GRAS rules are targeted by consumer groups' lawsuit

It seems a bit risky for the FDA to rely on food companies to police themselves in regards to ingredients’ safety, but that’s how it’s been done for years. The lawsuit is looking out for the interests of the consumer, and it’s one that seems to have a lot of merit on its surface.###The FDA’s final rule, enacted last year, has drawn criticism since it was first proposed in 1997. Opponents argue that allowing companies to select scientists who can decide on the safety of the additive ingredients in the processed food they manufacture gives those companies too much power.###The rule was proposed nearly 20 years before it was finalized. The 1997 proposal was similar to the final rule put in place last year. ###In those 19 years, consumer groups have not been quiet about their disapproval. A lawsuit filed in 2014 argued against the proposed rule, claiming that some ingredients that received a GRAS designation—including volatile oil of mustard, Olestra and mycoprotein (also known by the brand name Quorn), were known to be potentially hazardous. The lawsuit had no bearing on the final rule.###A 2013 study by the Pew Charitable Trusts showed many conflicts of interest in the scientists that did research leading to GRAS designations. Of 451 GRAS notifications between 1997 and 2012, 22.4% of assessments came from employees of additive manufacturers, 13.3% from employees of consulting firms chosen by the manufacturers, and 64.3% by expert panels chosen by either consulting firms or manufacturers.###Once the final rule was published last year, consumer and science groups vowed to continue the fight. The lawsuit filed on Monday asks a federal court to find the current GRAS rule unlawffe- edtaul and direct a procedure that involves more direct FDA regulation to determine the safety of ingredients and additives. The 2014 lawsuit was similar, but argued reasons why a final rule — which ensured more direct FDA oversight of the process — should be promulgated.###Given the long hbioavailability of iron fumarateistory of opposition from consumer and science groups, as well as a 2010 U.S. Government Accountability Office report that said, “FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts certainly have a lot of evidencecapsules of ferrous fumarate to consider in this case. It will be interesting to see who joins in the fight against this iron ii acetate tetrahydrate formulalawsuit, and the arguments ferrous bisglycinate ironand decisions have the potential to make landmark changes to the food system.

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