Fda

WASHINGTON >> U.S. health officials on Monday proposed a rule change that would require food manufacturers to notify regulators before introducing new ingredients or additives into processed or packaged foods.

The proposal would change a decades-old policy that advocates have called a regulatory loophole, blaming it 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 rationale for new ingredients, giving regulators the opportunity to investigate if they see a potential risk.

Currently companies can decide for themselves if an ingredient or additive is “generally recognized as safe,” or GRAS, and there is no requirement to notify or submit evidence to the FDA, although some firms do.

“Shifting to a mandatory notification system closes a decades-old information gap, giving the FDA the comprehensive visibility needed to enhance postmarket safety,” acting FDA Commissioner Kyle Diamantas told reporters on Monday.

The FDA will take comments on the proposal for 120 days.

Susan Mayne, former director of FDA’s food program, said the new requirement would give the FDA a clearer picture of the vast number of ingredients on the U.S. market, though only a small portion would actually undergo review.

“This is a reasonable first step towards a more complete inventory, but most self-affirmed GRAS ingredients will still not be reviewed for safety by the FDA, with food ingredient safety continuing to be risk-based,” said Mayne, who is now a public health expert at Yale University.

The FDA also plans to publish a list of company-submitted ingredients.

Mayne said Americans should understand that “inclusion on the list would not mean FDA thinks the ingredient is safe.”

In the U.S., an estimated 10,000 additives are allowed in food, including thickeners, preservatives and packaging ingredients.

— The Associated Press