delete PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
FDA regulation establishing Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, covering personnel hygiene, facility maintenance, equipment standards, record-keeping, and quality control procedures to ensure product safety and consistency.
This regulation creates a massive regulatory burden on dietary supplement manufacturers, costing millions in compliance expenses while creating barriers to entry that protect large incumbents. The extensive facility requirements, personnel hygiene mandates, and documentation requirements impose costs that get passed to consumers, while the FDA's track record shows regulatory capture and ineffective oversight. Free market competition and private certification would better ensure product quality without the $2 trillion compliance cost burden.