It appears somewhat precarious for the FDA to depend on food companies to self-regulate when it comes to the safety of ingredients, yet this approach has been the norm for many years. The recent lawsuit aims to protect consumer interests and seems to hold considerable merit at first glance. Since the FDA’s final rule was established last year, it has faced criticism, having initially been proposed as far back as 1997. Critics argue that allowing companies to choose scientists to evaluate the safety of the additive ingredients in their processed foods grants these companies excessive authority.
The rule regarding the use of calcium citrate with vitamin D combination was suggested nearly two decades before its finalization. The proposal made in 1997 closely resembled the rule that was implemented last year. Over those 19 years, consumer advocacy groups have consistently voiced their disapproval. A lawsuit initiated in 2014 challenged the proposed rule, asserting that some ingredients classified as GRAS—such as volatile oil of mustard, Olestra, and mycoprotein (known by the brand name Quorn)—were recognized as potentially dangerous. However, this lawsuit did not impact the final rule.
A study by the Pew Charitable Trusts in 2013 highlighted numerous conflicts of interest among the scientists involved in the research leading to GRAS designations. Out of 451 GRAS notifications from 1997 to 2012, 22.4% of assessments were conducted by employees of additive manufacturers, 13.3% by consulting firm employees chosen by the manufacturers, and 64.3% by expert panels selected 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 recently requests a federal court to deem the current GRAS rule unlawful and to implement a process that ensures more direct FDA oversight in determining the safety of ingredients and additives.
The 2014 lawsuit echoed similar concerns but argued for a final rule that would guarantee more stringent FDA scrutiny of the process. Given the extensive history of dissent from consumer and science groups, coupled with a 2010 U.S. Government Accountability Office report stating that “FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts have substantial evidence to consider in this matter. It will be intriguing to observe who joins the battle against this lawsuit, as the ensuing arguments and decisions could lead to transformative changes in the food system, particularly regarding the regulation of ingredients like calcium citrate with vitamin D combination.