The FDA publishes these revisions as Notices in the Federal Register. The levels represent limits at which FDA will regard the food product "adulterated" and subject to enforcement action under Section 402(a)(3) of the Food, Drug, and Cosmetics Act.Īs technology improves, the FDA may review and change defect action levels on this list. The defect levels do not represent an average of the defects that occur in any of the products-the averages are actually much lower. It is incorrect to assume that because the FDA has an established defect action level for a food commodity, the food manufacturer need only stay just below that level. Products harmful to consumers are subject to regulatory action whether or not they exceed the action levels. The FDA set these action levels because it is economically impractical to grow, harvest, or process raw products that are totally free of non-hazardous, naturally occurring, unavoidable defects. That practice renders the final food unlawful regardless of the defect level of the finished food. Likewise, the mixing of blending of food with a defect at or above the current defect action level with another lot of the same or another food is not permitted. Poor manufacturing practices may result in enforcement action without regard to the action level. These "Food Defect Action Levels" listed in this booklet are set on this premise-that they pose no inherent hazard to health. Title 21, Code of Federal Regulations, Part 110.110 allows the Food and Drug Administration (FDA) to establish maximum levels of natural or unavoidable defects in foods for human use that present no health hazard.
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