Bill would make big change to GRAS system

A new bill to revamp the food additive approval system would do away with the self-determined GRAS route to market. 

The bill was introduced recently by Rep. Rosa DeLauro, D-Conn. Dubbed the Toxic Free Foods Act, it would mandate that all new food ingredients submit safety dossiers directly to FDA before going to market. 

DeLauro also submitted a similar bill in 2021. 

In 2022, a similar bill, Ensuring Safe and Toxic-Free Foods Act of 2022, was also introduced.  

Neither became law.  

Under current regulations, companies introducing a new chemical entity or new food source into the food supply can convene their own panel of experts to vet the safety data on the ingredient, thereby determining that it meets the standard to be called “Generally Recognized as Safe (GRAS).” 

DeLauro alleges system is unsafe 

In introducing the bill, Rep. DeLauro contended that the GRAS system was originally intended to cover common ingredients with long histories of use like flours, vegetable oils and spices. 

However, in the years since the self-determined pathway was created in 1997, it has been applied to a plethora of new ingredients, all of which have been determined as safe by the manufacturers or marketers themselves without federal oversight. 

In the dietary supplement realm, self-determined GRAS has been viewed as alternative path to market in lieu of filing a New Dietary Ingredient (NDI) notification on a new ingredient. Some observers of the market have even contended that self-determined GRAS has appeared on ingredients that failed to obtain a no-objection letter from FDA on an NDI filing. 

“When Americans are shopping at the grocery store, they should be confident that the food they are purchasing is safe for consumption and does not contain any harmful chemical additives that could result in illness or death,” said Rep. DeLauro. 

“Consumers are and should be alarmed that the FDA permits food chemical makers to determine whether most food chemicals are safe – and then to decide whether to even notify the FDA of its industry-funded determinations,” DeLauro said in a statement. 

“The FDA has also failed to keep pace with our trading partners, who have banned or limited many common food chemicals. While other nations methodically review safety questions, many food chemicals have not been reviewed for safety by the FDA in more than 50 years, despite new uses or new science linking chemicals to cancer or other harms. While we are grateful that the FDA has created a new Office of Food Chemical Safety, I remain concerned that the FDA has not prioritized addressing the GRAS loophole,” she added. 

While acute safety issues with new ingredients are rare, they are not unheard of. In 2022 more than 300 adverse events reporting gastrointestinal issues and acute liver injury were associated with a food product called French Lentil and Leek Crumbles made by the company Daily Harvest. The product contained tara flour, which is a protein-rich powder made from the seeds of the Caesalpinia spinosa tree. 

The ingredient was found to contain a non-protein amino acid called baikiain that was deemed the likely cause of the liver injury in people who consumed the product. 

In May FDA determined that tara flour does not qualify as a GRAS ingredient. It’s unclear if there was a self-determined GRAS dossier on the ingredient. 

Data supports existing system 

The tara flour incident was branded by the Environmental Defense Fund as an example of a “broken GRAS” system. However, the data doesn’t necessarily support that conclusion. In the past 30 years since the self-determination system was formally put into place, trillions of servings of foods and supplements have been consumed that contained thousands of new ingredients. Yet incidents like the Daily Harvest episode remain extreme outliers. 

“While it is easy to think of theoretical issues, it is a time-tested process that has allowed countless safe ingredients to enter the market without burdening an already overtaxed federal agency. GRAS self-affirmations are based on rigorous, expert reviews of evidence, and the hope is always that legislation is based on the same,” said Ivan Wasserman, a partner in the law firm Amin Wasserman Gurnani. 

“It should go without saying that it is vitally important that as an industry we continue only to rely on the highest quality self-affirmations, not only to ensure the safety of our products, but also not to give any fodder to detractors,” he added. 

Support for DeLauro bill 

DeLauro’s bill has garnered support from interest groups in the food space such as the Center for Food Safety (CFS). 

“For years, FDA has allowed food and chemical companies to decide whether long-lasting toxic chemicals, such as PFAS or orthophthalates, are safe to eat. The Toxic Free Food Act will make FDA take charge of food safety instead of the industry,” said CFS Policy Director Jaydee Hanson. 

CFS cited a Pew study that showed that in the 2003 to 2013 time frame, almost all new food additives took the self-determined GRAS route to market. The report estimated that there are now more than 3,000 new chemical entities in the food supply whose safety has not been formally vetted by FDA.