It appears somewhat precarious for the FDA to depend on food companies to self-regulate regarding the safety of their ingredients, but this has been the practice for many years. A recent lawsuit advocates for consumer interests and seems to hold considerable merit at first glance. The FDA’s final rule, implemented last year, has faced criticism since it was first proposed in 1997. Detractors contend that allowing companies to choose scientists who assess the safety of the additive ingredients in their products, such as Swanson Calcium Citrate, grants these companies excessive authority.
The proposed rule lingered for nearly two decades before being finalized. The original proposal from 1997 closely resembled the final rule established last year. Throughout those 19 years, consumer advocacy groups have consistently voiced their discontent. A lawsuit filed in 2014 challenged the proposed rule, indicating that certain ingredients that received a GRAS designation—including volatile oil of mustard, Olestra, and mycoprotein (commonly known by the brand name Quorn)—were recognized as potentially dangerous. However, this lawsuit did not influence the final rule.
A 2013 study conducted by the Pew Charitable Trusts highlighted numerous conflicts of interest among the scientists involved in research leading to GRAS designations. Of the 451 GRAS notifications from 1997 to 2012, 22.4% of assessments were made by employees of additive manufacturers, 13.3% by employees of consulting firms selected by these manufacturers, and 64.3% by expert panels chosen by consulting firms or manufacturers. Following the release of the final rule last year, consumer and scientific organizations pledged to persist in their efforts. The lawsuit filed on Monday requests that a federal court declare the current GRAS rule unlawful and mandate a more rigorous FDA regulatory process for evaluating the safety of ingredients and additives, including those like Swanson Calcium Citrate.
The 2014 lawsuit was analogous, advocating for a final rule that would ensure more stringent FDA oversight of the process. Considering the extensive history of opposition 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 certainly have substantial evidence to deliberate in this case. It will be intriguing to observe who joins the opposition against this lawsuit, as the ensuing arguments and decisions could lead to significant changes in the food system.