Mitigating Risk in Dietary Supplement Manufacturing: A Practical Guide for Brands
Mitigating Risk in Dietary Supplement Manufacturing: A Practical Guide for Brands
In the fast-evolving world of dietary supplements, risk mitigation isn’t just about regulatory compliance. It’s about protecting your brand, your consumers, and your bottom line. From raw material sourcing to final packaging, every step in the process presents opportunities for error or degradation. So how can dietary supplement companies proactively reduce risk and ensure product integrity?
Let’s break it down.
Step 1: Understand How Your Product Is Made
Risk mitigation starts with process awareness. Whether you're manufacturing tablets, soft gels, powders, or chews, each format comes with unique vulnerabilities:
- Tablets: Monitor moisture content and stability conditions. Are your tablets absorbing ambient moisture? This can impact dissolution and shelf life.
- Soft Gels: Active ingredients can migrate into the capsule shell, impacting potency and performance. For accurate results, testing the fill only is standard. If leaching is expected, it should be addressed before testing begins.
- Encapsulated Products: Ensure encapsulation remains intact during handling and testing. Broken capsules can skew results and reduce efficacy.
- Packaging: Is your product in a clear container exposed to light? Many compounds, such as vitamins, can degrade quickly.
Step 2: Validate Your Inputs—Don’t Just Trust the COA
A Certificate of Analysis (COA) is a starting point, not a guarantee. To truly mitigate risk:
- Test Your Raw Materials: Use validated, fit-for-purpose methods to confirm identity, potency, and purity.
- Verify Marker Compounds: Ensure the method being used for testing can accurately detect and quantify the active forms.
- Assess Overages: Are you seeing more of an ingredient than expected? This could indicate formulation drift, poor blending, or inaccurate input tracking.
Step 3: Know Your Product’s Age and Storage Conditions
Shelf life isn’t just a number. It’s a function of time, temperature, humidity, and light exposure.
- When was the product made?
Older batches may show degradation, especially if storage conditions weren’t optimal. - How is it stored?
Products exposed to heat, light, or moisture can lose potency or develop unwanted byproducts.
Step 4: Align Inputs with Claims
Every supplement should have a clear target specification:
- What is your label claim?
- What is your input level?
- Do you have defined values for acceptable ranges?
Without tight alignment between formulation and claim, you risk under-delivering—or overcompensating with unnecessary overages that complicate testing and stability.
Final Guidance: Build a Risk-Aware Culture
Mitigating risk isn’t a one-time fix—it’s a mindset. Encourage your team to:
- Question assumptions (e.g., “Is the COA enough?”)
- Validate every input and method
- Monitor environmental conditions
- Collaborate across departments—from R&D to QA to marketing
By embedding risk awareness into every stage of product development and release, dietary supplement companies can deliver safer, more consistent products while building lasting trust with consumers.
Connect with our experts today to proactively manage risk and ensure confidence in your dietary supplement products.
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Meet the Author – Senior Analytical Services Manager, Mollie Van Alst
Mollie Van Alst is a member of our Eurofins Nutrition Analysis Center laboratory in Des Moines, IA, which specializes in nutrition analysis of several food & beverage matrices. She serves as the Senior Analytical Services Manager and has been with Eurofins for eight years. Mollie's subject matter expertise lies in FDA nutrition labeling, specifically the Nutrition Facts Panel portion but also other components (such as labeling claims). Her day-to-day involves troubleshooting lab results as they pertain to nutrition labeling, such as mass balance discrepancies or fitness for regulatory compliance. Mollie actively tracks regulatory changes and shares her expertise through client-focused educational sessions and resources.
