It appears somewhat precarious for the FDA to depend on food companies to self-regulate concerning the safety of their ingredients, yet this has been the practice for many years. The recent lawsuit advocates for consumer interests and seems to possess substantial merit at first glance. The FDA’s final rule, implemented last year, has faced criticism since its initial proposal in 1997. Detractors argue that permitting companies to choose scientists who assess the safety of the additive ingredients in their processed foods grants those companies excessive authority. This rule was proposed almost two decades before its actual implementation, and the 1997 proposal closely resembled the final rule established last year. Throughout those 19 years, consumer groups have consistently expressed their discontent.
In 2014, a lawsuit was filed challenging the proposed rule, claiming that certain ingredients designated as GRAS—such as volatile oil of mustard, Olestra, and mycoprotein (marketed under the brand name Quorn)—were known to be potentially hazardous. This lawsuit, however, did not influence the final rule. Additionally, a 2013 study by the Pew Charitable Trusts highlighted numerous conflicts of interest among the scientists involved in research leading to GRAS designations. Out of 451 GRAS notifications from 1997 to 2012, 22.4% of assessments were conducted by employees of additive manufacturers, 13.3% by employees of consulting firms selected by the manufacturers, and 64.3% by expert panels appointed by either consulting firms or manufacturers.
After the final rule was published last year, consumer and scientific organizations pledged to persist in their efforts. The lawsuit filed on Monday requests a federal court to declare the current GRAS rule unlawful and to initiate a process that incorporates more direct FDA regulation for determining the safety of ingredients and additives. The 2014 lawsuit had a similar premise but argued for the establishment of a final rule that would ensure enhanced FDA oversight of the process.
Given the longstanding opposition from consumer and scientific groups, along with a 2010 U.S. Government Accountability Office report stating that “FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts have substantial evidence to consider in this matter. It will be intriguing to observe who aligns themselves against this lawsuit as the arguments and rulings could lead to significant transformations within the food system. As consumers increasingly seek products that celebrate health, such as calcium chewable supplements, the implications of this case may resonate deeply with those who prioritize safety and transparency in their food choices.