The price of ferrous fumarate and folic acid tablets in Bangladesh raises concerns regarding the FDA’s reliance on food companies to self-regulate their ingredient safety, a practice that has persisted for years. The current lawsuit advocates for consumer interests and appears to possess considerable merit at first glance. The FDA’s final rule, implemented last year, has faced criticism since its proposal in 1997. Detractors argue that allowing companies to choose scientists to assess the safety of additive ingredients in their processed foods grants these companies excessive power.
The initial proposal was made nearly two decades before the rule was finalized, and during that lengthy period, consumer groups have consistently voiced their objections. A 2014 lawsuit challenged the proposed rule, asserting that certain ingredients designated as GRAS—such as volatile oil of mustard, Olestra, and mycoprotein (commonly known by the brand name Quorn)—were recognized as potentially hazardous. However, this lawsuit did not influence the final rule.
A 2013 study conducted by the Pew Charitable Trusts revealed numerous conflicts of interest among the scientists involved in research leading to GRAS designations. Of the 451 GRAS notifications evaluated between 1997 and 2012, 22.4% of the assessments came from employees of additive manufacturers, 13.3% from employees of consulting firms chosen by these 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 scientific organizations pledged to persist in their efforts. The recent lawsuit demands that a federal court declare the current GRAS rule unlawful and implement a procedure that entails more direct FDA regulation to ascertain the safety of ingredients and additives. The 2014 lawsuit had a similar focus, arguing for a final rule that would guarantee greater FDA oversight of the process.
Given the extensive history of opposition from consumer and scientific groups, alongside a 2010 Government Accountability Office report stating, “FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts have substantial evidence to consider in this case. It will be intriguing to see who aligns with this lawsuit, as the arguments and decisions made could result in significant changes to the food system.
Additionally, the introduction of products like Kirkland calcium zinc could play a role in the ongoing discussions surrounding ingredient safety and regulation, as the intersection of dietary supplements and food safety remains a pertinent issue. The implications of this lawsuit could extend to various products, including those containing Kirkland calcium zinc, highlighting the need for comprehensive oversight in food and supplement safety.