# 2026-12238: FDA Reviews Supplement Safety Paperwork Yet Again

2026-12238, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-06-18, effective Submit written comments (including recommendations) on the collection of information by July 20, 2026.; PRIA reads it as touching household money (as of 2026-06-25).

- Canonical: https://policyrisk.com/federal-register/2026-12238
- As of: 2026-06-25
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-12238
- Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 36861
- Published: 2026-06-18
- Effective: Submit written comments (including recommendations) on the collection of information by July 20, 2026.
- Comments close: 2026-07-20
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-06-25

## In one line

FDA Reviews Supplement Safety Paperwork Yet Again

## Summary

The FDA is asking for public feedback by July 20, 2026, on their rules that keep dietary supplements safe and made right. These rules affect companies that make, package, label, or store supplements, helping ensure products are high quality without adding extra costs. This review keeps the safety standards up-to-date and clear for everyone involved.

## Abstract

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

## Effects PRIA read

- Recordkeeping Rule Imposes Large Time Burden: cost, high. If you make, package, label, hold, import, or export dietary supplements, the FDA’s CGMP recordkeeping rules require many types of records (personnel, sanitation, calibration, production controls, complaints, etc.). FDA estimates the total annual recordkeeping burden across the industry is 929,140…
- Option to Petition to Reduce 100% Testing: benefit, low. Manufacturers that would otherwise be required to test 100% of incoming dietary ingredients may petition the FDA under 21 CFR 10.30 for an exemption to reduce testing frequency under section 111.75(a)(1). FDA estimates the reporting burden for a petition for exemption is 8 hours per petition.
- No Capital or O&M Costs Reported: benefit, low. FDA states there are no capital costs or operating and maintenance (O&M) costs associated with this information collection. That means FDA did not estimate required spending on equipment or ongoing maintenance tied to these recordkeeping rules.
- Flexibility on Recordkeeping Technology: benefit, low. FDA says the part 111 regulations do not require specific automated, electronic, mechanical, or other technologies for recordkeeping. Companies are free to use whatever forms of information technology best assist them in recordkeeping and reporting.
- Small Businesses Represent Substantial Share: cost, medium. FDA estimates that a substantial proportion of firms subject to part 111 are small businesses and acknowledges that compliance burden may vary by firm size and complexity, but FDA reports only an average burden rather than size-specific estimates.

## Related documents

- [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11
- [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13
- [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
- [2026-20727](https://policyrisk.com/federal-register/2026-20727): Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorgani…, 2026-10-09

## Sources
- [2026-12238 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/18/2026-12238/agency-information-collection-activities-submission-for-office-of-management-and-budget-review)
- [2026-12238 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-18/pdf/2026-12238.pdf)

## Related
- [Previous: 2026-12237, Agency Information Collection Activities; Submission for Office of Management a…](https://policyrisk.com/federal-register/2026-12237)
- [Next: 2026-12239, Agency Information Collection Activities; Proposed Collection; Comment Request;…](https://policyrisk.com/federal-register/2026-12239)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-12238 (as of 2026-06-25).