FDA Regulations to Establish Minimum CGMP Requirements for Manufacturing, Packaging, Labeling, and Holding of Dietary Supplements

Short summary

FDA proposes updates to CGMP recordkeeping requirements for dietary supplement manufacturers, with comment deadline July 20, 2026. Industry estimates 929,140 annual compliance hours; FDA acknowledged cost concerns and will allow flexibility in record-keeping methods but declined to scale back requirements.

• •FDA expands CGMP recordkeeping mandates under 21 CFR Part 111 for dietary supplement manufacturers, packagers, and importers
• •Public comment deadline July 20, 2026; estimated 929,140 annual hours compliance burden industry-wide
• •FDA permits flexibility in technology and maintenance methods but rejects cost-scaling arguments

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