The U.S. Department of Health and Human Services (HHS) said on March 10 that it is seeking to terminate a rule allowing food manufacturers to use additives without formal regulatory approval.
The Generally Recognized As Safe (GRAS) rule allows companies to self-approve the inclusion of additives in food items without requiring a review and the approval of the U.S. Food and Drug Administration (FDA). The rule enables manufacturers to add an ingredient even if the FDA has not determined its safety.
On Monday, HHS Secretary Robert F. Kennedy Jr. directed the acting FDA commissioner to explore the possibility of eliminating the “self-affirmed GRAS pathway” available to companies, the department said in a statement.
“This will enhance the FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers,” HHS said.
As of now, manufacturers submit notices through the FDA’s GRAS notification program, which is not a mandatory process. The agency assesses 75 such submitted notices on average each year.
By eliminating the self-affirm pathway, companies would be required to publicly notify the FDA before introducing new ingredients to food items. The notification must include details such as underlying safety data and the intended use of the ingredients
A 2022 analysis conducted by the activist organization Environmental Working Group found that “nearly 99 percent of all food chemicals introduced since 2000 were greenlighted for use by the food and chemical industry” through the GRAS rule, without requiring FDA approval.
Out of the 766 new chemicals added to the food supply since 2000, only 10 involved companies petitioning the FDA to approve the ingredient.
Nine out of the 10 FDA petitions were filed before 2010. The only petition filed post-2010 was in 2018, EWG said.
“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” Kennedy said.
“Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”