Q: What are FDA requirements for Food Additives?


A: "Food additives" are substances which may by their intended uses become components of food, either directly or indirectly, or which may otherwise affect the characteristics of the food. The term specifically includes any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding the food, and any source of radiation intended for any such use (Sec. 201(s)).

But the law excludes from the definition of a "food additive":

  1. Substances generally recognized as safe by qualified experts.

  2. Substances used in accordance with a previous approval ("prior sanction") under either the Federal Food, Drug, and Cosmetic Act, the Poultry Products Inspection Act (21 U.S.C. 451) or the Federal Meat Inspection Act (21 U.S.C. 601).

  3. Pesticide chemicals in or on raw agricultural products.

  4. Color additives.

  5. New animal drugs.

    But note that pesticide chemicals, color additives, and new animal drugs are subject to similar safety requirements of other sections of the law).

Manufacturers or importers not certain whether the chemicals or other ingredients used in their foods are subject to the safety clearance requirements of the Federal Food Drug Cosmetic Act (FFDCA) may seek an opinion from the Food and Drug Administration. If premarket approval is required, this may mean that studies, including animal feeding tests, will have to be carried out in accordance with recognized scientific procedures, and the results submitted to the Food and Drug Administration for evaluation. General principles for evaluating the safety of food additives are published in 21 CFR 170.20. General instructions for preparing a food additive petition are in 21 CFR 171. The "Delaney Clause" in the law (Sec. 409(c)(3)) provides that no food additive may be found safe if it produces cancer when ingested by humans or animals, or if it is shown by other appropriate tests to induce cancer, except that such ingredient may be used in animal feeds if it causes no harm to the animal and provided there are no residues of the ingredient in the meat or other edible products reaching the consumer. This latter provision is primarily applicable to veterinary drugs added to animal feed.

If the Food and Drug Administration concludes from the evidence submitted to it that the additive will be safe, a regulation permitting its use will be issued. This regulation may specify the amount of the substance which may be present in or on the foods, the foods in which it is permitted, the manner of use, and any special labeling required.

A substance approved as a food additive is still subject to all the general requirements of the Federal Food, Drug, and Cosmetic Act.

The Saccharin Study and Labeling Act passed November 23, 1977, prohibited for 18 months any new regulations restricting or banning the sale of saccharin or products containing it. Congress has extended the legislation several times, most recently to May 1, 1997. It requires further scientific evaluation of the carcinogenic potential of saccharin, and a label warning: "Use of this product may be hazardous to your health. This product contains saccharin which has been determined to cause cancer in laboratory animals."

Artificially sweetened products are required to be labeled as Special Dietary Foods (21 CFR 105.66). The foods permitted to contain such sweeteners, and the amounts, are specified in the Food Additive Regulations.

Sulfiting agents are permitted for use in food under 21 CFR 182.3616, 182.3637, 182.3739, 182.3766, 182.3798, and 182.3862. Their use is prohibited on fruits and vegetables intended to be served or sold raw to consumers, or to be presented as fresh; in meats; and on foods that are a significant source of vitamin B1. When a sulfiting agent is present in a detectable amount (10 parts per million) in a finished food, regardless of whether it has been directly added or indirectly added, it must be declared on the label of the food. If the sulfiting agent is added directly to the food and has a technical or functional effect in the finished food, it must be declared on the label irrespective of the amount present in the finished food.

-Access the Code of Federal Regulations for the provisions mentioned above.
-For additional information see Information Materials for the Food and Cosmetics Industries.

 

Source: Excerpted from Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration (1997).
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