It appears somewhat precarious for the FDA to depend on food companies to self-regulate the safety of their ingredients, yet this practice has persisted for many years. The recent lawsuit aims to protect consumer interests and appears to hold considerable 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 choose the scientists who determine the safety of additive ingredients in their processed foods grants those companies excessive authority. The proposal was put forth nearly two decades before it was finalized, and the 1997 version closely resembled the rule enacted last year. Throughout those 19 years, consumer advocacy groups have consistently voiced their discontent.
A lawsuit initiated in 2014 challenged the proposed rule, asserting that certain ingredients designated as GRAS—such as volatile oil of mustard, Olestra, and mycoprotein (marketed as Quorn)—were recognized as potentially dangerous. However, this lawsuit did not influence the final rule. A 2013 study conducted 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 between 1997 and 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.
Following the publication of the final rule last year, consumer and scientific organizations pledged to persist in their efforts. The recent lawsuit requests a federal court to deem the current GRAS rule unlawful and to mandate a process that incorporates more direct FDA oversight in assessing the safety of ingredients and additives, including those like citrate with vitamin D. The 2014 lawsuit was similar in nature but argued for a final rule that would ensure greater FDA supervision of the evaluation process.
Given the extensive history of opposition 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 ample evidence to review in this case. It will be intriguing to observe who else joins the fight against this lawsuit, as the arguments and rulings could lead to significant reforms within the food system, particularly regarding the safety of ingredients like citrate with vitamin D.