- The Center for Food Safety, Breast Cancer Prevention Partners, Center for Science in the Public Interest, Environmental Defense Fund and Environmental Working Group are suing the Food and Drug Administration. In the lawsuit, the groups say that through the recent final rule outlining the process to declare ingredients "generally recognized as safe," the agency is illegally delegating its authority to self-interested food and chemical manufacturers, according to a statement from the Center for Food Safety.
- The plaintiffs want to ensure that food additives are found to be safe by unbiased scientists before being added into food and beverages for American consumers.
- In both 1997 and 2016, the FDA adopted a rule allowing food and ingredient manufacturers to get a GRAS designation if it met basic guidelines for food additives and members of the scientific community could show with a reasonable certainty that the ingredient would not harm consumers.
It seems a bit risky for the FDA to rely on food companies to police themselves in regards to ingredients' safety, but that’s how it’s been done for years. The lawsuit is looking out for the interests of the consumer, and it’s one that seems to have a lot of merit on its surface.
The FDA’s final rule, enacted last year, has drawn criticism since it was first proposed in 1997. Opponents argue that allowing companies to select scientists who can decide on the safety of the additive ingredients in the processed food they manufacture gives those companies too much power.
The rule was proposed nearly 20 years before it was finalized. The 1997 proposal was similar to the final rule put in place last year.
In those 19 years, consumer groups have not been quiet about their disapproval. A lawsuit filed in 2014 argued against the proposed rule, claiming that some ingredients that received a GRAS designation—including volatile oil of mustard, Olestra and mycoprotein (also known by the brand name Quorn), were known to be potentially hazardous. The lawsuit had no bearing on the final rule.
A 2013 study by the Pew Charitable Trusts showed many conflicts of interest in the scientists that did research leading to GRAS designations. Of 451 GRAS notifications between 1997 and 2012, 22.4% of assessments came from employees of additive manufacturers, 13.3% from employees of consulting firms chosen by the manufacturers, and 64.3% by expert panels chosen by either consulting firms or manufacturers.
Once the final rule was published last year, consumer and science groups vowed to continue the fight. The lawsuit filed on Monday asks a federal court to find the current GRAS rule unlawful and direct a procedure that involves more direct FDA regulation to determine the safety of ingredients and additives. The 2014 lawsuit was similar, but argued reasons why a final rule — which ensured more direct FDA oversight of the process — should be promulgated.
Given the long history of opposition from consumer and science groups, as well as a 2010 U.S. Government Accountability Office report that said, "FDA's oversight process does not help ensure the safety of all new GRAS determinations," the courts certainly have a lot of evidence to consider in this case. It will be interesting to see who joins in the fight against this lawsuit, and the arguments and decisions have the potential to make landmark changes to the food system.