What does FDA GRAS (Generally Recognized as Safe) require and does it protect your family?
FDA GRAS is a classification meaning a substance is 'generally recognized, among qualified experts, as having been adequately shown to be safe' for its intended use. Critically, GRAS status can be self-determined by manufacturers without FDA pre-approval - meaning many air fryer coating materials have never been independently reviewed by the agency.
Renee · Founder & Lead Researcher, R3
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The claim: If a substance is FDA GRAS, the FDA has tested and approved it as safe
The reality: GRAS is not FDA approval. A substance can be GRAS through self-determination by the manufacturer without any FDA involvement. Even when a company voluntarily notifies the FDA, the agency's 'no questions' response is not an approval - it means the FDA did not object to the company's own safety assessment. An estimated 3,000 to 4,000 food and food-contact substances in the US have self-determined GRAS status with no FDA notification or review. The GRAS system places the burden of safety determination on manufacturers, not on the FDA.
If you have ever read a product listing that says a nonstick coating is "FDA approved" or "FDA GRAS," you probably felt reassured. The FDA reviewed it, found it safe, and gave it a green light. That is the impression most families walk away with.
The reality is more complicated - and worth understanding. GRAS is a real FDA classification, but it does not work the way most people assume. The distinction between "FDA approved" and "GRAS" matters, especially for families evaluating the materials in air fryer baskets, cookware coatings, water bottles, and water filter components.
GRAS stands for "Generally Recognized as Safe." Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a substance can be used in food or food-contact materials if it is either:
The GRAS classification exists because when Congress passed the Food Additives Amendment of 1958, thousands of substances were already in widespread use in food and food-contact materials. Requiring formal approval for every one of them was impractical. GRAS was the solution: substances with a well-established safety record could continue to be used without going through the full food additive approval process.
The key language is "generally recognized." This means the safety of the substance must be widely accepted among qualified scientific experts. It is not enough for one company to believe its chemical is safe - there must be a general consensus.
Here is where the system gets complicated. There are three ways a substance can achieve GRAS status:
Before 1997, a manufacturer could petition the FDA to officially "affirm" that a substance was GRAS. The FDA would review the scientific evidence and, if it agreed, publish a regulation confirming the GRAS status. This process involved genuine FDA scientific review.
In 1997, the FDA replaced the formal affirmation process with a voluntary notification system (finalized as a rule in 2016). Under this system, a company prepares a GRAS determination - including a safety assessment and evidence of expert consensus - and submits it to the FDA as a notification.
The FDA reviews the notification and issues one of three responses: "no questions" (meaning the FDA has no objection to the GRAS determination), the notification is "ceased" (the company withdrew it), or the FDA informs the company that the GRAS notice does not provide sufficient basis for GRAS status.
Important: an FDA "no questions" letter is not an approval. It means the FDA reviewed the notification and did not raise objections based on the information submitted. The burden of demonstrating safety remains entirely on the company.
This is the part that catches most families by surprise. A company can determine on its own that a substance is GRAS - and use it in food or food-contact materials - without ever notifying the FDA. There is no legal requirement to submit a GRAS notification. The company simply needs to be able to demonstrate, if challenged, that the substance meets the legal standard of general recognition of safety among qualified experts.
In practice, this means: - A manufacturer decides its chemical is GRAS - The manufacturer assembles supporting evidence (published studies, expert panel opinions) - The manufacturer begins using the chemical in products - The FDA may never know the substance is in use - If safety concerns arise later, enforcement falls to the FDA
A 2014 study published in the journal *JAMA Internal Medicine* found that of the roughly 1,000 GRAS notifications voluntarily submitted to the FDA between 1997 and 2014, all but a handful were from parties with a financial interest in the substance's approval. Of the approximately 10,000 substances in the US food supply (including food-contact substances), an estimated 3,000 to 4,000 have been self-determined as GRAS by manufacturers without any FDA notification.
The nonstick coatings on air fryer baskets and cookware contain multiple chemical components. Some are authorized through FDA food-contact notifications (FCNs), some through FDA food additive regulations (21 CFR 177), and some through GRAS determinations.
PTFE (polytetrafluoroethylene) - the primary polymer in traditional nonstick coatings - has FDA authorization for food-contact use under 21 CFR 177.1550. This is distinct from GRAS; it is a specific food additive regulation. But the processing aids, adhesion promoters, and other additives in nonstick coating formulations may rely on GRAS status or food-contact notifications rather than full food additive approval.
The nonstick coating on your air fryer basket contains multiple chemical components. The primary polymer - PTFE - has FDA authorization under 21 CFR 177.1550, which is a genuine FDA-reviewed regulation. But the processing aids, adhesion promoters, and other additives in the coating formulation may rely on GRAS status - including self-determined GRAS with no FDA review. When a manufacturer says their coating is 'FDA compliant,' they are not lying. But the phrase can mean anything from 'the FDA independently reviewed every component' to 'we determined the components are safe and never told the FDA.' We look beyond the marketing claim to identify the actual regulatory pathway for each component.
GRAS itself is a regulatory classification, not a chemical. The health concerns relate to the system's limitations:
Unreviewed substances. An estimated 3,000 to 4,000 substances in the US food supply have self-determined GRAS status without any FDA review. Some of these may pose health risks that have not been independently evaluated.
Conflict of interest in expert panels. GRAS determinations require assessment by qualified experts. But companies typically hire and pay the experts who review their own chemicals, creating financial conflicts that may bias safety assessments.
Outdated safety data. Some substances received GRAS status decades ago based on evidence that would not meet current safety assessment standards. Re-evaluation is not systematically required.
Cumulative exposure. GRAS determinations evaluate individual substances. They do not assess the cumulative effect of exposure to multiple GRAS substances from multiple sources simultaneously - a scenario that describes most people's actual daily chemical exposure.
FDA GRAS framework: - Legal basis: Federal Food, Drug, and Cosmetic Act, Section 201(s) and Section 409 - GRAS notification final rule: 81 FR 54960, published August 17, 2016 - Administered by: FDA Center for Food Safety and Applied Nutrition (CFSAN) - GRAS notification database: Publicly searchable at fda.gov - Notification is voluntary - no legal requirement to inform FDA of self-GRAS determinations
Three pathways to GRAS status: 1. FDA GRAS affirmation (pre-1997, now discontinued as formal process) 2. GRAS notification to FDA with "no questions" response (voluntary, post-1997) 3. Self-GRAS determination by manufacturer without FDA notification (no regulatory involvement)
Relationship to other FDA pathways: - Food additive approval (21 CFR): Full FDA pre-market review and published regulation - most rigorous pathway - Food-contact notification: FDA review of manufacturer safety assessment - intermediate pathway - GRAS notification: FDA review-without-objection of manufacturer GRAS determination - less rigorous - Self-GRAS: No FDA involvement - manufacturer takes full responsibility
Ongoing developments: - FDA "Closer to Zero" initiative (2022) for reducing toxic elements - Increased CFSAN scrutiny of GRAS notifications (2023-present) - GAO recommendations for mandatory GRAS notification (not yet enacted)
Who is most at risk
Look for these
Watch out for
What this does NOT cover
Drug or medical device safety - GRAS applies only to food and food-contact substances Environmental safety or ecological impact of substances Long-term cumulative exposure effects from multiple GRAS substances simultaneously The safety of a substance when used outside its intended GRAS conditions (different temperature, pH, or food type) Coating durability over time - GRAS evaluates the substance itself, not how it performs after years of use and wear Post-market surveillance or mandatory adverse event reporting for GRAS substances
How to verify
Search the FDA GRAS Notices inventory at fda.gov/food/generally-recognized-safe-gras/gras-notices to see if a specific substance has a filed GRAS notification and the FDA's response. Check the FDA's Inventory of Effective Food Contact Substance Notifications at fda.gov for food-contact notifications. Search 21 CFR Parts 170-199 at ecfr.gov for substances with formal food additive approval. For self-determined GRAS substances, there is no public database - the FDA may not know the substance is in use. Independent verification through third-party certifications (NSF/ANSI, UL) provides an alternative safety check.
FDA Food Additive Approval vs. GRAS
Food additive approval involves full FDA pre-market review and a published regulation. GRAS can be self-determined by manufacturers without any FDA involvement. Food additive approval is the most rigorous FDA pathway.
GRAS Notification vs. Self-GRAS
GRAS notification is voluntary - the company submits its safety assessment and the FDA reviews it. Self-GRAS means the company determined safety on its own and never notified the FDA. Both are legal, but self-GRAS has no independent check.
US GRAS vs. EU Positive List
The US allows manufacturers to self-determine that substances are safe. The EU requires every food-contact plastic substance to be independently evaluated by EFSA and authorized on a positive list before use. No self-determination pathway exists in the EU.
GRAS vs. Food-Contact Notification
Food-contact notifications are specific to food-contact substances and involve FDA review of the manufacturer's safety assessment. GRAS can apply to food ingredients and food-contact substances. Food-contact notifications are more targeted and involve FDA evaluation.
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No, and this is one of the most important distinctions in food safety regulation. FDA approval (food additive approval under 21 CFR) means the FDA has independently reviewed safety data and published a regulation authorizing the substance. FDA GRAS means the substance is 'generally recognized as safe' - which can be determined by the manufacturer itself without any FDA review. A GRAS notification to the FDA results in a 'no questions' letter, not an approval. Many substances used in food-contact materials have self-determined GRAS status with no FDA involvement at all.
Yes. Under the current GRAS system, a manufacturer can assemble scientific evidence, convene an expert panel, determine that a substance is GRAS, and begin using it in food or food-contact materials - all without notifying the FDA. The GRAS notification process is voluntary. The manufacturer is legally responsible for ensuring the substance is actually safe, but there is no requirement for independent government review before the substance enters commerce.
It depends on the specific coating components. PTFE - the primary nonstick polymer - has FDA authorization under 21 CFR 177.1550, which is a formal food additive regulation (stronger than GRAS). However, nonstick coating formulations contain multiple additional components - processing aids, adhesion promoters, stabilizers - that may have different regulatory pathways. Some may be authorized through food-contact notifications, some through GRAS notification, and some through self-GRAS determination. The regulatory status of the complete coating formulation is rarely disclosed to consumers.
Estimates vary, but research published in *JAMA Internal Medicine* and analyses by the Pew Charitable Trusts suggest that 3,000 to 4,000 substances in the US food supply have self-determined GRAS status without any FDA notification. The exact number is uncertain precisely because the FDA is never notified - there is no public database of self-GRAS determinations. Only the approximately 1,000 voluntary GRAS notifications submitted since 1997 are publicly available.
The FDA has made incremental changes. The 2016 final rule formalized the voluntary GRAS notification process and encouraged (but did not require) companies to notify the FDA of GRAS determinations. The FDA's Closer to Zero initiative (2022) targets toxic elements in food. CFSAN has increased scrutiny of GRAS notifications. The GAO has recommended mandatory GRAS notification, but Congress has not enacted legislation requiring it. The fundamental structure - where self-determination without FDA review is legal - remains unchanged.
Not necessarily - many GRAS substances have long, well-established safety records. Table salt, vinegar, and many common food ingredients are GRAS. The issue is not GRAS as a category but the self-determination pathway that allows substances to enter food-contact use without independent review. For air fryers and cookware, we recommend looking beyond GRAS claims to third-party certifications and checking whether the manufacturer can identify the specific FDA regulatory pathway for each component in their food-contact materials.
The EU does not recognize US GRAS status. Every substance used in EU food-contact plastics must be independently evaluated by EFSA and authorized on the EU positive list under EU 10/2011. A substance that is self-GRAS in the US with no FDA review would need full EFSA evaluation before it could be used in food-contact materials sold in the EU. This is why the EU system is considered more precautionary - there is no self-determination shortcut.
Here is the concern: a nonstick coating formulation may contain 10 or more chemical components. The primary polymer (PTFE) has FDA authorization. But the other components may have varying levels of regulatory review - some through FDA food-contact notifications, some through self-GRAS determination with no FDA review at all.
When a manufacturer says their coating is "FDA compliant" or "meets FDA standards," this is technically accurate even if some components were self-determined as GRAS without FDA review. The statement is not false - but it can be misleading if it creates the impression that the FDA has independently evaluated the entire coating formulation.
There is a persistent confusion between "FDA GRAS" and "FDA approved" in product marketing. Here is the clear distinction:
FDA approved (food additive): The FDA has reviewed a petition containing safety data and published a regulation authorizing the substance for specific uses. The FDA's scientists independently evaluated the evidence. This is genuine pre-market approval.
FDA GRAS (with notification): A company determined the substance is GRAS, submitted a notification to the FDA, and the FDA responded with "no questions." The FDA reviewed the company's determination but did not conduct an independent evaluation. This is review-without-objection, not approval.
FDA GRAS (self-determined): A company determined the substance is GRAS based on its own expert panel review and scientific evidence. The FDA was never notified. The FDA has not reviewed or evaluated the substance. The company takes full legal responsibility for its safety determination.
For families reading product claims, this matters. A product described as "FDA GRAS" may have undergone rigorous FDA review, casual FDA review, or no FDA review at all - and the label does not tell you which.
The EU food-contact framework under EC 1935/2004 does not have a GRAS equivalent. In the EU:
The EU system is more precautionary because it does not allow manufacturers to determine the safety of their own chemicals without regulatory review. The US GRAS system places more trust - and more responsibility - on manufacturers.
The FDA has acknowledged the limitations of the GRAS system. In its 2016 final rule establishing the current GRAS notification process, the agency noted that voluntary notification was preferable to mandatory notification because the FDA lacked the resources to review all potential GRAS substances.
Critics - including the Government Accountability Office (GAO), the Natural Resources Defense Council, and the Pew Charitable Trusts - have documented specific concerns:
In 2022, the FDA launched the "Closer to Zero" initiative for reducing toxic elements in food, and in 2023, the agency began reassessing certain GRAS substances. The Center for Food Safety and Applied Nutrition (CFSAN) has increased scrutiny of GRAS notifications. But the fundamental structure - where manufacturers can self-determine safety without FDA review - remains unchanged.
When we evaluate air fryers, cookware, bottles, and water filters, we do not treat GRAS status as equivalent to independent safety verification. Here is our framework:
FDA food additive approval (21 CFR listing): Highest confidence. The FDA has independently reviewed safety data and published a regulation authorizing the substance.
FDA food-contact notification with "no questions" letter: Moderate confidence. The FDA reviewed the company's safety assessment but did not conduct an independent evaluation.
GRAS notification with FDA "no questions" letter: Lower confidence than food additive approval. The FDA reviewed the company's GRAS determination and did not object - but the FDA's review of GRAS notifications is less rigorous than food additive review.
Self-determined GRAS with no FDA notification: Lowest confidence. The substance may be perfectly safe, but we have no independent verification. We note the absence of FDA review.
We pair GRAS status with third-party certifications, manufacturer transparency, and independent lab testing to build a complete picture. Products from manufacturers that voluntarily submit GRAS notifications - even though they are not required to - demonstrate a commitment to transparency that we score positively. Products that rely entirely on self-determined GRAS without third-party verification receive lower confidence scores for chemical safety.