Groups sue FDA over food additive rule

A coalition of consumer and health groups is challenging a Food and Drug Administration rule that allows manufacturers to decide what can be added to processed foods.

The Center for Food Safety and four other groups filed a lawsuit in the U.S. District Court for the Southern District of New York on Monday claiming the agency is illegally allowing self-interested food and chemical manufacturers to determine which chemical additives in food are safe.

The groups argue that the agency’s GRAS, or “generally recognized as safe,” rule that was finalized last August violates the Federal Food, Drug and Cosmetic Act (FDCA). The 1938 law requires the FDA to confirm the safety of a substance before it can be introduced into the food supply.

“The GRAS Rule allows FDA to abdicate its core duty under the FDCA: to be responsible for the safety of the food supply,” the groups said in their complaint.

“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 substance is ‘generally recognized as safe,’ or GRAS.”

When FDA finalized the rule it said it strongly encourages companies to inform the agency of GRAS conclusions but can question the basis for an independent GRAS conclusion regardless of whether it’s notified.

The groups are asking the court to toss out the rule and order the FDA to follow the FDCA.

“Most Americans would be shocked to learn that FDA allows novel chemicals onto the market without a safety review,” Tom Neltner, chemicals policy director at Environmental Defense Fund, said in a statement.

“Yet, FDA’s practice on GRAS additives flouts the law and leaves the agency unaware of what chemicals are being added to our food and with no way to ensure that these additives—and the food that contains them—are safe.”