Lawsuit: FDA GRAS Rule Undermines Food Safety

An FDA rule is unconstitutional and weakens the integrity of America’s food safety system,  according to several groups in a lawsuit filed Monday in New York.

Adopted in August 2016, the final rule clarifies criteria in FDA regulations for when the use of a substance in food is not subject to premarket approval because it is generally recognized as safe (GRAS). In 1997 and again last year, FDA adopted a practice that allows chemical and food manufacturers to determine for themselves without notifying FDA that food chemicals are safe, according to a news release announcing the groups’ lawsuit.

The complaint for declaratory and injunctive relief was filed by the Center for Food Safety, Breast Cancer Prevention Partners, Center for Science in the Public Interest, Environmental Defense Fund and Environmental Working Group. The lawsuit names as defendants Health and Human Services Secretary Tom Price, M.D., FDA Commissioner Scott Gottlieb, M.D., and FDA.

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

Marianna Naum, an FDA spokesperson, said the agency does not comment on pending litigation.

In announcing the final rule in a constituent update, FDA encouraged companies to notify the agency of its GRAS conclusions, and FDA said it could question the basis for an independent GRAS conclusion regardless of whether it was notified and take appropriate action. FDA explained “the notification procedure yields important information that aids the agency’s food safety monitoring efforts."

Under the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FDCA), any substance intentionally added to food is a food additive subject to premarket approval by FDA unless the use of the substance is GRAS or otherwise exempt from the food additive definition.

“General recognition of safety requires common knowledge, throughout the expert scientific community knowledgeable about the safety of substances directly or indirectly added to food, that there is a reasonable certainty that the substance is not harmful under the conditions of its intended use," FDA explained in its final GRAS rule.

FDA’s critics, however, lamented that GRAS determinations function as a major loophole swallowing the normal requirement for premarket approval of food additives and are riddled with conflicts of interest because manufacturers or their consultants make most GRAS determinations.

“The GRAS rule allows FDA to abdicate its core duty under the FDCA: to be responsible for the safety of the food supply," the lawsuit alleged.

While the GRAS exemption was created to cover ingredients that are widely known to be safe, such as vegetable oil, an estimated 3,000 chemicals are in use that have never been examined by FDA, the plaintiffs proclaimed in the news release.

“FDA has a duty to ensure the products we buy and feed our families are safe," said Cristina Stella, staff attorney for the Center for Food Safety and co-counsel in the lawsuit, in a statement. “The secretive GRAS system makes it impossible for FDA to carry out its core responsibility to the public."

The lawsuit was filed in the U.S. District Court for the Southern District of New York. The consumer, health and food safety groups requested a declaration that the final rule violates the FDCA, Administrative Procedure Act and the U.S. Constitution. The lawsuit also requested a declaration that the GRAS rule is unlawful because, among other reasons, it does not require FDA to independently review GRAS determinations.

Finally, the groups requested the court vacate the GRAS rule with directions to FDA to correct any legal deficiencies, award plaintiffs’ attorneys’ fees and reasonable expenses, and grant other injunctive and declaratory relief as the court deems appropriate.