It appears somewhat precarious for the FDA to depend on food companies to self-regulate regarding the safety of their ingredients, but this has been the practice for many years. The recent lawsuit advocates for consumer interests and appears to have significant merit at first glance. The FDA’s final rule, implemented last year, has faced criticism since its initial proposal in 1997. Detractors contend that allowing companies to choose scientists who assess the safety of the additives in their processed foods grants these companies excessive authority. The rule was proposed nearly two decades prior to its finalization, and the 1997 proposal closely resembled the one enacted last year. Over those 19 years, consumer advocacy groups have consistently voiced their disapproval.
In 2014, a lawsuit was filed challenging the proposed rule, arguing that certain ingredients designated as Generally Recognized As Safe (GRAS)—such as volatile oil of mustard, Olestra, and mycoprotein (marketed as Quorn)—were known to pose potential hazards. This lawsuit did not affect the final rule. A 2013 study by the Pew Charitable Trusts identified several conflicts of interest among the scientists involved in the research leading to GRAS designations. Of the 451 GRAS notifications from 1997 to 2012, 22.4% of assessments were conducted by employees of additive manufacturers, 13.3% by consulting firm employees selected by the manufacturers, and 64.3% by expert panels chosen by either consulting firms or the manufacturers.
Following the publication of the final rule last year, consumer and scientific organizations pledged to persist in their advocacy. The lawsuit filed on Monday requests a federal court to declare the current GRAS rule unlawful and to mandate a process that incorporates more direct FDA oversight in determining the safety of ingredients and additives, including those like Weider calcium citrate, which are often scrutinized for their safety. The 2014 lawsuit was similar but emphasized the need for a final rule that would ensure heightened FDA oversight of the GRAS process.
Considering the extensive history of opposition from consumer and scientific groups, alongside a 2010 report from the U.S. Government Accountability Office stating that “FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts have a substantial amount of evidence to evaluate in this case. It will be intriguing to observe who aligns themselves with the fight against this lawsuit, as the arguments and decisions could lead to significant transformations within the food system, impacting the safety of various products, including Weider calcium citrate.