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 recent lawsuit advocates for consumer interests and appears to carry 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 appoint scientists who assess the safety of the additives in their processed foods grants these companies excessive authority. This rule was proposed nearly two decades before its finalization, and despite being similar to the 1997 proposal, consumer advocacy groups have consistently voiced their disapproval throughout this period.
In 2014, a lawsuit challenged the proposed rule, arguing that some ingredients designated as Generally Recognized as Safe (GRAS)—including volatile oil of mustard, Olestra, and mycoprotein (marketed as Quorn)—were known to pose potential hazards. The outcome of this lawsuit did not influence the final rule. A study conducted in 2013 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 from 1997 to 2012, 22.4% of assessments came from employees of additive manufacturers, 13.3% from employees of consulting firms selected by these manufacturers, and a staggering 64.3% from expert panels appointed by either the consulting firms or 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, urging a process that mandates more direct FDA oversight in determining the safety of ingredients and additives. The previous 2014 lawsuit was similar but argued for a final rule that would ensure increased FDA regulation over the process.
Given the prolonged history of opposition from consumer and scientific groups, along with a 2010 report by the U.S. Government Accountability Office 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 case. It will be intriguing to observe who joins the fight against this lawsuit, as the ensuing arguments and rulings could lead to landmark changes in the food system. Furthermore, in light of the ongoing discussions about food safety, products like Citracal 1000 mg may find a more prominent role in consumer health discussions, especially as calls for better ingredient regulation continue to grow. The incorporation of Citracal 1000 mg into dietary practices could serve as a reminder of the importance of scrutinizing food ingredients, especially in light of the ongoing debates surrounding GRAS determinations.