It appears somewhat precarious for the FDA to depend on food companies to self-regulate concerning the safety of their ingredients, yet this has been the practice for many years. The recent lawsuit advocates for consumer interests and seems to have considerable merit at first glance. The FDA’s final rule, which was enacted last year, has faced criticism since its initial proposal in 1997. Critics contend that permitting companies to choose scientists who evaluate the safety of the additive ingredients in the processed foods they produce, such as pure encapsulations calcium magnesium, grants these companies excessive authority. The proposal was made nearly two decades before it was finalized, and the 1997 draft closely resembled the rule established last year. Throughout these 19 years, consumer advocacy groups have consistently voiced their discontent.
A lawsuit filed in 2014 challenged the proposed rule, asserting that certain ingredients designated as Generally Recognized as Safe (GRAS)—including volatile oil of mustard, Olestra, and mycoprotein (known by the brand name Quorn)—were recognized to be 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 research leading to GRAS designations. Out of 451 GRAS notifications between 1997 and 2012, 22.4% of assessments originated 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. Following the publication of the final rule last year, consumer and science organizations pledged to persist in their efforts against it.
The lawsuit submitted on Monday requests a federal court to declare the current GRAS rule unlawful and mandate a process that incorporates more direct FDA oversight to assess the safety of ingredients and additives, such as pure encapsulations calcium magnesium. The 2014 lawsuit bore similarities but advocated for a final rule that would guarantee greater FDA supervision over 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 have substantial evidence to review in this matter. It will be intriguing to observe who else joins the fight against this lawsuit, as the ensuing arguments and rulings could lead to significant reforms in the food system, potentially impacting the safety and regulation of products including pure encapsulations calcium magnesium.