"Food additive" is defined by the Food and Drug Administration (FDA) as any substance that — directly or indirectly — becomes a component or otherwise affects the characteristics of any food. This definition includes any substance used in the production, processing, treatment, packaging, transportation or storage of food.

Additives are used to maintain or improve safety, freshness, nutritional value taste, texture and appearance. The use of food additives has become more prominent in recent years due to the increased production of prepared, processed, and convenience foods. 

According to the FDA, “Direct food additives are those that are added to a food for a specific purpose in that food.” For example, using phosphates in meat and poultry products to retain moisture and protect the flavor.

“Indirect food additives are those that become part of the food in trace amounts due to its packaging, storage or other handling,” according to the FDA. For instance, minute amounts of packaging substances may find their way into foods during storage. Food packaging manufacturers must prove to the FDA that all materials coming in contact with food are safe before they are permitted for use in such a manner.

FDA defines a color additive as any dye, pigment, or substance which—when added or applied to a food, drug, or cosmetic, or to the human body — is capable (alone or through reactions with other substances) of imparting color. FDA is responsible for regulating all color additives to ensure that foods containing color additives are safe to eat, contain only approved ingredients, and are accurately labeled.

Color additives are used in foods for many reasons: 1) to offset color loss due to exposure to light, air, temperature extremes, moisture, and storage conditions; 2) to correct natural variations in color; 3) to enhance colors that occur naturally; and 4) to provide color to colorless and "fun" foods. Without color additives, colas wouldn't be brown, margarine wouldn't be yellow, and mint ice cream wouldn't be green. Color additives are now recognized as an important part of practically all processed foods we eat.

Today, food and color additives are more strictly studied, regulated, and monitored than at any other time in history. FDA has the primary legal responsibility for determining their safe use. To market a new food or color additive (or before using an additive already approved for one use in another manner not yet approved), a manufacturer or other sponsor must first petition FDA for its approval. These petitions must provide evidence that the substance is safe for the ways in which it will be used. As a result of recent legislation, since 1999, indirect additives have been approved via a premarket notification process requiring the same data as was previously required by petition.

Before any substance can be added to food, its safety must be assessed in a stringent approval process. The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) shares responsibility with FDA for the safety of food additives used in meat, poultry, and egg products. All additives are initially evaluated for safety by FDA.

When an additive is proposed for use in a meat, poultry, or egg product, its safety, technical function, and conditions of use must also be evaluated by the Risk, Innovations and Management Staff of FSIS, as provided in the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Egg Products Inspection Act, and related regulations. 

Although FDA has overriding authority regarding additive safety, FSIS may apply even stricter standards that take into account the unique characteristics of meat, poultry, and egg products. Several years ago, for instance, permission was sought to use sorbic acid in meat salads. Although sorbic acid was an approved food additive, permission for use in meat salad was denied because such usage could mask spoilage caused by organisms that cause foodborne illness.

Additives are never given permanent approval. FDA and FSIS continually review the safety of approved additives, based on the best scientific knowledge, to determine if approvals should be modified or withdrawn.

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.

In 1938, the Federal Food and Drug Act was revised to account for changes in medical science and food technology, and was renamed the Federal Food, Drug, and Cosmetic Act. Among the many provisions of the law was a requirement for truthful labeling of additives.

The 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act provided for the first specific regulations of food additives. Approval of new food additives was required before they could be marketed, and the responsibility for proving their safety was placed on the manufacturer.

To use or market a substance to be used as a food additive, a company must first file a petition with the FDA outlining the tests that prove the substance to be safe under the proposed conditions of use. If it is approved as safe under the proposed conditions of use, FDA prescribes in its regulations, the types of foods it may be used in, and how it may be used.

The Food Additives Amendment exempted two groups of food additives from FDA's testing and approval process. One is the list of substances known as "generally recognized as safe" (GRAS). This group includes a variety of substances, from commonly used flavorings and spices to phosphates and carrageenan. These substances are considered harmless under prescribed conditions of use. Past extensive use of these substances has produced no known harmful effects. 

The other group of additives known as "substances with prior sanction" was approved by USDA and FDA for use in foods prior to the passage of the 1958 Food Additives Amendment. Examples of these types of substances include potassium nitrite and sodium nitrite. Additives can be removed from the lists if tests indicate the substances are not safe for human consumption.

The 1960 Color Additives Amendment brought all colors, natural and synthetic, under the Food, Drug, and Cosmetic Act. Color additives may not be used to deceive consumers or to conceal blemishes or inferiorities in food products. Colors used in foods, drugs, and cosmetics must be approved by the FDA before they can be marketed.

The Food Additives Amendment and the Color Additives Amendments include the Delaney Clause, which prohibits the approval of an additive "if it is found to induce cancer when ingested by" people or animals, or "if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in" people or animals. Any substance found to cause cancer is regulated under the general safety provisions of these laws, as well as by the Delaney Clause.

The statutes and regulations to enforce the statutes require certain information on labels of meat and poultry products so consumers will have complete information about a product. In all cases, ingredients must be listed on the product label in the ingredients statement in order by weight, from the greatest amount to the least.

Substances such as spices and spice extractives may be declared as "natural flavors," "flavors," or "natural flavoring" on meat and poultry labels without naming each one. This is because they are used primarily for their flavor contribution and not their nutritional contribution. See Natural Flavorings on Meat and Poultry Labels.

Substances such as dried meat, poultry stock, meat extracts, or hydrolyzed protein must be listed on the label by their common or usual name because their primary purpose is not flavor. They may be used as flavor enhancers, binders, or emulsifiers. They must be labeled using the species of origin of the additive, for example, dried beef, chicken stock, pork extract, or hydrolyzed wheat protein.

Color additives must be declared by their common or usual names on labels (for example, FD&C Yellow 5 or annatto extract), not collectively as colorings. These labeling requirements help consumers make choices about the foods they eat.