Answer · confidence: partial
How do FDA's 'safe' food rules, including self-approved ones, compare with FEMA's reviews?
Research question: How do FDA's GRAS regulations and notice inventory, including any self-affirmed GRAS determinations, structure safety review and disclosure compared with the FEMA Expert Panel's published evaluations?
Since 1958, manufacturers could independently determine that a substance is GRAS and exempt it from FDA pre-market review without notifying the agency 2, and most additives entering the market since 1970 have reached it through such self-determinations 5. Under the 1997 proposed notification rule, FDA checks whether submitted documentation meets statutory criteria rather than reviewing the scientific proof of safety 14. The August 2026 proposal would make GRAS notification mandatory for most ingredients, with a 45-day initial filing review that does not assess whether a substance is actually GRAS 46. The facts do not describe the FEMA Expert Panel's evaluations, so no direct comparison can be drawn; the newest FDA-related fact is dated August 11, 2026, about two months before October 2026 1.
Checked 2026-10-20. Only documented and supported facts are used.
Dig deeper on this questionSources
[1] supported
If finalized, the proposed rule would require GRAS notices for substances that companies self-determine to be GRAS for use in human or animal food, unless an exception applies.
"If finalized, the rule would require submission of GRAS notices for substances self-determined to be GRAS under the conditions of their intended use in human or animal food, unless an exception applies."FDA Issues Proposed Rule on Substances Generally Recognized as Safe (GRAS)
[2] supported
Since 1958, manufacturers could independently determine that a substance is GRAS and exempt it from mandatory FDA pre-market review, without notifying FDA.
"Since Congress created the GRAS exemption in 1958, manufacturers have been able to independently determine that substances are generally recognized as safe under their intended conditions of use and therefore exempt from mandatory FDA pre-market review."No More GRAS Self-Affirmations? FDA Proposes Mandatory GRAS Notifications
[3] supported
The proposal would not create a pre-market approval framework for GRAS substances, and companies could keep marketing self-determined GRAS substances while FDA reviews the notice.
"Notably, the Proposed Rule would not establish a pre-market approval framework for GRAS substances (and FDA acknowledges that it lacks the authority to do so). Companies may continue to market self-determined GRAS substances before and while FDA reviews the GRAS notice."FDA Issues Proposed Rule on Substances Generally Recognized as Safe (GRAS)
[4] supported
The proposed rule would make GRAS notification mandatory for most ingredients added to foods marketed in the U.S., a change from the long-standing voluntary notification approach.
"The proposed rule would change that approach by requiring GRAS notifications for most ingredients added to foods marketed in the United States."No More GRAS Self-Affirmations? FDA Proposes Mandatory GRAS Notifications
[5] supported
Most additives entering the market since 1970 have reached it through producer or industry self-determinations of safety rather than FDA evaluation and approval.
"Most additives entering the market since 1970 have done so based upon producer or industry self-determinations of safety rather than by FDA evaluation and approval."GRAS-Fed Americans: Sick of Lax Regulation of Food Additives (2016)
[6] supported
FDA proposes a 45-day initial period to decide whether a GRAS submission is adequate to file, and this step does not assess whether the substance is actually GRAS.
"FDA proposes a 45-day initial evaluation period for determining whether a submission is adequate to file."FDA Issues Proposed Rule on Substances Generally Recognized as Safe (GRAS)
[7] supported
Under the proposal, FDA would publish qualifying transition submissions in its listing, but the listing would not mean FDA has reviewed or agreed with the underlying GRAS conclusion.
"FDA would publish qualifying submissions, but listing would not mean that FDA has reviewed or agreed with the underlying GRAS conclusion."No More GRAS Self-Affirmations? FDA Proposes Mandatory GRAS Notifications
[8] supported
The proposed FDA rule (RIN 0910-AJ02) would for the first time mandate premarket notification for substances determined to be GRAS.
"would, for the first time, mandate premarket notification for substances determined to be Generally Recognized as Safe (GRAS)."New Details Emerge on FDA's GRAS Rulemaking: Updated Timeline, Narrower Scope, and Open Questions on Statutory Authority
[9] supported
Most substances that are food additives avoid pre-market approval by claiming GRAS status, and they reach the market under a 1997 proposed rule allowing voluntary notification of the producer's GRAS self-determination.
"Instead, these substances currently reach the market under the FDA’s 1997 Proposed Rule allowing voluntary notification to FDA of the producer’s GRAS self-determination."GRAS-Fed Americans: Sick of Lax Regulation of Food Additives (2016)
[10] supported
Listing a streamlined submission on FDA's public list does not mean the Agency has reviewed the substance's GRAS status.
"Inclusion on the list would not represent Agency review of GRAS status."FDA Issues Proposed Rule on Substances Generally Recognized as Safe (GRAS)
[11] supported
For full GRAS notices, FDA proposes a 45-day initial filing review and generally a response within 180 days after filing, extendable twice by 90 days.
"For full GRAS notices, FDA proposes a 45-day initial filing review and generally would respond within 180 days after filing, subject to two possible 90-day extensions."No More GRAS Self-Affirmations? FDA Proposes Mandatory GRAS Notifications
[12] supported
Under the 2026 Unified Agenda entry, uses of food substances subject to mandatory notification would be presumed not to be GRAS unless the notification requirement has been met, which would effectively foreclose self-affirmation as a lawful pathway.
"Uses of food substances that are subject to the mandatory notification requirement will be presumed by FDA not to be GRAS unless the notification requirement has been met."New Details Emerge on FDA's GRAS Rulemaking: Updated Timeline, Narrower Scope, and Open Questions on Statutory Authority
[13] supported
In its 2016 GRAS final rule preamble, FDA acknowledged that it lacks express statutory authority to require companies to submit GRAS notices.
"lack[s] express statutory authority to require companies to submit GRAS notices."New Details Emerge on FDA's GRAS Rulemaking: Updated Timeline, Narrower Scope, and Open Questions on Statutory Authority
[14] supported
Under the 1997 proposed notification rule, FDA checks whether submitted documentation meets the statutory criteria rather than reviewing the scientific proof of safety, and this cursory review is to be completed within ninety days.
"Under the 1997 Proposed Rule, the FDA reviews not the scientific evidence for proof of safety, but rather the documentation submitted for sufficiency under the statutory criteria for notification."GRAS-Fed Americans: Sick of Lax Regulation of Food Additives (2016)
[15] supported
A 2010 General Accounting Office finding stated that because companies were not required to give FDA information about their GRAS determinations, FDA officials could not estimate how many determinations occurred without notification to the agency.
"The General Accounting Office concluded in 2010 that “because companies are not required to provide information to FDA regarding their GRAS determinations,”"GRAS-Fed Americans: Sick of Lax Regulation of Food Additives (2016)
[16] supported
The 2026 Agenda entry does not explain how FDA would treat confidential or trade secret information in mandatory GRAS submissions, even though GRAS determinations rest on chemical identities and use levels that notifiers may consider proprietary.
"The 2026 Agenda entry also does not address how the FDA would handle confidential, trade secret, or otherwise proprietary information in mandatory GRAS submissions."New Details Emerge on FDA's GRAS Rulemaking: Updated Timeline, Narrower Scope, and Open Questions on Statutory Authority