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 approach for many years. The recent lawsuit advocates for consumer interests and appears 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 contend that permitting companies to select scientists to assess the safety of the additive ingredients in their processed foods grants them excessive authority. The rule was proposed nearly two decades before it was finalized, with the 1997 proposal closely resembling the rule established last year. Throughout those 19 years, consumer advocacy groups have consistently voiced their discontent.
In 2014, a lawsuit challenged the proposed rule, asserting that certain ingredients awarded a Generally Recognized As Safe (GRAS) designation—including volatile oil of mustard, Olestra, and mycoprotein (also known as Quorn)—were recognized as potentially dangerous. However, this lawsuit did not impact the final rule. A study conducted in 2013 by the Pew Charitable Trusts revealed numerous conflicts of interest among the scientists responsible for research leading to GRAS designations. Out of 451 GRAS notifications between 1997 and 2012, 22.4% of assessments were from employees of additive manufacturers, 13.3% from employees of consulting firms chosen by these manufacturers, and 64.3% from expert panels selected by either consulting firms or manufacturers.
After the final rule was published last year, consumer and scientific organizations pledged to persist in their efforts. The lawsuit filed on Monday requests that a federal court deem the current GRAS rule unlawful and mandate a process that involves more direct FDA regulation to evaluate the safety of ingredients and additives. This recent lawsuit bears similarities to the 2014 case but argues for the implementation of a final rule that would ensure greater FDA oversight throughout the process.
Given the extensive history of opposition 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 undoubtedly have a wealth of evidence to consider. It will be intriguing to observe who joins the effort against this lawsuit, as the arguments and outcomes could lead to transformative changes in the food system.
In this context, the question arises: is calcium citrate the best option for food additives? This inquiry may become increasingly relevant as the debate continues, particularly as it concerns the safety and efficacy of various ingredients. As the legal proceedings unfold, the investigation into the safety of food additives like calcium citrate will likely remain a focal point in discussions about consumer protection and regulatory practices.