How to Ensure Your Supplement Manufacturing is Compliant with Industry Regulations
Feb 28, 2025
The supplement industry has seen significant growth in recent years, driven by rising consumer interest in health and wellness.
However, with growth comes responsibility.
Manufacturers must navigate a complex set of regulations to ensure the safety, quality, and integrity of their products.
In this guide, we will cover the main considerations regarding supplement manufacturing compliance.
Let’s begin!
Key Supplement Manufacturing Regulations
Several key regulations govern the manufacturing of supplements, each playing a crucial role in ensuring product safety, accuracy, and quality. These include:
Dietary Supplement Health and Education Act (DSHEA): This act defines dietary supplements and sets the framework for their regulation. It establishes requirements for ingredient safety, labeling, and manufacturing practices.
Current Good Manufacturing Practices (cGMPs): These are a set of guidelines established by the FDA to ensure supplements are consistently produced and controlled according to quality standards. They focus on proper facility maintenance, equipment calibration, and staff training.
Dietary Supplement and Nonprescription Drug Consumer Protection Act: This act requires manufacturers to report any serious adverse events associated with their supplements. It aims to protect consumers by ensuring transparency and accountability.
These regulations establish guidelines that manufacturers must follow to ensure their products are safe, accurately labeled, and meet quality standards.
Essential Compliance Steps for Supplement Manufacturers
Now, let’s explore practical steps manufacturers can take to ensure their processes align with regulatory standards.
1. Adhere to FDA Labeling Requirements
The FDA has specific requirements for labeling dietary supplements, which aim to provide consumers with clear and accurate product information.
This includes ingredient labeling, serving sizes, and warning statements for potential allergens or other risks.
Example: If a supplement contains a high dose of vitamin K, the label might need a warning to inform individuals taking blood thinners to consult their healthcare provider before use. Additionally, those labelings must include:
Accurate Ingredient Labeling: Ingredients must be listed in descending order of weight.
Supplement Facts Panel: The panel should include serving sizes and daily value percentages.
Allergen Labeling: Any allergens, such as soy or nuts, must be clearly stated.
2. Implement Good Manufacturing Practices (cGMPs)
cGMPs ensure that supplements are produced consistently and meet quality standards. Manufacturers must establish rigorous quality assurance systems to minimize risks in production.
Quality Assurance Systems: Establish quality control and testing procedures for raw ingredients and finished products in accordance with 21 CFR Part 111.
Personnel Training: Train all employees involved in the manufacturing process to meet the standards outlined in 21 CFR 111.14.
Equipment Maintenance: Regularly maintain and calibrate equipment to ensure precise measurements (21 CFR 111.27).
Record Keeping: As required by 21 CFR 111.35, keep accurate records of all manufacturing processes, from ingredient sourcing to testing results and distribution.
Third-Party Audits: Conduct regular internal and third-party audits to verify compliance with cGMP standards.
Example: A company manufacturing dietary supplements like omega-3 capsules should test each batch for purity, ensuring that it is free from harmful levels of heavy metals like mercury.
3. Ensure Marketing and Advertising Compliance
Supplement marketing must be handled carefully to avoid misleading or unsubstantiated claims.
Adherence to advertising regulations is essential to maintaining consumer trust and protecting the brand.
Avoid Disease Claims: Stick to structure-function claims, unless the product has been FDA-approved as a drug.
Qualified Health Claims: These claims must be used with appropriate disclaimers and FDA evaluation.
Disclose Material Connections: All endorsements or testimonials must be clearly disclosed and in line with FTC guidelines.
Example: If a company advertises a supplement claiming to support immune health, it must ensure that the claim is substantiated by scientific evidence and accompanied by an appropriate disclaimer.
Regulatory Frameworks and Standards
Several key laws and standards are the foundation of supplement manufacturing regulation. Understanding these is crucial for ensuring compliance.
Dietary Supplement Health and Education Act (DSHEA)
DSHEA defines dietary supplements and establishes their regulatory framework. It outlines the requirements for safety and manufacturing standards.
Definition of Dietary Supplements: Supplements are products intended to supplement the diet and contain ingredients like vitamins, minerals, or herbs.
Pre-Market Notification: Manufacturers must notify the FDA before marketing supplements with new dietary ingredients (NDI).
Burden of Proof: The FDA must prove that a supplement is unsafe before it can be removed from the market under DSHEA.
Current Good Manufacturing Practices (cGMPs)
The cGMP guidelines ensure that manufacturers follow safe and quality standards in every step of production.
21 CFR Part 111: This regulation covers personnel training, equipment maintenance, and record-keeping.
Preventing Contamination: cGMPs require measures to avoid contamination from harmful substances, such as heavy metals or microorganisms.
Ensuring Quality: Manufacturers must verify the identity, purity, strength, and composition of products through regular testing.
Dietary Supplement and Nonprescription Drug Consumer Protection Act
This act requires adverse event reporting to ensure the FDA can monitor the safety of supplements after they reach consumers.
This creates a system where manufacturers must report issues, such as harmful reactions to their products, thus helping to ensure public safety.
Quality Assurance and Control Measures
Maintaining compliance doesn’t stop at understanding regulations; manufacturers need to implement thorough quality control throughout the entire manufacturing process.
Ingredient Sourcing and Testing
Suppliers must meet rigorous quality standards to ensure the ingredients used in supplements are safe and effective.
Manufacturers should verify the identity and purity of each ingredient, often requiring a Certificate of Analysis (COA) from suppliers.
For example, if a supplier provides ginseng extract for a supplement, the manufacturer should request a COA to verify its potency and purity before incorporating it into the product.
Manufacturing Process Controls
The manufacturing process must be controlled and documented to ensure consistency and quality.
This includes keeping detailed batch records and validating manufacturing processes.
Another example is if a manufacturer produces a batch of vitamin D supplements, they need to track every ingredient and the exact process used to create the batch, ensuring each product is identical in quality.
Finished Product Testing
Testing finished products is crucial to ensure that they meet the required standards for quality and labeling accuracy.
Identity Testing: Verify that each finished product contains the correct ingredients.
Purity Testing: Ensure the product is free from contaminants like heavy metals, pesticides, and microorganisms.
Strength and Composition Testing: Confirm that the product contains the correct amount of each ingredient, as stated on the label.
Modernizing Regulations and Future Directions
As the supplement industry grows, so too must the regulations that govern it.
Let’s look at some key areas where regulatory updates are on the horizon.
Mandatory Product Listing (MPL)
The FDA is considering implementing a requirement for manufacturers to list all dietary supplements in a public database.
This move aims to enhance transparency, allowing both consumers and regulatory bodies to track the supplements available on the market easily.
By centralizing product information, the FDA could ensure that consumers can access accurate, up-to-date details about the supplements they purchase, strengthening consumer confidence and product accountability.
Enhanced Manufacturing Oversight
As the industry evolves, so too must the regulations that govern it.
One of the anticipated changes is an increase in manufacturing oversight, particularly through third-party audits and more rigorous inspections.
These measures would ensure that manufacturers are adhering to cGMP standards, with a focus on high-risk products that pose a greater potential threat to public safety.
Enhanced oversight is likely to become a crucial component in maintaining the integrity of the supplement industry.
Choose a Compliant Contract Manufacturer
When working with contract manufacturers, it is essential to ensure they adhere to regulatory standards. Here is what can help you to choose the right one:
Due Diligence and Research
Before entering into a partnership with a contract manufacturer, thorough research is essential.
You need to go beyond surface-level checks and get a deep understanding of their operations and processes.
What you can do is:
Review Records: Examine batch records, stability testing data, and any documentation demonstrating their ability to produce quality products consistently.
Reputation and References: Don’t just take their word for it—look into their reputation in the industry. Ask for references from other clients and research their track records.
This process isn’t about ticking boxes - it’s about ensuring that their manufacturing environment meets your standards and aligns with your commitment to quality and safety.
A well-established manufacturer will be transparent about their processes, and it’s essential to verify their claims through independent sources.
Certifications and Audits
Certifications are essential, but they’re just the starting point.
A manufacturer’s certifications, such as cGMP, indicate they meet regulatory standards - but it doesn’t end there.
What you should check:
Certifications: Confirm they hold key certifications like cGMP and check whether they are accredited by respected organizations like NSF International or the U.S. Pharmacopeia (USP).
Third-Party Audits: Make sure that the manufacturer undergoes regular third-party audits. These audits provide an additional layer of accountability and help ensure the manufacturer maintains high standards.
Certifications and audits go hand in hand, offering assurance that the manufacturer consistently meets industry regulations.
However, you should always dig deeper to understand how they use those certifications to drive compliance in their daily operations.
Quality Control and Assurance
Quality control should never be an afterthought - it’s the foundation of a compliant manufacturing process.
The manufacturer’s approach to quality control will determine whether your products meet the standards you’ve set.
What you need to look for:
Quality Control Procedures: Review their quality control practices to see if they cover everything from raw ingredient testing to in-process checks.
Traceability Systems: Ensure the manufacturer can track each ingredient from its source to the final product. A robust traceability system allows you to identify and resolve any quality issues that may arise quickly.
By evaluating their quality control and assurance systems, you can gain confidence in their ability to produce safe and effective supplements consistently.
It's vital that their quality standards align with both regulatory requirements and your own company values.
Maintain Compliance and Address Challenges
Regulatory Updates and Training
Regulations are constantly evolving, so your manufacturer must be equipped to adapt.
To ensure they stay compliant:
Training Programs: Verify that they have continuous training programs in place for their staff. This ensures that everyone, from production to packaging, is up-to-date with the latest regulations and best practices.
Regular training prepares the team for changes in regulatory requirements and allows them to respond quickly to new compliance challenges.
Handling Non-Compliance Issues
Even with the best planning, non-compliance issues can occasionally arise.
The key is to have a proactive system in place to address these issues and prevent them from becoming bigger problems.
What you should ask about:
CAPA Systems: Ensure that the manufacturer has a Corrective and Preventive Action (CAPA) system in place. This system helps them resolve compliance issues as soon as they occur and implement measures to prevent recurrence.
A strong CAPA system ensures that any discrepancies are handled swiftly, minimizing the impact on your business and the safety of your customers.
Continuous Improvement Strategies
Manufacturers should always be looking for ways to improve their processes and maintain high standards.
What to expect:
Investing in Technology: Manufacturers should be open to adopting new technologies that enhance compliance and improve efficiency.
Process Refinement: Look for manufacturers who regularly evaluate and refine their processes. Whether through automation, better testing equipment, or improved training, constant improvement keeps their production methods at the cutting edge.
By fostering a culture of continuous improvement, your manufacturer will be able to adapt to new industry trends, incorporate the latest technologies, and stay ahead of potential compliance challenges.
Conclusion
Navigating supplement manufacturing regulations may be challenging, but it also opens up valuable opportunities for those who take a proactive approach.
As regulations evolve, manufacturers that prioritize investing in effective systems, thorough training, and a strong compliance culture will be positioned to not only meet but exceed industry standards.
With a well-rounded, technology-driven approach to quality control and documentation, manufacturers can mitigate compliance risks, build consumer trust, and create a distinct advantage in a competitive marketplace.
How Can Signify Transform Your Supplement Manufacturing Compliance?
Signify is an AI-powered regulatory compliance automation platform designed to streamline supplement manufacturing, ensuring adherence to safety standards and mitigating risks efficiently.
With real-time insights and automated processes, Signify helps supplement manufacturers stay audit-ready, respond quickly to regulatory changes, and reduce the burden of manual compliance efforts.
Key Benefits of Using Signify
Automated Compliance Testing: Signify’s AI-driven platform continuously evaluates compliance data, identifying risks early and preventing non-conformities before they arise.
Regulatory Risk Intelligence: Stay ahead of changing regulations with instant conformity checks. Signify flags emerging risk factors, allowing you to address issues quickly and stay compliant.
Smart Documentation Management: Simplify audit preparation with automated organization and linking of all compliance records. This ensures a transparent documentation trail for reporting and traceability.
Proactive Compliance Monitoring: Signify’s AI engine analyzes labels, SOPs, and supplier documentation in real-time, spotting regulatory inconsistencies before they become issues.
Remediation Guidance: When compliance gaps are identified, Signify offers actionable corrective steps to help you swiftly align with evolving supplement manufacturing regulations.
Ready to simplify compliance?
Schedule a demo today to see how Signify can streamline your regulatory processes, minimize risks, and maintain high supplement safety standards - all within a single platform.
