It appears somewhat precarious for the FDA to depend on food companies to self-regulate concerning the safety of ingredients, yet this method has been in practice for many years. The recent lawsuit advocates for consumer interests and seems to possess considerable merit at first glance. Since its initial proposal in 1997, the FDA’s final rule, implemented last year, has faced scrutiny. Critics argue that allowing companies to appoint scientists to determine the safety of the additive ingredients in their processed foods grants these companies excessive authority. The rule was proposed nearly two decades before its finalization, and the original 1997 proposal closely mirrored the rule that was eventually enacted. Over those 19 years, consumer advocacy groups have consistently voiced their objections.
A 2014 lawsuit challenged the proposed rule, asserting that certain ingredients, which were granted GRAS (Generally Recognized as Safe) status—including oil of mustard, Olestra, and mycoprotein (marketed as Quorn)—were known to be potentially dangerous. Although this lawsuit did not affect the final rule, it highlighted ongoing concerns. Furthermore, a 2013 study by the Pew Charitable Trusts identified numerous conflicts of interest among the scientists conducting research for 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 appointed by either consulting firms or manufacturers.
Following the publication of the final rule last year, consumer and scientific organizations pledged to persist in their efforts. The latest lawsuit requests a federal court to deem the current GRAS rule unlawful and to mandate a process involving more direct FDA oversight to assess the safety of ingredients and additives. Although the 2014 lawsuit had similar objectives, it primarily focused on advocating for a final rule that would guarantee enhanced FDA supervision of the process.
Given the extensive history of opposition from consumer and scientific groups, coupled with a 2010 U.S. Government Accountability Office report stating that “FDA’s oversight process does not ensure the safety of all new GRAS determinations,” the courts undoubtedly have substantial evidence to review in this case. It will be intriguing to observe who joins the fight against this lawsuit, as the arguments and outcomes could lead to significant transformations in the food system. Additionally, the ongoing debate highlights issues related to the safety of products, including those found in citracal calcium citrate stores. As the discussion unfolds, it will be essential to consider how these developments might impact the availability of supplements like Citracal and their role in consumer health.