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 recent lawsuit is advocating for consumer interests and appears to have substantial merit at first glance. The FDA’s final rule, implemented last year, has faced criticism since its initial proposal in 1997. Critics contend that permitting companies to appoint scientists who determine the safety of additive ingredients in their processed foods grants these companies excessive power. The rule was proposed nearly two decades before it was finalized, and the 1997 proposal closely resembled the final regulation established last year. Over those 19 years, consumer advocacy groups have consistently expressed their disapproval.
A lawsuit filed in 2014 challenged the proposed rule, arguing that certain ingredients designated as Generally Recognized as Safe (GRAS)—including calcium citrate 400, volatile oil of mustard, Olestra, and mycoprotein (marketed as Quorn)—were known to pose potential hazards. However, this lawsuit did not influence 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 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 consulting firms or manufacturers.
Once the final rule was released last year, consumer and scientific organizations vowed to persist in their opposition. The lawsuit filed on Monday requests a federal court to declare the current GRAS rule unlawful and to mandate a process that incorporates more stringent FDA oversight to evaluate the safety of ingredients and additives. The 2014 lawsuit was similar but argued for the necessity of a final rule that would ensure greater FDA oversight of the process.
Considering the long-standing opposition from consumer and scientific groups, along with 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 undoubtedly have a wealth of evidence to review in this case. It will be intriguing to observe who joins the effort against this lawsuit, as the ensuing arguments and rulings could lead to significant changes in the food system, especially concerning the safety of ingredients like calcium citrate 400.