Dietary Supplements Operations Hub
Execution guides for supplement compliance, cGMP controls, and premarket obligations.
FDA cGMP Requirements for Food Manufacturers in 2026
Current food cGMP requirements under 21 CFR 117 for human food facilities.
Supplement Master Manufacturing Record (MMR): Practical Template Guide
Learn how to structure a compliant supplement Master Manufacturing Record with process controls, tolerances, and revision governance.
Supplement Batch Record Review Checklist for cGMP Execution
A practical checklist to review supplement batch records, catch release defects, and improve cGMP documentation quality.
Supplement Label Claim Risk Audit: How to Reduce Enforcement Exposure
Build a risk-based claim audit workflow for supplement labels and digital listings before products launch.
DSHEA Structure/Function Claims Compliance: A Practical Workflow
Understand how to manage structure/function claim language, substantiation, and disclaimer controls under DSHEA.
Supplement Ingredient Identity Testing Workflow: Lot-Level Controls
Set up identity-testing workflows for supplement ingredients with clear sampling, disposition, and supplier-risk controls.
Dietary Supplement Facility Registration with FDA: Complete Guide
Dietary supplement facilities must register with FDA under 21 CFR Part 207/Part 225. Learn the registration process, GMP requirements, and how foreign manufacturers can comply.
Dietary Supplement cGMP: 21 CFR Part 111 Requirements Explained
21 CFR Part 111 establishes cGMP requirements for dietary supplements including identity testing, batch records, quality control, and CAPA. Learn what FDA inspectors look for.
NDI Notification: New Dietary Ingredient Premarket Process Explained
New Dietary Ingredients require a 75-day premarket notification to FDA with safety evidence. Learn what qualifies as an NDI, the submission process, and common pitfalls.
Dietary Supplement Adverse Event Reporting: Requirements and Process
Dietary supplement companies must report serious adverse events to FDA within 15 business days using MedWatch 3500A. Learn the process, what qualifies, and the 6-year record retention requirement.
503B Outsourcing Facility Registration: FDA Requirements Explained
503B outsourcing facilities can compound drugs without individual prescriptions but must register with FDA, comply with cGMP, and report adverse events. Learn about DQSA requirements and the 503A vs 503B framework.
Drug cGMP Basics: 21 CFR Parts 210 and 211 for Foreign Manufacturers
Current Good Manufacturing Practice for drugs is codified in 21 CFR Parts 210 and 211. Learn about facility design, production controls, laboratory testing, and what foreign manufacturers need to know for FDA compliance.
Turn supplement guidance into workflows
Operationalize registration and ongoing compliance with structured support.