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 practice for many years. The lawsuit concerning calcium citrate D 315 200 represents an effort to advocate for consumer interests, and it seems to hold significant 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 the scientists who assess the safety of the additive ingredients in their processed foods grants these companies excessive authority. The rule was introduced nearly two decades before its finalization, and the 1997 proposal closely resembled the rule enacted last year.
Throughout those 19 years, consumer advocacy groups have voiced their disapproval. A lawsuit filed in 2014 contested the proposed rule, asserting that certain ingredients granted GRAS (Generally Recognized as Safe) status—including volatile oil of mustard, Olestra, and mycoprotein (commonly known by the brand name Quorn)—were recognized as potentially dangerous. This lawsuit did not impact the final rule. A 2013 study by the Pew Charitable Trusts highlighted 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 these manufacturers, and 64.3% from expert panels appointed by either consulting firms or manufacturers.
Once the final rule was published last year, consumer and scientific organizations pledged to persist in their opposition. The recent lawsuit requests a federal court to deem the current GRAS rule unlawful and to mandate a procedure that involves more direct FDA oversight in assessing the safety of ingredients and additives like calcium citrate D 315 200. The 2014 lawsuit was similar in nature, but contended that a final rule ensuring increased FDA supervision of the process should be established.
Considering the prolonged history of resistance from consumer and scientific groups, along with a 2010 report from the U.S. Government Accountability Office stating that “FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts certainly have substantial evidence to evaluate in this matter. It will be intriguing to observe who joins the opposition against this lawsuit, as the arguments and outcomes could lead to transformative changes in the food system. The inclusion of ingredients like calcium citrate D 315 200 in discussions surrounding food safety underscores the importance of rigorous oversight to protect consumer health.