Why Quality Systems Matter – Premier Research Labs

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This in-depth podcast explores why robust quality systems are essential in the dietary supplement industry, focusing on Premier Research Labs’ approach to testing, standards, and integrity in manufacturing.

 Key Topics Covered:

• Why Quality Matters: Beyond being legally required (21 CFR 111), quality ensures safety, efficacy, and trust in the product — especially when consumers and their families rely on it.
• Going Above & Beyond: PRL commits to NSF and USP certifications and employs rigorous internal standards, far exceeding minimal FDA requirements.
• Flaws in Industry Oversight: FDA oversight is minimal due to limited resources — only 4–5% of companies are inspected. Self-regulation becomes critical.
• Orthogonal Testing: PRL combines HPTLC, microscopy, and other methods to verify purity, identity, and detect adulteration — especially in botanicals.

 Common Issues in the Industry:

• Skip Lot Testing: Many companies stop testing batches after initial validation. PRL tests every lot.
• Cross-contamination: Examples include oregano in celery seed or thyme in oregano due to shared equipment or storage.
• Economic Adulteration: Vendors sometimes sell nutrient-depleted or diluted ingredients, e.g., carrot powder made of dyed corn starch, or fig powder stripped of nutrients.
• Microbial Contamination: Even clean suppliers can slip. PRL discovered salmonella in pea protein and aflatoxins (carcinogenic molds) in herbs like cayenne and chaste tree.

Data Transparency:

• FDA public dashboards now allow anyone to search company inspection records.
• PRL has zero FDA 483s in its history, a testament to their high standards.

 Quality in Action – Case Studies:

1. Alfalfa Leaf: Looked perfect in chromatography but was contaminated with starch and glass—caught via microscopy.
2. Turmeric: Adulterated with added starch to simulate proper texture.
3. Celery Seed: Cross-contaminated with oregano oil—visible only in TLC analysis.
4. Fig Powder: Depleted of active compounds—essentially “shell powder” sold as the real thing.
5. Cayenne & Chaste Tree: Found with aflatoxins despite clean histories.
6. Pea Protein: Contaminated with salmonella; PRL rejected the batch even though retests were clean.

 Final Takeaways:

• Question Everything: Don’t accept CoAs (Certificates of Analysis) without your own testing.
• Demand Transparency: Ask your manufacturer about their microbial, mycotoxin, and identity testing.
• True Quality = Trust: Only a robust, multi-step system can deliver consistent and effective supplements.
• You Get What You Pay For: Lower cost often means cutting corners in sourcing and testing.