The Principle Requirements of the Federal Food, Drug, and Cosmetic Act Relating to Foods

Below is a synopsis of the principal requirements of the Federal Food, Drug, and Cosmetic Act relating to foods, in nonlegal language. The numbers in parentheses are the pertinent sections of the statute itself, or sections (secs.) in Title 21 of the Code of Federal Regulations (21 CFR).

Health Safeguards

  • A food is illegal (adulterated) if it bears or contains an added poisonous or deleterious (harmful) substance which may render it injurious to health (Sec. 402(a)(1)).

  • A food is illegal if it bears or contains a naturally occurring poisonous or deleterious substance which ordinarily renders it injurious to health (Sec. 402(a)(1)).

  • Food additives (Sec. 201(s)) must be determined to be safe by FDA before they may be used in a food, or become a part of a food as a result of processing, packaging, transporting, or holding the food (Sec. 409).
  • Raw agricultural products are illegal if they contain residues of pesticides not authorized by, or in excess of, tolerances established by regulations of the Environmental Protection Agency (Sec. 402(a)(2)(b) and Sec. 408)).

  • A food is illegal if it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health (Sec. 402(a)(4)).

  • Food containers must be free from any poisonous or deleterious substance which may cause the contents to be injurious to health (Sec. 402(a)(6)). Some packaging materials, for example plastic or vinyl containers, may be "food additives" subject to regulations (Sec. 409).

  • Only those colors found safe by the Food and Drug Administration may be added to food (Sec. 721). A food is illegal if it bears or contains an unsafe color(s) (Sec. 402(c)). Unless exempt by regulation, colors for use in food must be from batches tested and certified by the Food and Drug Administration (Sec. 721(c)).

  • A food is illegal if any part of it is filthy, putrid, decomposed or otherwise "unfit" (Sec. 402(a)(3)).

  • A food is illegal if it is the product of a diseased animal or one that has died otherwise than by slaughter (Sec. 402(a)(5)).

Economic Safeguards

  • Damage or inferiority, in food, must not be concealed in any manner (Sec. 402(b)(3)), Nor may any substance be added to, mixed, or packed with a food to increase its bulk or weight, reduce its quality or strength, or make it appear better or of greater value than it is (Sec. 403(b)(4)). For example, yellow coloring used to make a food appear to contain more eggs than it actually contains.

  • Food labels or labeling (circulars, etc.) must not be false or misleading in any particular (Sec. 403(a)(1)). Labeling is misleading not only if it contains false or misleading statements but also if it fails to reveal material facts (Sec. 201(n)).

  • A food must not be sold under the name of another food (Sec. 403(b)). For example, canned bonito labeled as tuna.

  • A substance recognized as being a valuable constituent of a food must not be omitted or abstracted, in whole or in part, nor may any substance be substituted for the food in whole or in part (Sec. 402(b)(1) and (2)). For example, an article labeled as "milk" or "whole milk" from which part of the butterfat has been skimmed.

  • Food containers must not be so made, formed, or filled as to be misleading (Sec. 403(d)). For example, a food for which a standard of fill-of-container has been prescribed (Sec. 401) must comply with the fill requirements, and if the fill falls below that which is specified, its label must bear a statement that it falls below such standard (Sec. 403(h)(2)).
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