What does FDA GRAS (Generally Recognized as Safe) require and does it protect your family?
FDA GRAS (Generally Recognized as Safe)
Type
Regulation / Standard
Sources
9 cited
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.
Also known as: Generally Recognized as Safe, GRAS, GRAS designation, GRAS notification, Self-GRAS, GRAS self-determination
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Reality Check
✕What brands claim
If a substance is FDA GRAS, the FDA has tested and approved it as safe
✓What it actually means
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.
What is FDA GRAS (Generally Recognized as Safe)?
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.
What GRAS Actually Means
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:
1.Approved as a food additive through the formal FDA petition process, with pre-market review by FDA scientists, OR
2.Generally recognized as safe based on either a history of common use in food before 1958, or scientific procedures demonstrating safety for the intended use
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.
The Self-GRAS Problem
Here is where the system gets complicated. There are three ways a substance can achieve GRAS status:
1. FDA GRAS Affirmation (Historical)
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.
2. GRAS Notification (Voluntary, Post-1997)
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.
3. Self-GRAS Determination (No FDA Involvement)
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.
What This Means for Air Fryer and Cookware Coatings
PTFE (polytetrafluoroethylene) - the primary polymer in traditional nonstick coatings - has FDA authorization for food-contact use under .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.
Processing aids and additives in food packaging materials
Health concerns & context
Health concerns
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.
Regulatory status
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?
Families who assume 'FDA GRAS' means the FDA has independently reviewed and approved a substance - the self-GRAS pathway involves no FDA review at all
Children, whose developing systems are more vulnerable to chemical exposures and whose exposure-to-body-weight ratios are higher than adults
Consumers purchasing products marketed as 'FDA approved' when the actual status is self-determined GRAS - the marketing claim overstates the regulatory review
Households using food-contact products containing multiple GRAS substances whose cumulative exposure has never been assessed
How to read the label
Look for these
Products with ingredients that have FDA food additive approval (21 CFR listing) rather than relying solely on GRAS status
Manufacturers that voluntarily submit GRAS notifications to the FDA and publish the 'no questions' responses
Products with third-party certifications (NSF, UL) that independently verify material safety beyond GRAS self-determination
Brands that disclose the regulatory pathway for each ingredient in their food-contact materials
Watch out for
Marketing claims of 'FDA approved' when the actual regulatory status is GRAS - these are different and the distinction matters
Products with no disclosed regulatory pathway for food-contact materials - neither FDA food additive approval, food-contact notification, nor GRAS notification
Vague claims like 'meets FDA standards' or 'FDA compliant' without specifying which FDA pathway applies
What this does NOT cover
Drug or medical device safety - GRAS applies only to food and food-contact substancesEnvironmental safety or ecological impact of substancesLong-term cumulative exposure effects from multiple GRAS substances simultaneouslyThe 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 wearPost-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.
How it compares
Certification
Electrical Safety
Chemical Safety
Mandatory (US)
Notes
FDA GRAS (Generally Recognized as Safe)(this page)
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R3 Bottom Line
What this means for your family
1GRAS is not FDA approval - it is a classification that can be self-determined by manufacturers without any FDA review, notification, or involvement. An estimated 3,000 to 4,000 food and food-contact substances in the US have self-determined GRAS status.
2When a product claims its materials are 'FDA compliant' or 'FDA safe,' ask which specific FDA pathway applies: food additive approval (strongest), food-contact notification (moderate), GRAS notification (FDA reviewed but not approved), or self-GRAS (no FDA involvement).
3Air fryer nonstick coatings contain multiple components with varying regulatory pathways - the primary PTFE polymer has formal FDA authorization, but processing aids and additives may rely on self-determined GRAS status with no independent review.
4Third-party certifications from independent labs provide verification that GRAS self-determination cannot. When evaluating food-contact products, pair regulatory status with independent testing data for the most complete safety picture.
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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.
Can a manufacturer decide its own chemical is safe without the FDA?
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.
Are the nonstick coatings on air fryers FDA GRAS?
It depends on the specific coating components. [PTFE](/learn/ingredients/ptfe-teflon) - 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](/learn/standards/fda-food-contact-notification), some through GRAS notification, and some through self-GRAS determination. The regulatory status of the complete coating formulation is rarely disclosed to consumers.
How many substances have self-determined GRAS status without FDA review?
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.
Has the FDA tried to fix the GRAS system?
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.
Should I avoid products with GRAS ingredients?
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](/category/air-fryer) and [cookware](/category/cookware-set), 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.
How does the EU handle substances that are GRAS in the US?
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](/learn/standards/eu-food-contact-ec-1935). 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.
GRAS vs. FDA Approved: The Distinction That Matters
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.
How GRAS Compares to the EU System
The EU food-contact framework under EC 1935/2004 does not have a GRAS equivalent. In the EU:
Substances used in food-contact plastics must be on a positive list authorized by the European Commission after independent scientific evaluation by EFSA
There is no self-determination pathway - every substance requires regulatory authorization before use
Migration limits are set for individual authorized substances based on EFSA risk assessment
Manufacturers must provide Declarations of Compliance documenting regulatory compliance
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's Awareness of the Problem
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:
The FDA cannot verify the safety of substances it does not know about
Financial conflicts of interest are endemic in GRAS expert panels (companies hire the experts who review their own chemicals)
The notification system is voluntary, meaning there is no mechanism to ensure the FDA learns about new GRAS determinations
Post-market surveillance of GRAS substances is limited
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.
How R3 Uses GRAS Status in Product Evaluation
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.
FDA GRAS notification inventory (publicly searchable database)
Product marketing claims referencing 'FDA GRAS' or 'FDA safe' for food-contact materials