The Center for Food Safety, Environmental Defense Fund, Center For Science In The Public Interest, Breast Cancer Prevention Partners, Environmental Working Group have filed a lawsuit against the FDA (you can read the complaint here) alleging that the FDA’s rule for Substances Generally Recognized as Safe (the “GRAS” rule) is undermining the integrity of the food safety system by allowing manufacturers an ability to certify a substance as GRAS without notice to the public or the government – in spite of the requirements that additives undergo an FDA approval process pursuant to the FDA Food Additives Amendment to the Food Drug and Cosmetic Act.

In a press release, the consumer groups stated that the exception is swallowing the rule:

The GRAS exception is overwhelming the food safety system. 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 “generally recognized as safe.” Today an estimated 3,000 chemicals that have never been scrutinized by the FDA are in use.

The complaint alleges that (1) the GRAS rule is an unconstitutional sub-delegation of the FDA’s authority to businesses; (2) the FDA’s rule improperly forestalls judicial review of regulatory decisions; and (3) that the GRAS classification criteria conflicts with the requirements of the Food Drug and Cosmetic Act.

“Chemical and food processing industries should not be in charge of saying whether or not food is safe. Industry has their bottom line profits in mind, not consumer or environmental safety,” said Tina Sigurdson, Assistant General Counsel for the Environmental Working Group. “Leaving it up to industry to regulate itself is a classic case of the fox guarding the henhouse, at the expense of public health.”

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