A federal district court has ruled that a lawsuit will move forward that challenges a key US Food and Drug Administration’s (FDA) food contact materials regulation.
The suit, brought last year by several NGOs, focuses on the FDA’s Generally Recognized as Safe (Gras) rule.
Updated in 2016, the Gras rule allows manufacturers to use a food additive without pre-market approval, provided it meets the same safety standards as approved substances. Notification to the FDA of a manufacturer’s determination that a substance is Gras is voluntary.
Co-litigant the Environmental Defense Fund alleges that the rule "allows food manufacturers to make secret Gras safety determinations for chemicals added to food, without notifying FDA or the public, and to use the chemical in food without anyone else’s knowledge".
The NGOs have asked the court to find that the Gras rule is not in accordance with law, and that it exceeds FDA’s statutory authority.
Last September, the FDA moved to dismiss the case on the grounds that plaintiffs did not have legal standing to bring the case.
But Judge Vernon Broderick dismissed the motion on 12 September, finding that two of the plaintiffs – the Center for Food Safety (CFS) and the Environmental Defense Fund (EDF) – "plausibly allege harm to their members".
"Members of CFS and EDF have been and will be exposed to potentially dangerous substances that were introduced into the food supply without FDA oversight, public participation, or the opportunity for judicial review," the court’s opinion says.
This satisfies the ‘injury-in-fact’ requirement of standing that is needed for the groups to take the case forward.
The court, however, found that co-plaintiffs the Breast Cancer Prevention Partners (BCPP), Center for Science in the Public Interest, and the Environmental Working Group (EWG) did not sufficiently support their claim of standing in the suit, as they are not membership organisations. They have been dismissed from the case.
The suit is being heard in the US District Court for the southern district of New York.