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Consumer Groups Sue FDA over Food Additive Rule

A coalition of consumer, health and food safety groups has sued the Food and Drug Administration over an August 2016 final rule that these groups contend undermines the integrity of the U.S. food safety system by giving manufacturers excessive leeway to determine the safety of chemicals added to food. According to the Center for Food Safety, the FDA rule allows food manufacturers to decide for and by themselves and in secret what can be added to processed foods, in violation of U.S. law and the U.S. Constitution.

The FDA rule under challenge amended and clarified the criteria for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act because the substance is generally recognised as safe under the conditions of its intended use. Specifically, the rule addresses the types of scientific evidence that can be used to demonstrate safety as well as the role of publications in evaluating whether the scientific evidence of safety is generally available and accepted. The FDA hoped the clarified criteria would help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act.

This rule also replaced the voluntary GRAS affirmation petition process with a voluntary notification procedure that was originally established under an interim policy and pilot programme for human food in 1997 and animal food in 2010. Under this procedure any person may notify the FDA of a conclusion that a substance is GRAS under the conditions of its intended use. The FDA believes that this procedure will enable stakeholders to be aware of whether the agency has questioned the basis of a conclusion of GRAS status.

While the FDA indicated last year that the GRAS rule represented its most recent step to strengthen oversight of substances added to human and animal food, the plaintiffs argue in their lawsuit that it “allows potentially unsafe food additives to be used in the food supply (human and animal) without FDA review, approval, oversight, or knowledge” in violation of the FD&C Act, the Administrative Procedure Act and the U.S. Constitution. The plaintiffs further contend that “under the procedures and criteria laid out in the GRAS Rule, manufacturers of substances used in processed food can self-certify – without notice to FDA or the public, and in furtherance of their own financial interests – that a use of a substance is ‘generally recognized as safe,’ or GRAS.” Since the GRAS rule does not require a manufacturer to notify the FDA about any self-certified GRAS determinations or keep records documenting or explaining the basis of GRAS determinations, the plaintiffs argue, such determinations as well as the use of GRAS substances in the food supply remain entirely secret from the FDA and the public.

According to the Center for Food Safety, an independent study by the Pew Charitable Trusts found that almost all new chemicals added to food over the last decade were deemed by manufacturers to be GRAS. The study estimates that approximately 3,000 chemicals that have never been scrutinised by the FDA are currently in use.

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