FDA’s New GRAS Rules Give Companies Free Reign on Food Additives
Last week, the FDA announced its final rules for determining the safety status for food ingredients best known as GRAS (generally recognized as safe).
“Unlike food additives, substances determined to be GRAS are not subject to pre-market approval by regulators, thought they must meet the same safety standards as additives,” reports Bloomberg.
These substances can include pesticide and herbicide residues, artificial colors, and fortification supplements.
Under the new rules, data must meet FDA safety standards set by the Federal Food, Drug and Cosmetic Act in order to achieve GRAS standing, and the substances must also exhibit safety as “common knowledge” by the scientific community.
The FDA’s GRAS procedures also include voluntary notifications, meaning the companies are not forced to communicate their use of these substances with the agency, but rather “strongly encouraged” to notify the agency of GRAS determinations made on the substances.
Under the updated GRAS ruling, the FDA would be required to respond to these notifications within 180 days of filing if there were cause for concern about the substances.
But according to Senator Ed Markey (D-Mass), the ruling is inherently problematic if companies aren’t forced to disclose GRAS findings to the agency in the first place.
“The FDA missed an opportunity to strengthen the GRAS process by requiring mandatory reporting of GRAS substances,” he said in a statement. “I plan to explore whether a legislative remedy is needed to ensure the safety of our food supply.”
According to FoodNavigator-USA, toxicologists say there’s not cause for concern over the current GRAS rules—that it’s unlikely dangerous ingredients have “slipped through the net,” putting American health at risk.
But that’s assuming the chemicals are those already well documented and considered safe by the FDA.
“If the agency is unaware of what chemicals are being added to food, it cannot efficiently ensure that these additives—and the food that contains them—are safe,” Tom Neltner, chemicals policy director for the Environmental Defense Fund told FoodNavigator-USA.
The FDA maintains that its rules will only strengthen the nation’s food system and that they will improve pre-market evaluation of food substances.
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