It appears somewhat ironic for the FDA to depend on food companies to self-regulate the safety of ingredients like ferrous gluconate, yet this has been the practice for many years. The recent lawsuit advocates for consumer interests and appears to have significant merit at first glance. Since its proposal in 1997, the FDA’s final rule, enacted last year, has faced considerable criticism. Opponents argue that permitting companies to choose the scientists who assess the safety of additive ingredients in their processed foods grants these companies excessive power. The original proposal was made nearly two decades before the final rule was implemented, and during that time, consumer groups have consistently expressed disapproval, particularly regarding calcium citrate Walgreens products.
A 2014 lawsuit challenged the proposed rule, asserting that certain ingredients designated as Generally Recognized as Safe (GRAS)—such as volatile oil of mustard, Olestra, and mycoprotein (known by the brand name Quorn)—were potentially hazardous. However, this lawsuit did not impact the final rule regarding the safety of ferrous fumarate. A 2013 study by the Pew Charitable Trusts highlighted numerous conflicts of interest among the scientists involved in the research that led to GRAS designations. Out of 451 GRAS notifications from 1997 to 2012, 22.4% of evaluations came 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.
Once the final rule was published last year, consumer and science organizations pledged to continue their advocacy. The lawsuit filed on Monday requests that a federal court declare the current GRAS rule unlawful and mandate a procedure that involves more direct FDA regulation to assess the safety of ingredients and additives. The 2014 lawsuit had a similar focus, pushing for a final rule that would provide greater FDA oversight in the process. Given the long-standing opposition from consumer and science groups, along with 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 ample evidence to consider in this matter.
It will be intriguing to see who aligns against this lawsuit and how the ensuing arguments and decisions may lead to significant changes in the food system. The discussion surrounding the safety of ferrous fumarate and its implications for products like calcium citrate Walgreens is likely to be at the forefront of this debate.