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Allergens & Sensitizers Biotechnology FMP Meat and Poultry Products Natural Labeling & Claims Organic Vanilla

 

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External Resources

Enforcement

  • Adulteration

    • The FD&CA does not specifically address the adulteration of food by environmental or accidental contaminants.  Rather the statute uses the presence of a "poisonous or deleterious substance to determine adulteration.  The basic statutory provision is found in section 402(a)(1) of the FDCA, 21 21 U.S. Code 342

  • FD&C Act

    • Food Drug & Cosmetic Act gives FDA enforcement authority.  FD&C Act contains several chapters that are applicable to enforcement of food labeling

  • Misbranding

    • The FDA specifies when a product is not labeled correctly as "misbranded"; 21 CFR 101.18

  • U.S. Code

    • The Code is a consolidation by subject matter of the general and permanent laws of the United States. This website is an easy search tool for every title.  There are 54 titles of the Code. The titles are listed on the Search & Browse page

General Labeling Regulations & Definitions

  • eCFR

    • Electronic Code of Federal Regulations provides you the resource to browse for a specific regulation or to search for a specific topic

  • eCFR database search tool

    • FDA CFR data base search tool: (CFR) is a codification of the general and permanent rules published in the Federal Register. Title 21 of the CFR is reserved for rules of the Food and Drug Administration. Each title (or volume) of the CFR is revised once each calendar year. A revised Title 21 is issued approximately April 1st of each year

  • FDA Food Labeling Guide

    • FDA Food Labeling guide (2013): This is a guidance document and represents (FDA's) current thinking on this topic.  The most frequently raised questions are addressed using a Q&A format. They are grouped by the food labeling area of interest. The Table of Contents helps to locate your food labeling area of interest

  • Labeling Definitions

    • Defines "Labeling" and "Labeling material"

  • Pasteurized

    • Pasteurized when used to describe a dairy ingredient means that every particle of such ingredient shall have been heated in properly operated equipment under specified time and temperature requirements.  The term "ultra pasteurized" is defined as well

  • Principal Display Panel (PDP)

    • General Provisions includes Principal display panel of package form food, Information Panel, Identity labeling of food in Packaged form, and Food designation of ingredients

  • Standards of Identity

    • Federal standard of identity designates the name of the product by regulation.  Food standards are established to promote fair competition among manufacturers and to eliminate consumer confusion.  General provisions of Food Standards are found in 21 CFR Part 130
Information Panel - Ingredient Labeling

  • Citizen petition to establish a "new" common or usual name

    • Establishing a "New" Common or Usual Name through common usage and/or the filing of a citizen petition

  • Class Names

    • FDA recognizes a number of permitted class names for food ingredient labeling.  21 CFR 101.4(b) (3-12)

  • Common or Usual Name

    • Common or Usual Name of a food ingredient must accurately identify or describe in as simple and direct terms as possible identifying the basic nature of the food ingredient or its characterizing properties. 21 CFR 102.5

  • Definition

    • The term "common or usual name" of a food is defined.   The general provisions for the Common or Usual Name for Nonstandardized foods must accurately identify the nature of the food or its characterizing properties or ingredients

  • Exempt from Labeling:

    • Incidental Additives, Processing Aids; Migrating Substances

  • FALCPA (Allergens)

    • FALCPA is an amendment to the Federal FD&C Act.  It requires labels of a food containing an ingredient that is or contains protein from a "major food allergen " to declare the presence of such allergen in the manner described by the law.  FALCPA applies to food products that are labeled on or after January 1, 2006

  • FALCPA Q&A

    • Q&A regarding FALCPA is useful in answering inquiries about FALCPA, food allergen labeling, gluten, and consumer advising

  • Fats and Oils

    • Fats and Oils or Fats and Oils Used Interchangeably; 21 CFR 101.4(b)14

  • Irradiated Foods

    • Irradiated Foods are treated like any other ingredient and listed by their common or usual name.  However, the customer must be notified in some fashion regarding irradiation

  • Natural

    • Specific flavoring labeling regulations which includes the definition of “natural flavor” at Section 101.22(a)(3).

  • Nonstandardized Foods Specific Labeling Requirements

    • Requirements for specific nonstandardized foods are outlined.  Contains common terms such as "protein hydrolysate" which is defined

  • Spices, flavorings, colorings and chemical preservatives

  • Water

    • Water other than that permitted to reconstitute an ingredient must be labeled 21 CFR 101.4; Water as an "adulterant" CPG 555.875
Product Naming

  • Fanciful Names

    • A fanciful name stems from the imagination rather than regulation or reason.  A fanciful name should not be used alone if the name imitates, mimics or purports to be a product with a standard of identity

  • Food Dressings & Flavorings

    • 21 CFR 169 Standardized Food Dressing and Flavorings - (Requirements for Specific Standardized Food Dressings and Flavorings): Federal standard of identity for vanilla products, including vanilla extract. This regulation contains a definition for “unit weight of vanilla beans” which governs the specific standards for products

  • Standardized Frozen Desserts

    • 21 CFR 135.110 (Requirements for Specific Standardized Frozen Desserts): Subsection 110 of this regulation contains the definitions for what is commonly referred to as “Category 1,” “Category 2,” and “Category 3” ice cream products

  • Statement of Identity/Common, Usual Name

    • If a product is an imitation of another product then it must be labeled as "imitation"

 

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