FDA Wants Comments on Food Reporting Recordkeeping Drudgery Now
Published Date: 8/17/2026
Notice
Summary
The Food and Drug Administration (FDA or the Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's third-party disclosure and recordkeeping requirements for reportable food.
Analyzed Economic Effects
4 provisions identified: 1 benefits, 3 costs, 0 mixed.
Mandatory Supply-Chain Notifications
If you are an owner, operator, or agent in charge of a food facility (a “responsible party”) and you have information on a reportable food, FDA may require you to notify immediate previous sources and immediate subsequent recipients. FDA estimates 1,200 mandatory reporters will each make the four listed notification types once per year, with each notification taking 0.6 hours (36 minutes), about 2.4 hours per respondent annually and 2,880 total hours industry‑wide.
Required Notification Content Elements
When notifying supply‑chain partners about a reportable food, FDA may require the notification to include any or all of these items: (1) date the food was determined reportable; (2) description including quantity; (3) extent and nature of adulteration; (4) investigation results if known; (5) disposition of the article when known; (6) product information found on packaging (product codes, use‑by dates, and names of manufacturers/packers/distributors); (7) contact information for the responsible party; (8) contact information for linked supply‑chain parties notified; (9) information FDA requires in notifications; and (10) the unique number described in section 417(d)(4) of the FD&C Act.
Two-Year Recordkeeping Requirement
Responsible persons must maintain records related to reportable food reports and notifications for a period of 2 years. FDA estimates 1,200 mandatory reporters will each maintain one record per reportable food, with an average burden of 0.25 hours (15 minutes) per record, totaling about 300 hours industry‑wide annually.
Electronic Submission via Safety Portal
FDA states it intends to implement the Reportable Food Registry using its electronic Safety Reporting Portal and considers that the most efficient and cost‑effective means to submit reportable food reports. Submissions for reportable food reports are associated with OMB control number 0910‑0291.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
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).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20063, Request for Nominations for Voting Members of Food and Drug Administration Advisory Committees
The FDA is looking for smart, qualified people to join its advisory committees and help make important decisions about food and drugs. If you have the right skills, you can apply anytime, but get your nomination in by November 30, 2026, for the best chance at current openings. This is a great chance to influence public health without any cost to you!
Previous / Next Documents
Previous: 2026-16713, Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BIZENGRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Next: 2026-16715, Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements
The FDA is updating how it collects info for Investigational New Drug (IND) applications, which doctors and researchers use to test new or unapproved drugs. They want your feedback by September 16, 2026, to make sure the process is clear and efficient. This update affects anyone running clinical drug studies and aims to keep things smooth without adding extra costs or delays.