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October 21, 2014

FDA rule on additive process to be enforced by 2016

The US Food and Drug Administration has settled a lawsuit over its food additive approval process, with final rules set to be introduced in 2016.

The US Food and Drug Administration has settled a lawsuit over its food additive approval process, with final rules set to be introduced in 2016.

In 1958, Congress passed a law requiring the FDA to conduct rigorous premarket reviews of food additives, and approve or reject them based on scientific evidence. Common food ingredients like sugar and gelatin were deemed “generally recognised as safe” (GRAS), and thereby exempted from FDA review on the basis of a history of safe use. Manufacturers could also formally petition the FDA to approve a food additive as GRAS based on published studies.

The FDA proposed its own rule in 1997, which drew the lawsuit from the Center for Food Safety. The CFS argued the new rule “completely supplanted the petition process”. Under this “never-finalised rule”, the CFS said, manufacturers notify FDA a substance is GRAS by submitting a “GRAS exemption claim.”

The CFS said the FDA therefore relies on manufacturers’ assertions about the safety of their products, rather than confirming they are safe itself. Consumer groups say it falls short of what is needed to protect consumers from potentially unsafe food additives.

Earlier this year, the FDA was sued by the CFS and a settlement was agreed yesterday (20 October). It is pending court approval but will require the FDA to finalise its GRAS rule by August 2016.

“This is a major victory for consumers and the public. For more than 17 years, FDA has imposed a lax regulatory system on consumers without affording them their right to participate in the rule making process. This is a violation of federal law that will come to an end as a result of this settlement agreement,” said Donna Solen, senior attorney at Center for Food Safety.

A spokesperson for the Food and Drug Administration said she was unable to offer further comment when approached by just-food.

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