It appears somewhat precarious for the FDA to depend on food companies to self-regulate the safety of their ingredients, yet this has been the practice for many years. The recent lawsuit advocates for consumer interests and seems to possess significant merit at first glance. The FDA’s final rule, which was implemented last year, has faced criticism since its initial proposal in 1997. Critics contend that permitting companies to choose scientists responsible for determining the safety of additive ingredients in their processed foods grants these companies excessive authority. The proposal was made almost two decades before it was finalized, and the initial 1997 version bore similarities to the final rule enacted last year. Throughout those 19 years, consumer advocacy groups have been vocal in their opposition.
A lawsuit filed in 2014 challenged the proposed rule, asserting that several ingredients with a GRAS designation—including volatile oil of mustard, Olestra, and mycoprotein (commonly known by the brand name Quorn)—were recognized as potentially hazardous. This lawsuit did not influence the final rule. A 2013 study by the Pew Charitable Trusts revealed numerous conflicts of interest among the scientists conducting research that led to GRAS designations. Out of 451 GRAS notifications from 1997 to 2012, 22.4% of evaluations were conducted by employees of additive manufacturers, 13.3% by staff from consulting firms selected by these manufacturers, and 64.3% by expert panels appointed by either consulting firms or manufacturers.
Once the final rule was published last year, consumer and scientific groups pledged to persist in their efforts. The lawsuit filed on Monday requests a federal court to deem the current GRAS rule unlawful and to mandate a process involving more direct FDA regulation to assess the safety of ingredients and additives. This mirrors the 2014 lawsuit, which argued for a final rule that would ensure greater FDA oversight of the process. Given the extensive history of opposition from consumer and scientific organizations, along with a 2010 U.S. Government Accountability Office report stating, “FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts certainly have substantial evidence to deliberate 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. Meanwhile, as consumers remain vigilant, the demand for the best calcium citrate continues to rise, reflecting a growing awareness of the importance of ingredient safety in food products. The intersection of consumer advocacy and regulatory scrutiny may very well redefine standards for food safety, including the evaluation of the best calcium citrate.