Understanding Food Adulteration

An important function of food laws is to prevent the production and distribution of adulterated food. In general, adulterated foods are foods that are contaminated or most likely to be contaminated with hazards that will render the food unfit for consumption. There are three types of adulteration. These include economic, aesthetic, and intentional. Economic adulteration occurs when inferior ingredients are added to food, yet the product is marketed as superior. This may or may not result in physical harm. Aesthetic adulteration is contamination resulting from filth, putrid or decomposed substance. In this situation, contaminants are added indirectly to the food, usually as a result of poor sanitary practices. Intentional adulteration, as the name suggests, is the deliberate contamination of food with the intent to cause injury. Food companies are now required under the Food Safety Modernization Act (FSMA) to put practices in place that will prevent the intentional adulteration of food.

Definition of Adulteration

The statutory definition of adulteration can be found in 21 CFR 342. A product is adulterated if it meets any of the following criteria:

1. It contains an unsafe “added substance” that can render the food “injurious to health”. “Added” means that the injurious substance was included in whole or in part as a result of the action of man. Examples would be the addition of food additives, hormones, and animal drugs. However, a natural toxin in food could also be an added substance if it is increased to unsafe levels due to actions attributable to man such as improper ripening and storage, and plant breeding.
2. It contains a “non-added substance” in amounts that would render the food injurious to heath. Non-added substances are substances found inherently in the food material that do not “ordinarily” (under normal circumstances) render the food injurious to health. They are inherent in the food either because they are a natural part of the food or is introduced inevitably from its natural environment. Examples of these substances include aflatoxin, paralytic shellfish toxin, certain pesticides, and mercury.
3. It contains any poisonous or deleterious substance
4. It contains an unsafe, excessive, or unapproved food, color additive or new animal drug
5. It contains a food or color additive found to cause cancer
6. It contains pesticide residues exceeding tolerances
7. It contains a filthy or decomposed substance
8. It was made under unsanitary conditions where it “may have been contaminated”
9. It is in whole or in part the product of a diseased animal or animal killed other than by slaughter
10. Its container is composed in whole or in part of a poisonous or deleterious substance
11. It is exposed to unsafe levels of radiation
12. A valuable component has been removed in whole or in part
13. Any substance has been substituted for a valuable component
14. A substance was added to increase its bulk or weight
15. A substance was added to reduce its quality or strength
16. Damage or inferiority of the product has been concealed
17. The product was affected in some way to make it appear better than it really is
18. It is otherwise unsafe for food

Tolerances for Added Substances

Tolerances are established by the FDA through the rule making process to regulate “added substances”. Criteria for establishing tolerances are:

1. The added substance cannot be avoided by just following good manufacturing practices (GMPs)
2. The set tolerance level must be adequate to protect the safety of the public
3. No new technological improvement is anticipated in the near future that will question the appropriateness of the standard

A substance may be considered to be added in one form of the food, but yet not added in another form. For example, E.coli and Salmonella in ready-to-eat meats are added substances since they are not inherent in the product but is added during handling. However the same bacteria are not “added substances” in raw meat since they are an inherent characteristic of the product and will be cooked to prevent injury to health.

Unlike tolerances which deals with added substances, “action levels” are established to provide guidance on acceptable levels of non-added substances that could exceed safe levels. Note that I said guidance. Therefore, action levels are not created by the rule making process but established as guide in FDA policy statements as warning to the food industry.

Reference: Sanchez, M. C. (2015). Food law and regulation for non-lawyers – A US perspective. New York, NY: Springer International.