It appears somewhat precarious for the FDA to depend on food companies to self-regulate regarding the safety of their ingredients, yet this has been the established practice for years. The recent lawsuit is advocating for consumer interests and appears to have significant merit at first glance. The final rule issued by the FDA last year has faced criticism since its initial proposal in 1997. Critics argue that permitting companies to choose scientists to assess the safety of additive ingredients in processed foods grants them excessive authority. The proposal was made nearly two decades before being finalized, and the 1997 draft closely resembled last year’s rule. Throughout those 19 years, consumer advocacy groups have consistently expressed their disapproval.
In 2014, a lawsuit was filed against this proposed rule, asserting that several ingredients designated as GRAS (Generally Recognized as Safe)—such as volatile oil of mustard, Olestra, and mycoprotein (marketed under the brand name Quorn)—were potentially hazardous. This lawsuit did not influence the final rule. A study conducted by the Pew Charitable Trusts in 2013 highlighted numerous conflicts of interest among the scientists involved in research leading to GRAS designations. Out of 451 GRAS notifications between 1997 and 2012, 22.4% of the assessments originated from employees of additive manufacturers, 13.3% from employees of consulting firms selected by those manufacturers, and 64.3% from 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 opposition. The lawsuit filed on Monday requests a federal court to deem the current GRAS rule unlawful and to mandate a procedure that incorporates more direct FDA oversight in assessing the safety of ingredients and additives. The 2014 lawsuit was similar but argued for the necessity of a final rule that would ensure greater FDA oversight of the process.
Considering the extensive history of resistance from consumer and scientific groups, 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 considerable evidence to review in this case. It will be intriguing to observe who joins the battle against this lawsuit, as the arguments and rulings could potentially lead to landmark changes within the food system. Additionally, the implications for products like calcium citrate softgels could be significant, as increased regulation may affect their safety assessments and market presence. The ongoing developments in this legal battle may also encourage a reevaluation of how ingredients, including calcium citrate softgels, are classified within the food industry.