Court Suggests Critics Ask Congress To Change FDA's GRAS Rule – Same For NDI Notifications?

Federal judge suggests consumer health and environmental advocacy groups made strong arguments about potential for unsafe ingredients in foods available in the US through the self-GRAS process, but FDA adopted and exercises the rule entirely in line with congressional intent of the authorizing legislation.

• Source: Alamy

Critics of the US Food and Drug Administration’s policy for reviewing new dietary ingredient notifications could look for direction in a recent federal court ruling upholding the agency’s rule allowing self-determinations for food ingredients as generally regarded as safe.

In the US District Court for Southern New York, Judge Vernon Broderick stated in a recent opinion and order that the non-profit consumer and public health advocacy groups challenging the rule in a

However, the agency wrote and adopted the rule and exercises its authorities under it entirely in line with congressional intent of the authorizing legislation provided in the Food Additives Amendment passed in 1958, Broderick explained in his order published on 30 September granting the FDA’s

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