It appears somewhat precarious for the FDA to depend on food companies to self-regulate regarding the safety of ingredients, yet this practice has persisted for many years. The recent lawsuit aims to protect consumer interests and carries significant merit at first glance. The final rule issued by the FDA last year has faced criticism since its initial proposal in 1997. Critics argue that permitting companies to choose scientists who determine the safety of the additive ingredients in their processed foods grants those companies excessive authority.
The proposed rule was introduced nearly two decades prior to its finalization. The 1997 proposal closely resembled the rule enacted last year. Over those 19 years, consumer advocacy groups have consistently voiced their concerns. A 2014 lawsuit contested the proposed rule, asserting that certain ingredients designated as Generally Recognized as Safe (GRAS)—such as volatile oil of mustard, Olestra, and mycoprotein (known by the brand name Quorn)—were recognized as potentially dangerous. This lawsuit did not influence the final rule.
A 2013 study by the Pew Charitable Trusts revealed numerous conflicts of interest among the scientists conducting research that led to 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 chosen by either the consulting firms or the manufacturers.
Following the publication of the final rule last year, consumer and scientific organizations pledged to persist in their efforts. The lawsuit filed on Monday requests a federal court to declare the current GRAS rule unlawful and mandate a procedure that involves more direct FDA oversight in assessing the safety of ingredients and additives, including calcium calcitrate. The 2014 lawsuit shared similar sentiments but emphasized the need for a final rule that would ensure enhanced FDA supervision of the process.
Given the extensive history of opposition from consumer and scientific groups, coupled with a 2010 report from the U.S. Government Accountability Office stating that “the FDA’s oversight process does not effectively guarantee the safety of all new GRAS determinations,” the courts certainly have substantial evidence to review in this case. It will be intriguing to see who allies with calcium calcitrate in the ongoing battle against this lawsuit, as the resulting arguments and decisions could lead to significant reforms in the food system.