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Consultant and long-time Food and Drug Administration (FDA) food labeling expert James Summers answers the many questions surrounding FDA food labeling regulations and compliance in Food Labeling Compliance Review. This comprehensive manual and fully searchable, accompanying CD-ROM are designed to aid in understanding the requirements of the FDA. Food Labeling Compliance Review is a must-have for regulatory officials, industry personnel, and others responsible for assuring that the label and labeling of domestic and imported food products in interstate commerce comply with the requirements of the Federal Food, Drug and Cosmetic Act, as amended. The new fourth edition of Food Labeling Compliance Review fully covers recently enacted provisions requiring labeling for allergens, trans fats, and qualified health claims. Clearly illustrated with dozens of charts, sample label panels and 'Nutrition Facts' boxes, Food Labeling Compliance Review is the practical, no-nonsense tool needed by both the experienced and inexperienced food label reviewer. Current, complete, and accurate food labeling guidance concerning FDA regulations Covers new requirements for labeling allergens, trans fats, and qualified health claims Essential for all food manufacturers, packers, labelers, relabelers, and distributors Fully illustrated with clear Q and A explanations Fully-searchable CD-ROM enables quick look ups.
Intro -- FOOD LABELING COMPLIANCE REVIEW -- Contents -- I. Introduction -- II. Overview of the History of Food Labeling -- III. Definitions -- IV. Changes in Food Labeling Regulations Resulting from NLEA -- A. Ingredient Labeling -- B. Certified Color Additives -- C. Common or Usual Names for Nonstandardized Foods -- 1. Protein Hydrolysates (21 CFR 102.22) -- 2. Beverages that Contain Fruit or Vegetable Juice (21 CFR 101.30and 102.23) -- D. Standardized Foods -- 1. General Provisions (21 CFR Part 130) -- 2. Specific Varieties of Foods (21 CFR Parts 131 through 169) -- E. Nutrition Labeling -- 1. Mandatory Labeling -- 2. Nutrition Labeling Exemptions -- 3. Nutrient Content Declarations -- 4. Nutrition Label Format -- 5. Serving Sizes -- 6. Daily Values - DRVs and RDIs -- 7. Nutrient Content Descriptors -- 8. Health Claims -- F. Descriptive Claims: Fresh, Freshly Frozen, Fresh Frozen, Frozen Fresh (21 CFR 101.95) -- G. Others: Noncertified Color Additives, Spices and Flavorings -- V. Outline for Compliance Review -- A. Establish Jurisdiction -- 1. Food Subject to the Requirements of the Federal Food, Drug, and Cosmetic Act, as Amended (FD&CA) -- 2. On Requests for Information on a Label Review and Certificate of Free Sale -- B. Determine the Completeness and Accuracy of the Required Label Information (21 CFR Part101) -- 1. Identity Statement (21 CFR 101.3) -- 2. Net Quantity of Contents Statement (21 CFR 101.105) -- 3. ingredient Statement (21 CFR 101.4) -- 4. Name and Address of the Place of Business (21 CFR 101.5) -- 5. Nutrition Labeling (21 CFR 101.9) -- C. Determine the Degree of Compliance with Applicable Regulations -- D. Advise Respon1sible Firm of Label(s) Needing Corrections -- 1. Unfitted Letter -- 2. Product Recall -- 3. Warning Letter -- 4. Seizure -- 5. Citation -- 6. Prosecution -- 7. Injunction.
