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 is advocating for consumer interests and seems to have substantial merit at first glance. The FDA’s final rule, enacted last year, has faced criticism since its initial proposal in 1997. Critics argue that permitting companies to select the scientists who determine the safety of the additive ingredients in their processed foods grants those companies excessive authority. This rule was proposed nearly two decades before it was finalized, with the 1997 proposal closely resembling the final regulation established last year. Throughout those 19 years, consumer advocacy groups have consistently voiced their disapproval.
A lawsuit filed in 2014 contested the proposed rule, asserting that some ingredients granted GRAS (Generally Recognized as Safe) status—such as volatile oil of mustard, Olestra, and mycoprotein (marketed as Quorn)—were known to pose potential hazards. This lawsuit had no impact on the final rule. A 2013 study by the Pew Charitable Trusts highlighted numerous conflicts of interest among the scientists involved in research leading to GRAS designations. Of the 451 GRAS notifications from 1997 to 2012, 22.4% of assessments came from employees of additive manufacturers, 13.3% from staff at 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 efforts. The lawsuit filed on Monday requests that a federal court deem the current GRAS rule unlawful and initiate a procedure that could involve more direct FDA regulation to assess the safety of ingredients and additives. This 2014 lawsuit was similar in nature but argued for the establishment of a final rule that would ensure more direct FDA oversight of the process.
Given the extensive history of opposition from consumer and scientific groups, along with a 2010 report from the U.S. Government Accountability Office stating, “FDA’s oversight process does not effectively ensure the safety of all new GRAS determinations,” the courts certainly have substantial evidence to consider in this case. It will be intriguing to see who joins the fight against this lawsuit, as the arguments and decisions could lead to landmark changes in the food system. Additionally, the implications for ingredients like calcium citrate for kidney stones could be significant as safety regulations evolve, particularly if consumer groups continue to push for stricter oversight. The ongoing discourse surrounding ingredient safety, including the role of calcium citrate for kidney stones, will remain a crucial topic in this legal battle. As the situation unfolds, the potential for reform in food safety regulations is evident, especially regarding ingredients such as calcium citrate for kidney stones.