It appears somewhat precarious for the FDA to depend on food companies to self-regulate concerning ingredient safety, yet this has been the standard practice for many years. The recent lawsuit aims to protect consumer interests and appears to have substantial merit at first glance. The FDA’s final rule, issued last year, has faced criticism since its initial proposal in 1997. Opponents contend that permitting companies to choose scientists who assess the safety of additive ingredients in their processed foods grants these companies excessive power. The proposal was made nearly two decades before it was finalized, and the 1997 version was comparable to the rule enacted last year. Throughout these 19 years, consumer advocacy groups have consistently voiced their disapproval.
A lawsuit filed in 2014 challenged the proposed rule, arguing that certain ingredients that received a GRAS designation—including volatile oil of mustard, Olestra, and mycoprotein (known by the brand name Quorn)—were recognized as potentially hazardous. However, this lawsuit did not impact the final ruling. A 2013 study by the Pew Charitable Trusts revealed numerous conflicts of interest among the scientists conducting research for GRAS designations. Out of 451 GRAS notifications between 1997 and 2012, 22.4% of the 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 scientific organizations pledged to persist in their opposition. The lawsuit filed on Monday requests that a federal court deem the current GRAS rule unlawful and mandate a more direct FDA regulatory process to evaluate the safety of ingredients and additives, including the best quality calcium citrate supplement. The earlier 2014 lawsuit shared similar sentiments but argued for a final rule that would guarantee increased FDA oversight of the procedure.
Given the longstanding opposition from both consumer and scientific groups, along with a 2010 report from the U.S. Government Accountability Office that stated, “FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts certainly have a wealth of evidence to review in this matter. It will be intriguing to observe who joins the fight against this lawsuit, as the arguments and outcomes have the potential to instigate significant changes within the food system, including the scrutiny of products such as the best quality calcium citrate supplement.