It appears somewhat precarious for the FDA to depend on food companies to self-regulate concerning the safety of their ingredients, yet this practice has been in place for many years. The recent lawsuit aims to protect consumer interests and appears to have considerable merit at first glance. Since its proposal in 1997, the FDA’s final rule, established last year, has faced significant criticism. Detractors contend that allowing companies to choose scientists responsible for evaluating the safety of additive ingredients in their processed foods grants these companies excessive authority. Notably, the rule was proposed nearly two decades prior to its finalization, with the 1997 proposal closely resembling the rule implemented last year. Over these 19 years, consumer advocacy groups have consistently voiced their objections.
A lawsuit initiated in 2014 challenged the proposed rule, asserting that several ingredients designated as Generally Recognized as Safe (GRAS)—such as volatile oil of mustard, Olestra, and mycoprotein (marketed as Quorn)—were recognized as potentially harmful. This lawsuit, however, did not influence the final ruling. Furthermore, a 2013 study by the Pew Charitable Trusts highlighted numerous conflicts of interest among the scientists involved in GRAS research. Out of 451 GRAS notifications from 1997 to 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 advocacy. The lawsuit filed on Monday requests a federal court to deem the current GRAS rule unlawful and to implement a procedure that entails more direct FDA regulation for assessing the safety of ingredients and additives. The 2014 lawsuit was similar in nature but argued for the establishment of a final rule that would ensure enhanced FDA oversight throughout the process.
Given the longstanding opposition from consumer and scientific entities, along with a 2010 report from the U.S. Government Accountability Office stating that “FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts have substantial evidence to evaluate in this matter. It will be intriguing to observe who joins the battle against this lawsuit, as the resulting arguments and decisions could potentially lead to landmark transformations in the food system.
In this context, it’s interesting to note products like Solaray Cal Mag Citrate 2:1, which consumers often seek for their health benefits. The inclusion of such supplements underscores the importance of transparency and regulation in food safety. As discussions about the GRAS rule continue, the need for reliable and safe dietary supplements, such as Solaray Cal Mag Citrate 2:1, becomes even more critical for informed consumer choices.