Relying on food companies to self-regulate their ingredients’ safety appears quite risky for the FDA, yet this has been the practice for many years. The current lawsuit advocates for consumer interests and seems to have substantial merit at first glance. The FDA’s final rule, enacted last year concerning ferric sodium edetate, has faced criticism since its initial proposal in 1997. Opponents argue that permitting companies to choose scientists to determine the safety of additives in their processed foods grants them excessive power. The proposal lingered for nearly 20 years before being finalized, with the 1997 suggestion closely resembling last year’s rule.
During those nearly two decades, consumer advocacy groups have continuously voiced their discontent. A 2014 lawsuit challenged the proposed rule, asserting that certain ingredients designated as GRAS (Generally Recognized as Safe)—including volatile oil of mustard, Olestra, and mycoprotein (marketed under the brand name Quorn)—were potentially dangerous. However, this lawsuit did not influence the final rule. A 2013 study by the Pew Charitable Trusts revealed significant conflicts of interest among scientists conducting research leading to GRAS designations. Out of 451 GRAS notifications between 1997 and 2012, 22.4% of assessments stemmed from employees of additive manufacturers, 13.3% from consulting firms selected by these manufacturers, and 64.3% from expert panels chosen by either consulting firms or the manufacturers themselves.
With the publication of the final rule last year, consumer and science organizations pledged to pursue further action. The recent lawsuit requests a federal court to deem the existing GRAS rule unlawful and to implement a process that involves more direct FDA regulation of the safety assessments for ingredients and additives, including calcium citrate solubility attributes. The previous 2014 lawsuit had a similar aim, arguing for a final rule that would ensure enhanced FDA oversight.
Given the extensive history of opposition from consumer and science advocates, as well as a 2010 report from 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 have substantial evidence to review in this matter. It will be intriguing to see who else joins the fight against this lawsuit, as the arguments and rulings could lead to significant changes in the food system, especially concerning substances like calcium citrate and its solubility in various contexts.