FDA Moves to Close Food Additive Safety Loophole

Federal regulators proposed a rule Monday requiring food manufacturers to notify the FDA before introducing new ingredients deemed generally recognized as safe.

By Springs Daily Staff, Newsroom
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Federal health officials moved Monday to close a regulatory gap that has allowed thousands of food ingredients to enter the U.S. market without government review, a change that could affect the packaged and processed foods sold on grocery shelves across Colorado Springs and the country.

U.S. health officials proposed a rule change that would require food manufacturers to notify regulators before introducing new ingredients or additives into processed or packaged foods, targeting a decades-old policy that advocates have called a regulatory loophole and blamed for allowing thousands of unvetted ingredients into the U.S. food supply.

Under the proposed rule from the Food and Drug Administration, companies would have to document and submit their safety findings for new ingredients, giving regulators the opportunity to investigate if they see a potential safety risk. Currently, companies can decide for themselves if an ingredient or additive is "generally recognized as safe" and there is no requirement to notify or submit evidence to the FDA, although some do.

At least 111 substances of unknown safety have been added to foods, drinks and supplements sold in the United States without alerting the FDA, according to a study released this March. In the U.S., an estimated 10,000 additives are currently allowed in food, including thickeners, preservatives and packaging ingredients.

Starting in 1997, the FDA began allowing companies to independently determine that a new additive is safe based on publicly available scientific evidence and the consensus of qualified experts. However, the list of products deemed GRAS by companies grew to include many synthetic and natural additives, all incorporated into the food supply without independent review. The process has created a "secret GRAS loophole," according to the consumer advocacy group Center for Science in the Public Interest, that "undermines the integrity of our food safety system."

Acting FDA Commissioner Kyle Diamantas stressed Monday that the new policy would not require all new ingredients to undergo FDA review, saying that type of mandatory review would need to be enacted by Congress in order to rewrite FDA's authority over the food supply. Under the proposal, the FDA would be expected to review new ingredient submissions within 180 days, and if regulators have safety concerns they could request additional information from manufacturers or ask that they delay introducing the ingredient.

Legislation underway in Congress would grant FDA more authority to require studies for certain food additives to stay on the market, and the administration said it is working with Congress "on legislative options to further address the GRAS process and nutrition reform," noting those talks have been bipartisan. Food industry officials contend their internal reviews of additives are as rigorous as the FDA's own processes.

In a related but separate move, the FDA said it completed work on the federal government's first-ever definition of ultraprocessed food but did not release any details or the proposed language, saying it has submitted the definition to the White House for further review. The definition is still working through review with multiple federal agencies including the U.S. Department of Agriculture, and there have been concerns, primarily from the USDA, that the definition could be overly broad and inadvertently classify too many foods as ultraprocessed, according to three people familiar with internal discussions.

Neither of Monday's announcements are likely to immediately impact American diets, which are packed with fats, sodium and sugar and are blamed for a host of chronic diseases such as obesity, diabetes and heart disease.

The FDA will take public comments on the proposed GRAS notification rule for 120 days, and the fate of the ultraprocessed food definition remains pending White House and interagency review.

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