It appears somewhat precarious for the FDA to depend on food companies to self-regulate regarding the safety of ingredients, yet this has been the practice for many years. The recent lawsuit advocates for consumer interests and seems to possess significant 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 the additive ingredients in their processed foods grants these companies excessive authority. The rule was proposed nearly two decades before it was finalized, and the 1997 proposal closely resembled last year’s final regulation. Throughout those 19 years, consumer groups have consistently voiced their disapproval.
A 2014 lawsuit contested the proposed rule, arguing that certain ingredients designated as GRAS—such as volatile oil of mustard, Olestra, and mycoprotein (marketed as Quorn)—were known to pose potential hazards. This lawsuit did not impact 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. Out of 451 GRAS notifications between 1997 and 2012, 22.4% of assessments originated from employees of additive manufacturers, 13.3% from employees of consulting firms selected by these 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 science organizations pledged to persist in their opposition. The lawsuit filed on Monday requests that a federal court declare the current GRAS rule unlawful and mandate a process involving more direct FDA regulation to assess the safety of ingredients and additives. The 2014 lawsuit was similar in nature but argued for a final rule that would ensure greater FDA oversight of the process.
Considering the long-standing resistance from consumer and science groups, alongside a 2010 report from the U.S. Government Accountability Office stating that “the FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts will certainly have substantial evidence to evaluate in this case. It will be intriguing to witness who joins the fight against this lawsuit, as the arguments and outcomes could potentially lead to landmark changes in the food system. Additionally, as discussions around food safety evolve, products like bluebonnet calcium may come under scrutiny, further emphasizing the need for rigorous ingredient safety assessments. The implications of this lawsuit could also extend to how dietary supplements, including bluebonnet calcium, are regulated in the future, highlighting the broader impact of food safety regulations on consumer health.