Food Law

Accessibility


| Share

Adulterated and Misbranded

This page introduces the board prohibitions against adulterated and misbranded foods. These prohibitions are the foundation for food safety law -- not only in the United States but also for many nations in our global society.

.

The prohibitions against "adulterated" and "misbranded" food appear in several U.S. federal 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 or misbranded foods.

.

For example

  • 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 these U.S. federal statutes only apply 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.  An example of food in interstate commerce 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.  A third example would be a commodity produced and processed in one state but ingredients used in the processing were 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 is never 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 U.S. 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 in the United States falls outside the jurisdiction of U.S. federal law.

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

 

  • Food that is NOT in interstate commerce are those items that never leave (i.e., they are consumed in) the state in which they are produced.  These locally-produced and consumed foods will NOT be considered as having entered interstate commerce and thus will not be subject to federal law. These foods will be subject to state law, and as we will study, state food laws can be as demanding as federal food laws.
  • Food that is "in interstate commerce" and thus subject to federal regulation are also subject to state oversight.  Why?  Because states generally regulate ALL foods within the state, even though the food also is regulated by federal law as part of interstate commerce.  As we continue our study, we will want to think about 1) how food businesses comply with both state and federal food laws, and 2) how federal agencies and state agencies coordinate or collaborate in overseeing food.

Adulterated Food

As stated above, federal law (as well as state laws) prohibit adulterated foods.  So what is the definition of adulterated food?

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; the regulations then specify what additives and packaging can safely be used in food (food additives are discussed in detail on another page)
  • 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
    • USDA agricultural commodity standards and grades were not necessarily established to define whether the commodity could be used in food production; accordingly, there is little relationship between USDA ag commodity standards and grades used by the ag production sector and the concept of adulterated food in the processing sector.
  • 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
    • Note, the food does not have to be unsafe in order for it to be adulterated; even food that is safe to consume will be considered adulterated if it passed through an area that is insanitary and that could have contaminated the food.
  • 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; the regulations then specify what color additives can safely be used in food
  • 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.

.

Other Observations about Adulterated Food

  • The prohibitions against adulterated and misbranded foods under U.S. federal law primarily apply to the processing sector of the food industry.
  • State law also generally prohibits adulterated and misbranded foods; these laws usually apply to the processing sector and the retail/food service sector.
  • Food processors are required to establish that their food product meets legal requirements/standards; that is, establish that the food is not adulterated or misbranded.  It is not the government's responsibility to establish that food is adulterated or misbranded; food is assumed to be adulterated or misbranded (and thus illegal to sale) unless the food business can establish that the food meets the applicable legal requirements.
    • The idea that food is presumed to NOT meet standards until it is proven to meet standards is different than the general notion of U.S. criminal law that "an individual is considered innocent until proven guilty."  Certainly the risk of not allowing safe food to be sold is less critical that the risk of punishing an innocent person, but it is interesting to note this "reversal" in thinking between food regulatory laws and criminal laws, such as robbery.
  • Congress continues to expand the definition of adulterated and misbranded by adding subsections to the federal statutory law.
    • For example, 21 U.S.C. 343(a) (which addresses false or misleading labels) was first enacted by Congress in 1938 whereas 21 U.S.C. 343(w) (which deals with labeling of major food allergens) was added to the definition of misbranded foods in 2004.
    • Likewise, the list of Prohibited acts was extended in 2002 when subsection 21 U.S.C. 331(dd) was added; this subsection prohibits a food business from selling food if the business has not registered its facilities with the FDA.
  • Adding a substance to a food product during processing is assumed to cause food to be adulterated, for example, unless there is a regulation allowing the particular food processing practice.  Food businesses can seek a federal regulation to allow a new food ingredient by petitioning the regulating agency (either the FDA or USDA, depending on the food product being processed).
    • See 9 CFR Part 172 for a list of regulations permitting specified substances to be added to food.
    • See 9 CFR Part 171 for the regulation that allows food businesses to petition FDA to promulgate a regulation to allow another substance to be added to food.

 

Basic strategies to protect against adulterated food

  • assess safety of ingredients and additives
  • determine that the ingredients and additives can be used in the food according to federal regulations
  • assure sanitary processing, packaging, storage, transportation, and handling  
  • 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)
  • devise and implement a food safety/HACCP plan

 

Misbranded Food

Misbranded food also is prohibited by federal (and many state) law.

A food item is considered misbranded (21 U.S.C. §343):

  • If its container is made, formed, or filled to be misleading (also see 21 CFR 100.100)
  • If its labeling is false or misleading
  • If the package label does not include the name and place of business of the manufacturer, packer, or distributor; and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count
  • If it is intended for human consumption and offered for sale, unless its label bears nutrition information that provides the serving size; the number of servings per container; the total number of calories derived from any source, and derived from the total fat, in each serving size; the amount of total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein contained in each serving size; and any vitamin, mineral, or other nutrient required to be placed on the label if the Secretary determines that such information will assist consumers in maintaining healthy dietary practices
  • If any word, statement, or other information required by law to appear on the label is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use
  • If it is offered for sale under the name of another food
  • If it is an imitation of another food, unless its label bears the word "imitation"
  • If it purports to be a food for which a standard of identity has been prescribed, unless it conforms to such standard, and its label bears the name of the food specified in the standard, and the common names of optional ingredients
  • Unless its label bears the common or usual name of the food, and if fabricated from two or more ingredients, the common or usual name of each such ingredient and if the food purports to be a beverage containing vegetable or fruit juice, a statement with appropriate prominence of the total percentage of such fruit or vegetable juice contained in the food
  • If it purports to be a food for which a standard of quality has been prescribed and its quality falls below such standard, unless its label bears a statement that it falls below such standard
  • If it contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact
    • This requirement does not apply to a pesticide chemical when used in or on a raw agricultural commodity which is the produce of the soil
  • If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements
  • If it is a raw agricultural commodity which is the produce of the soil, bearing or containing a pesticide chemical applied after harvest, unless the shipping container of such commodity bears labeling which declares the presence of such chemical and the common name and function of such chemical
    • Except no such declaration shall be required while the commodity is being displayed for sale at retail
  • Unless provided a legal exception, if it is a food intended for human consumption which is offered for sale and for which a nutrition and health-related claim is made
  • In the case of vitamins and minerals, its advertising is false or misleading
  • If it is a dietary supplement; and the label fails to list the name and quantity of each ingredient; or with respect to a proprietary blend of ingredients, the total quantity of all ingredients in the blend; or the label fails to identify the product by using the term "dietary supplement;" or the label fails to identify any part of the plant from which the ingredient is derived; or
  • If it purports to be for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties in order fully to inform purchasers as to its value for such uses
  • If its packaging or labeling is in violation of an applicable package standards (15 U.S.C. §§1472 and 1473 - child-proofing and exception for elderly)

 

Basic strategies to protect against misbranded foods

  • Mandate and monitor labeling; assure the labeling complies with labeling regulations
  • Monitor advertising and promotional claims; assure the claims align with regulations pertaining to making claims about the food product
  • Assure labels are not damaged or removed
  • Assure information on labels and other consumer communications are not misleading

 

Other laws that prohibit adulterated and misbranded food

Adulterated and misbranded are the two major prohibitions in food law.  This section briefly points to two state laws and two national/international examples of laws or principles that prohibit adulterated and misbranded foods.

  • North Dakota:  N.D.C.C. §19-02.1-02
    • "The following acts and the causing thereof within the state of North Dakota are hereby prohibited: 1. The manufacture, sale, or delivery, holding or offering for sale of any food, drug, device, or cosmetic that is adulterated or misbranded.
    • Also see N.D.C.C. 19-02.1-09 (adulteration defined) and N.D.C.C.19-02.1-10 (misbranding defined)

 

  • South Dakota:
    • SDCL 39-4-2.   Conditions constituting adulteration of food. For the purposes of this title food shall be deemed to be adulterated:
      • (1) If any substance has been mixed and packed with it so as to reduce, lower, or injuriously affect its quality or strength;
      • (2) If any substance has been substituted wholly or in part for it;
      • (3) If any valuable constituent thereof has been wholly or in part abstracted;
      • (4) If it be mixed, colored, powdered, coated, or stained in a manner whereby damage or inferiority is concealed;
      • (5) If it contain any poisonous or otherwise deleterious ingredient, added or natural, which may render it injurious to health: provided that when in the preparation of food products for shipment they are preserved by an external application applied in such manner that the preservative is necessarily removed mechanically, or by maceration in water, or otherwise before eating, and directions for the removal of such preservative shall be plainly and conspicuously printed on the label of the package, the provisions of this chapter shall be construed as applying only when such products are ready for consumption;
      • (6) If it consists in whole or in part of a filthy, decomposed, or putrid animal or vegetable substance, or of any portion of any animal unfit for food, whether manufactured or not; or if it is the product of a portion of a diseased animal or of an animal which has been fed upon the uncooked offal from a slaughterhouse or other substance unfit for animal food, or of one that has died otherwise than by slaughter; or
      • (7) If in the manufacture, sale, distribution, transportation, or in the offering or exposing for sale, distribution, or transportation, it is not at all times securely protected from all filth, flies, dust, contamination, or other unclean, unhealthful, or insanitary conditions.
    • SDAC 44:02:07:01.  Definitions. Words defined in SDCL 34-18-1 have the same meaning when used in this chapter. In addition, the terms used in this chapter mean:
      • (1)"Adulterated," one or more of the following conditions of food:
        • (a)  Bears or contains a poisonous or deleterious substance in a quantity which may render it injurious to health;
        • (b)  Bears or contains a poisonous or deleterious substance for which no safe tolerance has been established by law or is in excess of such a tolerance if one has been established;
        • (c)  Consists in whole or in part of any filthy, putrid, or decomposed substance or otherwise is unfit for human consumption;
        • (d)  Has been processed, prepared, packed, or held under unsanitary conditions, by which it may have become contaminated with filth or rendered injurious to health;
        • (e)  Is in whole or in part the product of a diseased animal or an animal which has died otherwise than by slaughter; or
        • (f)  Is contained in a container which is composed in whole or in part of any poisonous or deleterious substance which may render the contents injurious to health:

 

  • Canada:  Food and Drugs Act (R.S., 1985, c. F-27)
    • 4. No person shall sell an article of food that
      • (a) has in or on it any poisonous or harmful substance;
      • (b) is unfit for human consumption;
      • (c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance;
      • (d) is adulterated; or
      • (e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions.
    • 5.(1) No person shall label, package, treat, process, sell or advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.

     

  • European Union
REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 28 January2002 laying down the general principles and requirements of food law, establishing the European Food
Safety Authority and laying down procedures in matters of food safety at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:031:0001:0024:EN:PDF
See Article 14 Food Safety Requirements (p. 10) and Article 16 Presentation (p. 11)

 

Additional Prohibitions

Despite the history that most food law is based on the prohibitions against adulterated and misbranded foods, U.S. federal legislation defines additional prohibitions.  For example, food firms are in violation of the law and engaged in prohibited activities (and thus are subject to penalties/fines or the food may be seized) if the firm 1) is not registered with the FDA (21 U.S.C. 331(dd)), 2) refuses to allow an inspection of the facility or records (21 U.S.C. 331(f), or 3) fails to report a problem (21 U.S.C. 331(mm)).

 

Summary

Businesses are prohibited from selling food if the food is adulterated, or misbranded, or the firm has otherwise committed a "prohibited" act.  A significant focus throughout the study of food law is on understanding 1) the broad definitions of adulterated and misbranded and 2) legally-mandated business practices to reduce the risk that food is adulterated or misbranded.

  • U.S. federal food law applies only to food that is in "interstate commerce."
  • Food that has been modified or altered is considered adulterated unless there is a regulation allowing the modification, alteration, or addition.
  • A food business can petition the FDA to issue a regulation that would allow for a specific modification that the business wants to use in its food processing, but the petition needs to be supported with evidence that the requested process does not render the food unsafe.

 

 

Email David.Saxowsky@ndsu.edu

This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

This material is protected by U.S. copyright laws.

Creative Commons License
Feel free to use and share this content, but please do so under the conditions of our Creative Commons license and our Rules for Use. Thanks.