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Adulterated Food

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Adulterated Food

The prohibition against adulterated food is one of the two major prohibitions embedded in US food law.  This prohibition is defined to encompass a range of concerns.

Prohibition against "adulterated" food appears in several laws; for example, the Food, Drug and Cosmetic Act ( 21 U.S.C. 331 ), the Meat Inspection Act ( 21 U.S.C. 610; 9 CFR 301.2), the Poultry Products Inspection Act ( 21 U.S.C. 458; 9 CFR 381.1) and the Egg Products Inspection Act ( 21 U.S.C. 1037; 9 CFR 590.5). The purpose of this web page is to overview the range of prohibitions and mandates that are in place to achieve the goal of preventing adulterated foods.


Repeats introduction to misbranded food

  • The following acts ... are prohibited: (a) The introduction ... into interstate commerce ... of any food . that is adulterated or misbranded. (b) The adulteration or misbranding of any food ... in interstate commerce... (c) The receipt in interstate commerce of any food ... that is adulterated or misbranded . 21 U.S.C. 331

  • No person ... shall, with respect to any cattle, sheep, swine, goats, horses, mules, or other equines, or ... meat or meat food products of any such animals ... sell ... any such articles ... which ... are adulterated or misbranded . 21 U.S.C. 610

  • No person shall ... sell ... any poultry products which ... are adulterated or misbranded . 21 U.S.C. 458

  • ... No operator of any official plant shall allow any egg products to be moved from such plant if they are adulterated or misbranded ... 21 U.S.C. 1037

Interstate commerce

Note that the statute only applies to food in interstate commerce; accordingly, we need to define interstate commerce.  In general terms, any business transaction that occurs in more than one state is interstate commerce.  A food example would be a commodity produced in one state and then shipped to and consumed by someone in another state.  Similarly, a commodity that is produced and processed in one state and then shipped to and consumed in another state is interstate commerce.  Another example would be a commodity produced and processed in one state but ingredients used in the processing where shipped in from another state; this food product would be considered an item of interstate commerce even before the product is shipped to another state, or even if the product never is shipped to another state, because an ingredient moved from one state to another state.  Likewise, any product that moves in international commerce is within the regulatory jurisdiction of the federal government.  Bottom line -- the combination of the broad definition of interstate commerce and the extensive movement of commodities, food ingredients, and food products leaves very little food outside the definition of interstate commerce.  Consequently, very little food falls outside the jurisdiction of federal law.

See United States v. Carolene Products Co., 304 U.S. 144 (1938) (USSCt)

Adulterated food is defined as (21 U.S.C. 342)

  • Food that contains any poisonous or deleterious (injurious to health; harmful) substance,
    • Exception: "but in case the substance is not an added substance, such food shall not be considered adulterated ... if the quantity of such substance in such food does not ordinarily render it injurious to health." This implies that a minimum amount of naturally occurring deleterious substance will be tolerated as long as the amount is so low it will not cause injury to the consumer.
    • Do we need to distinguish between adulteration resulting from intent to defraud, intent to injury, and negligence?
  • Food that contains a pesticide chemical residue that is unsafe
  • Food that contains any food additive that is unsafe
  • Food that contains a new animal drug that is unsafe
  • Food that consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food
  • Food that has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health
  • Food that is, in whole or in part, the product of a diseased animal or of an animal which has died other than by slaughter
  • Food if its container is composed of any poisonous or deleterious substance which may render the contents injurious to health
  • Food that has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption under the law
  • Food wherein any valuable constituent has been in whole or in part omitted, substituted, damage concealed, or substance added to increase bulk or weight,
  • Food that contains an unsafe color additive,
  • Confectionery containing alcohol or nonnutritive substance,
  • Dietary supplement that presents a significant or unreasonable risk of illness or injury,
  • Dietary supplement prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations,
  • Additives, microbes, and conditions that could lead to contamination; 21 CFR 110.5; must not have conditions that can lead to contamination, and
    • Note that this prohibition does not address only the food product, but the conditions under which the food product is manufactured; thus this prohibition extends the reach of the regulatory agency.
  • Food offered for import that has previously been refused admission, unless the person reoffering the food affirmatively establishes that the food complies with applicable requirements
  • Oleomargarine containing filthy, putrid matter.

Basic strategies to protect against adulterated food

  • assess safety of ingredients and additives
  • assure sanitary processing
  • conduct inspections
    • inspections are ongoing (e.g., meat packing plants by FSIS), periodic (processing plant inspections by FDA), or voluntary (e.g., fish inspections by Department of Commerce)

Last updated February 6, 2010

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