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Food Safety Assessment

FDA’s Food Ingredient Approval Process: Safety Assurance Based on Scientific Assessment

Before a low-calorie sweetener is approved for commercial use, it must undergo extensive testing (which can cost millions of dollars) and years of regulatory scrutiny. U.S. food safety laws prohibit the Food and Drug Administration (FDA) from approving a low-calorie sweetener (or any food ingredient) that has not been shown to be “safe,” which the agency defines as “a reasonable certainty in the minds of competent scientists that the substance is not harmful…” The burden of demonstrating safety is on the petitioner requesting approval. The petitioner is required to provide FDA with extensive data and comprehensive reports of research concerning safety. In addition to scientific evidence, FDA also considers projected consumption levels, as well as specific use levels requested in the petition.

A recent article, “FDA’s food ingredient approval process: Safety assurance based on scientific assessment,” provides an in depth review of the FDA’s food additive approval and Generally Recognized as Safe (GRAS) processes and is an excellent resource for those who would like to learn more about the FDA’s process of approving a new food additive.

FDA’s Food Ingredient Approval Process

faq2Do you have questions about low-calorie sweeteners? Want to learn more about maintaining a healthy lifestyle? You asked and we listened. Our resident Registered Dietitians answered the most popular questions about low-calorie sweeteners.

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