FDA Premarket Approval:

Process of Approving Olestra as a Food Additive

HRD-92-86: Published: Apr 7, 1992. Publicly Released: Apr 7, 1992.

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Pursuant to a congressional request, GAO reviewed a company's efforts to obtain approval to market a noncaloric fat substitute.

GAO found that factors contributing to the extended period of time it is taking the Food and Drug Administration (FDA) to approve the product include: (1) the lack of a clear approval process for macroingredient food additives; (2) the broad range of the product's original intended uses; (3) the time spent developing testing protocols and conducting tests; and (4) a FDA requirement to conduct a study of the product's effects on pigs. GAO also found that: (1) 21 years have elapsed since the company obtained its first patent for the product; (2) although the company's competitors believed that its decision to concentrate all of its resources on getting the product approved as a drug cost it valuable time, the company believed that FDA would more readily approve the product as a drug than as a food additive; (3) FDA stated that, had the company focused earlier on the product's use as a food additive, it could have had more quickly resolved current safety questions; and (4) although in 1987, the company submitted a food additive petition citing the product's intended uses, the petition created major challenges for FDA, since the company's test results and other data applied to various formulations and potentially broad uses for the product.

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