Added Substances

The FDCA does not define added. Because the burden the FDA must carry is higher under the may-render-injurious standard, obviously the agency often prefers to use the ordinarily-injurious-to-health standard associated with "added" substances. FDA regulations define added broadly. A substance is added if it is not an inherent constituent of the food; is the result of environmental, agricultural, industrial, or other contamination; or if the natural amount of the inherent substance has been increased to abnormal levels by mishandling or other intervening acts. See 21 C.F.R. 109.3. Must the presence of a substance be attributable in whole or in part to an act of man? The following cases offer conflicting approaches to this question.