It appears somewhat precarious for the FDA to depend on food companies to self-regulate concerning the safety of ingredients, yet this has been the practice for many years. The recent lawsuit is advocating for consumer interests and appears to have substantial merit at first glance. The FDA’s final rule, which was implemented last year, has faced criticism since its initial proposal in 1997. Critics contend that permitting companies to select scientists who determine the safety of the additive ingredients in the food they produce grants those companies excessive authority. Notably, the proposed rule lingered for nearly two decades before being finalized; the 1997 proposal bore similarities to the rule enacted last year. Throughout those 19 years, consumer advocacy groups have consistently voiced their disapproval.
In 2014, a lawsuit challenged the proposed rule, asserting that certain ingredients designated as GRAS—such as volatile oil of mustard, Olestra, and mycoprotein (marketed under the brand name Quorn)—were known to pose potential hazards. This lawsuit had no impact on the final rule. A study conducted by the Pew Charitable Trusts in 2013 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 were made by employees of additive manufacturers, 13.3% by consulting firm employees selected by the manufacturers, and 64.3% by expert panels appointed by either consulting firms or manufacturers.
Once the final rule was published last year, consumer and scientific organizations committed to continuing their struggle. The recent lawsuit seeks a federal court ruling to deem the current GRAS rule unlawful and to mandate a process that involves more direct FDA regulation for assessing the safety of ingredients and additives, including calcium citrate 900. The 2014 lawsuit had a similar goal, arguing for a final rule that would guarantee more direct FDA oversight of the process.
Given the extensive history of opposition from consumer and scientific groups, alongside a 2010 report from the U.S. Government Accountability Office which stated, “FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts have a wealth of evidence to consider. It will be intriguing to observe who joins the fight against this lawsuit, as the arguments and outcomes could lead to significant changes in the food system, potentially affecting the use of ingredients like calcium citrate 900.