News
Toxic Free Food Act: US to close GRAS loophole
16 Oct 2024Amid scientific, industry, and Congress backing, the US Food and Drug Administration (FDA) will create an assessment system for food chemicals under the Toxic Free Food Act to prevent food chemicals being commercialised without safety checks.

On 25 September, Congresswoman Rosa DeLauro introduced the Toxic Free Food Act to tackle the ‘General Recognised as Safe’ (GRAS) loophole. The decision comes after long-standing efforts to demonstrate that the loophole’s presence, which allows companies to declare their ingredients as safe without necessarily conducting rigorous safety testing, puts food safety and public health at risk.
The legislation requires the Food and Drug Administration (FDA) to close the GRAS loophole and ensure chemical food additives receive FDA approval and oversight. It would include specific restrictions on substances that cause cancer or human reproductive or developmental toxicity. The FDA is now working to create a postmarket assessment system for food chemicals.
Congresswoman DeLauro also sent a public comment to the FDA, urging the agency to close the GRAS loophole that allows companies to self-certify that new ingredients are safe for consumers and voluntarily choose to notify the FDA of their decisions.
A long-standing legal loophole
Industrialised food growth has led to a US legal loophole in US law for foods deemed GRAS. The oversight raises potential implications for food safety and public health, as it can lead to hazardous chemicals entering food products and bodies.
“The GRAS loophole allows food companies to decide whether additives are safe to add, skirting FDA oversight and allowing potentially dangerous chemicals to reach the market,” said Congresswoman Rosa DeLauro about the Bill. “That cannot stand.”
Industry support for introducing the Act includes endorsements from the Environmental Working Group, Consumer Reports, and the Center for Science in the Public Interest.
A recent analysis published in the American Public Health Association membership organisation has explored the FDA’s regulatory timeline regarding food ingredients and additives.
“Industry loves a loophole,” Dariush Mozaffarian, director of the Food is Medicine Institute, said in a LinkedIn post on one of the analysis’ core findings. “Thousands of compounds of dubious safety have been added to foods since 1990, with no oversight by FDA – or even knowledge they’re being added,” Mozaffarian said. The researchers of the recent analysis have been advocating for a stop to this lack of awareness and oversight.
GRAS status: Opening the floodgates
“Congress created the loophole in 1958,” Jennifer Pomeranz, associate professor at the School of Global Public Health at New York University, told Ingredients Network. The Food Additives Amendment of 1958 (FAA) allowed the FDA to require premarket approval of additives based on their intended use.
For a food additive to be considered GRAS and therefore excluded from the food additive pre-approval process, it must be “recognised, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures…to be safe under the conditions of its intended use”.
Research recognises that “scientific procedures” or “experience based on common use in food” have been given as methods to recognise safety. The absence of pre-approval safety has led some to question the FDA’s scrutiny of these substances deemed GRAS.
The GRAS exemption was designed to apply to substances typically considered “safe additives” before the arrival of the FAA. According to research, an estimated 1,000-plus chemicals were deemed GRAS and used in foods without FDA oversight or notification.
“However, the public health concerns are vast and go well beyond the loophole,” said Pomeranz. The loophole allows industry entities to introduce chemicals into the food supply without FDA or public knowledge. “But the additional problem is that the FDA does not have the resources, staff or a well-defined framework to evaluate the chemicals already in our food supply,” she added.
In addition, little action is then taken. “Even when there is evidence of harm, it can take decades for the FDA to require the removal of the ingredient,” said Pomeranz.
Aware that the US has ingredients in its food supply that are banned in Europe, states are acting to protect public health. Several substances banned in Europe are permitted in the US, including titanium dioxide (E171), brominated vegetable oil (BVO) (E443), potassium bromate (E924), azodicarbonamide (E927a) and propylparaben (E217).
“So, the loophole allows chemicals to enter the food supply without FDA oversight (or any premarket control), and then the FDA can’t and doesn’t evaluate all of them postmarket,” added Pomeranz.
In their analysis, researchers state several factors render relying on postmarket authority ineffective and unreliable to guarantee a safe food supply. These factors include the prominence of GRAS substances and additives in the food industry that require review, insufficient knowledge about the presence of self-GRAS ingredients, a lack of resources and time delays.
These led the researchers to recommend an alternative framework to evaluate the safety of GRAS substances and food additives. They suggest possible solutions to address the loophole and effectively work to close it, including a new, mandatory premarket GRAS notification or public affirmation process that sits alongside the ongoing use of the obligatory food additive premarket review process.
Researchers are also considering introducing a new regular, robust, transparent postmarket FDA review of GRAS substances and food additives. The researchers also suggest that the FDA adopts user fees, enabling them to proceed with a comprehensive premarket review of GRAS substances and food additives and additional resources agreed by Congress.
Related news

Value is a top priority for today’s F&B consumers
3 Apr 2025
Research from global consultancy Hartman Group suggests there are six core values that brands must tap into to connect with consumers’ needs.
Read more
Lidl GB debuts on TikTok Shop with high-protein foods promotion
2 Apr 2025
Lidl GB has become the first UK grocery retailer to sell on TikTok Shop, with its limited edition run of high-protein bundles selling out in under 20 minutes.
Read more
Make plant-based meat ‘tastier and more affordable’ to fight climate change
31 Mar 2025
The UK’s Climate Change Committee is calling for tastier, more affordable plant-based meat offerings as part of measures to counteract the nation’s environmental impact.
Read more
Clean-label cereals prompt fortification debate
28 Mar 2025
Marks & Spencer has caused a stir with the launch of a range of breakfast cereals in the UK containing minimal ingredients.
Read more
Changing global food retail environments linked to rise in obesity
27 Mar 2025
Changes in retail food environments – particularly the growing prominence of large chains – are positively correlated with rising obesity prevalence, a study suggests.
Read more
UK consumers could be eating cultivated meat within two years
26 Mar 2025
Cell-cultivated products (CCPs), from chicken nuggets to beefburgers, could be on UK supermarket shelves by 2027 after regulators launched a sandbox to accelerate approvals.
Read more
Future F&B flavours favour exploration and explosive taste profiles
25 Mar 2025
Exploration and experimentation will define the future of flavour, according to Mintel, as consumers seek out taste profiles and textures that offer an adventurous eating experience.
Read more
Partnership plans to scale cultivated meat production
21 Mar 2025
Food technology innovator Ever After Foods (EAF) and multinational food leader Bühler are striving to overcome hurdles to access and accelerate the development of cultivated meat.
Read more
Global consumers enjoy food less and perceive it as less healthy
20 Mar 2025
Enjoyment of food and its perceived healthiness is dwindling among most global populations, according to findings from Gallup and Ando Foundation/Nissin Food Products.
Read more
Plans to abandon mandatory Nutri-Score labelling ‘would be a step back’
17 Mar 2025
Critics have slammed reports that mandatory Nutri-Score labelling is to be abandoned as “a step back” that puts citizens’ health at risk.
Read more