FDA Reviews Supplement Safety Paperwork Yet Again
Published Date: 6/18/2026
Notice
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.
Analyzed Economic Effects
5 provisions identified: 3 benefits, 2 costs, 0 mixed.
Recordkeeping Rule Imposes Large Time Burden
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 hours. The OMB control number for this collection is 0910-0606.
Small Businesses Represent Substantial Share
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.
Option to Petition to Reduce 100% Testing
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
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
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.
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.
2025-01840, 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.
2026-19281, Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
The FDA wants your thoughts on keeping the rules for telling them about imported food before it arrives. This affects food importers who must keep sharing info to keep our food safe. You’ve got until November 20, 2026, to send in your comments—no cost changes, just a chance to help shape the process!
2026-19284, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs
The FDA is asking for public feedback on their plan to keep collecting info about orphan drugs—special medicines for rare diseases. This helps make sure drug makers follow rules and get the right approvals, keeping the process smooth and fair. Comments are open until October 21, 2026, and this review won’t cost anyone extra but keeps important protections in place.
Previous / Next Documents
Previous: 2026-12237, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles and Medicated Feeds
The FDA is updating how companies that make special animal medicines and feeds keep their records and follow quality rules. This affects manufacturers of Type A medicated articles and medicated feeds, helping ensure safe and reliable products for animals. Comments on these changes are open until July 20, 2026, and the updates aim to keep things clear without adding extra costs.
Next: 2026-12239, Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
The FDA wants your thoughts on how they collect info about using drugs in animals in ways not originally approved (called extralabel use). This affects vets, farmers, and animal drug makers who report this info. You’ve got until August 17, 2026, to share your comments—no cost changes, just making sure the paperwork is clear and easy.