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Purpose of Food Law (sec 2)
Before studying this section, at a minimum review module 1C of SAFE 401/601 (overview of US food system) and all of SAFE 402/602 (foodborne hazards).
Society has imposed rules on businesses that produce, process, transport, store, market, and prepare food products to minimize the adverse consequence of unsafe foods. The purpose of the laws is to
- Cause food businesses to do what they can to assure their product is safe.
- Prohibit food businesses from taking actions that will render their product unsafe.
- Assure consumers have the information needed to make their decisions.
- Prohibit businesses from providing misleading information to consumer.
- Assure that consumers have an opportunity to learn about nutrition, food preparation techniques, and how to understand and use information about food products
Food law will NOT guarantee safe food; the best that can be accomplished with safe food practices is to REDUCE the risk of unsafe food.
More specifically, U.S. law pursues these objectives by prohibiting “adulterated” and “misbranded” foods.
The following excerpt from Rose Acre Farms, Inc., v. Madigan, (U.S. Court of Appeals for the Seventh Circuit, Nos. 91-2358 and 91-2514. February 10, 1992) illustrates the role of food law. It is not just to protect animals, for example; it is to protect consumers.
"Rose Acre [an egg producer] observes that salmonella is not dangerous to the animals; it is contagious among animals but does not injure them. According to Rose Acre, only diseases dangerous to animals fall within the jurisdiction of the Secretary of Agriculture. When the disease is dangerous exclusively to humans, Rose Acre insists, the Food and Drug Administration is the appropriate regulator. The Secretary of Agriculture has neither statutory mandate nor expertise in dealing with human diseases, it submits...
"The district judge rejected Rose Acre's contention, and properly so... Control of illness among farm animals is for the welfare of humans: to protect our health from diseases animals carry, and to protect our wallets from the costs of sacrificing additional animals should the infection spread. Salmonella spreads from animals to people; it spreads among animals, potentially increasing the financial cost to farmers; and fear of salmonella depresses the demand for dairy and poultry products, again injuring agriculture. Nothing in the text of secs. 111, 114, 114a, or 120 confines the Secretary to addressing diseases fatal to animals."
Based on this court decision, USDA proceeded to enforce its regulations against Rose Acre Farms, Inc.
The preceding excerpt illustrates one purpose of food law, but there are other reasons why food laws have been enacted.
- Protect the public health from the adverse consequences of unsafe foods.
- Convey information to consumers, such as package labeling requirements (labeling strives to provide consumers with information so the consumers can make an informed decision) and education programs.
- Protect against fraud to assure buyers receive what the buyers believe is being purchased; e.g., assure that the package contains what the label states.
- Assure fair trade practices to prevent sellers from misrepresenting what they are selling and from misleading consumers about the quality of the product.
- Protect the environment -- recognizing that food production systems impact air and water qualities.
- Protect consumers from malicious or intentional attacks on the food system.
You are urged to read A Description Of The U.S. Food Safety System -- a web site prepared by Food Safety and Inspection Service (FSIS) of the USDA. This description provides a general overview of the U.S. food safety system. Also consider the following excerpt from a USDA web page.
"During the early part of the first century in America, people lived off the land. They grew their own foods or bought them from someone they knew and trusted. There was no need for food safety laws. As the country grew and became more industrialized, the number of people who produced their own foods decreased drastically. Therefore, the nation depended on the newly emerging food industry to produce and distribute its food. Unfortunately, during the 1850's, there was much dishonesty concerning adding substances to foods.
"The first efforts to pass laws to govern foods were state laws (1850 and beyond). These laws were difficult to enforce. The first major Federal law governing food was the 1906 Federal Food and Drug Act. It set the framework for the regulation of foods and stated that it was illegal to sell misbranded or adulterated foods and drugs in interstate commerce. It listed chemicals that were illegal to add to foods, such as borax or formaldehyde. The law was weak in that there was no method of enforcement and no punishment."
Taken from Additives in Meat and Poultry Products
Adulterated and Misbranded Food
As stated previously, the two major prohibitions in U.S. law pertain to adulterated foods and misbranded foods. Both of these concepts have been given broad definitions and therefore encompass a variety of activities.
Overview of Legal Definition of Adulterated Food
U.S. federal law prohibits adulterated food which is defined in 21 U.S.C. §342 (a federal statutory law) to include
- Food that contains any poisonous or deleterious substance
- 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
- A confectionery food containing alcohol or nonnutritive substance
- Oleomargarine containing filthy, putrid matter
- 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;
An easy to understand example of an adualterated food is one that was contaminated or render unsafe during the manufacturing process. Accordingly, FDA has promulgated regulations setting forth good manufacturing practices (GMP) for food processing businesses to follow, see 21 CFR part 110.
Overview of Legal Definition of Misbranded Food
U.S. Federal law prohibits misbranded food is prohibited which is defined in 21 U.S.C. §343 (a federal statutory law) as including
- Food if its container is made, formed, or filled to be misleading (see 21 CFR §100.100)
- Food if its label does not bear required information, such as
- the name and place of business of the manufacturer, packer, or distributor;
- an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count,
- the common or usual name of the food,
- if the food product is fabricated from two or more ingredients, the common or usual name of each such ingredient
- 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
- nutrition information that provides the serving size; the number of servings per container; the total number of calories and number of calories derived from 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
- the presence of any artificial flavoring, artificial coloring, or chemical preservative (except this requirement shall not apply to a pesticide chemical when used on a raw agricultural commodity).
- See 21 CFR part 101.
- Food that does not conform to its standard of identity (see 21 CFR part 130).
- Food that falls below its standard of quality, unless its label bears a statement that it falls below such standard.
- Food for special dietary uses, unless its label provides information concerning its vitamin, mineral, and other dietary properties to fully inform purchasers as to its value for such uses.
- A raw agricultural commodity containing a pesticide chemical applied after harvest, unless the shipping container of such commodity bears labeling which declares the presence of such chemical (except no such declaration shall be required while the commodity is being displayed for sale at retail).
- Food with a color additive unless its properly packaged and labeled.
- Food whose packaging or labeling violates an applicable package standards (15 U.S.C. §§1472 and 1473).
- food intended for human consumption which is offered for sale and for which a nutrition and health-related claim is made.
- a dietary supplement whose 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.
The general purposes of U.S. food law are to minimize the risk of unsafe food (it is too costly to assure that food is safe) and that consumers have the information needed to make an informed decision. The next section introduces some of the U.S. federal, state, and international agencies and organizations involved in regulating or directing the food industry.
The next section overviews
Relevant Agencies and Organizations.
November 15, 2010