Authored by Naveen Athrappully via The Epoch Times,

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.”

According to the 2022 EWG analysis, one of the additives in the GRAS list at the time was butylated hydroxyanisole (BHA), which the National Toxicology Program had identified as a potential carcinogen. BHA is widely used as a preservative in the meat industry.

Another additive was the green tea extract EGCG, which the group said “may increase risk of cancer but is classified as GRAS.”

In an interview with The Epoch Times, adjunct professor in the department of medicine at the Icahn School of Medicine at Mount Sinai, Mona Calvo, said that many of the commonly used food additives that have secured GRAS listing did so between 1970 and 1975, a time when “people could not foresee the situation today.”

During that period, people mostly consumed home-cooked meals that used natural ingredients, unlike today when ultra-processed foods are now part of everyday diets.

Dr. Jaime Uribarri, a nephrology specialist at the Icahn School of Medicine, said that “once an additive-containing packaged food is in the marketplace, the FDA does not have a mechanism for regularly testing its safety, such as through periodic sampling checks.”

The HHS crackdown on GRAS comes as President Donald Trump issued a presidential action last month establishing the Make America Healthy Again Commission.

One of the provisions includes assessing how the potential over-utilization of certain food ingredients and chemicals poses a health threat to children.

In a March 11 post on social media platform X, Kennedy said he had positive discussions with CEOs of food brands such as Kraft Heinz, General Mills, Tyson Foods, Kellogg’s, and Pepsi “on advancing food safety and radical transparency to protect the health of all Americans, especially our children.”

“We will strengthen consumer trust by getting toxins out of our food,” he wrote.