Since 2000, the food and chemical industry has greenlighted nearly 99% of food chemicals introduced onto the market without federal safety review, according to a new EWG analysis.
The Food and Drug Administration is responsible for ensuring food is safe. But the industry instead is deciding what food chemicals are suitable for people to eat.
This problematic situation happened through companies exploiting a loophole in food chemicals laws allowing them to decide which chemicals are safe to consume. That’s contrary to what Congress intended when it passed the laws in 1958.
What’s more, this loophole is now the way most new chemicals, including some that are concerning, such as EGCG, propyl paraben and theobromine, are allowed in foods.
Since 2000, food and chemical companies have petitioned the FDA only 10 times to approve a new substance. By contrast, they have added 863 chemicals, through the “generally recognized as safe,” or GRAS, loophole. That’s 98.8% of new food chemicals.
The loophole lets those companies – not the FDA – decide when a substance is safe.
Figure 1. New food chemicals introduced to market from 2000 to 2025
Source: Food additive petitions filed in the Federal Register, and GRAS notices filed in the FDA’s GRAS notice inventory
A food additive petition triggers rigorous FDA pre-market safety review of a chemical, and the agency has to approve the substance before it can be used in the marketplace. The 1958 Food Additives Amendment intended this review to serve as the main path of approval for new food chemicals.
Nine of the 10 food additive petitions for new chemicals represented in the chart were first filed more than 10 years ago, including:
- In 2000, Ecolab Inc. filed a petition for an antimicrobial agent.
- In 2001, Avecia Inc. filed a petition for a preservative, later withdrawn.
- In 2002, Safe Foods Corp. filed a petition for an antimicrobial agent.
- In 2002, Intralytix Inc. filed a petition for an antimicrobial agent.
- In 2005, Kareem I. Batarseh filed a petition for an antimicrobial agent.
- In 2006, ARCH Chemicals Inc. filed a petition for an antimicrobial agent, later withdrawn.
- In 2008, Lubrizol Advanced Materials Inc. filed a petition for a stabilizer and texturizer.
- In 2008, Zentox Corp. filed a petition for an antimicrobial agent, later withdrawn.
- In 2009, Ajinomoto Co. filed a petition for a non-nutritive sweetener.
Just one food additive petition for a new chemical, vitamin D2 mushroom powder, has been filed in the past decade.
For the other 863 new food chemicals added to the food supply since 2000, food chemical companies exploited the GRAS loophole so they could make their own safety determinations.
Food chemical reviews
The GRAS loophole was intended to apply narrowly to common ingredients like sugar, vinegar and baking soda. But as EWG’s analysis shows, the loophole – not FDA safety review – has become the main way new chemicals are allowed into food.
A GRAS determination shows a company believes “the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use.” The company can submit a notice to the FDA about its conclusion, through a process that is entirely voluntary.
The FDA can review these notices and issue a “no questions” letter that means it doesn’t object to the finding. But it does not approve GRAS substances or affirm a company’s GRAS determination.
If the FDA does raise questions about a company’s safety conclusions, the company can withdraw its GRAS notice. But it can continue to use the ingredient anyway, without further FDA review and despite the agency’s reservations. Concerned citizens do not have the chance to provide public comment on, or challenge, GRAS determinations.
EWG’s analysis includes only substances that have gone through this voluntary process, because little to no information is available when companies make their own GRAS determinations but do not notify the FDA. So the analysis certainly undercounts what’s added to food through the GRAS loophole.
Experts estimate at least 1,000 substances have been added to the food supply without notice to the FDA.
EWG also looked at filings related to new or modified uses for existing food chemicals, in addition to new chemicals. For new or modified uses of existing food chemicals, petitions were submitted slightly more often: 48 times.
But those 48 petitions are dwarfed by the 220 GRAS notices submitted since 2000 for new or modified uses of existing chemicals, in addition to the 863 new substances for which industry exploited the GRAS loophole.
Loophole puts consumers at risk
Because of the GRAS loophole, harmful ingredients have made their way into, and continue to enter, the food supply.
For example, the Flavor and Extract Manufacturers Association, a trade group composed of industry insiders, reviews and makes GRAS determinations on nearly all flavor ingredients. This includes seven carcinogenic flavor ingredients the association rubber-stamped as GRAS. The chemicals were later banned, in 2018, in response to a petition by EWG and other nonprofit groups.
Other GRAS substances include BHA, classified as “reasonably anticipated to be a human carcinogen” by the National Toxicology Program, and BHT, which may disrupt hormone function by causing thyroid changes. Studies have also shown it affects animal development, which could indicate similar harms in humans. Green tea extract EGCG may increase risk of cancer but is classified as GRAS.
For decades, partially hydrogenated oils were considered GRAS – even though they are a major source of trans fat, which can increase cholesterol and harm the heart. When the FDA revoked GRAS status for these oils in a rare action, in 2015, it said removing them from food “could prevent thousands of heart attacks and deaths each year.”
Many of the GRAS notices lack critical health data.
A 2020 review of GRAS notices submitted since 1997 found they were almost all inadequate. Only one of 900 notices assessed the effect of the chemical in combination with other, similar chemicals, even though both manufacturers and the FDA must consider cumulative impacts as part of a safety determination.
It’s time to close the GRAS loophole
The FDA is charged with protecting the U.S. food supply but has fallen short.
Even Michael Taylor, a former FDA deputy commissioner for food, admitted in 2014 that the FDA “simply do[es] not have the information to vouch for the safety of many of these chemicals.”
The Trump FDA announced in March it will “explore rulemaking” to mandate GRAS notices. But so far the agency has pledged only to explore changing a system that has been broken for more than 60 years. Without more concrete action, the FDA’s actions so far can best be seen as a “plan to plan” to close the GRAS loophole.
Two states in the meantime have introduced legislation to bring more transparency to GRAS. The Food Safety and Chemical Disclosure Act in New York and the Food Chemical Disclosure Law in Pennsylvania would both make it illegal to sell food containing GRAS substances unless the manufacturer has submitted a scientifically robust GRAS notice either to the FDA or to a state agency as a support for the manufacturer’s GRAS determination.
Already this year, more than 30 states have introduced bills to address harmful chemicals in our food supply.
It’s time to close the GRAS loophole and prevent new chemicals from being added to food through a side door, without government oversight.
In Congress, the Food Chemical Reassessment Act of 2025, introduced by Rep. Jan Schakowsky (D-Ill.) and Rep. Rosa DeLauro (D-Conn.), aims to address inadequacies in food additive rules. The bill would require the FDA to regularly review and reassess food chemicals, many of which have not been reevaluated in decades.
The Ensuring Safe and Toxic-Free Foods Act, introduced by Sens. Ed Markey (D-Mass) and Cory Booker (D-N.J.), would narrow the GRAS loophole and require reassessment of food chemicals.
Congress should stop the continued use of unsafe chemicals in our food supply, while ensuring that states retain power to continue addressing toxic chemicals in food.
Methodology and additional findings
To compare uses of the GRAS loophole and petitions, EWG looked at how many of each were filed for new chemicals between January 2000 and May 2025.
To find out how often the loophole was used, EWG reviewed all filings in the FDA’s GRAS notice inventory since 2000. For new substance notices that were filed, EWG located and categorized all notices for duplicate substances, based on whether they were:
- The original filing for a new substance
- A refiling of a previous notice, or
- A filing for a new or different use of an existing food chemical.
Our analysis found that between 2000 and 2025, companies filed 863 original GRAS notices for novel food chemicals. Out of a total of 1,118 GRAS filings, 35 were refilings and 220 were filings for a new food chemical or varied use of an existing one.
Because submission of a GRAS notice is voluntary, this may be an undercount. Companies may have determined that chemicals or uses are GRAS but not notified the FDA or other authorities.
To find out how many food additive petitions were filed, EWG searched the Federal Register for food additive petitions filed since 2000. We identified a total of 97 petitions, including:
- 10 for new substances (three withdrawn).
- 48 for a new or different use of a chemical already approved through a previous food additive petition (one later withdrawn).
- 14 to ban or restrict existing food chemicals (one later withdrawn).
- 11 for food irradiation (two later withdrawn).
- 10 correcting or amending previous petitions (i.e., to change scope of use or correct information error).
- One submitted in response to a determination that a substance is not GRAS.
EWG’s comparison focuses only on GRAS notices in contrast to food additive petitions for new chemicals and requests to expand or change uses of chemicals already added directly to food.
