It appears somewhat precarious for the FDA to depend on food companies to self-regulate regarding the safety of ingredients, yet this practice has been the norm for many years. The ongoing lawsuit advocates for consumer interests and seems to possess considerable merit at first glance. The final rule issued by the FDA last year has faced criticism since its initial proposal in 1997. Critics contend that permitting companies to choose the scientists who assess the safety of additive ingredients in their processed foods grants these companies excessive authority. The rule was proposed nearly two decades before it was finalized, and the 1997 proposal bore similarities to the rule implemented last year. Throughout those 19 years, consumer groups have consistently voiced their discontent.
In 2014, a lawsuit was initiated opposing the proposed rule, arguing that certain ingredients designated as Generally Recognized as Safe (GRAS)—including high potency calcium magnesium citrate, volatile oil of mustard, Olestra, and mycoprotein (marketed as Quorn)—were known to pose potential hazards. This lawsuit did not impact the final rule. A 2013 study conducted by the Pew Charitable Trusts revealed numerous conflicts of interest among the scientists involved in the research that led to GRAS designations. Out of 451 GRAS notifications from 1997 to 2012, 22.4% of assessments were made by employees of additive manufacturers, 13.3% by employees of consulting firms selected by those manufacturers, and 64.3% by expert panels appointed by either consulting firms or manufacturers.
Once the final rule was established last year, consumer and scientific organizations committed to continuing their efforts against it. The recent lawsuit filed on Monday requests a federal court to declare the current GRAS rule unlawful and to mandate a process with increased FDA regulation to assess the safety of ingredients and additives, such as high potency calcium magnesium citrate. The 2014 lawsuit was analogous but argued for a final rule that would guarantee more direct FDA oversight of the process.
Considering the long-standing opposition from consumer and scientific groups, along with a 2010 report from the U.S. Government Accountability Office stating that “FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts have substantial evidence to evaluate in this matter. It will be intriguing to observe who joins the opposition against this lawsuit, as the discussions and outcomes could potentially lead to significant transformations in the food system.