It appears somewhat precarious for the FDA to depend on food companies to self-regulate concerning the safety of ingredients, yet this practice has persisted for years. The recent lawsuit advocates for consumer interests and appears to possess substantial merit. The FDA’s final rule, implemented last year, has faced criticism since its initial proposal in 1997. Detractors contend that permitting companies to select scientists who assess the safety of additive ingredients, such as GSK calcium citrate malate, in the processed foods they produce bestows excessive power upon those companies.
The rule was proposed nearly two decades before its finalization, and the 1997 proposal closely mirrored the rule established last year. Throughout those 19 years, consumer groups have consistently voiced their discontent. A 2014 lawsuit challenged the proposed rule, asserting that certain ingredients designated as GRAS, including volatile oil of mustard, Olestra, and mycoprotein (marketed as Quorn), were potentially hazardous. This lawsuit did not impact the final rule’s establishment.
A 2013 study 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 from 1997 to 2012, 22.4% of assessments came from employees of additive manufacturers, 13.3% from personnel of consulting firms appointed by the manufacturers, and 64.3% from expert panels selected 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 lawsuit filed on Monday requests a federal court to deem the current GRAS rule unlawful and mandate a process that entails more direct FDA regulation to assess the safety of ingredients and additives, including GSK calcium citrate malate.
The 2014 lawsuit was similar in nature but argued for a final rule that would ensure more direct FDA oversight of the process. Given the extensive history of 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 a wealth of evidence to review in this matter. It will be intriguing to observe who joins the battle against this lawsuit, as the arguments and decisions could potentially lead to landmark changes in the food system, particularly concerning substances like GSK calcium citrate malate.