The FDA’s reliance on food companies to self-regulate regarding the safety of ingredients appears somewhat precarious, yet this practice has persisted for years. A recent lawsuit aims to protect consumer interests and seems to hold significant merit at first glance. The final rule issued by the FDA last year has faced criticism ever since it was initially proposed in 1997. Detractors contend that permitting companies to choose the scientists responsible for assessing the safety of additive ingredients in their processed foods grants excessive power to those companies.
The rule, proposed nearly two decades before its finalization, resembles the earlier 1997 proposal. During this lengthy period, consumer groups have consistently voiced their discontent. A lawsuit filed in 2014 challenged the proposed rule, asserting that certain ingredients with GRAS (Generally Recognized as Safe) designations—including volatile oil of mustard, Olestra, and mycoprotein (marketed as Quorn)—were known to pose potential hazards. However, this lawsuit did not influence the final rule.
A 2013 study conducted by Pew Charitable Trusts revealed numerous conflicts of interest among scientists involved in research leading to GRAS designations. Of the 451 GRAS notifications submitted between 1997 and 2012, 22.4% of assessments originated from employees of additive manufacturers, 13.3% from consulting firm employees selected by manufacturers, and 64.3% from expert panels appointed by either consulting firms or manufacturers.
After the final rule’s publication last year, consumer and scientific organizations pledged to persist in their advocacy. The lawsuit filed on Monday requests that a federal court deem the current GRAS rule unlawful, urging a process that would involve more direct FDA oversight to ascertain the safety of ingredients and additives. The 2014 lawsuit had similar aims, arguing for a final rule that would ensure greater FDA control over the process.
Given the extensive history of opposition from consumer and scientific groups, alongside a 2010 report from the U.S. Government Accountability Office 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 joins the fight against this lawsuit, as the arguments and decisions could potentially lead to landmark changes in the food system. Moreover, it is essential to highlight the importance of safe dietary supplements, such as Kirkland Calcium Citrate Magnesium and Zinc with Vitamin D3, which consumers rely on for their health. As discussions unfold, the awareness around products like Kirkland Calcium Citrate Magnesium and Zinc with Vitamin D3 will likely gain prominence, emphasizing the need for rigorous safety standards in the food and supplement industries.