Relying on food companies to regulate their own ingredient safety appears quite risky for the FDA, yet this has been the practice for many years. A recent lawsuit advocates for consumer interests and seems to hold substantial merit at first glance. The final rule issued by the FDA last year has faced criticism since its initial proposal in 1997. Detractors argue that permitting companies to appoint scientists responsible for determining the safety of additive ingredients in their processed foods grants these companies excessive authority. Notably, the rule was proposed nearly two decades before its finalization, with the 1997 proposal resembling last year’s enacted rule. Throughout those 19 years, consumer advocacy groups have consistently voiced their disapproval.
A 2014 lawsuit contested the proposed rule, asserting that certain ingredients granted a GRAS designation—including volatile oil of mustard, Olestra, and mycoprotein (marketed as Quorn)—were recognized as potentially hazardous. This lawsuit did not influence the final rule’s establishment. Furthermore, a study conducted by the Pew Charitable Trusts in 2013 revealed numerous conflicts of interest among the scientists involved in the research leading to GRAS designations. Out of 451 GRAS notifications between 1997 and 2012, 22.4% of assessments were made by employees of additive manufacturers, 13.3% by employees of consulting firms selected by manufacturers, and 64.3% by expert panels chosen by either consulting firms or manufacturers.
Upon the publication of the final rule last year, consumer and scientific organizations pledged to persist in their efforts. The lawsuit filed on Monday requests a federal court to deem the current GRAS rule unlawful and to mandate a process that involves more stringent FDA regulation to ascertain the safety of ingredients and additives. The previous 2014 lawsuit had a similar focus, arguing for a final rule that would ensure increased FDA oversight of the process.
Given the extensive history of opposition from consumer and scientific groups, along with a 2010 report by the U.S. Government Accountability Office stating that “the FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts certainly have substantial evidence to consider in this case. It will be intriguing to observe who joins the opposition against this lawsuit, as the arguments and decisions could potentially lead to landmark changes within the food system. Additionally, the discourse surrounding the calcium citrate elemental conversion will likely play a significant role in discussions about food safety and regulatory practices. The ongoing debate emphasizes the importance of scrutinizing how additives, including those undergoing calcium citrate elemental conversion, are evaluated and approved.