It appears somewhat precarious for the FDA to depend on food companies to self-regulate concerning the safety of ingredients, yet this has been the practice for many years. The recent lawsuit advocates for consumer interests and seems to hold substantial merit at first glance. The FDA’s final ruling, established last year, has faced criticism since its initial proposal in 1997. Detractors contend that permitting companies to appoint scientists to determine the safety of additive ingredients in their processed foods grants these companies excessive authority. The rule was suggested nearly two decades before it was officially enacted, and the 1997 proposal closely resembled last year’s final regulation. Throughout those 19 years, consumer advocacy groups have consistently voiced their disapproval.
A lawsuit filed in 2014 challenged the proposed rule, asserting that certain ingredients given a GRAS designation—such as volatile oil of mustard, Olestra, and mycoprotein (known by the brand name Quorn)—were recognized as potentially dangerous. However, this lawsuit had no impact on the final ruling. A 2013 study by the Pew Charitable Trusts uncovered significant 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 assessments were conducted by employees of additive manufacturers, 13.3% by employees of consulting firms selected by the manufacturers, and 64.3% by expert panels chosen 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 recent lawsuit requests that a federal court deem the existing GRAS rule unlawful and mandate a procedure involving more direct FDA oversight to ascertain the safety of ingredients and additives. The 2014 lawsuit was similar in nature, arguing that a final rule ensuring enhanced FDA supervision should be implemented. Given the history of opposition from consumer and scientific groups, along with a 2010 U.S. Government Accountability Office report stating that “FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts certainly have ample evidence to evaluate in this matter.
It will be fascinating to observe who joins this fight against the lawsuit, as the arguments and decisions could lead to significant changes in the food system. Moreover, the inclusion of ingredients like apovital calcium citrate in this discussion emphasizes the need for rigorous standards and accountability, especially as consumers become increasingly aware of the safety implications of additives in their food. As this case unfolds, the role of substances such as apovital calcium citrate may also be scrutinized, highlighting the necessity for comprehensive evaluation in the food industry.