21 CFR 111: Dietary Supplement GMP Compliance Made Clear
Are you manufacturing or distributing dietary supplements in the U.S.? If so, 21 CFR Part 111 compliance isn't optional—it's the law. Also known as the Dietary Supplement Current Good Manufacturing Practices (CGMPs), these FDA regulations outline the minimum requirements for facilities that manufacture, package, label, or hold dietary supplements.
What is 21 CFR Part 111?
21 CFR 111 is a section of the U.S. Code of Federal Regulations that sets out CGMPs for dietary supplements. It ensures supplements are consistently produced and controlled for quality. Compliance is mandatory for:
Dietary supplement manufacturers
Labelers and packagers
Contract manufacturers and distributors
Failure to comply can result in warning letters, product recalls, import alerts, and reputational damage.
Core Requirements of 21 CFR 111
21 CFR 111 compliance spans across all critical aspects of supplement production:
Personnel qualifications and hygiene
Facility and equipment controls
Production and process control systems
Quality control procedures
Laboratory testing and product specifications
Packaging and labeling operations
Recordkeeping and documentation
Each of these elements must be addressed and documented in a compliant Quality Management System (QMS).
Why It Matters
Compliance with 21 CFR 111 is more than just a checkbox—it demonstrates your commitment to product safety, efficacy, and regulatory accountability. Customers, retailers, and investors increasingly expect validated GMP adherence.
How Wintersmith Advisory Can Help
Our regulatory consultants have deep experience helping dietary supplement firms:
Conduct gap assessments
Build and implement GMP-compliant procedures
Train staff on 21 CFR 111 expectations
Prepare for FDA inspections and mock audits
Develop robust quality systems and documentation protocols
We tailor our support to your operation—whether you're a startup or a global manufacturer.
Related Services
Explore how our other compliance services support your business:
FDA QSR Compliance (21 CFR 820)
ISO 13485 for medical device suppliers
FSMA & HACCP food safety compliance
Supplier audits and qualification
cGMP training and QMS implementation
Ready to Simplify 21 CFR 111 Compliance?
Let's build a system that stands up to scrutiny and builds customer trust. Contact Wintersmith Advisory today or schedule a discovery call or request a compliance gap assessment.
Contact us.
info@wintersmithadvisory.com
(801) 558-3928