It appears somewhat precarious for the FDA to depend on food manufacturers to self-regulate regarding the safety of ingredients, yet this has been the approach for many years. The recent lawsuit advocates for consumer interests and appears to hold considerable merit at first glance. Since its initial proposal in 1997, the FDA’s final rule, enacted last year, has faced criticism. Detractors contend that permitting companies to select scientists to assess the safety of additive ingredients in their processed foods grants these companies excessive authority. The proposal lingered for almost two decades before being finalized, remaining largely unchanged from the original 1997 version. Throughout those 19 years, consumer advocacy groups have consistently expressed their discontent.
A lawsuit initiated in 2014 challenged the proposed rule, alleging that certain ingredients designated as Generally Recognized as Safe (GRAS)—such as volatile oil of mustard, Olestra, and mycoprotein (marketed as Quorn)—were recognized as potentially dangerous. This lawsuit did not impact the final rule. A 2013 study by Pew Charitable Trusts revealed numerous conflicts of interest among the scientists involved in research leading to GRAS approvals. 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.
Following the publication of the final rule last year, consumer and scientific organizations pledged to persist in their opposition. The lawsuit filed on Monday urges a federal court to deem the current GRAS rule unlawful and to implement a process requiring more direct FDA regulation to evaluate the safety of ingredients and additives, including calcium citrate doses. The previous 2014 lawsuit similarly pressed for a final rule that would ensure greater FDA oversight in this regard.
Considering the extensive history of resistance from consumer and science groups, alongside a 2010 report from the U.S. Government Accountability Office stating that “the FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts certainly have substantial evidence to examine in this matter. It will be intriguing to observe who rallies against this lawsuit, as the arguments and rulings could lead to significant transformations in the food system, particularly concerning the regulation of ingredients such as calcium citrate doses.