# 2026-16296: FDA Demands Notices for 'Safe' Food Ingredients Now?

2026-16296, Substances Generally Recognized as Safe, is a Federal Register proposed rule from Health and Human Services Department, Food and Drug Administration published 2026-08-11, effective Either electronic or written comments on the proposed rule must be submitted by December 9, 2026. Submit comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by December 9, 2026.; deemed significant under Executive Order 12866; PRIA reads it as touching household money (as of 2026-11-10).

- Canonical: https://policyrisk.com/federal-register/2026-16296
- As of: 2026-11-10
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-16296
- Title: Substances Generally Recognized as Safe
- Type: Proposed Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 51834
- Published: 2026-08-11
- Effective: Either electronic or written comments on the proposed rule must be submitted by December 9, 2026. Submit comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by December 9, 2026.
- Comments close: 2026-12-09
- Significant: yes (OIRA_API)
- Touches household money: yes
- Regulation identifier numbers: 0910-AJ02
- Last updated: 2026-11-10

## In one line

FDA Demands Notices for 'Safe' Food Ingredients Now?

## Summary

The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

## Effects PRIA read

- GRAS Notices Become Mandatory: mixed, medium. FDA proposes to require anyone who introduces a substance into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act to submit a GRAS notice for human or animal food uses (including indirect additives such as from packaging). FDA estimates the present value of the rule's in…
- Time-Limited Streamlined Submission Option: cost, medium. The proposal includes a time-limited option allowing firms to submit a streamlined submission for certain uses of substances already in interstate commerce before the final rule's effective date; doing so would incur one-time per-manufacturer costs (including possible translation costs for non-Engl…
- Greater Public Disclosure of GRAS Uses: benefit, low. The rule would increase public disclosure and transparency about substances claimed to be GRAS for human and animal foods, giving consumers, state regulators, and advocacy groups more information about what is being added to the food supply.
- Not Notifying May Trigger FDA Review Priority: cost, medium. FDA states that if the mandatory notification requirement is not met for a substance's intended use, FDA would consider that noncompliance when prioritizing substances for post-market review, potentially increasing the chance of FDA scrutiny or action for non-notified uses.

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- [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29
- [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25
- [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27
- [2026-22657](https://policyrisk.com/federal-register/2026-22657): Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Mechanical Stimulator for the Relief of Congestion, 2026-11-06

## Sources
- [2026-16296 on federalregister.gov](https://www.federalregister.gov/documents/2026/08/11/2026-16296/substances-generally-recognized-as-safe)
- [2026-16296 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-08-11/pdf/2026-16296.pdf)

## Related
- [Previous: 2026-16288, English Language Proficiency; Out of Service Criteria](https://policyrisk.com/federal-register/2026-16288)
- [Next: 2026-16314, Employer Contributions to Trump Accounts and Nondiscrimination Rules for Depend…](https://policyrisk.com/federal-register/2026-16314)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-16296 (as of 2026-11-10).