The GRAS Loophole: How Companies Self-Certify Their Own Ingredients as “Safe”
At the heart of the invisible ingredient problem is a legal mechanism called “Generally Recognized as Safe,” or GRAS. The loophole was created in 1958 and was originally intended for common ingredients with a long history of safe use, such as vinegar, salt, and yeast. Over time, it became something far more expansive.
The current FDA process allows the food industry to regulate itself when it comes to thousands of added ingredients, by determining for itself which ingredients should be considered “generally recognized as safe” and deciding on their own whether or not to disclose the ingredients’ use and the underlying safety data to the FDA. In other words, companies can add new chemicals to food without telling anyone.
An EWG analysis of voluntary notifications to the agency since 2000 shows that nearly 99% of new food chemicals have exploited the GRAS loophole to come onto the market. Companies sent the agency 863 notifications for new substances between 2000 and 2024, though companies may have determined that an untold number of other chemicals were GRAS without notice to the FDA. In the same period, the FDA reviewed 10 new food additives and approved only seven through its pre-market review system.
Over 100 Unreviewed Chemicals Are Hiding in Everyday Foods Right Now
Over 100 chemicals of unknown safety are hiding in the food Americans eat every day, including sports drinks, snack bars, cereals and much more. This finding came from a March 2026 analysis by the Environmental Working Group, which identified substances that companies had quietly designated as GRAS without ever notifying the FDA.
While companies can choose to notify the FDA that they are designating a chemical as GRAS, they are not required to. The 111 GRAS chemicals in the EWG report were not disclosed to the agency. This isn’t a technicality. It means regulators, researchers, and the public have no reliable inventory of what is actually entering the food supply.
When FDA officials are asked how many GRAS substances are now in the food supply, they cannot answer. That admission, from the FDA’s own director for food chemical safety, captures the scale of the problem better than any statistic.
Food Additives Are Linked to Serious Health Risks
Food additives are present in more than half of food products. Several studies have suggested a link between the consumption of certain food additives and an increased risk of developing cancer. A 2025 study published in Food and Chemical Toxicology tested 32 of the most widely consumed additives for genotoxicity across human cell models including colon, liver, kidney, and neurons.
The observed genotoxicity of the mixtures could not be attributed to the relative concentrations of the individual additives. These findings suggest the possibility of toxic synergies in mixtures and highlight the challenges of studying the combined effects of multiple substances. Simply put, two additives that appear safe individually may behave very differently when combined inside your body.
Researchers found that those eating higher levels of ultra-processed foods had a higher risk of several chronic diseases. Food additives are one of the main hypotheses to explain these associations. This work draws on the NutriNet-Santé cohort, one of the world’s biggest ongoing web-based dietary health studies, which monitors the food intake of 173,000 adults.
Children Are Among the Most Exposed
A U.S.-based study showed that in 2018, people aged 2 to 19 got roughly two thirds of their calories from ultra-processed foods. That figure, already troubling on its own, takes on greater weight given what researchers are learning about how additives interact with developing bodies.
According to several studies, health issues such as asthma, attention deficit hyperactivity disorder, heart difficulties, cancer, obesity, and others are caused by harmful additives and preservatives. Some food additives may interfere with hormones and influence growth and development. This is one of the reasons why so many children are overweight. Children are more likely than adults to be exposed to these types of dietary intakes.
Red Dye No. 3 has been linked to cancer and behavioral problems in children. It is found in more than 2,000 food products, including many types of candy, cookies, and other food marketed to children. In 1990, the FDA banned Red 3 in cosmetics citing cancer risks, but didn’t ban it from food until 2025. That’s a 35-year gap between recognizing a risk in one product category and acting on it in another.
The “All Natural” Label Means Far Less Than You Think
Guidelines for who can make claims like “made with real ingredients” and “all natural” are loose, as the FDA does not have rigorous regulations for companies. A product labeled “all natural” per FDA regulations means only that nothing artificial or synthetic has been put into a food that wouldn’t be expected to be there. That definition leaves a remarkable amount of room for interpretation.
This particular regulation is not meant to address food production, processing, or manufacturing methods. According to one industry study, more than half of all food and beverage shoppers believe more regulations are needed. Consumer confidence in labels is running well ahead of what those labels actually guarantee.
The lawsuits are piling up. In 2024, a case was brought against Kraft Heinz over allegations surrounding a claim of “No Artificial Flavors, Preservatives, or Dyes” on boxes of Macaroni and Cheese that contained citric acid, sodium phosphate, and sodium triphosphate. That case is a useful snapshot of how frequently packaging claims and actual ingredient lists tell different stories.
PFAS: “Forever Chemicals” in Your Food Packaging
PFAS and microplastics are known as “forever chemicals” because they don’t break down easily and can build up in the environment, leading to potential risks for both wildlife and humans. Their route into your food is often indirect, traveling through packaging, cookware, contaminated soil, and water rather than being added as a deliberate ingredient.
PFOA is used in non-stick cookware coatings and grease-resistant food packaging and can leach into food at high temperatures. PFOS helps create grease-proof packaging for fast-food wrappers, pizza boxes, and microwave popcorn bags. In 2024, the FDA announced that manufacturers had stopped selling grease-proofing materials containing certain PFAS for use in food packaging in the U.S.
Long-term exposure to PFAS can induce reproductive toxicity, hepatotoxicity, and metabolic disorders affecting the blood, liver, and kidneys. Long-chain PFAS are also linked to cardiovascular disease, immune system disorders, and cholesterol metabolism. Research published in early 2025 in the journal Foods reviewed the global scope of these health risks in detail.
Microplastics Have Reached the Human Brain
Once inside the body, these substances don’t just pass through like other particles do. They are persistent, resist breaking down, and can travel in the bloodstream and accumulate in organs. The smaller the particles, the more likely they are to cross the gut lining or blood-brain barrier.
Brain tissue analyzed in a recent study contained significant levels of microplastics, particularly polyethylene. The 2025 study, published in Nature Medicine, revealed concentrations in the brain were seven to 30 times higher than in other organs. That number stopped many researchers in their tracks when it was published.
A 2024 Consumer Reports study found that fast-food chicken nuggets contained tens of thousands of nanograms of phthalates per serving, while a can of tomato sauce contained just a fraction of that amount. The wide variation shows how processing methods can dramatically affect contamination levels, even within the same meal.
The Cocktail Problem: When Safe Ingredients Become Unsafe Together
Individual safety tests only tell part of the story. Regulators typically evaluate additives one at a time, but that’s not how they enter the body. When we eat ultra-processed food, we do not just eat one type of artificial sweetener or other additive, but often mixtures that may have synergistic or antagonistic interactions.
European researcher Mathilde Touvier, whose team leads the NutriNet-Santé cohort study, has focused specifically on these cocktail effects. Her research disentangles mixtures of chemicals in ultra-processed food to understand how they may increase risk for disease, including cardiovascular diseases and cancer.
Research published in 2024 found that dietary exposures to carrageenans, guar gum, and xanthan gum elevated the risk of type 2 diabetes for adults. These are not obscure industrial chemicals. They’re stabilizers and thickeners found in plant-based milks, salad dressings, and dozens of other everyday products.
The Regulatory Response: Too Slow, Too Fragmented?
In March 2025, HHS Secretary Kennedy directed the acting FDA commissioner to take steps to explore potential rulemaking to revise the GRAS Final Rule and eliminate the self-affirmed GRAS pathway. This would enhance the FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers.
States are not waiting for federal action. In 2024, more than a dozen states introduced food safety bills. In 2025, more than 30 states introduced bills, and new laws passed in Arizona, Louisiana, Texas, Utah, Virginia, and West Virginia. This wave of state-level activity signals that public pressure on the issue is real and growing.
Still, critics say that the pace of reform is badly mismatched with the scale of the problem. In 2022, food made with the GRAS ingredient tara flour was believed to have caused over 300 illnesses and 113 hospitalizations. Researcher and report co-author Maricel Maffini has noted that the FDA only acts after people are harmed. That pattern, reactive rather than preventive, is what advocates are pushing hardest to change.
What Consumers Can Actually Do
Clean-label initiatives are rising as concerns surrounding ultra-processed foods intensify, and more consumers are prioritizing what is not in their products. According to a recent Clean Label Insights Study by Acosta Group, roughly four out of five shoppers say purchasing clean-label food products is important to them. Consumer behavior is shifting, and the food industry is noticing.
Practical steps matter, even if they don’t solve the systemic problem. Filtering water to reduce PFAS and microplastics is advisable, and a high-quality reverse osmosis or activated carbon filter is useful. Bottled water often contains microplastics, so filtered tap water in a reusable stainless steel or glass bottle is a better option.
Reading labels more critically remains genuinely useful. More people are now questioning claims like “fat-free” or “long shelf life” and examining ingredient lists more critically. Choosing minimally processed foods, cooking at home when possible, and reducing reliance on ultra-processed products directly reduces exposure to the additives that concern researchers most. These steps don’t require a chemistry degree. They just require knowing that the problem is real.
The Bigger Picture: A Food System Built on Trust That Hasn’t Been Earned
When companies covertly declare chemicals GRAS, there is often no publicly available data on identity, composition, safe consumption levels, or potential health hazards. That’s not a description of a fringe product or an obscure supply chain. It’s a description of how a large share of modern food additives currently enter the market.
This wave of newly proposed legislation signals a major cultural and regulatory shift: food safety is no longer just about bacteria or contamination. It’s about the chemicals and colors hidden in everyday products. That shift in framing, from contamination as an accident to contamination as a systemic design flaw, is arguably the most important development in food policy in decades.
The invisible ingredients problem is, at its core, a transparency problem. Science can identify the risks. Law can create the frameworks. What’s missing is the political will and institutional follow-through to match the scale of what’s been allowed to accumulate in the food supply over 60-plus years. Knowing that the problem exists, and that it has a name, is the reasonable starting point for expecting something better.
