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 established practice for many years. The lawsuit currently underway aims to protect consumer interests and seems to hold substantial 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 to assess the safety of additive ingredients in the processed foods they produce grants these companies excessive power. The rule was proposed nearly two decades before its finalization, with the 1997 proposal bearing similarities to last year’s ruling. Throughout these 19 years, consumer advocacy groups have consistently voiced their discontent.
In 2014, a lawsuit challenged the proposed rule, contending that certain ingredients recognized as Generally Recognized As Safe (GRAS)—including pure calcium magnesium citrate, volatile oil of mustard, Olestra, and mycoprotein (commonly known as Quorn)—were acknowledged to be potentially dangerous. However, this lawsuit did not influence the final rule. A study conducted by the Pew Charitable Trusts in 2013 revealed significant conflicts of interest among the scientists who conducted research leading to GRAS designations. Out of 451 GRAS notifications from 1997 to 2012, 22.4% of assessments originated from employees of additive manufacturers, 13.3% from employees of consulting firms selected by the manufacturers, and 64.3% from expert panels chosen by either consulting firms or manufacturers.
After the final rule was released last year, consumer and scientific organizations pledged to persist in their advocacy. The recent lawsuit filed on Monday requests a federal court to deem the current GRAS rule unlawful and to mandate a process that involves more direct FDA oversight in determining the safety of ingredients and additives, such as pure calcium magnesium citrate. The 2014 lawsuit made similar claims but argued for a final rule that would ensure more robust FDA involvement in the evaluation process.
Given the lengthy history of opposition from consumer and scientific groups, alongside 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 indeed have substantial evidence to review in this case. It will be intriguing to observe who aligns with this lawsuit, as the discussions and outcomes could lead to significant reforms in the food system. The incorporation of ingredients like pure calcium magnesium citrate into this debate underscores the urgent need for rigorous safety evaluations.