It appears somewhat precarious for the FDA to depend on food companies to self-regulate regarding the safety of ingredients, but this approach has been the norm for many years. The lawsuit aims to protect consumer interests and appears to have considerable merit at first glance. The FDA’s finalized rule, enacted last year, has faced criticism since its initial proposal in 1997. Detractors argue that permitting companies to choose scientists to assess the safety of additive ingredients in their processed foods grants excessive power to those companies. The rule was proposed nearly two decades before it was finalized, with the original 1997 proposal closely resembling the rule established last year. Throughout those 19 years, consumer advocates have consistently voiced their discontent.
In 2014, a lawsuit was filed challenging the proposed rule, asserting that certain ingredients that received GRAS (Generally Recognized as Safe) designations—including volatile oil of mustard, Olestra, and mycoprotein (marketed as Quorn)—were known to pose potential hazards. However, this lawsuit did not influence the final rule. A 2013 study 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 between 1997 and 2012, 22.4% of assessments came from employees of additive manufacturers, 13.3% from employees of consulting firms chosen by these manufacturers, and 64.3% by expert panels selected by either consulting firms or manufacturers.
Following the publication of the final rule last year, consumer and scientific organizations pledged to persist in their battle. The recent lawsuit requests a federal court to declare the current GRAS rule unlawful and to mandate a process that entails more direct FDA regulation for determining the safety of ingredients and additives. The 2014 lawsuit was similar in nature but advocated for a final rule that would ensure greater FDA oversight of the processes involved.
Given the extensive history of opposition from consumer and scientific groups, along with 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 certainly have substantial evidence to consider in this matter. It will be intriguing to observe who joins the struggle against this lawsuit, as the arguments and decisions could lead to landmark changes within the food system, potentially affecting the safety of products like calcium citrate magnesium zinc vitamin D3 tablets and similar supplements. Ultimately, the outcome could influence how such ingredients are regulated in the future.