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Suing the FDA to Protect Food Safety

A supermarket aisle.

Chemical and food manufacturers often seek to add chemicals to processed food, typically to enhance flavor, add nutrients, or prevent spoilage. The public expects, and the law demands, that FDA ensure the safety of Americans’ food.

Stephenie Schukraft / CC BY-NC 2.0

What's at Stake

The FDA rule allows manufacturers to decide for and by themselves—in secret—what can be added to processed foods. Today, an estimated 3,000 chemicals that have never been scrutinized by the FDA are in use.

Overview

Consumer, health, and food safety groups are challenging a Food and Drug Administration (FDA) rule that undermines the integrity of our food safety system. Chemical and food manufacturers often seek to add chemicals to processed food, typically to enhance flavor, add nutrients, or prevent spoilage. Chemicals also often leach into foods from processing equipment and packaging. While Congress has required that FDA itself determine that chemical additives are safe before they can be used in food, the FDA rule allows manufacturers to decide for and by themselves—in secret—what can be added to processed foods. The groups assert this rule is unconstitutional and illegal.

The public expects, and the law demands, that FDA ensure the safety of Americans’ food. Center for Food Safety (CFS), Breast Cancer Prevention Partners, Center for Science in the Public Interest, Environmental Defense Fund, and Environmental Working Group—represented by legal counsel from CFS and Earthjustice—are suing the agency for illegally delegating that authority to self-interested food and chemical manufacturers. They also allege that, while Congress mandates an open and public process, FDA allows manufacturers to make these decisions about food additives without any disclosure to either FDA or the public. The lawsuit was filed in the United States District Court for the Southern District of New York.

Federal law requires FDA to ensure that substances used in food are safe, taking into account consumers’ entire diet and all exposure to the chemical and similar chemicals. But any substance designated as “generally recognized as safe” (GRAS) by FDA or by a food or chemical company can bypass the rigorous pre-market review and approval process applied to food additives. The GRAS exemption was initially created to cover ingredients that are widely known to be safe, such as vegetable oil, but has been applied in recent practice to novel chemicals and is now a loophole that has swallowed the law.

Under pressure from industry, in 1997 and again in 2016, FDA adopted a practice that allows food and chemical manufacturers to decide for themselves, without notice to FDA or the public, that food chemicals are safe—even if the chemicals are new, not widely studied, and not widely accepted as safe. CFS filed suit in 2014 to challenge FDA’s use of an interim rule that initially put this practice into place. That successful challenge forced FDA to stop using the interim rule and instead finalize the GRAS rule. The lawsuit challenges the final rule that formalizes this practice.

Independent watchdogs have criticized the GRAS system for being rife with industry conflicts of interest because the vast majority of GRAS determinations are made by either the manufacturers themselves or their hired consultants. Moreover, the current system that allows secret GRAS determinations makes it nearly impossible for FDA or manufacturers to assess the cumulative effect of all similar chemicals on consumers—as the law requires.

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.

Case Updates

May 22, 2017 | Legal Document

Complaint For Declaratory And Injunctive Relief GRAS Rule Challenge

Plaintiffs Center for Food Safety, Breast Cancer Prevention Partners, Center for Science in the Public Interest, Environmental Defense Fund, and Environmental Working Group (“Plaintiffs”) seek declaratory and injunctive relief with respect to a final rule promulgated by the United States Food and Drug Administration (“FDA”) entitled “Substances Generally Recognized as Safe,” 81 Fed. Reg. 54,960 (Aug. 17, 2016) (“final rule” or “GRAS Rule”).