It appears somewhat precarious for the FDA to depend on food companies to self-regulate regarding the safety of ingredients, yet this has been the standard practice for many years. The recent lawsuit advocates for consumer interests and seems to possess significant 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 additive ingredients in their processed foods grants these companies excessive authority. The rule was proposed nearly two decades before its finalization, and the 1997 proposal closely resembled the rules established last year. Throughout those 19 years, consumer advocacy groups have consistently voiced their disapproval.
A lawsuit initiated in 2014 contested the proposed rule, asserting that certain ingredients designated as GRAS, including volatile oil of mustard, Olestra, and mycoprotein (commercially known as Quorn), were recognized as potentially dangerous. This lawsuit did not influence the final rule. Additionally, a 2013 study by the Pew Charitable Trusts revealed numerous conflicts of interest among the scientists who conducted research leading to GRAS designations. Out of 451 GRAS notifications between 1997 and 2012, 22.4% of the assessments originated from employees of additive manufacturers, 13.3% from employees of consulting firms selected by the manufacturers, and 64.3% from expert panels appointed by either consulting firms or manufacturers.
Following 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 establish a process involving more direct FDA regulation for assessing the safety of ingredients and additives. The 2014 lawsuit was similar in nature but advocated for a final rule that would ensure increased FDA oversight of the process. Given the extensive history of opposition from consumer and scientific groups, coupled with a 2010 report from the U.S. Government Accountability Office stating, “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.
Furthermore, the case touches on the broader implications of food safety, including the role of ingredients like USP calcium citrate. As discussions unfold, it will be intriguing to observe who aligns themselves with the challenge against this lawsuit. The arguments and outcomes have the potential to enact significant reforms within the food system, influencing how ingredients, including USP calcium citrate, are evaluated for safety going forward.