WASHINGTON — The US Department of Health and Human Services has ordered the Food and Drug Administration to find a “pathway” to eliminate the self-affirmed generally recognized as safe status for food and beverage ingredients.

“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 US food supply without notification to the FDA or the public,” said Robert F. Kennedy Jr., secretary of the HHS. “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.”  

Eliminating the self-affirmation process would require companies seeking to introduce new ingredients in foods to publicly notify the FDA of their intended use of such ingredients, along with underlying safety data, before they are introduced in the food supply. Currently, the FDA encourages manufacturers to submit GRAS notices through the agency’s GRAS notification program, but industry can self-affirm that the use of a substance is GRAS without notifying the FDA.

“The FDA is committed to further safeguarding the food supply by ensuring the appropriate review of ingredients and substances that come into contact with food,” said Acting FDA Commissioner Sara Brenner, MD, MPH. “The FDA will continue to follow our authorities and leverage our resources to protect the health of consumers to ensure that food is a vehicle for wellness.”

The FDA’s GRAS program has been a focal point of discussion for the past six months. For example, in early September an article published in The New England Journal of Medicine encouraged the FDA to take a more active role in the approval of new ingredients.

Response to the HHS announcement has been mixed with industry groups saying they will work with the FDA and public health advocates saying the FDA needs to do more.

“The consumer packaged goods industry is committed to maintaining the integrity of America’s food supply and consumer transparency,” said Sarah Gallo, senior vice president of product policy for the Consumer Brands Association,” Washington. “FDA’s generally recognized as safe process plays an important role in enabling companies to innovate to meet consumer demand. As the administration looks to revise GRAS, we stand ready to work with agency experts on continued analysis of safe ingredients and increase consumer transparency.”

The Environmental Working Group (EWG), a group focused on public health advocacy, encouraged the FDA to go farther.

“The fact that chemical companies can conclude a chemical is safe to eat and then bring it onto the market without first notifying the FDA shows just how broken our food chemical safety system has become,” said Scott Faber, senior vice president for government affairs for the EWG. “Simply pledging to ‘take steps to explore’ changing a system that has been broken for more than 60 years is not the change consumers rightly expect. Until the FDA takes real action to put itself in charge of food chemical safety, this announcement is best seen as a ‘plan to plan,’ not real progress toward ensuring our food is safe.”

The group went on to note that Congress intended that 99% of the chemicals that are formulated into foods and beverages are reviewed for safety by the FDA.