Product & Ingredient Naming FDA Tom Her PurFoods, LLC
Contents 1. Introduction 2. Statement Identity/Product Name 3. Ingredient Labeling 4. Questions 2 Inc. All rights reserved Inc. All rights reserved.
Label vs. Labeling Labeling : on package, flyer, web site, etc All labels and other written, printed or graphic matter: 1. Upon any article or any its containers or wrappers, or 2. Accompanying such article Label : on package A display written, printed, or graphic matter upon the immediate container any article 3 Inc. All rights reserved Inc. All rights reserved.
Statement Identity
Statement Identity: General Guidelines Must appear on Principal Display Parallel to the base Legible In English Product Name 5 Inc. All rights reserved Inc. All rights reserved.
Statement Identity: Format FDA: must be legible & reasonably sized 6 Inc. All rights reserved Inc. All rights reserved.
Product Form Must be described if available in different forms and not visible to the consumer: Sliced, chunked, ground, whole, halved, etc 7 Inc. All rights reserved Inc. All rights reserved.
Product Name (Statement Identity) Rules Thumb: Standard Identity for many commodities 8 Inc. All rights reserved Inc. All rights reserved.
Statement Identity 1. Standard Identity Must be used if defined 2. Common & Usual Name Must be used if relevant 3. Descriptive Name Not to be misleading 4. Fanciful Name May be used if obvious in nature 9 Inc. All rights reserved Inc. All rights reserved.
Statement Identity 1. Standard Identity Must be used if defined 2. Common & Usual Name Must be used if relevant 3. Descriptive Name Not to be misleading 4. Fanciful Name May be used if obvious in nature 10 Inc. All rights reserved Inc. All rights reserved.
Statement Identity 1. Standard Identity Must be used if defined 2. Common & Usual Name Must be used if relevant 3. Descriptive Name Not to be misleading 4. Fanciful Name May be used if obvious in nature 11 Inc. All rights reserved Inc. All rights reserved.
Statement Identity 1. Standard Identity Must be used if defined 2. Common & Usual Name Must be used if relevant 3. Descriptive Name Not to be misleading 4. Fanciful Name May be used if obvious in nature 12 Inc. All rights reserved Inc. All rights reserved.
Format Requirements On PDP / alternate PDP Parallel to package base Bold Type* 13 Inc. All rights reserved Inc. All rights reserved.
Statement Identity Reasonably related to the most prominent printed matter Generally considered to be at least ½ the size the largest print Brand names are not statements identity and should not be unduly prominent 14 Inc. All rights reserved Inc. All rights reserved.
Imitation Products IF the food resembles a traditional food but is nutritionally inferior, imitation must be stated in equal size and prominence 15 Inc. All rights reserved Inc. All rights reserved.
Flavor Naming Food alone: Orange Cake The Product Name is based on what ingredients the taste is derived from Food + Natural Flavor: Natural Orange Flavored Cake Natural Flavor only: Natural Orange Flavored Cake Food + Natural Flavors: Natural Orange Flavored Cake with other natural flavors Food + Artificial Flavor: or Artificial Flavor only: 16 Artificially Flavored Orange Cake Orange Artificially Flavored Cake Flavor statement must be ½ height food name Inc. All rights reserved Inc. All rights reserved. 21 CFR 101.22 (h)
Ingredients Statement
Ingredients Statement A list the product ingredients in descending order predominance predominant by weight by specific ingredient Principal Display Panel or Information Panel 18 Inc. All rights reserved Inc. All rights reserved.
Ingredients: Use Statement Identity Ground Wheat Wheat Flour Or Common & Usual Name Sucrose Sugar 19 Inc. All rights reserved Inc. All rights reserved.
Ingredients: Use Specific Names Vegetables (tomato, carrot, spinach), Water, Salt, Pepper Water, Tomato, Carrot, Spinach, Salt, Pepper Avoid abstract grouping ingredients to affect the apparent order predominance 20 Inc. All rights reserved Inc. All rights reserved.
Ingredients Statement: Complex Ingredients A complex ingredient is made up more than one ingredient. The elements a complex ingredient must be sub-listed, in parentheses, after its name (should include any sub-listings or flavors) 21 Inc. All rights reserved Inc. All rights reserved.
Ingredients at 2% or less To avoid packaging reprints or conceal formulas, ingredients at 2% or less total formula may be listed in any order, provided: They are preceded by the statement Contains 2% or less or Less than 2% (May use 1.5% or 1% or 0.5% if all ingredients listed meet that maximum level.) 22 Inc. All rights reserved Inc. All rights reserved.
Ingredient Statement The term ingredients is not required 23 Inc. All rights reserved Inc. All rights reserved.
Ingredient Statement Prominent, conspicuous, easy to read 24 Inc. All rights reserved Inc. All rights reserved.
Ingredient Statement Minimum size: 1/16 inch - Letter height - Based on lowercase o if used 25 Inc. All rights reserved Inc. All rights reserved.
Ingredient Categories Spices Fat and Oil Blends Colors Flavors Leavenings, Yeast Nutrients, Dough Conditioners, Firming Agents Preservatives 26 Inc. All rights reserved Inc. All rights reserved.
Spices Declared by the common and usual name or collectively using spices : Apples, water, sugar, ginger, cinnamon, nutmeg Apples, water, sugar, spices Apples, water, sugar, spices, cinnamon 27 The term spice means any aromatic vegetable substance in the whole, broken, or ground form, except for those substances which have been traditionally regarded as foods, such as onions, garlic and celery Paprika, turmeric, and saffron or other spices which are also colors, shall be declared as spice and coloring unless declared by their common or usual name. 21 CFR 101.22 (a)(2) Inc. All rights reserved Inc. All rights reserved.
Fat & Oil Blends May use category with and/or designation Vegetable Oils (Corn oil, safflower oil, and/or canola oil) - Must state source: animal, vegetable, marine - Must list all potential oils included - Not allowed if fat/oil is the primary ingredient - For use when predicting oil source is difficult 28 Inc. All rights reserved Inc. All rights reserved.
Colors Certified colors Synthetic uniform approved food additives e.g., FD&C Red 40 Non-certified colors Any substance added to color the product There is no such thing as a natural color 29 Inc. All rights reserved Inc. All rights reserved.
Certified Colors Certified Colors Must be listed by name FD&C and No are optional FD&C Red No 40 Red 40 FD&C Blue No 1 Lake Blue 1 Lake 30 Inc. All rights reserved Inc. All rights reserved.
Non-Certified Colors Non-certified colors Listed by name or as artificial color Spices acting as colors must be indicated artificial color caramel color colored with beet juice paprika spice and coloring 31 Inc. All rights reserved Inc. All rights reserved.
Flavors Natural Flavors - List by name or as natural flavor Artificial Flavors - List by name or as artificial flavor 32 Inc. All rights reserved Inc. All rights reserved.
Flavors For Example: Milk, sugar, cocoa powder, natural vanilla flavor, artificial chocolate flavor Milk, sugar, cocoa powder, natural vanilla flavor, artificial flavors Milk, sugar, cocoa powder, natural and artificial flavors 33 Inc. All rights reserved Inc. All rights reserved.
Ingredient Category Grouping Leavening (Baking Soda, Monocalcium Phosphate) Yeast Nutrients (Calcium Sulfate, Ammonium Phosphate) Dough Conditioners (L-cysteine, Ammonium Sulfate) Firming Agents (Calcium Bisulphite, Calcium Carbonate) or, and/or, contains one or more the following 34 Inc. All rights reserved Inc. All rights reserved.
Preservatives Must be listed by name and function A mold inhibitor To protect flavor To promote color retention 35 Inc. All rights reserved Inc. All rights reserved.
Questions
Biography Tom Her Corporate Labeling Compliance Officer PurFoods, LLC Corporate Headquarters 3210 SE Corporate Woods Drive Ankeny, Iowa 50021 Telephone: 515.963.7034 Tom.Her@PurFoods.com 37 Tom Her is responsible for creating and maintaining FDA and USDA compliant labels in the company s complete product line. He started with PurFoods in 2000 and has been instrumental in the company s phenomenal growth and success. He has an extensive background in the food industry including eight years doing management training and marketing for Arby s Restaurants in over 30 markets throughout Iowa, Illinois, Wisconsin and Nebraska. Tom owned and operated a large ballroom and catering business for nine years. He also served on the Board Directors the National Ballroom and Entertainment Association and the Minnesota Ballroom Operators Association. Inc. All rights reserved Inc. All rights reserved.
About PurFoods, LLC www.purfoods.com www.momsmeals.com 38 PurFoods was founded in 1999 to help people, who care for a loved one and want to ensure they have access to healthy meals that are convenient to prepare. The company began in a small kitchen in central Iowa. They currently have large production facilities in Iowa and Ohio. Distribution is handled by fulfillment centers in Iowa, Ohio and Nevada as well as a fleet well over 100 home delivery vehicles across the United States. Largest product line is Mom s Meals Nourish Care Senior Meal Programs Post-acute hospital discharge Care Transitions Chronic Conditions High-risk readmissions Inc. All rights reserved Inc. All rights reserved.