ABSTRACT
Food is de•ned in section 201(f) of the Food, Drug, and Cosmetic (FD&C) Act as “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” Examples of food include
• Dietary supplements and dietary ingredients • Infant formula
• Beverages (including alcoholic beverages and bottled water)
• Fruits and vegetables • Fish and seafood • Dairy products and shell eggs • Raw agricultural commodities for use as food or
components of food • Canned and frozen foods
De•nition of Food ..................................................................................................................................................................... 621 Standards of Safety for Food Additives, Color Additives, GRAS Ingredients, and New Dietary Ingredients (Dietary Supplements) ............................................................................................................................................................................. 622
Food Additives ..................................................................................................................................................................... 623 Color Additives .................................................................................................................................................................... 623 GRAS Ingredients ................................................................................................................................................................ 626
Safety Evaluation of a GRAS Ingredient ........................................................................................................................ 627 Examples of Approaches for GRAS Determination for Speci•c Types of Food Products ............................................. 628
Estimated Daily Intake ......................................................................................................................................................... 629 Food Consumption Surveys ............................................................................................................................................ 630 Food Usage Data ............................................................................................................................................................. 631 Food Survey Results ........................................................................................................................................................ 631
Dietary Supplements ............................................................................................................................................................ 631 Summary of Regulatory Paths for GRAS Substances, Food Additives, and Dietary Supplements ......................................... 633 Food Contact Substances .......................................................................................................................................................... 633 Food Allergy ............................................................................................................................................................................. 634
Introduction .......................................................................................................................................................................... 634 Oral Tolerance and Food Allergy ......................................................................................................................................... 635 IgE-and Non-IgE-Mediated Hypersensitivity Reactions .................................................................................................... 635 Diagnosing Food Allergy ..................................................................................................................................................... 636 Threshold Doses ................................................................................................................................................................... 636 Allergenic Determinants ...................................................................................................................................................... 638
Common Foodborne Toxicants ................................................................................................................................................. 638 Pesticide Residues ................................................................................................................................................................ 638 Heavy Metals ....................................................................................................................................................................... 638 Bacteria and Viruses ............................................................................................................................................................. 638
Bacterial Infections and Intoxications ............................................................................................................................. 638 Viral Foodborne Illnesses ..................................................................................................................................................... 641 Mycotoxins ........................................................................................................................................................................... 642
Prevention and Control of Microbial Food Hazards ................................................................................................................. 646 Natural Occurring Toxins in the Food Supply .......................................................................................................................... 648
Mushroom Peptides .............................................................................................................................................................. 648 Toxicants in Food of Plant Origin ........................................................................................................................................ 651
Miscellaneous Plant Toxicants ........................................................................................................................................ 661 Marine Toxins ...................................................................................................................................................................... 661 Foodborne Bioterrorism ....................................................................................................................................................... 663
References ................................................................................................................................................................................. 665
chewing gum)
• Live food animals • Animal feeds and pet food
Food is presumed to be safe (sections 201(f) and 402(a)(1) of the FD&C Act). However, as with any substance, safety is not absolute and the regulatory paradigms, safety standard, risk assessment process, and ultimate responsibility and authority for ensuring the safety of foods and food ingredients have evolved over time.
