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.

Abstract image visually representing 21 CFR 111 compliance, featuring bold “21 CFR 111” text on a blue gradient background with icons symbolizing dietary supplement regulation, FDA oversight, and GMP checklist requirements.

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