In an blog post published on April 18, 2019, non-governmental organization Environmental Defense Fund (EDF) informed about the latest update in a long standing lawsuit (FPF reported) filed against the U.S. Food and Drug Administration (FDA) challenging its rule on chemicals in food and food packaging that are identified as GRAS (Generally Recognized as Safe) (FPF reported). EDF and others challenged the FDA rule two years ago, and a federal district court denied an FDA request to dismiss the challenge (FPF reported).

Most recently on March 26, 2019, EDF and the Center for Food Safety filed a “Motion for Summary Judgement” arguing that the FDA’s GRAS rule allows the industry to regulate itself and goes against the FDA’s mandate. Specifically, EDF identifies and summarizes in its blog post the following ways in which it says the FDA has violated the law under the GRAS rule:

  • “FDA unlawfully delegated to food manufacturers its authority to determine the safety of chemicals added to our food;
  • The GRAS Rule makes it impossible for FDA and food manufacturers to consider the cumulative effect of related substances in the diet despite a legal requirement;
  • FDA ignored evidence in the record that documented serious weaknesses in the program;
  • The GRAS Rule lacks sufficient criteria to ensure compliance with the FFDCA [Federal Food Drug and Cosmetic Act of 1938].”

The FDA has until May 28, 2019 to respond to the motion. However, Tom Neltner from EDF told Chemical Watch that he “wouldn’t be surprised if we have a decision from the judge by the end of the year . . . the judge took a long time on the first motion … so it could take a while. It could be another year.” If the judge were to decide against the FDA’s GRAS rule, it could have retroactive effects on previous applications of the rule and “call into doubt all of the [previous determinations] that industry has done in secret,” said Neltner.

Read more

Tom Neltner (April 18, 2019). “EDF asks judge to rule on legality of FDA rule allowing companies to secretly decide on chemicals in our food.” EDF

Lisa Martine Jenkins (April 25, 2019). “Consumer advocates ask court to vacate US FDA Gras rule.” Chemical Watch