The Foundation of Quality: Risk Management for Dietary Supplements
Introduction
Ensuring safety in dietary supplements is paramount. A thorough risk assessment lays the foundation for quality, consumer protection, and regulatory compliance. Whether introducing a new product or improving an existing line, effective risk management is crucial for maintaining product integrity and safeguarding brand reputation.
Why Risk Assessment Matters
Risk assessment is about identifying potential issues before they become real problems. In the dietary supplement industry, that starts with safety. No manufacturer wants to produce a product that may harm consumers.
Beyond safety, risk assessments help companies ensure the ingredients they’re using have the quality and potency they expect and are free of contaminants. While different suppliers of dietary ingredients may have claims of potency and certificates of analysis, those claims should be verified. If an ingredient doesn’t meet the purity or potency standards a client expects, they will be held responsible because their name is on the finished product.
Risk assessment isn’t just a regulatory checkbox. It’s a smart business strategy that balances quality assurance with budget realities.
Understanding What a Risk Assessment Covers
Risk assessment begins with a close look at the ingredients in a product. Are they plant-based? Are they prone to microbial contamination? Have they passed through multiple hands before reaching the client’s facility? Every detail counts.
Suppliers are a major piece of the puzzle. Where ingredients come from and how well those suppliers are qualified can drastically influence risk. Another possible point of risk is whether the ingredient was sourced in the U.S. or outside the U.S.
Customers also need to know what their risk tolerance is. Do you need ingredients that are 100% pure, or is 90% acceptable? It helps to have a customized plan and specifications that identify your risk tolerance level.
What to Do When Results Do Not Match Expectations?
If test results show a material doesn’t meet specifications, it should be rejected. Cutting corners can lead to greater costs later, including possible regulatory action or damage to the brand’s reputation.
Having a backup plan with qualified secondary suppliers and alternative ingredients is also a good idea, so you're not left scrambling and making rash decisions if something goes wrong. Having documented standard operating procedures (SOPs) in place for how to handle these situations should help if issues arise.
How DSHEA Fits Into Risk Assessment
The Dietary Supplement Health and Education Act (DSHEA) sets the legal foundation for dietary supplement labeling and content. It requires that products deliver 100% of the nutrients listed on their labels through the end of their shelf life.
DSHEA is only part of the equation. Risk assessment is also tied directly to good manufacturing practices (GMPs), as defined in 21 CFR Part 111. These rules are about building quality into the process from the start, and not relying solely on end-product testing. While GMPs may not necessarily roll over to ingredient suppliers, if you’re a manufacturer, you must be confident in the materials that make up your finished product. Having a good upfront practice of qualifying raw materials, with non-contaminated, safe materials, will provide the best outcome for high-quality dietary supplements.
The U.S. Food and Drug Administration (FDA) regulates dietary supplements. If your product isn’t compliant with GMPs, it can cause many issues and potentially destroy your brand reputation.
When Should Risk Assessments Be Conducted?
Ideally, risk assessments should begin at the earliest stages of product development, before manufacturing starts. That includes testing for contaminants, verifying ingredients, and assessing supplier reliability.
But risk assessment doesn’t stop there. Additional checks are needed throughout a product’s life cycle. Shelf-life testing ensures that nutrients remain potent over time. Manufacturers also need a protocol for testing within the product’s life cycle to check for potential changes in potency or contamination introduced during production.
The Role of NDINs in Risk Management
An ingredient that wasn’t used in the U.S. before 1994, and therefore has no documentation of its safety, is considered a new dietary ingredient and requires a New Dietary Ingredient Notification (NDIN). These ingredients are not classified as Generally Recognized as Safe (GRAS) and are prohibited in products. Using substances that lack FDA recognition poses a significant risk—if discovered, the FDA may issue a warning and mandate a product recall.
While testing and evaluation for NDINs is possible, the process can take up to two years. As a precaution, it's best to avoid new dietary ingredients when formulating a new dietary supplement, as the risk often outweighs the reward.
Conclusion
In an industry where consumer trust, product quality, and regulatory compliance are paramount, robust risk assessment isn’t just good practice; it’s a competitive advantage.
At Eurofins, we empower dietary supplement companies to make informed, confident decisions—from raw material sourcing to final product release. Our team helps establish strategic frameworks that optimize budgets, minimize risk, and allocate resources where they matter most.
By identifying potential risks early, verifying ingredient integrity, and ensuring compliance with DSHEA and GMP standards, manufacturers can uphold product safety, regulatory compliance, and brand reputation with confidence.
Do you have concerns on the safety of your products? Reach out today to connect with an expert.
Additional Resources
Setting Chemical Contaminant Specifications for Dietary Supplements
