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.
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