It appears somewhat precarious for the FDA to depend on food companies to self-regulate regarding the safety of ingredients, yet this practice has persisted for many years. The recent lawsuit aims to protect consumer interests and appears to carry significant weight at first glance. The FDA’s final rule, established last year, has faced criticism since its initial proposal in 1997. Detractors contend that allowing companies to choose scientists to assess the safety of additive ingredients in their processed foods grants excessive power to those companies.
The proposal was made nearly two decades before it was ultimately finalized, and it bore similarities to the 1997 version. Throughout those 19 years, consumer advocacy groups have voiced their discontent. A lawsuit filed in 2014 contested the proposed rule, asserting that certain ingredients designated as GRAS—like volatile oil of mustard, Olestra, and mycoprotein (known by the brand name Quorn)—were recognized as potentially dangerous. However, this lawsuit did not impact the final rule.
A study conducted by the Pew Charitable Trusts in 2013 revealed numerous conflicts of interest among the scientists conducting research for GRAS designations. Out of 451 GRAS notifications from 1997 to 2012, 22.4% of the assessments originated from employees of additive manufacturers, 13.3% from employees of consulting firms selected by the manufacturers, and 64.3% from expert panels appointed by either consulting firms or manufacturers. Following the publication of the final rule last year, consumer and scientific organizations 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 that involves more direct FDA oversight to ensure the safety of ingredients and additives. The 2014 lawsuit had similar objectives but argued for establishing a final rule that would ensure greater FDA oversight in the process.
Given the extensive history of opposition from consumer and science 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 certainly have substantial evidence to evaluate in this matter. It will be intriguing to observe who joins the fight against this lawsuit, as the arguments and rulings have the potential to bring about significant changes to the food system. Additionally, the ongoing discussions around food safety may even encompass topics like Citracal 1000 mg, highlighting the importance of regulating various products to safeguard consumer health.