ISO 17025 lab outlines aflatoxin, ochratoxin, and fumonisin testing for supplement brands against FDA, USP , and EU limits
IRVINE, CA, UNITED STATES, March 18, 2026 /EINPresswire.com/ — Qalitex Laboratories, an ISO 17025-accredited third-party testing laboratory serving dietary supplement brands and food manufacturers across North America, today outlined the risks of mycotoxin contamination in botanical dietary ingredients and the critical testing protocols brands need to ensure compliance with FDA and EU safety standards.
Mycotoxins are toxic compounds produced by certain mold species that can contaminate agricultural products during growth, harvest, storage, or processing. In dietary supplements, the mycotoxins of greatest concern include aflatoxins (B1, B2, G1, G2), ochratoxin A, fumonisins (B1, B2), deoxynivalenol (DON), zearalenone, and T-2/HT-2 toxins. Aflatoxin B1 is classified by the International Agency for Research on Cancer (IARC) as a Group 1 carcinogen, the highest level of evidence for human carcinogenicity.
FDA action levels for aflatoxins in food are set at 20 parts per billion (ppb) total aflatoxins. For dietary supplements, USP General Chapter provides guidance on mycotoxin limits, while EU Regulation (EC) No 1881/2006 establishes maximum levels for botanical ingredients exported to EU markets.
“Mycotoxin contamination is one of the hardest risks for brands to anticipate because it is invisible — you cannot see, smell, or taste it in an ingredient,” said Nour Abochama, Vice President of Operations at Qalitex Laboratories. “Ingredients with the highest mycotoxin risk are commonly used botanicals such as turmeric, ginger, black pepper, ashwagandha, milk thistle, and dried fruits. Many brands source the same ingredient for years without testing, leaving an unseen risk in their supply chain.”
Qalitex Laboratories utilizes LC-MS/MS (liquid chromatography-tandem mass spectrometry) for mycotoxin analysis, providing the sensitivity, specificity, and multi-analyte capability required for comprehensive screening. The laboratory’s mycotoxin panel covers aflatoxins B1, B2, G1, G2 (individually and as total aflatoxins), ochratoxin A, fumonisins B1 and B2, deoxynivalenol, zearalenone, and T-2/HT-2 toxins. For brands requiring broad-spectrum testing, a multi-mycotoxin panel screens over 10 compounds simultaneously. Results are reported against FDA action levels, USP guidance, and EU maximum residue limits, with a typical turnaround of 3–5 business days.
“Brands sourcing botanicals from overseas suppliers — particularly from South Asia, Southeast Asia, and Africa — must test every incoming lot for mycotoxins,” said Abochama. “Supplier certificates of analysis (COAs) without mycotoxin data are not sufficient. Brands should ask: does your COA include mycotoxin testing, what method was used, and what are the detection limits? A simple ‘not detected’ result may not meet FDA action level standards if the method lacks sensitivity.”
Resources:
Full mycotoxin testing information: https://qalitex.com/services/mycotoxin-testing/
About Qalitex Laboratories:
Qalitex Laboratories is an ISO 17025-accredited third-party analytical testing laboratory with facilities in Irvine and San Diego, California. The laboratory provides COA testing, heavy metal analysis via ICP-MS, microbiology testing per USP and , preservative efficacy testing, stability studies under ICH guidelines, and regulatory compliance support for dietary supplement brands, cosmetic companies, and consumer goods manufacturers. Turnaround times start at 48 hours for standard panels, and testing programs comply with 21 CFR Part 111, California Proposition 65, Amazon supplement compliance, and Health Canada NHP Directorate standards.
Nour Abochama
Qalitex Laboratories
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