Mycotoxin Testing in Supplements and Botanicals: A Growing Concern
Mycotoxins are toxic secondary metabolites produced by molds like Aspergillus, Penicillium, and Fusarium. These compounds can contaminate a wide range of food and supplement ingredients, often before production even begins. For dietary supplements, dairy products, and especially infant formula, robust mycotoxin testing is not just a quality measure—it’s a public health imperative.
Food safety and regulatory teams are under increasing pressure to monitor for mycotoxins in dietary supplements, especially as consumer demand for plant-based products continues to rise. Contaminants like ochratoxin A in botanicals and aflatoxins in raw materials pose serious risks to product quality and consumer health. Targeted mycotoxin testing for supplements is critical to meet global compliance standards and protect your brand from costly recalls or regulatory action.
ELISA vs. LC-MS/MS: Choosing the Right Testing Method
Testing for mycotoxins isn’t one-size-fits-all. The right method depends heavily on the ingredient matrix and target mycotoxins of concern. Two common techniques dominate the space for mycotoxin testing, and each has its unique place in ensuring food safety:
ELISA (Enzyme-Linked Immunosorbent Assay) is known for being cost-effective and high-throughput, making it a practical choice for routine screening, especially when working with simpler matrices like clean powders or single-ingredient extracts. However, its limitations become more apparent in complex blends or samples prone to interference. ELISA tends to have lower specificity and sensitivity, which increases the risk of false positives or ambiguous results.
LC-MS/MS (Liquid Chromatography–Tandem Mass Spectrometry), by contrast, is considered the gold standard for complex or high-risk matrices. It’s particularly effective for analyzing botanicals, hemp, dairy products, and infant formulas, where accuracy, precision, lower reporting limits, and high confidence in adequate analyte identification are critical. This method offers much lower detection limits and can quantify multiple mycotoxins simultaneously with high sensitivity and selectivity. LC-MS/MS is also better suited for testing newer or more variable ingredients, and is often required when meeting strict global thresholds, such as those established by the European Union.
Which Mycotoxins Matter Most—and How Do You Know?
The list of regulated mycotoxins continues to grow. Some of the most common include:
- Aflatoxins (B1, B2, G1, G2, M1)
- Ochratoxin A
- Fumonisins
- Deoxynivalenol (DON)
- Zearalenone
- T-2/HT
- Patulin
The relevance of each depends on the ingredient type, geographic origin, intended use, and regulatory market. For example:
- Aflatoxin B1 is a well documented risk in grains and cereals.
- Aflatoxin M1 (a metabolite of Aflatoxin B1) is a key concern in dairy and infant formula.
- Ochratoxin A often appears in herbs, spices, and hemp.
- Fumonisins and DON are common in grains and cereals.
- Patulin continues to be a growing risk in infant food products.
Start by referencing contaminant limits set by the FDA, European Union, China’s NHC, or Codex Alimentarius. These bodies define maximum levels for food and supplement safety and often have different thresholds based on product use (e.g., adult vs. infant exposure).
When and Where Should Testing Occur in the Supply Chain?
Mycotoxin contamination can occur at any point from harvest to finished product. Smart testing strategies involve multiple checkpoints:
1. Raw Material Intake – Catch contamination early, before blending or production.
2. Post-Blending – Ensure combined ingredients haven’t introduced new risk.
3. Finished Product Testing – Verify compliance and release only safe, validated lots.
A robust plan will consider ingredient risk, supplier history, crop variability, and regional climate patterns (e.g., humidity and temperature during storage or transit).
Common Blind Spots in Testing Programs
Even established brands face pitfalls like:
- Relying solely on COAs from suppliers
- Skipping testing during seasonal transitions or new harvests
- Underestimating cross-contamination risks in multi-ingredient blends
- Assuming past performance equals future safety
These gaps can compromise both compliance and consumer safety. Without a robust, proactive testing strategy, even well-established products can be vulnerable to contamination and regulatory setbacks.
Balancing Compliance with Cost
High-volume testing, especially with LC-MS/MS, can feel expensive. But skipping or reducing test frequency is a risk multiplier. Food safety teams can optimize budgets by:
- Prioritizing high-risk ingredients or suppliers
- Consolidating test panels using multi-mycotoxin methods to report multiple analytes under a single run
- Auditing supplier data and only re-testing where variance is likely
Staying Ahead of Global Mycotoxin Regulations
Compliance isn’t static. As new ingredients gain popularity and international markets tighten controls, the regulatory landscape continues to evolve:
- The EU has tightened mycotoxin limits across food groups, including infant and cereal-based foods.
- China continues expanding testing panels for imported botanicals.
- Emerging markets are adopting Codex and EU-style standards, particularly for infant nutrition and plant-based exports.
Regular engagement with your third-party labs, industry working groups, and regulatory bulletins is key to staying current.
Mycotoxins in Dietary Supplements: A Growing, Underestimated Risk
As the global supplement market continues to grow—especially in botanical and plant-based categories—so does the risk of contamination from mycotoxins.
Multiple studies have revealed significant levels of aflatoxins, ochratoxin A, fumonisins, zearalenone, and vomitoxin in widely consumed supplements like milk thistle, green barley, ginkgo biloba, red clover, flax, and goji berry products.1,2 Some samples have shown co-occurrence of three or more mycotoxins at once—a major toxicological concern, since combined exposure may lead to additive or even synergistic effects on liver, kidney, and immune health.3
In one extensive UPLC-MS/MS screening, mycotoxins were detected in over 90% of analyzed supplement samples, with milk thistle supplements reaching mycotoxin levels as high as 37 mg/kg, far exceeding recommended limits for safe exposure.1 Similarly, a review of over 60 studies showed that mycotoxigenic fungi like Aspergillus flavus, Fusarium verticillioides, and Penicillium expansum frequently colonize raw botanical materials both pre- and post-harvest.3
What makes supplements especially vulnerable is the complexity of their ingredient matrices and sourcing variability. Many are imported from regions with limited regulatory oversight or inconsistent agricultural practices. Dried herbs, roots, and seeds—common in supplement production—are highly susceptible to fungal growth during storage and transport, especially under humid conditions.2
Vigilance Over Convenience
Mycotoxin testing is no longer a niche concern solely for feed and grain producers—it’s a frontline defense in food and supplement safety. Whether you’re sourcing turmeric, hemp, milk powder, or herbal extracts, the risks are real and the regulations are clear. Proactive testing, tailored methods, and strategic checkpoints in your supply chain can save time, money, and consumer trust.
Want to validate your current testing approach or expand to new markets? Contact us today to discuss your goals and how we can support your testing needs.
References
1. Veprikova, Z., et al. (2015). Mycotoxins in Plant-Based Dietary Supplements: Hidden Health Risk for Consumers. Journal of Agricultural and Food Chemistry, 63(28), 6633–6643. https://doi.org/10.1021/acs.jafc.5b02105
2. Pallarés, N., et al. (2022). Mycotoxins in Raw Materials, Beverages and Supplements of Botanicals: A Review of Occurrence, Risk Assessment and Analytical Methodologies. Food and Chemical Toxicology, 165, 113013. https://doi.org/10.1016/j.fct.2022.113013
3. Rocha-Miranda, F., & Venâncio, A. (2019). Mycotoxigenic Fungi in Plant-Based Supplements and Medicines. Current Opinion in Food Science, 30, 27–31. https://doi.org/10.1016/j.cofs.2018.08.003
