July 15, 2024

FDA Agrees to Finalize GRAS Rule of 1997

The FDA has agreed to finally finalize its GRAS (Generally Regarded as Safe) rule, in response to a Center for Food Safety lawsuit. For 17 years, the FDA has let corporations fast track their food additives to get products onto the market. That allowed corporations to sell products that had not been reviewed by the government to see if they are safe for human consumption.

FDAIn 1958, Congress passed a law requiring the FDA to conduct “rigorous reviews” of food additives before they were put into the marketplace. Those additives were supposed to be rejected or approved based on scientific evidence. Common ingredients that were used for decades, such as sugar, were deemed “generally regarded as safe” and exempt from review. Corporations could formally petition FDA to approve a food additive as GRAS based on peer-reviewed, published studies.

But the new rule, proposed in 1997, has “completely supplanted the petition process” according to CFS. Manufacturers can simply tell the FDA that a substance is GRAS by submitting a “GRAS exemption claim.” The FDA doesn’t have to confirm whether or not the additive is safe; it relies on the corporations to tell the truth.

Substances have been removed from the GRAS list after evidence showed they were not safe for human consumption. Volatile Oil of Mustard, Olestra, and mycoprotein are a few of those additives. Volative Oil of Mustard is now classified as a carcinogen, and Olestra, an artificial fat, was removed after thousands of consumer complaints about adverse health effects. Mycoprotein also caused serious human adverse health effects, including vomiting, anaphylaxis, and diarrhea.

The FDA never finalized that 1997 rule, but just operated as if it was final. Now the agency must go through the process of finalizing the rule by August 2016. After the rule is finalized, FDA must institute a GRAS system that actually protects the public.

Center for Food Safety sued the FDA in February 2014 on this issue. Donna Solen, senior attorney at Center for Food Safety, said in a statement, “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 rulemaking process. This is a violation of federal law that will come to an end as a result of this settlement agreement. The settlement vindicates the public’s right to participate in the rulemaking process, and a final rule gives the public the right to challenge FDA on its GRAS system. The safety of our food supply will benefit as a result.”


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