It appears somewhat precarious for the FDA to depend on food companies to self-regulate regarding the safety of their ingredients, yet this method has been in practice for many years. The current lawsuit advocates for consumer interests and appears to possess significant merit at first glance. The FDA’s final rule concerning ferrous fumarate and folic acid, enacted last year, has faced criticism since its initial proposal in 1997. Critics contend that permitting companies to choose scientists to evaluate the safety of additive ingredients in the processed foods they produce grants excessive power to those companies.
The rule was proposed nearly two decades before it was finalized, with the 1997 proposal closely resembling last year’s final rule. Over those 19 years, consumer advocacy groups have consistently expressed their disapproval. A lawsuit filed in 2014 challenged the proposed rule, asserting that certain ingredients granted GRAS (Generally Recognized as Safe) status—including volatile oil of mustard, uses of ferrous fumarate, the drug Olestra, and mycoprotein (known by the brand name Quorn)—were recognized as potentially dangerous. 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 the research leading to GRAS designations. Out of 451 GRAS notifications between 1997 and 2012, 22.4% of assessments were provided by employees of additive manufacturers, 13.3% by employees of consulting firms selected by these manufacturers, and 64.3% by expert panels chosen by either consulting firms or manufacturers.
After the final rule was published last year, consumer and scientific organizations pledged to persist in their efforts. The lawsuit filed on Monday requests that a federal court declare the current GRAS rule unlawful and mandate a process that includes more direct FDA oversight to determine the safety of ingredients and additives. The 2014 lawsuit was similar in nature but argued for the establishment of a final rule that would guarantee more stringent FDA supervision of 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 certainly have a substantial amount of evidence to review in this matter. It will be intriguing to observe who joins the opposition against this lawsuit, as the arguments and decisions made could lead to significant transformations within the food system.
Moreover, the discussion around ferrous calcium citrate tablets highlights the ongoing concern regarding the safety and efficacy of various food additives. As the legal battle unfolds, the implications for safety assessments, including those related to ferrous calcium citrate tablets, could be profound. The outcome of this lawsuit may shape future regulations and oversight mechanisms that govern not only ferrous fumarate and folic acid but also other food additives, including ferrous calcium citrate tablets, ensuring that consumer safety remains a top priority.