What constitutes “adulteration” per the FDA?
A product does not need to contain a foreign substance to be considered “adulterated” by the FDA.
- Anonymous1 decade agoFavorite Answer
"Adulteration" is a legal term meaning that a food product fails to meet federal or state standards. Adulteration usually refers to noncompliance with health or safety standards as determined, in the United States, by the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA).
Definition of Adulterated Food
The Federal Food, Drug, and Cosmetic (FD&C) Act (1938) provides that food is "adulterated" if it meets any one of the following criteria: (1) it bears or contains any "poisonous or deleterious substance" which may render it injurious to health; (2) it bears or contains any added poisonous or added deleterious substance (other than a pesticide residue, food additive, color additive, or new animal drug, which are covered by separate provisions) that is unsafe; (3) its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) it bears or contains a pesticide chemical residue that is unsafe. (Note: The Environmental Protection Agency [EPA] establishes tolerances for pesticide residues in foods, which are enforced by the FDA.)
Food also meets the definition of adulteration if: (5) it is, or it bears or contains, an unsafe food additive; (6) it is, or it bears or contains, an unsafe new animal drug; (7) it is, or it bears or contains, an unsafe color additive; (8) it consists, in whole or in part, of "any filthy, putrid, or decomposed substance" or is otherwise unfit for food; or (9) it has been prepared, packed, or held under unsanitary conditions (insect, rodent, or bird infestation) whereby it may have become contaminated with filth or rendered injurious to health.
Further, food is considered adulterated if: (10) it has been irradiated and the irradiation processing was not done in conformity with a regulation permitting irradiation of the food in question (Note: FDA has approved irradiation of a number of foods, including refrigerated or frozen uncooked meat, fresh or frozen uncooked poultry, and seeds for sprouting [21 C.F.R. Part 179].); (11) it contains a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use recommended in labeling (for example, foods or dietary supplements containing aristolochic acids, which have been linked to kidney failure, have been banned.); (12) a valuable constituent has been omitted in whole or in part or replaced with another substance; damage or inferiority has been concealed in any manner; or a substance has been added to increase the product's bulk or weight, reduce its quality or strength, or make it appear of greater value than it is (this is "economic adulteration"); or (13) it is offered for import into the United States and is a food that has previously been refused admission, unless the person reoffering the food establishes that it is in compliance with U.S. law [21 U.S.C. § 342].
- Anonymous4 years ago
Pretty good arguments here.