Authority of Food and Drug Administration To Promulgate Regulations Allowing Food Manufacturers To Use Safe and Suitable Optional Ingredients

B-164031(2).154: Apr 28, 1978

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GAO examined the authority of the Food and Drug Administration (FDA) to promulgate regulations allowing food manufacturers to use safe and suitable optional ingredients instead of using the so-called recipe approach in the preparation of food products. Under the new regulations, manufacturers can use ingredients that perform an appropriate function in the foods in which they are used and at a level no higher than necessary to achieve the intended purpose in the food. The legislative history of the Food, Drug and Cosmetic Act does not support the argument that FDA is constrained to use only the recipe approach when it promulgates standards of identity for food products. GAO concluded that the Commissioner of Food and Drugs has been given broad power to promulgate regulations concerning food products whenever doing so could be reasonably expected to promote honesty and fair dealing in the interest of consumers. GAO believed that the Commissioner's decision to adopt another method for developing standards for identity, known as the safe and suitable approach, is a reasonable exercise of that authority. Whether the promulgation of standards of identity allowing for the use of the safe and suitable ingredients will promote honesty and fair dealing in the interests of consumers was a question that GAO was not in a position to resolve.