Legislative Foundation
The Dietary Supplement Health and Education Act (DSHEA) of 1994 established the fundamental regulatory framework for dietary supplements, creating a distinct product category separate from conventional foods and drugs. Under DSHEA’s provisions, Congress specifically authorized the U.S. Food and Drug Administration to develop current good manufacturing practice (cGMP) requirements for dietary supplement products. This legislative mandate culminated in the publication of 21 CFR Part 111 as a final rule on June 25, 2007, following extensive industry consultation and a multi-year rulemaking process.
FDA established minimum cGMPs for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement.
The regulation established a phased compliance timeline based on company size, recognizing the diverse nature of the dietary supplement industry. Large manufacturers with 500 or more full-time equivalent employees were required to comply by June 25, 2008, followed by medium-sized companies (20-499 employees) on June 25, 2009, and small manufacturers (fewer than 20 employees) by June 25, 2010. This staggered implementation approach enabled companies to develop suitable quality systems and infrastructure tailored to their operational scale and resources.
Regulatory Structure and Scope
The cGMP regulation for dietary supplements is organized into 16 comprehensive subparts (A through P), each addressing such various issues as personnel, physical plant, production and process controls, holding and distributing, consumer complaints, and records and record keeping. The regulatory framework covers all entities involved in dietary supplement manufacturing, packaging, labeling, or holding operations, including domestic and foreign companies whose products enter U.S. commerce.
The regulation establishes a quality-focused approach that differs significantly from pharmaceutical cGMPs by emphasizing manufacturing consistency and contamination prevention rather than requiring pre-market efficacy demonstration. This framework aligns with DSHEA’s intent to protect consumer access to supplements while ensuring basic safety and quality standards.
FDA Inspection Activity, Enforcement
FDA annually inspects about 500 to 600 dietary supplement facilities, which is about 5% of known facilities. In FY24, the agency performed approximately 600 domestic and foreign inspections (with the majority taking place in the U.S.) — an increase of about 20% from the previous year.
When FDA finds alleged violations of the cGMPs, it typically reports these “observations” on a document known as a Form 483. At the conclusion of an inspection, this form is presented and discussed with the company’s senior management. FDA encourages companies to respond to the FDA Form 483 in writing with their corrective action plan and then swiftly implement that corrective action plan.
Failure to respond to FDA and address its cGMP observations could result in further action from the agency, including but not limited to, a warning letter that is made public, and even an injunction shutting down a manufacturing plant.
Sources:
- https://www.govinfo.gov/content/pkg/FR-2007-06-25/pdf/07-3039.pdf (final cGMP rule published in Federal Register on June 25, 2007)
- FDA increases annual domestic, foreign dietary supplement inspections (SupplySide Supplement Journal, Dec. 13, 2024)
- Dietary Supplement Health and Education Act of 1994 (Text of statute provided by National Institutes of Health)