Blog: Dean BestUS campaigners lobby FDA on GRAS rules

Dean Best | 16 April 2015

Four campaign groups in the US have urged the country's Food and Drug Administration to close a "loophole" in regulations on food additives and bring the rules - due to be finalised by August next year - in line with policies first drawn up over 50 years ago.

The FDA is set to finalise regulations on which ingredients are deemed "generally recognised as safe" (GRAS).

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. The FDA proposed its own rule in 1997, which prompted legal action 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." Last October, the two sides settled the suit, with the FDA set to finalise the rules next summer.

"The commitment by FDA to finish this rule by the end of next summer means that - after nearly two decades - the issue of GRAS will be decided as a matter of federal law. Yet the intervening 18 years have amply demonstrated that the program is a failure," Laura MacCleery, chief regulatory affairs attorney at the Center for Science in the Public Interest, one of the four campaign groups, told just-food. "We commented to ensure that FDA fully considers its obligations under the 1958 law to assure the safety of the food supply as it considers how to move forward on GRAS substances and to let the agency know that continuing under this system would be illegal."

In an 80-page regulatory comment filed yesterday, the CSPI - along with consumer watchdog Consumers Union, public health and environment campaign NGO Environmental Working Group and environmental advocacy group the Natural Resources Defense Council -  told the FDA its process for determining what substances are GRAS in agency parlance violates the 1958 law that requires FDA oversight of whether ingredients are safe before they can be used in food.

"Congress sensibly intended that certain common ingredients already in wide use, like vinegar or baking soda, would be exempt from the pre-market testing requirements it set up for food additives," MacCleery said. "But FDA has let companies completely abuse that limited exemption and hide the use of new food chemicals from regulators and the public."

Erik Olson, director of the NRDC's health programme, added: "The FDA’s job is to ensure the safety of our food supply; it should be doing much more to protect our health - not outsourcing decisions on the safety of thousands of chemicals in our food to industry."

In response, the FDA said under the current voluntary arrangements manufacturers are advocated to tell the regulator the ingredients they have deemed are GRAS. "FDA encourages companies to notify FDA about food ingredients that the company has determined are GRAS. While notification is not required, it is a way for companies to ensure that their GRAS determinations are based on sound data and information," a spokesperson said.

The spokesperson said the FDA was continuing to work on regulations to "formalise" the voluntary programme. "Under a settlement in a suit brought last year by the Center for Food Safety, FDA agreed to issue that regulation by August 31, 2016. FDA will consider carefully all comments submitted to it regarding the GRAS notification regulation currently under development."





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