Dietary Supplements
Ensuring Safety, Quality, and Compliance
At cGMP Consulting, we understand dietary supplement manufacturing and the regulations specific to this industry. We help manufacturers produce safe and high-quality products.
Key Benefits of Our Consulting Services:
- Interpret and execute dietary supplement regulations efficiently
- Ensure compliance with 21 CFR Part 111 and other applicable regulations, guidelines and standards
- Improve supplement manufacturing processes by applying best practices to ensure operational excellence along with compliance
- Reduce the risk of FDA observations and enforcement actions such as 483s, Warning Letters, and Consent Decrees
Regulatory Requirements for Dietary Supplements
Compliance with dietary supplement regulations is essential for manufacturers, packagers, and distributors of dietary supplements. These rules ensure:
- Compliance with cGMP (Current Good Manufacturing Practices)
- Consistent product quality, safety, and effectiveness
- Proper manufacturing, packaging, labeling, and distribution controls
Following dietary supplement regulations helps prevent contamination, mislabeling, and product recalls. Need expert guidance?
Key 21 CFR Part 111 Requirements
- Personnel must be qualified and properly trained.
- Facilities and equipment must be properly designed, cleaned, and maintained.
- Raw materials must be verified for identity, purity, strength, and composition before use in production.
- Production processes require clear documentation and control.
- Labels must comply with FDA food supplement regulation, accurately reflecting contents and claims.
- Finished products must undergo final testing and meet all specifications before being released.
- Products must be held and distributed under appropriate temperature and humidity. Traceability must be ensured and adulteration prevented.
- Detailed and accurate records must be maintained, along with procedures for returned or recalled products and handling complaints.
Why Compliance Matters
- Safety: Protects consumers from unsafe or contaminated products.
- Quality: Ensures consistency and efficacy across all batches.
- Market Access: Many retailers and markets demand compliance with FDA-regulated supplement standards, including GMP Certification.
- Avoid Enforcement Actions: Compliance reduces the risk of recalls, penalties, and facility shutdowns.
Common Challenges in the Dietary Supplement Industry
Despite their best efforts, manufacturers often face significant challenges:
Complying with dietary supplement FDA regulations requires expertise in both production processes and labeling requirements.
Ensuring raw materials and suppliers meet required standards can be challenging and time-consuming.
Developing robust Quality Management Systems (QMS) is essential but resource-intensive.
Ensuring labels comply with food supplement regulations and that testing is sufficient for claims substantiation can be a complex challenge, requiring thorough verification and regulatory expertise.
Responding to 483 observations, warning letters, consent decrees, or failed inspections requires immediate and effective action.
Tailored Services for Dietary Supplements
At cGMP Consulting, we offer a comprehensive range of services to address the unique needs of the dietary supplement industry:
Creating and implementing a comprehensive Quality Management System tailored to your operations, including raw material and finished product specifications and Master Manufacturing Records.
Preparing your staff and operations for FDA scrutiny with realistic assessments and actionable recommendations so your inspection goes smoothly.
Assisting with supplier inspections, FDA form 483s, Warning Letters, Consent Decrees, or other enforcement actions.
Why Choose cGMP Consulting?
1.
Expertise & Experience
Our team has provided service to numerous dietary supplement manufacturers, combining technical knowledge and regulatory insight to deliver unparalleled support.
2.
Global Reach
With clients and projects spanning multiple countries, we understand international regulations and can help your business manage compliance on a global scale.
3.
Tailored Solutions
We understand that no two companies are the same, and we customize our approach to meet your specific challenges and goals.
4.
Proven Track Record
From startups to established enterprises, we’ve successfully guided companies through complex compliance challenges, delivering measurable results and operational excellence.
5.
Comprehensive Approach
We have successfully worked with dietary supplement companies requiring our services to achieve and maintain compliance with FDA dietary supplement regulations or regain market access after enforcement actions.
Case Study
Establishing Compliance after Consent Decree
A dietary supplement manufacturer under a Consent Decree approached us for help. Their operations had been halted by the FDA due to non-compliance with 21 CFR Part 111, and they needed immediate action to resume production.
Our Approach
Results
The client successfully resumed operations, regained market entry, and positioned themselves for sustained compliance and growth.
Industry Expertise
Dietary Supplements
Key questions to evaluate GMP certification readiness, spot gaps, and build a stronger quality system for FDA-regulated industries.
Learn how six key trends are reshaping dietary supplement manufacturing and 21 CFR Part 111 compliance across the industry.
Learn how a risk-based approach streamlines facilities, utilities, and equipment qualification for smarter, compliant pharmaceutical manufacturing.
Ensure compliance with controlled room temperature qualification and temperature mapping for warehouses, freezers, and incubators.
