Supplement Scoop: FDA Wants Your Label Lowdown
Published Date: 2/24/2026
Notice
Summary
The FDA wants to hear from companies that make, package, label, or store dietary supplements about their current manufacturing rules. They’re asking for feedback on how they collect information to make sure supplements are safe and high-quality. If you’re involved in dietary supplements, you’ve got until April 27, 2026, to share your thoughts—no extra costs, just your voice!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Major Recordkeeping Burden for Supplement Makers
Dietary supplement businesses must follow 21 CFR part 111 recordkeeping across many areas (personnel, sanitation, equipment, production controls, quality control, components/packaging, batch records, complaints, etc.). FDA estimates the total annual recordkeeping burden at 929,140 hours (including 279,120 hours for quality control records under §111.140, 279,120 hours for components/packaging records under §111.180, and 204,160 hours for batch production records under §111.260). The Agency also states there are no capital or operating and maintenance costs associated with this collection.
Option to Reduce 100% Ingredient Testing
Under 21 CFR 111.75(a)(1), a manufacturer that currently performs 100% identity testing of incoming dietary ingredients may petition the FDA (under 21 CFR 10.30) to request an exemption to reduce the testing frequency if it demonstrates no material diminution of assurance. FDA estimates the reporting burden for such a petition as 1 response taking 8 hours.
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Key Dates
Department and Agencies
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