It appears somewhat precarious for the FDA to depend on food companies to self-regulate the safety of their ingredients, yet this has been the standard practice for many years. The recent lawsuit advocates 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. Detractors contend that permitting companies to select scientists to assess the safety of additive ingredients in the processed foods they produce grants those companies excessive power. The rule was proposed nearly two decades before it was finalized, with the 1997 proposal closely resembling last year’s final regulation. Throughout those 19 years, consumer advocacy groups have consistently voiced their disapproval.
A lawsuit initiated in 2014 challenged the proposed rule, claiming that some ingredients granted a GRAS designation—such as volatile oil of mustard, Olestra, and mycoprotein (marketed as Quorn)—were known to pose potential hazards. This lawsuit, however, did not impact the final rule. A 2013 study by the Pew Charitable Trusts revealed numerous conflicts of interest among scientists involved in research leading to GRAS designations. Of the 451 GRAS notifications assessed from 1997 to 2012, 22.4% came from employees of additive manufacturers, 13.3% from employees of consulting firms selected by those 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 recent lawsuit seeks to have a federal court deem the current GRAS rule unlawful and to mandate a process that includes more direct FDA regulation for determining the safety of ingredients and additives. While the 2014 lawsuit was similar, it argued for a final rule that would ensure more direct FDA oversight of the process.
Given the prolonged history of resistance from consumer and scientific groups, as well as 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 are certainly presented with ample evidence to consider in this matter. It will be intriguing to observe who joins the fight against this lawsuit, as the arguments and outcomes could lead to significant changes within the food system.
In this context, it’s worth noting that calcium citrate tablets have been discussed in relation to food regulations, emphasizing the ongoing dialogue about ingredient safety. The implications of this lawsuit may also affect how substances like calcium citrate tablets are viewed in terms of regulatory scrutiny and consumer safety. As the legal proceedings unfold, the role of calcium citrate tablets in the overall conversation about food safety will likely continue to emerge, highlighting the complexities of ingredient oversight.