RFK Jr. Wants to Change the GRAS Rule — Here’s Why It Matters

Robert F. Kennedy Jr. is making one of his first significant moves as the head of the U.S. Department of Health and Human Services by attempting to close a controversial safety loophole within the U.S. Food and Drug Administration (FDA).

On March 10, Kennedy announced that he is directing “the acting FDA commissioner to take steps to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.” This, he shared, “will enhance the FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers.” 

Here's what you need to know about the GRAS rule and what Kennedy plans to do about it. 

What is the GRAS rule? 

As Food & Wine previously reported, the FDA's GRAS designation allows companies to decide whether the additives they put in their food products are safe for consumption, allowing them to bypass review if it's “generally” recognized as safe.

In a 2013 report, the Pew Research Center wrote that it was a legal loophole “intended for common food ingredients; manufacturers have used this exception to go to market without agency review on the grounds that the additive used is ‘generally recognized as safe.’” It noted that the FDA interpreted this law as having no obligation “on firms to tell the agency of any GRAS decisions. As a result, companies have determined that an estimated 1,000 chemicals are generally recognized as safe and have used them without notifying the agency.” 

And all this is decided by consultants and experts hired by the individual companies, which is a definite conflict of interest. 

“The law does not give the FDA the authority it needs to efficiently obtain the information necessary to identify chemicals of concern that are already on the market, set priorities to reassess these chemicals, and then complete a review of their safety,” Pew added. “Moreover, the agency has not been given the resources it needs to effectively implement the original 1958 law.” 

According to a 2022 review by the Environmental Working Group, almost 99% of all food chemicals introduced since 2000 were greenlit under GRAS and not via a review by the FDA.

What issues has the GRAS loophole created? 

Over the years, several issues have emerged, notably in 2022, when hundreds of people were hospitalized after consuming Daily Harvest's French Leek and Lentil Crumbles, with 39 individuals requiring gallbladder removal. The likely cause was identified as the company's new ingredient, tara flour, which was used under the GRAS rule. In 2024, the FDA determined that tara flour “in human food does not meet the GRAS standard and is an unapproved food additive.” 

So what does Kennedy want to do now? 

“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 shared in the statement. “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.”  

The HHS statement also noted that removing the GRAS rule would necessitate companies to inform the FDA of any modifications to their formulations or new ingredients, including safety data and how they intend to use the ingredients in their products. And it appears the FDA is on board with the change.

“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,” Dr. Sara Brenner, the Acting FDA Commissioner, added. “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.”

As for the businesses this will affect, Sarah Gallo, a senior vice president at the Consumer Brands Association, shared a cautiously optimistic statement, noting, “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.”

However, other advocates for food safety say this statement is still too tame. 

“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,” Scott Faber, the Environmental Working Group’s senior vice president for government affairs, shared. “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.”