITY T he statement of identity is the name of the supplement and can be shown in one of the following ways: • The common or usual name of the dietary ingredient, followed or preceded by the term “dietary supplement.” • The common or usual name of the dietary ingredient plus the word “supplement.” • Or, if there is no common or usual name and the nature of the supplement is not obvious, the statement of identity must be an appropriately descriptive term. Vitamin D DIETARY SUPPLEMENT DIETARY SUPPLEMENT Vit. D CALCIUM SUPPLEMENT Herbal Supplement with Vitamins NOTE The Statement of Identity is not the brand. Package Elements. Required: Always. Location: PDP . Format: Bold type, same size or larger than most prominent printed element, parallel to the base. SUPPLEMENTS PACKAGING 101 9 esha NET QUANTITY OF CONTENTS, OR AMOUNT OF PRODUCT T he net quantity statement tells consumers how much of the supplement is in the container or package. This is either the total number of capsules/pills or the net fluid amount, and is listed by weight, measure, numerical count (e.g. 100 tablets), or combination thereof. Required: Always. Location: Bottom 30% of PDP . Format: Prominent, conspicuous, and easy to read. Type size depends on package size. (See bullet points and chart below.) • The smallest type size permitted for the net quantity of contents statement is based on the size of the principal display panel. • If the principal display panel is 5 square inches or less, the requirement for placement within the bottom 30 percent does not apply when the declaration of net quantity of contents meets the other requirements of 21 CFR 101.105(f). Minimum Type Size Area of PDP 1/16 in. (4.5 point) 5 sq. in. 1/8 in. (9 point) More than 5 sq. in. but not more than 25 sq. in. 3/16 in. (13.5 point) More than 25 sq. in. but not more than 100 sq. in. 1/4 in. (18 point) More than 100 sq. in. but not more than 400 sq. in. 1/2 in. (36 point) Over 400 sq. in. Package Elements. SUPPLEMENTS PACKAGING 101 10 esha Required: Always. Location: This must be placed near the ingredients statement, which is usually on the information panel. NAME AND ADDRESS OF THE MANUFACTURER, PACKER, OR DISTRIBUTOR. This element must list the following: • Name and address of the manufacturer, packer, or distributor. Unless the name given is the actual manufacturer, it must be accompanied by a qualifying phrase that states the firm’s relation to the product, e.g., “manufactured for” or “distributed by”; • Street address; • City or town; • State (or country, if outside the United States); and • ZIP code (or mailing code used in countries other than the United States). Package Elements. SUPPLEMENTS PACKAGING 101 11 esha Supplement Facts Panel. T he Supplement Facts panel is rigorously regulated, which is why this eBook devotes an entire section to it. PLACEMENT Supplement Facts Serving Size 1 Tablet Servings Per Container 60 Amount Per Serving % Daily Value Vitamin A 900 mcg 100% Vitamin C 90 mg 100% Vitamin D 20 mcg (800 IU) 100% Vitamin E 15 mg 100% Thiamin 1.2 mg 100% Riboflavin 1.3 mg 100% Niacin 16 mg 100% Vitamin B6 1.7 mg 100% Folate 680 mcg DFE 170% (400 mcg folic acid) Vitamin B12 2.4 mcg 100% Biotin 30 mcg 100% Pantothenic Acid 5 mg 100% Choline 550 mg 100% Fluoride 20 mg † † Daily Value not established Required: Always. Location: Usually on the information panel, alongside or near the ingredients list and the manufacturer’s information. Supplement Facts Serving Size 2 Tablet Servings Per Container 50 Amount Per Serving % Daily Value Calcium (as Calcium Citrate, Calcium Malate) 500 mg 38% Magnesium (as Magnesium Citrate, Magnesium Oxide) 250 mg 60% Supplement Facts Serving Size 1 Capsule, Servings 50, Amount Per Serving: Rose Hip Extract (flower) 50 mg, Echinacea Extract (whole) 50 mg. Supplement Facts Serving Size 2 Tablet Servings Per Container 50 Amount Per Serving %DV Vitamin C (as Ascorbic Acid) 500 mg 556% Zinc (as Zinc Amino Acid Chelate) 20 mg 182% Copper (as Copper Amino Acid Chelate) 1.2 mg 133% Herbal Blend 100 mg † Rose Hips (flower) 50 mg † Echinacea Purpurea Extract (whole herb) 50 mg † † Daily Value (DV) not established SUPPLEMENTS PACKAGING 101 12 esha DETERMINING SUPPLEMENT FACTS PANEL STYLE. T he rule of thumb is that you must use a standard Supplement Facts panel on packages with 12 sq. inches or larger. Most supplement bottles meet this minimum size requirement. If, however, your package is smaller than 12 sq. inches, you may use the linear format. Supplement Facts Serving Size 1 Tablet Servings Per Container 60 Amount Per Serving % Daily Value Vitamin A 900 mcg 100% Vitamin C 90 mg 100% Vitamin D 20 mcg (800 IU) 100% Vitamin E 15 mg 100% Thiamin 1.2 mg 100% Riboflavin 1.3 mg 100% Niacin 16 mg 100% Vitamin B6 1.7 mg 100% Folate 680 mcg DFE 170% (400 mcg folic acid) Vitamin B12 2.4 mcg 100% Biotin 30 mcg 100% Pantothenic Acid 5 mg 100% Choline 550 mg 100% Fluoride 20 mg † † Daily Value uploads/s3/ supplement-guide.pdf

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