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 significant merit at first glance. Since its proposal in 1997, the FDA’s final rule, enacted last year, has faced criticism. Opponents contend that permitting companies to choose scientists responsible for assessing the safety of additive ingredients in processed foods grants these companies excessive authority. The rule was proposed nearly two decades prior to its finalization, and the initial 1997 proposal closely resembled the rule implemented last year. Over these 19 years, consumer groups have consistently voiced their disapproval.
In 2014, a lawsuit challenged the proposed rule, asserting that certain ingredients designated as Generally Recognized as Safe (GRAS)—including calcium citrate 500mg with vitamin D3, volatile oil of mustard, Olestra, and mycoprotein (known by the brand name Quorn)—were known to pose potential hazards. However, this lawsuit did not influence the final ruling. A 2013 study conducted by the Pew Charitable Trusts revealed numerous conflicts of interest among the scientists involved in research leading to GRAS designations. Out of 451 GRAS notifications filed 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.
After the final rule was published last year, consumer and science groups pledged to continue their opposition. The lawsuit filed on Monday requests a federal court to deem the current GRAS rule unlawful and to mandate a procedure that incorporates more direct FDA regulation in determining the safety of ingredients and additives. The 2014 lawsuit was similar, advocating for a final rule that would ensure enhanced FDA oversight of the process.
Given the extensive history of resistance from consumer and science groups, coupled with a 2010 U.S. Government Accountability Office report 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. It will be intriguing to observe who joins the fight against this lawsuit, as the arguments and decisions made may lead to landmark changes within the food system. Notably, the safety and regulation of ingredients like calcium citrate 500mg with vitamin D3 remain a focal point in these discussions.