Adulteration of Food
ADULTERATION OF FOOD
ADULTERATION OF FOOD. "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].
The Federal Meat Inspection Act and the Poultry Products Inspection Act contain similar provisions for meat and poultry products. [21 U.S.C. § 453(g), 601(m).
Poisonous or Deleterious Substances
Generally, if a food contains a poisonous or deleterious substance that may render it injurious to health, it is adulterated. For example, apple cider contaminated with E. coli O157:H7 and Brie cheese contaminated with Listeria monocytogenes are adulterated. There are two exceptions to this general rule. First, if the poisonous substance is inherent or naturally occurring and its quantity in the food does not ordinarily render it injurious to health, the food will not be considered adulterated. Thus, a food that contains a natural toxin at very low levels that would not ordinarily be harmful (for instance, small amounts of amygdalin in apricot kernels) is not adulterated.
Second, if the poisonous or deleterious substance is unavoidable and is within an established tolerance, regulatory limit, or action level, the food will not be deemed to be adulterated. Tolerances and regulatory limits are thresholds above which a food will be considered adulterated. They are binding on FDA, the food industry, and the courts. Action levels are limits at or above which FDA may regard food as adulterated. They are not binding on FDA. FDA has established numerous action levels (for example, one part per million methyl mercury in fish), which are set forth in its booklet Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed.
If a food contains a poisonous substance in excess of a tolerance, regulatory limit, or action level, mixing it with "clean" food to reduce the level of contamination is not allowed. The deliberate mixing of adulterated food with good food renders the finished product adulterated (FDA, Compliance Policy Guide [CPG § 555.200]).
Filth and Foreign Matter
Filth and extraneous material include any objectionable substances in foods, such as foreign matter (for example, glass, metal, plastic, wood, stones, sand, cigarette butts), undesirable parts of the raw plant material (such as stems, pits in pitted olives, pieces of shell in canned oysters), and filth (namely, mold, rot, insect and rodent parts, excreta, decomposition). Under a strict reading of the FD&C Act, any amount of filth in a food would render it adulterated. FDA regulations, however, authorize the agency to issue Defect Action Levels (DALs) for natural, unavoidable defects that at low levels do not pose a human health hazard [21 C.F.R. § 110.110]. These DALs are advisory only; they do not have the force of law and do not bind FDA. DALs are set forth in FDA's Compliance Policy Guides and are compiled in the FDA and Center for Food Safety and Applied Nutrition (CFSAN) Defect Action Level Handbook.
In most cases, DALs are food-specific and defect-specific. For example, the DAL for insect fragments in peanut butter is an average of thirty or more insect fragments per 100 grams (g) [CPG § 570.300]. In the case of hard or sharp foreign objects, the DAL, which is based on the size of the object and the likelihood it will pose a risk of choking or injury, applies to all foods (see CPG § 555.425).
A food is adulterated if it omits a valuable constituent or substitutes another substance, in whole or in part, for a valuable constituent (for instance, olive oil diluted with tea tree oil); conceals damage or inferiority in any manner (such as fresh fruit with food coloring on its surface to conceal defects); or any substance has been added to it or packed with it to increase its bulk or weight, reduce its quality or strength, or make it appear bigger or of greater value than it is (for example, scallops to which water has been added to make them heavier).
Microbiological Contamination and Adulteration
The fact that a food is contaminated with pathogens (harmful microorganisms such as bacteria, viruses, or protozoa) may, or may not, render it adulterated. Generally, for ready-to-eat foods, the presence of pathogens will render the food adulterated. For example, the presence of Salmonella on fresh fruits or vegetables or in ready-to-eat meat or poultry products (such as luncheon meats) will render those products adulterated.
For meat and poultry products, which are regulated by USDA, the rules are more complicated. Ready-to-eat meat and poultry products contaminated with pathogens, such as Salmonella or Listeria monocytogenes, are adulterated. (Note that hotdogs are considered ready-to-eat products.) For raw meat or poultry products, the presence of pathogens will not always render a product adulterated (because raw meat and poultry products are intended to be cooked, and proper cooking should kill pathogens). Raw poultry contaminated with Salmonella is not adulterated. However, USDA's Food Safety and Inspection Service (FSIS) has ruled that raw meat or poultry products contaminated with E. coli O157:H7 are adulterated. This is because normal cooking methods may not reduce E. coli O157:H7 below infectious levels. E. coli O157:H7 is the only pathogen that is considered an adulterant when present in raw meat or poultry products.
Enforcement Actions against Adulterated Food
If a food is adulterated, FDA and FSIS have a broad array of enforcement tools. These include seizing and condemning the product, detaining imported product, enjoining persons from manufacturing or distributing the product, or requesting a recall of the product. Enforcement action is usually preceded by a Warning Letter from FDA to the manufacturer or distributor of the adulterated product. In the case of an adulterated meat or poultry product, FSIS has certain additional powers. FSIS may suspend or withdraw federal inspection of an official establishment. Without federal inspection, an establishment may not produce or process meat or poultry products, and therefore must cease operations. With the exception of infant formula, neither FDA nor FSIS has the authority to require a company to recall an adulterated food product. However, the ability to generate negative publicity gives them considerable powers of persuasion.
State regulators generally have similar enforcement tools at their disposal to prevent the manufacture and distribution of adulterated food. In addition, many states have the authority to immediately embargo adulterated food and to impose civil fines. Federal agencies often will coordinate with state or local authorities to remove unsafe food from the market as quickly as possible.
See also Additives ; Botulism ; Food, Safety ; Genetic Engineering ; Government Agencies, U.S. ; Herbicides ; Inspection ; Microbiology ; Microorganisms ; Pesticides ; Poultry ; Toxins, Unnatural, and Food Safety ; Water: Safety of Water .
Federal Food, Drug, and Cosmetic Act, U.S. Code, vol. 21, section 342.
Federal Meat Inspection Act, U.S. Code, vol. 21, section 453(g).
Poultry Products Inspection Act, U.S. Code, vol. 21, section 601(m).
21 C.F.R. Parts 109–110
Food and Drug Administration, Center for Food Safety and Applied Nutrition. Defect Action Level Handbook. Washington, D.C.: Government Printing Office, 1995. Revised 1997, 1998. Available at http://www.cfsan.fda.gov/dms/dalbook.html.
Food and Drug Administration, Office of Regulatory Affairs. Compliance Policy Guides Manual. Washington, D.C.: Government Printing Office, 2000; updated 2001. Available at http://www.fda.gov/ora/compliance_ref/cpg/default.htm.
Food and Drug Administration. Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed. Washington, D.C.: Government Printing Office, 2000. Available at http://www.cfsan.fda.gov/lrd/fdaact.html.
Richard L. FrankRobert A. Hahn
Mixing something impure with something genuine, or an inferior article with a superior one of the same kind.
Adulteration usually refers to mixing other matter of an inferior and sometimes harmful quality with food or drink intended to be sold. As a result of adulteration, food or drink becomes impure and unfit for human consumption. The federal food and drug administration prohibits transportation of adulterated foods, drugs, and cosmetics in interstate commerce, as provided under the Food, Drug and Cosmetic Act (21 U.S.C.A. § 301 et seq. ). State and local agencies, acting under the authority of local laws, do the same to ban the use of such impure goods within their borders.