It appears somewhat precarious for the FDA to depend on food companies to self-regulate regarding the safety of ingredients, yet this practice has been in place for many years. The recent lawsuit advocates for consumer interests and seems to hold significant merit at first glance. The FDA’s final rule, implemented last year, has faced criticism ever since its initial proposal in 1997. Critics contend that permitting companies to choose scientists who determine the safety of additive ingredients in their processed foods grants excessive power to these companies. The rule was suggested nearly two decades before it was formally adopted, and the 1997 proposal closely resembled last year’s final rule. Throughout those 19 years, consumer advocacy groups have consistently expressed their disapproval.
A 2014 lawsuit challenged the proposed rule, asserting that certain ingredients designated as Generally Recognized as Safe (GRAS)—such as calcium citrate, volatile oil of mustard, Olestra, and mycoprotein (also marketed as Quorn)—were known to pose potential hazards. However, this lawsuit did not influence the final rule. Furthermore, a 2013 study by the Pew Charitable Trusts revealed numerous conflicts of interest among 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 consulting firms or manufacturers.
Following the publication of the final rule last year, consumer and science organizations pledged to persist in their efforts. The recent lawsuit requests that a federal court deem the current GRAS rule unlawful and mandate a process involving more direct FDA regulation to assess the safety of ingredients and additives, including calcium citrate. The 2014 lawsuit was akin to this one but argued for a final rule that would ensure greater FDA oversight of the process.
Given the longstanding opposition from consumer and science groups, along with a 2010 U.S. Government Accountability Office report stating, “FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts certainly have substantial evidence to review in this matter. It will be intriguing to observe who joins the cause against this lawsuit, as the arguments and outcomes have the potential to instigate significant reforms in the food system.